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September 20, 2022
Statistically significant mean reductions of 10.3 mmHg in 24-hour ambulatory systolic blood pressure and 11.7 mmHg in ambulatory pulse pressure after 6 months of therapy in control patients who crossed over to BackBeat CNT following completion of the randomized portion of the MODERATO II study
New Hope, PA, September 20, 2022 – Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies, today announced the presentation of positive long-term clinical results from the MODERATO II Control Patients Crossover Extension Study of BackBeat Cardiac Neuromodulation Therapy™ (“BackBeat CNT”) at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual conference being held in Boston, MA. BackBeat CNT is a bioelectronic therapy candidate that is compatible with standard pacemakers and designed to lower blood pressure.
MODERATO II was a European prospective, multi-center, randomized, double-blind pilot study investigating the efficacy of BackBeat CNT in patients with an indication for a pacemaker and persistent hypertension despite one or more anti-hypertensive medications. In the study, patients were randomized to treatment (BackBeat CNT plus continued medical therapy) or control (continued medical therapy) groups. Previously reported data on the study’s primary endpoint showed a clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure (“aSBP”) at 6 months in favor of BackBeat CNT.
Following completion of the randomized period and successful achievement of the primary endpoints, 14 control patients crossed over to active BackBeat CNT. Nine of the 14 patients had isolated systolic hypertension (“ISH”), a more difficult to treat form of hypertension characterized by elevated systolic blood pressure paired with normal or low diastolic blood pressure. The long-term results in these patients were encouraging and consistent with the reductions in the BackBeat CNT group during the randomized portion of the study and are summarized below:
“The long-term results in crossover patients are encouraging as they provide additional support that BackBeat CNT has the potential to deliver sustained and clinically meaningful reductions of systolic blood pressure in hypertensive patients indicated for a pacemaker,” said Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation, who presented the study findings. “The ability to reduce systolic pressure and pulse pressure while simultaneously controlling impact on diastolic pressure, may provide a unique therapeutic option for a broad range of patients, including the majority of this population, which suffers from isolated systolic hypertension.”
In June 2022, Orchestra BioMed entered into an exclusive license and collaboration agreement with Medtronic for the development and commercialization of BackBeat CNT as a potential treatment for hypertension in patients who are indicated for a cardiac pacemaker. This strategic collaboration is structured to provide Orchestra BioMed with development, clinical, and regulatory support for a planned global pivotal trial of BackBeat CNT in hypertensive patients who have been indicated for, and recently received, a cardiac pacemaker implant. Initiation of the trial is expected in the second half of 2023. Upon regulatory approval, Medtronic will have the global rights to commercialize BackBeat CNT-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the BackBeat CNT-enabled pacing systems.
About BackBeat CNT
BackBeat CNT is a bioelectronic therapy candidate designed to lower blood pressure. It is compatible with standard pacemakers and has been evaluated in pilot studies in patients with hypertension who also are indicated for pacemakers. It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with hypertension1.
The recent peer-reviewed European prospective, multi-center, randomized, double-blind pilot study, MODERATO II, showed that patients treated with the BackBeat CNT experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) when compared to control patients at six months. Orchestra BioMed plans to conduct a global pivotal trial to further evaluate the safety and efficacy of the BackBeat CNT in lowering blood pressure in a similar target population of patients who have been indicated for, and recently received, a cardiac pacemaker implant.
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s flagship product candidates include BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the significant risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo Corporation, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development.
On July 5, 2022, Orchestra BioMed announced the closing of a $110 million private equity financing as well as the execution of a definitive business combination agreement between Orchestra BioMed and Health Sciences Acquisitions Corporation 2 (Nasdaq: HSAQ) (“HSAC2”), which is structured to provide a minimum of $70 million in additional gross proceeds to the combined company at closing (the “Business Combination”).
About HSAC2
Health Sciences Acquisitions Corporation 2 is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The sponsor of HSAC2 is HSAC 2 Holdings, LLC, an affiliate of RTW Investments, LP.
About RTW Investments, LP
RTW Investments, LP is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging medical therapies by building and supporting the companies and/or academics developing them. For further information about RTW, please visit www.RTWfunds.com.
Important Information and Where to Find It
In connection with the Business Combination, HSAC2 has filed a registration statement on Form S-4 with the SEC, which includes a proxy statement/prospectus. Promptly after the registration statement is declared effective by the SEC, HSAC2 will mail the definitive proxy statement/prospectus and a proxy card to each shareholder of HSAC2 as of a record date for the meeting of HSAC2 shareholders to be established for voting on the proposed Business Combination. Before making any voting decision, investors and security holders of HSAC2 are urged to read these materials (including any amendments or supplements thereto) and any other relevant documents in connection with the transaction that HSAC2 has filed or will file with the SEC when they become available because they will contain important information about HSAC2, Orchestra BioMed, and the transaction. The preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other relevant materials in connection with the transaction (when they become available), and any other documents filed by HSAC2 with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov). The documents filed by HSAC2 with the SEC also may be obtained free of charge upon written request to Health Sciences Acquisitions Corporation 2, 40 10th Avenue, Floor 7, New York, NY 10014.
Participants in the Solicitation
HSAC2 and Orchestra BioMed and their respective directors and executive officers, under SEC rules, may be deemed participants in the solicitation of proxies of HSAC2’s shareholders in connection with the proposed Business Combination. HSAC2’s shareholders and other interested persons may obtain, without charge, more detailed information regarding the directors and officers of HSAC2 and a description of their interests in HSAC2 in HSAC2’s Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Additional information regarding the interests of each of HSAC2’s and Orchestra BioMed’s directors and executive officers in the proposed Business Combination will be available in the definitive proxy statement/prospectus when it becomes available.
No Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy, or a recommendation to purchase any securities of HSAC2 (or of the combined company) or Orchestra BioMed, nor shall there be any sale of any such securities, investments or other specific product in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.
References to Websites in this Press Release
The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements, including statements relating to the potential efficacy of our BackBeat CNT product candidate, the timing of our planned pivotal trial and regulatory approval of BackBeat CNT. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. Actual results may differ materially from these forward-looking statements. Factors that may cause the Company’s results to differ include, without limitation, those identified under the heading “Risk Factors—Risks Related to Orchestra’s Business and New Orchestra Following the Business Combination” in the Form S-4 registration statement filed by Health Sciences Acquisitions Corporation 2 with the U.S. Securities and Exchange Commission (the “SEC”) on August 8, 2022, as the same may be amended from time to time. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Orchestra BioMed Media Contact:
Bill Berry
Berry & Company Public Relations LLC
(212) 253-8881
bberry@berrypr.com
Orchestra BioMed Investor Contact:
Bob Yedid
LifeSci Advisors
(646) 597-6989
Bob@lifesciadvisors.com
1Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES)
July 5, 2022
Strategic collaboration with Medtronic to develop BackBeat Cardiac Neuromodulation Therapy™ as potential integrated hypertension treatment for cardiac pacemaker patients
Investors in $110 million Series D financing include Medtronic and Terumo as well as lead investor RTW Investments and founding investor Perceptive Advisors
Business combination with Health Sciences Acquisitions Corporation 2 (Nasdaq: HSAQ) (the “Business Combination”); upon closing, the common stock of the combined company is expected to be listed on Nasdaq under the ticker symbol “OBIO”; Business Combination is supported by $20 million in total forward purchase agreements and an up to $50 million backstop agreement
Business Combination and completed private equity financing are structured to ensure total gross proceeds of a minimum of $180 million, which is expected to fund the combined company into 2026 based on current plans and estimates
New Hope, PA, July 5, 2022 – Orchestra BioMed™, Inc. (“Orchestra BioMed”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, and Health Sciences Acquisitions Corporation 2 (“HSAC2”) today announced multiple significant transactions including:
“These significant transactions further validate the potential of Orchestra BioMed’s flagship development programs and our novel partnership-enabled business model. As the global leader in advanced cardiac pacing therapies, Medtronic is the ideal company to help us develop BackBeat CNT for the treatment of hypertension, which is remarkably common and drives significant health risk in the pacemaker population,” said David Hochman, Chairman, CEO and Co-Founder of Orchestra BioMed. “This new collaboration along with our established strategic partnership with Terumo for the development and commercialization of Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease exemplify our commitment to developing potential high-impact medical innovations with global medical technology leaders. The capital proceeds from our Series D financing and planned Business Combination provide Orchestra BioMed with a substantial financial runway and position us to achieve major milestones.”
“RTW is proud to lead these transactions, which we believe will enable Orchestra BioMed to further advance its BackBeat CNT and Virtue SAB programs. A recent double-blind, randomized pilot study published in the Journal of the American Heart Association (JAHA)1 showed that BackBeat CNT drove statistically significant and clinically meaningful reductions in blood pressure in its target patient population. These data support Orchestra BioMed’s plans to further investigate the potential for this therapy via a global pivotal study in collaboration with Medtronic,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW Investments, LP. “With two partnered programs expected to commence pivotal trials in 2023, we believe Orchestra BioMed is poised for success.”
About BackBeat CNT and the Strategic Collaboration with Medtronic
BackBeat CNT is an investigational bioelectronic treatment designed to lower blood pressure. It is compatible with standard pacemakers and has been evaluated in pilot studies in patients with hypertension who also are indicated for pacemakers. It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with hypertension2.
The recent peer-reviewed, double-blind, randomized pilot study, MODERATO II, showed that patients treated with the BackBeat CNT experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) when compared to control patients at six months. Orchestra BioMed plans to conduct a global pivotal trial to further evaluate the safety and efficacy of the BackBeat CNT in lowering blood pressure in a similar target population of patients who have been indicated for, and recently received, a cardiac pacemaker implant. The strategic collaboration with Medtronic will provide Orchestra BioMed with development, clinical, and regulatory support for this planned multi-national study. Upon regulatory approval, Medtronic will have the global rights to commercialize BackBeat CNT-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the BackBeat CNT-enabled pacing systems.
About Virtue SAB and the Strategic Collaboration with Terumo
Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (ISR) in the SABRE trial, a multi-center prospective, independent core lab-adjudicated clinical trial of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (“FDA”) for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.
Under the terms of their collaboration agreement, Orchestra BioMed and Terumo plan to execute a global clinical program in an effort to gain regulatory approval for commercial sale of Virtue SAB in multiple markets and indications. Terumo made an upfront payment of $30 million to Orchestra BioMed and Terumo will potentially make additional future clinical and regulatory milestone payments. Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SAB through royalties and per unit payments as the exclusive supplier of SirolimusEFR. Orchestra BioMed retains the rights to develop and license SirolimusEFR and other technologies used in Virtue SAB for clinical applications outside of coronary and peripheral vascular interventions.
About the Series D Financing
Gross proceeds from Orchestra BioMed’s completed Series D financing totaled $110 million, including a $40 million investment from Medtronic, a $20 million investment from RTW, and investments from other existing shareholders of Orchestra BioMed including Perceptive Advisors, Terumo Corporation, SternAegis Ventures and others. The Series D financing was not contingent on the consummation of the Business Combination.
Orchestra BioMed, subject to certain conditions, has further access to up to $40 million in term debt from the Avenue Venture Opportunities Fund, an affiliate of the Avenue Capital Group.
About the Business Combination
The Business Combination is expected to close in the fourth quarter of 2022. With the Series D financing proceeds already received by Orchestra BioMed, upon closing of the Business Combination, Orchestra BioMed Holdings expects to have sufficient cash to fund business operations into 2026 based on current plans and estimates. Funding will be used to support Orchestra BioMed Holdings’ business operations including planned pivotal trials for BackBeat CNT and Virtue SAB, which are scheduled to initiate in 2023. The Company also plans to identify additional promising therapeutic device innovations for potential strategic addition(s) to the Company’s product development pipeline that can be optimized using its partnership-based business model.
To ensure there is a minimum of $70 million in the HSAC2 trust account at the time of closing to fund the Company, Medtronic and RTW are each committing $10 million to the trust account through support agreements, and RTW is providing up to $50 million to backstop potential redemptions. Assuming no redemptions are made, an additional $90 million may be available from HSAC2’s trust account, providing maximum gross proceeds from the Business Combination and Series D transactions of $270 million to help fund the business.
The boards of directors of both HSAC2 and Orchestra BioMed have unanimously approved the proposed transaction, which is subject to approval by HSAC2 and Orchestra BioMed’s stockholders and the satisfaction or waiver of certain other customary closing conditions.
Upon closing, HSAC2’s current board of directors will resign and be replaced by Orchestra BioMed’s current board of directors.
The description of the Business Combination contained herein is only a summary and is qualified in its entirety by reference to the definitive agreement relating to the Business Combination, a copy of which will be filed by HSAC2 with the Securities and Exchange Commission (“SEC”) as an exhibit to a Current Report on Form 8 K, which can be accessed through the SEC’s website at www.sec.gov.
Advisors
Jefferies LLC and Piper Sandler & Co. acted as Joint Lead Placement Agents for the Series D Financing and Aegis Capital acted as Selling Agent. Jefferies LLC is acting as lead financial advisor and a capital markets advisor to Orchestra BioMed in relation to the proposed Business Combination. Piper Sandler & Co. acted as strategic advisor to Orchestra BioMed with respect to the strategic collaboration with Medtronic and is acting as a capital markets advisor to Orchestra BioMed in relation to the proposed Business Combination.
Chardan Capital Markets LLC and Barclays Capital Inc. are serving as financial and capital markets advisors to HSAC2 in relation to the proposed Business Combination.
Paul Hastings LLP is serving as legal counsel for Orchestra BioMed. Loeb & Loeb LLP is serving as legal counsel for HSAC2.
About Orchestra BioMed
Orchestra BioMed is a biomedical company with a business model designed to accelerate high-impact technologies to patients through risk-reward sharing partnerships. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s flagship product candidates include BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of certain forms of artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo Corporation, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development.
About HSAC2
Health Sciences Acquisitions Corporation 2 is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The sponsor of HSAC2 is HSAC 2 Holdings, LLC, an affiliate of RTW Investments, LP.
About RTW Investments, LP
RTW Investments, LP is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging medical therapies by building and supporting the companies and/or academics developing them. For further information about RTW, please visit www.RTWfunds.com.
Important Information and Where to Find It
In connection with the transaction described herein, HSAC2 intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus. Promptly after the registration statement is declared effective by the SEC, HSAC2 will mail the definitive proxy statement/prospectus and a proxy card to each shareholder of HSAC2 as of a record date for the meeting of HSAC2 shareholders to be established for voting on the proposed Business Combination. Before making any voting decision, investors and security holders of HSAC2 are urged to read these materials (including any amendments or supplements thereto) and any other relevant documents in connection with the transaction that HSAC2 has filed or will file with the SEC when they become available because they will contain important information about HSAC2, the Company, and the transaction. The preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other relevant materials in connection with the transaction (when they become available), and any other documents filed by HSAC2 with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov). The documents filed by HSAC2 with the SEC also may be obtained free of charge upon written request to Health Sciences Acquisitions Corporation 2, 40 10th Avenue, Floor 7, New York, NY 10014.
Participants in the Solicitation
HSAC2 and Orchestra BioMed and their respective directors and executive officers, under SEC rules, may be deemed participants in the solicitation of proxies of HSAC2’s shareholders in connection with the proposed Business Combination. HSAC2’s shareholders and other interested persons may obtain, without charge, more detailed information regarding the directors and officers of HSAC2 and a description of their interests in HSAC2 in HSAC2’s Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the SEC on March 31, 2022. Additional information regarding the interests of each of HSAC2’s and Orchestra BioMed’s directors and executive officers in the proposed Business Combination will be available in the definitive proxy statement/prospectus when it becomes available.
No Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy, or a recommendation to purchase any securities of HSAC2 (or of the combined company) or Orchestra BioMed, nor shall there be any sale of any such securities, investments or other specific product in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.
References to Websites in this Press Release
The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements may be identified by words such as “aims,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “would,” “plan,” “future,” “scheduled” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the expected timing of the closing of the Business Combination, other statements regarding the Business Combination’s effects, prospective performance, future plans, events, expectations, performance, objectives, estimates and forecasts of performance metrics, market capitalization and enterprise value, projections of market opportunity, the outlook for Orchestra BioMed’s or the Company’s business, the commercialization plans for Orchestra BioMed’s or the Company’s products, financial needs, anticipated timing or impact of clinical trials or data, approvals relating to the Business Combination, the ability to complete the Business Combination considering the various closing conditions and the accuracy of assumptions underlying the foregoing. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of HSAC2’s and Orchestra BioMed’s respective management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of HSAC2 and Orchestra BioMed.
These forward-looking statements are subject to a number of risks and uncertainties, including the inability of the parties to successfully or timely consummate the Business Combination, the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the Business Combination, if not obtained; the failure to realize the anticipated benefits of the Business Combination; matters discovered by the parties as they complete their respective due diligence investigation of the other parties; the ability of the Company following the Business Combination to maintain the listing of its shares on Nasdaq; costs related to the Business Combination; future financial performance of the Company following the Business Combination; expectations regarding future expenditures of the Company following the Business Combination; the Company’s ability to execute its business plans and strategy; the failure to satisfy the conditions to the consummation of the Business Combination, including the approval of the definitive merger agreement by the shareholders of HSAC2 and Orchestra BioMed; the satisfaction of the minimum cash requirements of the definitive merger agreement following any redemptions by HSAC2’s public shareholders; the risk that HSAC2’s shareholders will not approve the extension of the August 6, 2022 deadline to complete the Business Combination or that the Business Combination may not be completed by the extended deadline; the outcome of any legal proceedings that may be instituted against HSAC2 or the Company related to the Business Combination; the attraction and retention of qualified directors, officers, employees and key personnel of HSAC2 and Orchestra BioMed prior to the Business Combination, and the Company following the Business Combination; the Company’s ability to design, develop, manufacture and market innovative therapies to address cardiovascular disease and other significant medical conditions; the ability of the Company to partner with third parties for the development of its products and product candidates; the ability of the Company to achieve clinical and regulatory milestones pursuant to the Terumo partnership, the Medtronic collaboration and future partnerships; regulatory developments in the United States and foreign countries; the ability of the Company to compete effectively in a highly competitive market; the ability of the Company to ever achieve significant revenues or profitability; the Company’s ability to protect and enhance its corporate reputation, brand and intellectual property; the timing, costs, conduct, and outcome of clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for product candidates; whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; the potential market size and the size of the patient populations for product candidates, if approved for commercial use, and the market opportunities for product candidates; the ability to locate and acquire complementary products or product candidates and integrate those into the Company’s business; the uncertain effects of the COVID-19 pandemic and other global events; and those factors set forth in documents of HSAC2 filed, or to be filed, with SEC. The foregoing list of risks is not exhaustive.
If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that HSAC2 or Orchestra BioMed does not presently know or HSAC2 or Orchestra BioMed currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect HSAC2’s or Orchestra BioMed’s current expectations, plans and forecasts of future events and views as of the date of this press release. HSAC2 and Orchestra BioMed anticipate that subsequent events and developments will cause HSAC2’s or Orchestra BioMed’s assessments to change. However, while HSAC2 or Orchestra BioMed may elect to update these forward-looking statements at some point in the future, HSAC2 and Orchestra BioMed specifically disclaim any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing HSAC2’s or Orchestra BioMed’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Orchestra BioMed Investor Contact:
Bob Yedid
LifeSci Advisors
(646) 597-6989
Bob@lifesciadvisors.com
Orchestra BioMed Media Contact:
Bill Berry
Berry & Company Public Relations LLC
(212) 253-8881
bberry@berrypr.com
RTW Investments and HSAC2 Media Contact:
Josh Baldwin
RTW Investments LP
(917) 209-9916
jjgb@rtwfunds.com
1Z. Kalarus, et.al. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients with Hypertension: A Pilot Study. J Am Heart Assoc. 2021;10: e020492. DOI: 10.1161/JAHA.120.020492
2Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES)
November 5, 2021
BackBeat CNT treated patients experienced a mean reduction of 17.5 mmHg in office systolic blood pressure measured 24-months following therapy activation.
Patients with Isolated Systolic Hypertension (ISH) treated with BackBeat CNT experienced clinically meaningful and statistically significant reductions of 7.4 mmHg in ambulatory systolic blood pressure and 9.4 mmHg in ambulatory Pulse Pressure at 6 months compared to controls.
ISH is the predominant form of hypertension in patients over 60 years old and the most challenging to treat; elevated Pulse Pressure is a significant, independent risk factor of coronary heart disease.
New Hope, PA, November 5, 2021 – Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet clinical needs in procedure-based medicine, today announced multiple presentations of long-term clinical results and ISH subgroup data from the MODERATO II study of BackBeat Cardiac Neuromodulation Therapy™ (BackBeat CNT™) in patients with hypertension and an indication for a pacemaker at the Transcatheter Cardiovascular Therapeutics (TCT) 2021 annual conference being held in-person in Orlando, Florida, and virtually from November 4 – 6, 2021.
Results showed a mean reduction of 17.5 mmHg in office systolic blood pressure (oSBP) among all BackBeat CNT treated patients who completed 24-month follow-up. The previously reported primary endpoint of the 6-month double-blind, randomized portion of the trial demonstrated that BackBeat CNT treated patients experienced a clinically meaningful and statistically significant reduction of 12.3 mmHg in oSBP and 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) when compared to control patients (p=0.02, p=0.01). In a subgroup of patients with ISH, a dangerous and challenging to treat form of hypertension prevalent in older patients, treatment with BackBeat CNT resulted in clinically meaningful and statistically significant reductions of 7.4 mmHg in aSBP and 11.9 mmHg in oSBP when compared to control (continued medical therapy) patients at 6 months. Further, in patients with ISH, BackBeat CNT drove statistically significant reductions of 9.4 mmHg in ambulatory Pulse Pressure and 13.3 mmHg in office Pulse Pressure at 6 months as compared to control patients.
“We are very encouraged by the exploratory findings highlighting BackBeat CNT’s impact in patients with ISH, particularly since a substantial reduction in Pulse Pressure can dramatically lower overall cardiovascular risk,” said Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation, who presented the study findings. “The results from the MODERATO II study offer compelling preliminary evidence that BackBeat CNT may provide a safe and effective therapy for ISH, which is the most common form of hypertension in older patients and one that is difficult to treat. The challenging nature of ISH often leads to the exclusion of these patients from hypertension therapy studies and contributes to their position as the majority of inadequately treated hypertension patients.”
MODERATO II was a European prospective, multi-center, double-blind study investigating the efficacy of BackBeat CNT™ in patients with persistent hypertension (aSBP ≥130 mmHg and office systolic blood pressure (oSBP) ≥140 mmHg) despite one or more anti-hypertensive medications. Following a 30-day run-in period, during which patients received only standard pacing along with anti-hypertensive medications, 47 patients who met follow-up screening criteria for daytime aSBP were randomized to BackBeat CNT (n=26) or control (n=21) groups. Due to the advanced age and general poor health of the pacemaker population, the majority of the patients enrolled in the study had ISH, 23 patients in the treatment arm (88.5%) and 15 patients in the control arm (71.4%). ISH is defined as an oSBP >140 mmHg and diastolic BP <90 mmHg. Although patients with ISH were not a prespecified subgroup, exploratory findings revealed statistically significant improvements in aSBP, oSBP and Pulse Pressure in ISH patients treated with BackBeat CNT as compared to control. Additional key findings from study participants with ISH include:
“We are excited by BackBeat CNT’s significant and durable impact on blood pressure in the MODERATO II study,” said David Hochman, chairman and CEO of Orchestra BioMed. “The effects on ISH and Pulse Pressure are especially compelling given the prevalence of this particularly challenging form of hypertension in our initial target population of hypertensive patients indicated for a permanent pacemaker implant. We look forward to communicating next steps as we work to advance BackBeat CNT into definitive studies and towards regulatory approval.”
About Isolated Systolic Hypertension, Elevated Pulse Pressure and Pacemaker Patients
Based on data from the National Health and Nutrition Examination Survey (NHANES) III, 74.5% of U.S. adults over 60 years old have hypertension, with over 65% of them suffering from ISH. ISH patients have elevated systolic blood pressure (>140 mmHg), while their diastolic blood pressure remains normal or low (≤90 mmHg). ISH is a more difficult to treat form of hypertension because antihypertensive medications generally impact both systolic and diastolic pressure. It is estimated that over 80% of treatment failure patients over 60 years old have ISH.1 ISH patients experience elevated Pulse Pressure (the difference between systolic and diastolic pressures), which is a known significant, independent risk factor for coronary heart disease. According to published literature, a 10 mmHg increase in Pulse Pressure is associated with a 32% increase in risk of heart failure and a 24% increase in risk of stroke (after controlling for systolic BP and other risk factors)2. In addition, in men ≥60 years old (which happens to be the typical age of pacemaker patients), risk for coronary artery disease is three times larger in patients with Pulse Pressure of ≥70 mmHg compared to those with Pulse Pressure of 60 mmHg3.
Over 1.1 million pacemakers are implanted annually worldwide.4 More than 70% of patients indicated for a pacemaker suffer from hypertension.5 Given that pacemaker-indicated patients are typically older, it is estimated that the majority of hypertensive pacemaker patients suffer from ISH.1
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment designed to immediately, substantially, and persistently lower blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT is designed to mimic the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. The initial target treatment population for BackBeat CNT is patients with uncontrolled hypertension who are also indicated for a pacemaker. BackBeat CNT has the potential to be integrated into any dual-chamber pacemaker system, making this therapy highly suitable for Orchestra BioMed’s risk-reward sharing strategy of pursuing commercialization through a strategic partnership with a leading cardiac rhythm management company.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing, and organic development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Communications
646-970-4688
ggasaatura@lifescicomms.com
1Franklin SS, Jacobs MJ, Wong ND, et al. Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on National Health and Nutrition Examination Survey (NHANES) III. Hypertension. 2001 Mar;37(3):869-74. doi: 10.1161/01.hyp.37.3.869. PMID: 11244010. Accessed November 3, 2021
2Vaccarino V, Kasl SV, Abramson J, Krumholz HM. Depressive symptoms and risk of functional decline and death in patients with heart failure. J Am Coll Cardiol. 2001 Jul;38(1):199-205. doi: 10.1016/s0735-1097(01)01334-1. PMID: 11451275. Accessed November 3, 2021
3Gerd A, Paul C, Thomas E, et al. Importance of arterial pulse pressure as a predictor of coronary heart disease risk in PROCAM, Eur. Heart J. 2005 Oct; 26(20): 2120–2126, https://doi.org/10.1093/eurheartj/ehi467. Accessed November 3, 2021
4BIS Research, 2017, Global Pacemaker and Implantable Cardioverter Defibrillators (ICDs) Market. Accessed November 3, 2021
5Guha A, Xiang X, Haddad D, et al. Eleven-year trends of inpatient pacemaker implantation in patients diagnosed with sick sinus syndrome. J Cardiovasc Electrophysiol. 2017;28(8):933–943. doi:10.1111/jce.13248. Accessed November 3, 2021
August 17, 2021
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients
Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension
Primary safety endpoint achieved with no difference in major adverse cardiac events or other cardiac parameters between the treated and control groups at 6 months
New Hope, PA, August 17, 2021 – Orchestra BioMed™, Inc., ("Orchestra BioMed" or the "Company"), a biomedical innovation company focused on developing transformative therapeutic products for large unmet clinical needs in procedure-based medicine, today announced the publication of data from the double-blind, randomized MODERATO II study in the Journal of the American Heart Association (JAHA). The data demonstrated that BackBeat Cardiac Neuromodulation Therapy™ (CNT™), a programmable and adjustable bioelectronic therapy delivered via an active implantable cardiac pulse generator, significantly reduced 24-hour ambulatory systolic blood pressure (aSBP) in patients with persistent hypertension and a clinical indication for a pacemaker. The average age of the study population was 74 years, which is significantly older than patients generally enrolled in hypertension studies. There was also a higher prevalence of comorbid conditions in the study population and 81% of enrolled patients had isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension that is predominant in older patients.
"We were very encouraged by the results of this double-blind, randomized study demonstrating meaningful and sustained reduction in aSBP out to six months in a very challenging hypertensive patient population," said Karl-Heinz Kuck, M.D., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany, and study principal investigator. "BackBeat CNT has a favorable risk benefit profile as the device is already required for rhythm management and MODERATO II data offers compelling preliminary evidence that this therapy may provide a safe and effective means to help patients with persistent hypertension and an indication for a pacemaker achieve target blood pressure levels and thereby reduce cardiovascular risk."
MODERATO II was a European prospective, multi-center, double-blind study investigating the efficacy of BackBeat CNT™ in patients with persistent hypertension (aSBP ≥130 mmHg and office systolic blood pressure (oSBP) ≥140 mmHg) despite one or more anti-hypertensive medications and an indication for implantation or replacement of a dual-chamber pacemaker. Following a 30-day run-in period during which patients received only standard pacing along with anti-hypertensive medications, 47 patients who met follow-up screening criteria for daytime aSBP were randomized to BackBeat CNT (n=26) or control (n=21) groups. Prior to randomization, the mean aSBP for both groups was 136.3 mmHg and patients had been treated with, on average, over three prescribed anti-hypertensive drugs. Key MODERATO II data from the JAHA publication include:
An editorial by two renowned physicians in the field of device-based hypertension treatment, Lucas Lauder, M.D. and Felix Mahfoud, M.D., was published along with the data. The editorial commended the study authors for conducting a randomized, sham-controlled, device-based hypertension trial and noted that "…although the baseline blood pressure was lower, the relative change in aSBP in the treatment group was larger than in other sham-controlled trials in device-based hypertension treatment." The editorial further affirmed that MODERATO II data support BackBeat CNT as feasible and acceptably safe in the short term and noted that "…its efficacy in patients with isolated systolic hypertension, are to be highlighted." The editorial can be accessed here.
Over 1.1 million pacemakers are implanted annually worldwide.1 Patients indicated for a pacemaker have a particularly high rate of elevated blood pressure with more than 70% of these patients suffering from hypertension.2 Based on data from the National Health and Nutrition Examination Survey (NHANES) III, it is estimated that the majority of hypertensive pacemaker patients suffer from ISH3, a particularly challenging form of hypertension to treat with no specific pharmaceutical therapy currently approved. Longer-term follow up results from the MODERATO II study presented at the American College of Cardiology conference in May 2021, but not included in JAHA publication, showed that BackBeat CNT reduced oSBP in treated ISH patients by an average of 16.4 mmHg after 18 months of treatment.
1BIS Research, 2017, Global Pacemaker and Implantable Cardioverter Defibrillators (ICDs) Market
2Guha A, Xiang X, Haddad D, et al. Eleven-year trends of inpatient pacemaker implantation in patients diagnosed with sick sinus syndrome. J Cardiovasc Electrophysiol. 2017;28(8):933–943. doi:10.1111/jce.13248
3SS Franklin et all. Hypertension. 2001 Mar;37(3):869-74
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment designed to immediately, substantially, and persistently lower blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT is designed to mimic the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. The initial target treatment population for BackBeat CNT is patients with uncontrolled hypertension who are also indicated for a pacemaker. BackBeat CNT has the potential to be integrated into any dual-chamber pacemaker system, making this therapy highly suitable for Orchestra BioMed’s risk-reward sharing strategy of pursuing commercialization through a strategic partnership.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing, and organic development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Communications
646-970-4688
ggasaatura@lifescicomms.com
July 30, 2021
Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period.
Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p<0.01) at 6 months.
Office Systolic Blood Pressure (oSBP) decreased by an average of 13.1 and 20.9 mmHg at 6 and 12 months, respectively.
New Hope, PA, July 30, 2021 – Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet medical needs in procedure-based medicine, today announced that long-term follow-up data on hypertensive patients from the control group of the MODERATO II study who received crossover treatment with BackBeat Cardiac Neuromodulation Therapy™ (CNT™) were featured in a presentation at the Heart Rhythm Society meeting in Boston, MA on July 29th. The data demonstrated a clinically meaningful and statistically significant reduction in blood pressure in these patients, which was consistent with the decrease previously observed in the study’s treatment group during the same period.
“I continue to be impressed and encouraged by the observed reduction in blood pressure in patients treated with BackBeat CNT. Reductions in ambulatory and office systolic blood pressure were clinically significant and persistent in control patients who went on to receive crossover therapy,” stated Professor Zbigniew F. Kalarus, M.D., Ph.D., chairman of the department of cardiology at Silesian Center for Heart Diseases (SCHD), Zabrze, Poland. “Of additional importance is that the rate of adverse cardiac events in these patients was lower during the crossover period as compared to the control period, when patients were not receiving treatment with BackBeat CNT.”
MODERATO II is a European, prospective, multi-center, double-blind, randomized study of BackBeat CNT (n=26) vs. control (n=21) in patients with persistent hypertension (ASBP ≥130 mmHg and oSBP ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication. Of the 21 control patients (treated with antihypertensive medications only, BackBeat not activated), 14 were eligible for crossover to BackBeat CNT, and 13 completed 12 months of follow-up to-date (one patient died of cancer). Key interim study data:
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment designed to immediately, substantially, and persistently lower blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT is designed to mimic the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. The initial target treatment population for BackBeat CNT is patients with uncontrolled hypertension who are also indicated for a pacemaker.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing, and organic development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Communications
646-970-4688
ggasaatura@lifescicomms.com
May 17, 2021
Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years
88% of the treated patients had isolated systolic hypertension (ISH)
70.6% of all treated patients and 80% of treated ISH patients had their blood pressure under control at 24 months
New Hope, PA, May 17, 2021 – Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet clinical needs in procedure-based medicine, presented interim two-year data on its MODERATO II patients treated with BackBeat Cardiac Neuromodulation Therapy™ on May 15th, 2021 at the virtual American College of Cardiology (ACC) Meeting. The data demonstrated a clinically meaningful and statistically significant reduction of 16.6 mmHg in office Systolic Blood Pressure (oSBP) that was sustained out to two years.
“These data provide evidence of significant long-term reductions in systolic blood pressure with a lower-than-expected rate of major cardiac events when BackBeat CNT is activated for a period of up to two years,” stated Daniel Burkhoff, M.D., Ph.D., Director of Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation. “Of clinical significance is the fact that the majority of the patients in the MODERATO II study had ISH. In these patients, a significant reduction in systolic blood pressure with minimal effect on diastolic blood pressure is ideal and is difficult to achieve with antihypertensive medications. Furthermore, 80% of the ISH patients in MODERATO II had their blood pressure under control at 24 months, which could translate to meaningful reductions in cardiovascular events.”
MODERATO II is a European prospective, multi-center, double-blind, randomized study of BackBeat CNT (n=26) vs. control (n=21) in patients with persistent hypertension (ASBP ≥130 mmHg and oSBP ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication. Of the 26 treatment patients, 25 completed 18 months of follow-up (one patient died of cancer) and 17 reached 24 months of therapy to date. Key interim study data:
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and persistently lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. The initial target treatment population for BackBeat CNT is patients with uncontrolled hypertension who are also indicated for a pacemaker.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing, and organic development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Communications
ggasaatura@lifescicomms.com
May 23, 2020
Medical Device and Diagnostic Industry (MD+DI)
David Hochman, founder and CEO of Orchestra BioMed, shares how the company's risk-reward sharing business model has helped it stay afloat during the coronavirus pandemic.
May 8, 2020
Event: 2020 Heart Rhythm Scientific Sessions online
Webcast: https://cslide-us.ctimeetingtech.com/hrs20/attendee/eposter/poster/1407?q=burkhoff
April 28, 2020
New Hope, PA - Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Bob Laughner, an expert in global regulatory affairs for combination products, as Vice President, Regulatory Affairs. Mr. Laughner will play a lead role in advancing Orchestra BioMed’s Virtue® Sirolimus AngioInfusion™ Balloon (SAB) through global regulatory approvals.
“Bob has successfully spearheaded combination product development and regulatory efforts for a number of global medical device and biopharmaceutical companies, where he ultimately secured approvals and implemented life-cycle management strategies for their respective technologies,” said Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed. “We welcome Bob to our leadership team and look forward to his guidance as we work with our partner Terumo to advance Virtue SAB for the treatment of artery disease. We believe that Bob will also add value in advancing BackBeat CNT™ and other pipeline product candidates based on SirolimusEFR™, our extended focal release sirolimus formulation used in Virtue SAB.”
Mr. Laughner brings over a decade of leadership experience in combination product development and successful implementation of regulatory strategies for global medical device and biopharmaceutical companies. Before joining Orchestra BioMed, he served as the Regulatory Director, Medical Device and Combination Products at AstraZeneca, where he drove combination product regulatory strategies across the product portfolio. In this role, Mr. Laughner managed combination product regulatory submissions and meetings with the FDA and other global regulatory agencies, while also evaluating new technologies and implementing guidelines for their development, regulatory approval and life-cycle management. Prior to that, Mr. Laughner served as the Associate Director, Combination Products at MedImmune, an AstraZeneca company, where he developed regulatory strategies and submissions for combination products in their biologic portfolio and developed strategies to evaluate the safety and effectiveness of drug delivery systems, including novel and wearable technologies. Prior to MedImmune, Mr. Laughner was a regulatory scientist at Cook Medical, where he provided regulatory and scientific support in the development, testing, and regulatory approval for combination products and medical devices, including many novel technologies. Mr. Laughner has been involved in the development of international standards for drug delivery devices as an expert for various ISO committees, and is currently Co-Chair of the Association for the Advancement of Medical Instrumentation’s committee on Devices for Administration of Medicinal Products and Catheters. Mr. Laughner holds an M.S. in pharmacology and a B.A. in biology from Indiana University-Bloomington and holds certification in regulatory affairs from the Regulatory Affairs Professional Society.
“I share Orchestra BioMed’s commitment to providing high-impact solutions that address large unmet patient needs in procedure-based medicine. The Company’s innovative therapies, Virtue SAB and BackBeat CNT, have the potential to significantly improve treatment of artery disease and hypertension, respectively,” said Bob Laughner. “I’m delighted to be a part of the Orchestra BioMed team and look forward to advancing these important new therapies through the regulatory process.”
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine. The Company is led by a highly accomplished, multidisciplinary management team and board of directors with extensive experience in all phases of medical device development. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by the Company’s founding team. The Company’s flagship product candidates are Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of artery disease, the leading cause of mortality, and BackBeat Cardiac Neuromodulation Therapy™ for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for development and commercialization of Virtue SAB. Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2020 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. The Company has additional product candidates in its pipeline and plans to thoughtfully expand its product pipeline in the future through acquisitions, strategic collaborations, licensing, and organic development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance, or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Communications
646-970-4688
GGasaatura@lifescicomms.com
December 10, 2019
New York, NY – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced that it has entered into a $20 million credit facility agreement with Silicon Valley Bank (SVB), the bank of the world’s most innovative companies and their investors. This agreement provides up to $20 million of new capital to the Company for development and general corporate purposes, with an initial up to $10 million draw available at Orchestra BioMed’s sole option during the next 12 months and the remainder available to the Company following the completion of certain milestones.
The new $20 million credit facility adds to the capital resources available to Orchestra BioMed to accelerate product pipeline development and advance partnerships following the Company’s completion of a $34 million financing in July 2019. In June 2019, Orchestra BioMed also secured a $30 million payment and $5 million equity commitment as the upfront financial components of a global strategic partnership with Terumo Corporation to develop and commercialize Virtue® Sirolimus-Eluting Balloon (SEB), the first and only non-coated sirolimus-eluting angioplasty balloon system, in the percutaneous coronary and peripheral interventions fields. The U.S. Food and Drug Administration (FDA) granted Virtue SEB Breakthrough Designations for the treatment of coronary in-stent restenosis and below-the-knee peripheral artery disease. In September 2019, Orchestra BioMed announced CE mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension. The Company presented late-breaking clinical trial results at the TCT 2019 Conference demonstrating that BackBeat CNT drove statistically significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure vs. control in hypertensive patients also indicated for a pacemaker.
“The terms of the $20 million credit facility demonstrate SVB’s appreciation of our products and business model and a desire to forge a partnership with Orchestra BioMed to help support our future growth,” said David Hochman, chairman, CEO and founder of Orchestra BioMed. “We are excited about this creative lending solution that enhances an already strong capital position and bolsters our ability to optimize future pipeline opportunities.”
“Orchestra BioMed is committed to bringing innovative solutions to cardiovascular health and other significant procedure-based medical markets,” said Clark Hayes, managing director, Northeast Head of Business Development, Life Science and Healthcare at Silicon Valley Bank. “SVB is pleased to provide this capital facility to support both the short- and long-term growth initiatives of the business.”
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The Company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model aims to optimize capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
About Silicon Valley Bank
For more than 35 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Learn more at svb.com.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-970-4688
ggasaatura@lifescipublicrelations.com
December 5, 2019
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced upcoming presentations at the Innovation in Cardiovascular Interventions (ICI) Meeting in Tel-Aviv, Israel, taking place December 8-10, 2019 and the CSI Focus D-HF Congress in Paris taking place December 13-14, 2019.
The oral presentations will feature the Virtue® Sirolimus-Eluting Balloon which has Breakthrough Device Designation from the U.S Food and Drug Administration for the treatment of below-the-knee disease and coronary in-stent restenosis, for which the Company has a global strategic partnership with Terumo Corporation. The presentations will also feature BackBeat™ Cardiac Neuromodulation Therapy for which recently presented double-blind, randomized clinical results demonstrated a statistically significant reduction of 24-hour ambulatory systolic blood pressure.
Additional conference details can be found below.
ICI Meeting 2019
Title: Virtue® Sirolimus-Eluting Balloon: A Promising Breakthrough for Coronary In-Stent Restenosis and Beyond
Date/Time: December 10, 2019 at 9:10 AM IST
Session: Technology Parade
Presenter: Daniel Burkhoff, M.D., Ph.D.
Location: Hall J, David InterContinental Hotel
Title: Bioelectronic Hypertension Treatment Targeting Pacemaker Patients: Results of Moderato II randomized Study with BackBeat Cardiac Neuromodulation Therapy
Date/Time: December 10, 2019 at 4:12 PM IST
Session: Electrophysiology IV - Startup Companies
Presenter: Daniel Burkhoff, M.D., Ph.D.
Location: Hall I, David InterContinental Hotel
CSI Focus D-HF Congress
Title: Backbeat Cardiac Neuromodulation Therapy
Date/Time: December 13, 2019 at 1:40 PM CET
Session: Neuromodulation in the management of heart failure and its comorbidities: diabetes, sleep apnea and hypertension
Presenter: Prof. Felix Mahfoud
Location: Amphitheatre ABC
About Virtue® SEB
Virtue SEB is a novel, first-in-class drug/device combination product that delivers sustained-release bioabsorbable encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating. Virtue SEB’s ability to reliably deliver sirolimus via bioabsorbable sub-micron particles with a drug elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive preclinical studies published in a peer-reviewed journal. Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system to receive FDA Breakthrough Designation for below-the-knee stenosis as well as for coronary in-stent restenosis (ISR), another challenging indication for which the product has shown promising 3-year core-lab adjudicated efficacy and safety clinical results in the SABRE trial. Orchestra BioMed and Terumo plan to execute a global clinical program to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications including coronary ISR and below-the-knee stenosis.
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The Company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-970-4688
ggasaatura@lifescipublicrelations.com
November 19, 2019
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced David P. Hochman, chairman, CEO and founder, will present at the Canaccord Genuity MedTech and Diagnostics Forum on November 21, 2019 and the 31st Annual Piper Jaffray Healthcare Conference on December 4, 2019.
Additional conference details can be found below:
Canaccord Genuity MedTech and Diagnostics Forum
Date: November 21, 2019
Time: 9:00 AM ET
31st Annual Piper Jaffray Healthcare Conference
Date: December 4, 2019
Time: 2:10 PM ET
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The Company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-876-4783
ggasaatura@lifescipublicrelations.com
October 16, 2019
New Hope, PA – Orchestra BioMed™,Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced senior-level appointments to its product development teams. Juan Lorenzo, an expert in vascular devices, joins as vice president, product development, Focal Therapies and will play a leadership role in the development of the Virtue® Sirolimus-Eluting Balloon (SEB) for which the Company has a global strategic partnership with Terumo Corporation. Paul Goode, Ph.D., an expert in implantable neuromodulation devices joins as vice president, product development, Bioelectronic Therapies and will play a leadership role in the further development of BackBeat™ Cardiac Neuromodulation Therapy (CNT™) for which late-breaking double-blind, randomized clinical results recently presented at TCT 2019 demonstrated a statistically significant impact on 24-hour ambulatory systolic blood pressure.
“Juan and Paul each have a proven track record of success in advancing high-impact therapeutic solutions from concept and intellectual property development through clinical trials, regulatory approvals and on to commercialization,” said Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed. “We are excited to have them both join our leadership team at such an important time when our organization is accelerating late-stage development of both of our flagship therapies.”
“I am honored to join the Orchestra BioMed leadership team, which is comprised of experienced, talented individuals that share my passion for creating groundbreaking new therapies like BackBeat CNT. The clinical data demonstrating BackBeat CNT’s ability to immediately, substantially and chronically lower blood pressure in patients with uncontrolled hypertension despite medical therapies is impressive. I recognize how this novel technology transforms the most well-established bioelectronic device platform there is, pacemakers, into a potent treatment for one of the most challenging and pervasive medical conditions worldwide. I look forward to working with the team to advance this potentially game-changing solution,” said Paul Goode, Ph.D.
“I have spent my entire career focused on delivering enhanced therapeutic devices that help physicians improve patient care. Virtue SEB has the potential to become a breakthrough treatment for key remaining unmet needs in the large interventional vascular market. A strong product pipeline and differentiated, capital efficient strategy to leverage established strategic partners, like Terumo, are what attracted me to Orchestra BioMed. I look forward to working with the team and our partners to bring our products through development to physicians and patients worldwide,” said Juan Lorenzo.
Paul V. Goode has extensive research, development, regulatory and early commercialization experience with active implantable devices and bioelectronic therapies for heart failure, metabolic disease and esophageal reflux disease (GERD). Prior to joining Orchestra BioMed, he held several leadership positions at EndoStim including vice president R&D, chief technology officer, interim chief executive officer for an implantable gastric stimulator for GERD. He also served as vice president R&D for an implantable gastric stimulator for type 2 diabetes at MetaCure, director for engineering for an implantable cardiac stimulator at Impulse Dynamics, director of engineering and manager of algorithm development for an implantable glucose sensor at DexCom, Inc. He started his career at Intermedics and Guidant, companies specializing in cardiac pacemakers. Paul holds a Ph.D., an M.S. and a B.S. in electrical engineering from North Carolina State University.
Juan Lorenzo has more than three decades of experience in all aspects of medical device development from early concept to commercialization. Prior to joining Orchestra BioMed, he held several R&D leadership positions in Johnson & Johnson divisions starting in 1996 including CERENOVUS, Cordis Neurovascular, Cordis Corporation Cardiology and Cordis Research Corp. Over the span of his career, he has contributed to the development and market launch of 46 commercial products including vascular delivery systems, balloon expandable stents and pacemakers. Juan holds a B.S. in mechanical engineering from Florida International University.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat™ Cardiac Neuromodulation Therapy (CNT™) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The Company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
ggasaatura@lifescipublicrelations.com
September 28, 2019
Double-blind, randomized trial data demonstrates clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure at 6 months vs. control
High responder rate despite 88.5% of treated patients having isolated systolic hypertension (ISH)
Primary safety endpoint achieved with no difference in major cardiac adverse events (MACE) or other cardiac parameters between the two groups at 6 months
New Hope, PA – Orchestra BioMed™,Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced that late-breaking results from its MODERATO II double-blind, randomized study of BackBeat Cardiac Neuromodulation Therapy™ (CNT™) demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in hypertensive patients also indicated for a pacemaker. The results, which were presented as late-breaking science at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference, showed the study met its primary efficacy endpoint, with patients randomized to BackBeat CNT experiencing an 11.1 mmHg (p<0.001) reduction in mean 24-hour ambulatory systolic blood pressure (ASBP) at 6 months follow-up, resulting in a significant difference of 8.1 mmHg compared to control patients who were managed only with antihypertensive medications (p=0.01). The study also met its primary safety endpoint with no statistical difference in rate of major cardiac adverse events (MACE) between the two groups at 6 months follow-up.
“Achieving a statistically significant blood pressure reduction with BackBeat CNT in this patient population is particularly exciting given that over 70% of pacemaker patients have high blood pressure as well as other known co-morbidities,” said Karl-Heinz Kuck, M.D., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and study principal investigator who presented the results at TCT. “This is a particularly challenging at-risk population with a very high rate of isolated systolic hypertension and persistently elevated blood pressure despite multi-drug therapy. BackBeat CNT appears to be a promising treatment to significantly reduce systolic blood pressure and has a favorable risk benefit profile as the device is already required for rhythm management.”
All patients enrolled in the MODERATO II study, a European prospective, multi-center, double-blind, randomized study of BackBeat CNT vs. control in 47 patients with persistent hypertension (ASBP ≥130 mmHg and office systolic blood pressure (OSBP) ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication, were implanted with Orchestra BioMed’s Moderato® System, an implantable pulse generator that delivers BackBeat CNT as well as standard rhythm management functions that recently received CE mark approval. Following a 30-day run-in period during which patients received only standard pacing along with anti-hypertensive medications, patients who met follow-up screening criteria for daytime ASBP, were randomized to BackBeat CNT or control groups. Prior to randomization, mean ASBP for both groups were 136.3 mmHg with patients, on average, treated with over 3 prescribed anti-hypertensive drugs. After 6 months, mean ASBP was reduced by 11.1 mmHg (p<0.001) in the BackBeat CNT group as compared to a reduction of 3.1 mmHg in the control group (p=0.17). The treatment group saw a high (85%) overall response rate, with approximately 54% of the BackBeat CNT-treated patients experiencing ASBP reduction at 6 months of greater than 10 mmHg, an amount associated with a clinically meaningful reduction in risk of heart attack and stroke. The BackBeat CNT group also experienced significantly greater reduction, 12.4 mmHg, in OSBP over the control group (p=0.02). There were no MACE events in the BackBeat CNT group and 3 events in 2 patients in the control group. Additionally, there were no notable differences in echo parameters between the two arms. Diastolic blood pressure and heart rate did not change between groups during the study period.
“Achieving an 11.1 mmHg reduction in mean 24-hour ambulatory systolic blood pressure in the BackBeat CNT arm is a remarkable result, and clinically significant,” said David E. Kandzari, MD, FACC, FSCAI, chief scientific officer and director, Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA. “This data offers compelling preliminary evidence that this therapy may provide a safe and effective means to help the pacemaker population achieve target blood pressure levels and reduce cardiovascular risk.”
Over 1.1 million pacemakers are implanted annually worldwide.1 Patients indicated for a pacemaker have a particularly high rate of elevated blood pressure, with more than 70% of these patients suffering from hypertension.2 Based on 2017 American College of Cardiology/American Heart Association high blood pressure guidelines, it is estimated that over 60% of pacemaker patients have uncontrolled hypertension despite medical therapy.Over 1.1 million pacemakers are implanted annually worldwide. Patients indicated for a pacemaker have a particularly high rate of elevated blood pressure, with more than 70% of these patients suffering from hypertension. Based on 2017 American College of Cardiology/American Heart Association high blood pressure guidelines, it is estimated that over 60% of pacemaker patients have uncontrolled hypertension despite medical therapy.
"We are highly encouraged by these promising double-blind, randomized results with BackBeat CNT in the MODERATO II study,” said David Hochman, chairman and CEO of Orchestra BioMed. “We plan to use these results to help design registrational studies to support FDA and other global regulatory approvals for devices delivering BackBeat CNT and will be working to forge strategic collaborations to accelerate making this potentially high-impact therapy available to patients with known unmet needs.”
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
ggasaatura@lifescipublicrelations.com
1 BIS Research, 2017, Global Pacemaker and Implantable Cardioverter Defibrillators (ICDs) Market
2 Guha A, Xiang X, Haddad D, et al. Eleven-year trends of inpatient pacemaker implantation in patients diagnosed with sick sinus syndrome. J Cardiovasc Electrophysiol. 2017;28(8):933–943. doi:10.1111/jce.13248
September 17, 2019
First and only non-coated sirolimus-eluting angioplasty balloon system to receive Breakthrough Device designation for below-the-knee disease
Follows Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon in coronary in-stent restenosis granted in Q2 2019
New Hope, PA – Orchestra BioMed™, Inc., ("Orchestra BioMed" or the "Company"), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, in partnership with Terumo Corporation (Terumo, TSE: 4543), one of the world’s leading medical device manufacturers, today announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Virtue Sirolimus-Eluting Balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.
Peripheral artery disease (PAD) affects approximately 8.5 million people in the U.S and is growing dramatically in the elderly population.1 BTK (infrapopliteal) atherosclerosis is the most common cause of critical limb ischemia (CLI), which is associated with a high rate of amputations and poor survival outcomes.2 The treatment of BTK atherosclerotic disease is complex as lesions in these small diameter arteries tend to be diffuse, long and often involve calcification. Currently approved therapeutic options are limited and have been shown to be marginally effective, leaving substantial unmet need for more effective treatment options for BTK atherosclerosis.
"Virtue SEB’s unique design enables delivery of sustained-release sirolimus during angioplasty without the need for coating or permanent implant. This highly differentiated design makes this product the ideal candidate for Breakthrough Device Designation in BTK peripheral artery disease," said James P. Zidar, MD, FACC, FSCAI, clinical professor of medicine, UNC Health Systems, physician-in-chief, Heart & Vascular Corporate. "Currently, there is a significant unmet need in the BTK stenosis treatment landscape. The presence of underlying comorbidities renders many patients unsuitable for bypass surgery. Angioplasty with plain balloons, which has been the default endovascular therapy for years, has a low success rate. Adding a proven anti-restenotic agent like sirolimus has the potential to enhance this treatment approach and drive better patient outcomes."
Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. Manufacturers are then able to offer patients and healthcare providers quicker access to new medical devices by expediting the development, assessment, and review process.
"Our team is grateful that the FDA has recognized the potential value Virtue SEB can provide patients and physicians by granting this second Breakthrough Device Designation for an important arterial therapeutic indication," said Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed. "This designation will be critical as we continue to work with Terumo to accelerate Virtue SEB’s global clinical and regulatory program in both coronary and peripheral indications. In BTK disease, treatment with Virtue SEB has the potential to improve long-term outcomes and reduce periprocedural complications which can extend hospital stay and increase cost of treatment."
About Virtue® SEB
Virtue SEB is a novel, first-in-class drug/device combination product that delivers sustained-release bioabsorbable encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating. Virtue SEB’s ability to reliably deliver sirolimus via bioabsorbable sub-micron particles with a drug elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive preclinical studies published in a peer-reviewed journal.3 Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system to receive FDA Breakthrough Designation for below-the-knee stenosis as well as for coronary in-stent restenosis (ISR), another challenging indication for which the product has shown promising 3-year core-lab adjudicated efficacy and safety clinical results in the SABRE trial. Orchestra BioMed and Terumo plan to execute a global clinical program to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications including coronary ISR and below-the-knee stenosis.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
About Terumo™ Corporation
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with approximately US$6 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as "may," "will," "should," "expect," "could,” "scheduled,” "plan,” "intend,” "anticipate,” "believe,” "estimate,” "potential,” "propose” and "continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
ggasaatura@lifescipublicrelations.com
1 CDC. 2016. Peripheral Arterial Disease Fact Sheet [online] Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm[Accessed 7 August 2019]
2 Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013;382:1329-40
3 Stefan V, Mathias V, Indulis K, et al. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes, JACC Cardiovasc Interv. 2017 Oct 23;10(20):2029-2037. doi: 10.1016/j.jcin.2017.06.021
September 4, 2019
Late-breaking BackBeat CNT™ randomized, double-blind clinical results selected by Cardiovascular Research Foundation for presentation at TCT 2019
New Hope, PA – Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ (CNT) for treatment of hypertension while also providing standard pacemaker functions.
Additionally, the Cardiovascular Research Foundation (CRF) selected Orchestra BioMed’s MODERATO II clinical study of BackBeat CNT for a late-breaking science presentation at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference on September 28, 2019 at 12:45 pm PST in the main arena at The Moscone Center in San Francisco. The presentation titled, “MODERATO II: A Double-Blind Randomized Trial of Cardiac Neuromodulation Therapy in Patients with Hypertension,” will be presented by Karl-Heinz Kuck, MD., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and principal investigator for the MODERATO Studies. The MODERATO II results will also be highlighted at a press conference to be held at TCT during the morning of September 28, 2019. Every year, TCT late-breaking presentations feature major medical research breakthroughs and highlight the latest data on the most innovative treatments that will impact patient care and how physicians treat heart disease. The studies selected examine the safety and efficacy of minimally invasive techniques, pharmaceuticals, therapies and devices that demonstrate potential to treat or prevent cardiovascular disease.
“BackBeat CNT is an exciting new approach to device-based blood pressure management and has potential to be a primary treatment modality for the more than two-thirds of pacemaker patients at risk from hypertension,” said Dr. Karl-Heinz Kuck. “In the MODERATO I clinical trial, BackBeat CNT demonstrated excellent efficacy and safety results, particularly given that 78% of the study patients had isolated systolic hypertension and that patients’ average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared to patients in other device-based hypertension studies. I look forward to presenting the six-month primary endpoint results from the MODERATO II study of BackBeat CNT as a late-breaker at TCT later this month.”
“CE Mark approval and selection for late-breaking science presentation at TCT validate the potential for BackBeat CNT to benefit targeted high-risk hypertensive patients, such as those already indicated for a pacemaker,” said David Hochman, Chairman and CEO of Orchestra BioMed. “Effective treatment of these patients, the majority of whom have isolated systolic disease and persistent high blood pressure despite conventional pharmaceutical therapies, represents a significant market opportunity that could have substantial growth, value and market share implications for the field of cardiac rhythm management.”
About BackBeat CNT™
BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark approved Moderato™ implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT may be applicable to a wide range of hypertensive patients, including patients with isolated systolic disease and patients with uncontrolled hypertension despite multi-drug medical management.
About Orchestra BioMed™
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
ggasaatura@lifescipublicrelations.com
August 27, 2019
Dr. Donohoe brings nearly 30 years of successful clinical and regulatory experience advancing medical devices in the cardiology and endovascular space
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced the appointment of Dennis Donohoe, M.D., as full-time chief medical officer. Dr. Donohoe is a leading clinical development expert with an outstanding track record of success in steering high-impact therapeutic devices through clinical trials and regulatory approvals, including the CYPHER® sirolimus-eluting stent, the first FDA approved drug-eluting stent, for which he oversaw global registrational clinical development during his tenure as worldwide vice president of clinical, regulatory and medical affairs for Cordis Corporation (a Johnson & Johnson Company).
“Dennis Donohoe is a proven leader with extensive clinical and regulatory experience directly relevant to our therapeutic device product pipeline. We are thrilled that Dennis has agreed to join our management team on a full-time basis,” said David Hochman, chairman and chief executive officer of Orchestra BioMed. “We could not ask for a more qualified leader as we prepare to initiate a global clinical and regulatory development program focused on multiple coronary and peripheral indications for Virtue® SEB in collaboration with Terumo, our strategic partner. His extensive knowledge and expertise will also be vital to further our clinical and regulatory plans for BackBeat CNT for hypertension, our other flagship product, as well as additional pipeline development initiatives we expect to embark on in the future.”
Dr. Donohoe previously served as a part-time chief medical officer for Orchestra BioMed’s Focal Therapies group and its predecessor, Caliber Therapeutics, Inc, under a consulting agreement. For the last four years, Dr. Donohoe has been the owner of Donohoe Clinical Consultants, LLC, a clinical and regulatory advisory firm that provided services to a number of companies developing innovative products in the field of interventional cardiovascular devices. For twenty years prior to that, Dr. Donohoe worked in various clinical leadership roles within Johnson & Johnson: for eleven years, he was with Cordis, serving as the worldwide vice president of clinical, regulatory and medical affairs where he was responsible for the clinical development of cardiology, neurovascular and endovascular devices, including the CYPHER® stent. He also served as a board member of the Cordis franchise; He was the director of medical affairs for Ethicon, Inc., working on the clinical development of a variety of surgical devices used in laparoscopic surgery; He was also the director of clinical research at the Pharmaceutical Research Institute where he worked on clinical trials, including an antidepressant, oral hypoglycemic, a non-sedating antihistamine and a recombinant Hepatitis B vaccine. While at Johnson & Johnson, Dr. Donohoe received the Johnson Medal, the highest scientific recognition awarded by Johnson & Johnson in recognition for the clinical development of a topical growth factor for the treatment of chronic wounds. Prior to Cordis/Johnson & Johnson, Dr. Donohoe also served as director of clinical research in the gastrointestinal therapeutic group at Glaxo Pharmaceutical. Before joining the industry, he practiced family medicine in the Philadelphia area. Dr. Donohoe holds a medical degree from the Penn State Hershey Medical Center.
“I am excited to assume a full-time role as part of Orchestra BioMed’s leadership team during this critical growth period when I can help advance the development of Virtue SEB for coronary and peripheral artery disease as well as BackBeat CNT for targeted high blood pressure patient populations,” said Dr. Donohoe. “As a physician, I was impressed by how these therapies have the potential to improve outcomes in areas of high unmet medical need while seamlessly integrating into existing clinical workflows within interventional cardiology and cardiac rhythm management. I truly believe that eventual regulatory approval and adoption of these technologies could have a lasting impact for patients, physicians and hospital systems worldwide.”
About Orchestra BioMedTM
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and includes Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue® SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-876-4783
GGasaatura@lifescipublicrelations.com
July 10, 2019
Series B-1 Round Led by Perceptive, RTW and Soleus Capital with Strategic Participation from Terumo Corporation
Secures $64 Million in 2019 Capital Inflows, Including $30 Million Upfront Payment from Terumo Partnership
Financing Structure Provides Up to an Additional $57 Million in Follow-On Investments from Existing Shareholders
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced it has completed a $34 million Series B-1 Preferred Stock financing led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation (“Terumo”) and existing investors from SternAegis Ventures. In addition, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on the structure of its Series B-1 and Series B Preferred Stock financings. Proceeds from the financing will be used to accelerate and expand development of Orchestra BioMed’s lead and pipeline assets, including BackBeat Cardiac Neuromodulation Therapy (CNT) for hypertension. Proceeds will also support Orchestra BioMed’s commitments to its global strategic partnership with Terumo for the development and commercialization of the Virtue® Sirolimus-Eluting Balloon (SEB) for percutaneous coronary and peripheral vascular interventions.
Orchestra BioMed’s June 2019 partnership with Terumo included a $30 million up-front payment as well as significant future milestone payments from Terumo and meaningful revenue sharing through sales royalties and exclusive drug formulation supply payments. Terumo, one of the world’s leading medical device manufacturers, and Orchestra BioMed are executing a global clinical program for Virtue SEB, the first and only non-coated angioplasty balloon to deliver a sustained-release formulation of sirolimus during balloon angioplasty without the need for a coating or permanent implant. The FDA granted Virtue SEB Breakthrough Device Designation for coronary in-stent restenosis (ISR) in April 2019 and the companies are preparing to launch a U.S. registrational trial for this indication under an Investigational Device Exemption (IDE) from the FDA within the next year. Terumo and Orchestra BioMed also plan to expand Virtue SEB clinical trials into additional indications including small coronary vessels and peripheral artery disease below-the-knee in the U.S., Japan, China, and other markets. This strategic partnership with Terumo illustrates the long- term value of Orchestra BioMed’s business model and potential for collaboration with market leaders to accelerate development and commercialization of products like Virtue SEB to address large established medical procedure markets.
“This financing round, together with our recent global development and commercialization partnership with Terumo, validates our differentiated business strategy and unique approach for the development of high-impact therapeutic device solutions,” said David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. “Since the start of 2019, successful execution has generated over $64 million in capital inflows, including a significant upfront payment and strategic investment from our Virtue SEB global partnership. We are grateful to our investors and to Terumo, who’ve helped us achieve significant momentum and positioned us for meaningful value inflection as we seek to achieve key clinical milestones and expand our product development pipeline.”
Orchestra BioMed retained the rights to develop and license technology used in Virtue SEB in clinical applications outside of peripheral and coronary interventions. Proceeds from the Series B-1 financing will be used to develop additional clinical product candidates using sustained- release sirolimus in other large, procedure-based medical markets. Orchestra BioMed is also advancing its implantable cardiac neuromodulation therapy for hypertension, BackBeat CNT, shown in clinical studies to immediately, substantially and chronically lower blood pressure. A randomized clinical study to further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension recently completed enrollment and is on track to report six-month data later this year. With this Series B-1 financing, Orchestra BioMed plans to accelerate additional global BackBeat CNT clinical trials. In parallel, the Company is continually evaluating additional product acquisition opportunities in line with its strategy of developing high-impact solutions that address major needs in key markets and forming partnerships with established commercial leaders to drive global commercialization.
“We are now well positioned to accelerate and expand product development, not just for our lead programs, Virtue SEB and BackBeat CNT, but for our technology pipeline, which we expect to translate over time into multiple future product development and partnership opportunities and significant future cash flows,” said Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed. “A key focus for Orchestra BioMed moving forward will be clinical and regulatory execution. We are looking forward to launching multiple global clinical studies over the next several years to fully explore the clinical benefits of Virtue SEB for artery disease and BackBeat CNT for hypertension. We are also selectively looking to acquire or in- license additional high-impact product candidates that fit our partnership-focused business model.”
About Orchestra BioMedTM
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® SEB for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-876-4783
GGasaatura@lifescipublicrelations.com
June 13, 2019
Virtue® SEB is expected to become a flagship therapeutic product for Terumo and will strengthen its broad US and global portfolio of interventional solutions
Terms of the partnership include substantial up-front and milestone payments, equity investment, a strong commitment to global clinical program, as well as meaningful revenue sharing through royalty and exclusive drug formulation supply payments
Partnership validates Orchestra BioMed’s strategy to leverage alliances with established market leaders to drive global commercialization of its high-impact products
New Hope, PA – Orchestra BioMed, Inc. (Orchestra BioMed), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced it has formed a global strategic partnership with Terumo Corporation (Terumo, TSE: 4543), one of the world’s leading medical device manufacturers, for development and commercialization of Virtue® Sirolimus-Eluting Balloon (SEB), one of its lead assets, in the percutaneous coronary and peripheral interventions field.
Virtue SEB is the first and only non-coated drug-eluting angioplasty balloon that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus, the gold standard drug for preventing restenosis following a percutaneous interventional procedure. In April, the U.S. Food and Drug Administration (FDA) granted Virtue SEB Breakthrough Device Designation for treatment of coronary in-stent restenosis (ISR), which provides prioritized regulatory review for this challenging cardiovascular condition that represents more than 10% of total interventional coronary procedures and for which available treatment options are limited. In a prospective study of very challenging ISR patients, Virtue SEB demonstrated excellent angiographic results at six months as well as outstanding clinical outcomes out to three years. Orchestra BioMed plans to conduct a near-term U.S. registrational trial for ISR.
“We are delighted to be aligning with Terumo, which has a rich history of global leadership in medical devices. Terumo has a proven global distribution and operations infrastructure with the sales and marketing expertise necessary to make Virtue SEB broadly accessible to physicians and patients worldwide, pending regulatory approvals.” said David Hochman, chairman and chief executive officer of Orchestra BioMed. “This strategic partnership is a major milestone for Orchestra BioMed. It validates our differentiated strategy to focus on the development of high-impact therapies while leveraging alliances with established market leaders, like Terumo, to drive global commercialization of our products.”
“We are excited to partner with Orchestra BioMed and secure global rights to Virtue SEB, which we intend to make a flagship therapeutic product. It strongly compliments our broad US and global portfolio of interventional solutions. We believe Virtue SEB is an important innovation that has the potential to address key unmet needs in the interventional vascular space, while fitting seamlessly within current clinical practice and workflow,” said James Rushworth, CEO of Terumo Medical Corporation (North America) and chief commercial officer of the Interventional Systems Division of Terumo. “The unique design of Virtue SEB demonstrates Orchestra BioMed’s deep knowledge of the needs of interventional cardiologists and its capability to deliver innovative solutions that have the potential to improve patient outcomes.”
Virtue SEB strengthens the current cardiovascular product offering of Terumo Interventional Systems, Terumo Corporation’s largest division, which includes a complete, solution-based product portfolio used in advanced coronary and peripheral endovascular treatments, with market-leading solutions for vascular access, lesion access and intervention. Orchestra BioMed and Terumo are seeking to make Virtue SEB the first drug-eluting balloon approved for coronary use in the U.S. Orchestra BioMed expects to initiate a U.S. registrational trial for Virtue SEB in ISR under an Investigational Device Exemption (IDE) from the FDA within the next year. Virtue SEB is currently not approved in any market, but Terumo and Orchestra BioMed plan to conduct trials to support global regulatory approvals in indications including ISR, small coronary vessels, peripheral artery disease below-the-knee and other indications. Terumo and Orchestra BioMed’s objective is to commercialize Virtue SEB in the U. S., Japan, China, and other markets.
About Orchestra BioMedTM
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® SEB for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
About Terumo CorporationTM
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with approximately US$6 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use. Terumo contributes to society by providing valued products and services to the healthcare market, and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Public Relations
646-876-4783
GGasaatura@lifescipublicrelations.com
May 23, 2019
Novel implantable bioelectronic treatment delivers immediate, substantial, and sustained reduction in blood pressure
Data showed 14.2 mmHg reduction in 24-hour ambulatory systolic blood pressure at three months and 23.4 mmHg reduction in office cuff systolic blood pressure out to two years
Therapy applicable to a wide range of hypertensive patients including those with isolated systolic hypertension
Paris, France – Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced the presentation of two-year clinical data from the European Moderato I study of BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for hypertension at the EuroPCR Conference in Paris, France. Prof. Petr Neužil, M.D., Ph.D., CSc., FESC, head of the department of cardiology of Na Homolce Hospital in Prague, Czech Republic, presented data which showed a strong safety profile of BackBeat CNT and its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension (office BP > 150 mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.
"In the Moderato I study, BackBeat CNT demonstrated an impressive 14.2 mmHg reduction in 24-hour ambulatory systolic blood pressure at three months as well as a substantial and sustained 23.4 mmHg reduction in office cuff systolic blood pressure out to two years. These statistically significant results are very exciting as they support the potential for BackBeat CNT to become a broadly applicable therapy for device-based hypertension management” said Professor Neužil, one of the principal investigators of the study.
BackBeat CNT is applicable to a wide range of hypertensive patients, including isolated systolic disease and patients with high blood pressure despite medical therapy. The Moderato I study enrolled patients with uncontrolled hypertension despite multi-drug medical management and who are also indicated for a pacemaker.
“We are encouraged by the data from Moderato I study showing substantial reduction in systolic blood pressure which could potentially reduce the risk of heart attack and stroke,” said Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed. “We recently completed enrollment of patients in the Moderato II study to further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension and are on track to present 6-month data later this year.”
The Moderato II study is a prospective, 1:1 randomized double-blind active treatment with BackBeat CNT versus standard medical therapy trial in pacemaker-indicated patients with uncontrolled blood pressure and treated with at least one antihypertensive medication. The primary efficacy and safety endpoints will be assessed at six months.
“We are looking forward to Moderato II six-months results and the long-term potential of this exciting therapy to benefit high-risk patients with uncontrolled high blood pressure,” stated Professor Neužil.
In 2019, Orchestra BioMed plans to initiate enrollment in a randomized, double-blind study to assess the clinical safety and effectiveness of BackBeat CNT in patients with hypertension in the absence of antihypertensive medications. The primary efficacy endpoint will be the difference in the average 24-hour ambulatory systolic blood pressure in the active group compared to control at three months after randomization.
About BackBeat CNT
BackBeat CNT, a flagship product of Orchestra BioMed, is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). BackBeat CNT replicates the effects of multiple medications by reducing pre-load, after-load and sympathetic tone. The therapy can be delivered using standard rhythm management device hardware, such as dual-chamber pacemakers. BackBeat CNT is applicable to a wide range of hypertensive patients, including patients with isolated systolic disease and patients with uncontrolled hypertension despite multi-drug medical management.
About Orchestra BioMedTM
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® SEB for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Kristin Politi
LifeSci Public Relations
646-876-4783
KPoliti@lifescipublicrelations.com
April 24, 2019
First and only non-coated sirolimus-eluting angioplasty balloon system to show promising clinical results
Potential to offer significant advantages for treatment of coronary in-stent restenosis (ISR), a condition that represents over 10% of total interventional procedures
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet healthcare needs, announced today that it has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Virtue® Sirolimus-Eluting Balloon for the treatment of coronary in-stent restenosis (ISR).
Breakthrough Designation is granted to certain medical devices and device-led combination products that provide for a more effective treatment of life-threatening or irreversibly debilitating diseases. It enables manufacturers to provide patients and health care providers with timely access to medical devices by expediting their development, assessment, and review. Benefits of this designation include frequent interactions and feedback from FDA during the premarket review phase. Through this program, Orchestra BioMed can expect prioritized review of its submission for Virtue SEB.
“In Virtue SEB, we finally have a therapeutic innovation that truly warrants breakthrough designation for the treatment of coronary ISR, a particularly challenging condition for which available treatment options are limited,” commented Dean Kereiakes, M.D., FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center and professor of Clinical Medicine at The Ohio State University. “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential hazards of a permanent metal implant or a balloon coating that may produce downstream particulates and micro-emboli. Clinical results at three-year follow-up with Virtue SEB in ISR are very promising and I am very much looking forward to utilizing this exciting new technology in clinical trials in the U.S.”
“We believe Virtue SEB addresses an important unmet clinical need and provides an improved treatment alternative for a patient population with limited options. It is the first and only non-coated angioplasty balloon that provides arterial delivery of sirolimus, the proven gold standard drug used on drug-eluting stents for preventing restenosis of treated arteries.” commented Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed. “We plan to fully leverage the benefits of FDA Breakthrough Device designation as we seek to accelerate the U.S. clinical and regulatory development of Virtue SEB with the goal of providing physicians and patients with the benefits of our novel therapeutic device.”
About Virtue® SEB and Coronary ISR
Virtue SEB is a novel, first-in-class non-coated drug-eluting balloon system that delivers sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus, the proven gold-standard drug for preventing restenosis, to the artery during balloon angioplasty without the need for a coating. Virtue SEB’s ability to reliably deliver sirolimus via bioabsorbable particles directly to the artery with an elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive non-clinical studies published in a peer-reviewed journal. Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system to show promising clinical results in patients with coronary ISR.
Coronary ISR, the reclogging of an artery following the implant of a drug-eluting or bare metal stent, represents over 10% of total interventional cardiology procedures according the American College of Cardiology’s National Cardiovascular Data Registry (NCDR)2. FDA approved treatment options, such as plain balloon angioplasty and brachytherapy, are limited and offer subpar clinical outcomes. Juan Granada, M.D., associate professor of Medicine at the Columbia University College of Physicians and Surgeons and president and CEO of Cardiovascular Research Foundation, presented three-year clinical results with Virtue SEB from the Sirolimus Angioplasty Balloon for In-Stent Restenosis (SABRE) Trial at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 in San Diego, CA. In the SABRE trial, Virtue SEB demonstrated excellent efficacy and safety performance in a very challenging ISR patient population with predominantly long, diffuse lesions within stents that had been implanted, on average, nearly four years prior to the study enrollment. The per protocol primary safety and efficacy endpoint results of the study were as follows:
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact therapeutic solutions to address significant unmet needs in healthcare. The Company advances promising therapies through clinical development and aims to leverage strategic partnerships with established global leaders to optimize commercialization. This strategy positions Orchestra BioMed to generate long-term, high-margin cash flow from revenue sharing, royalty, licensing and product development agreements.
With a primary focus on the treatment of cardiovascular health issues that affect tens of millions of people worldwide, the Orchestra BioMed pipeline includes BackBeat Cardiac Neuromodulation Therapy, a patented implantable cardiac stimulation-based treatment for hypertension, and Virtue® Sirolimus-Eluting Balloon, a novel, first-in-class drug/device combination product that delivers programmed-release bioabsorbable nanoparticle encapsulated Sirolimus to the artery during balloon angioplasty for treatment of atherosclerosis. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies, including FreeHold Surgical (a wholly-owned subsidiary), Motus GI and Vivasure Medical.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
Media Contact:
Gloria Gasaatura
LifeSci Advisors
GGasaatura@lifescipublicrelations.com
Source: Orchestra BioMed, Inc.
April 2, 2019
Panel presentation will provide an overview and outlook on BackBeat Cardiac Neuromodulation Therapy, a potent, novel bioelectronic treatment for hypertension
Hypertension, considered the #1 contributing risk factor for death by WHO, is a global epidemic that affects over 100 million Americans and 1.2 billion people worldwide
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet healthcare needs, announced today that David Hochman, Chairman, Chief Executive Officer and Founder, will present and participate in a bioelectronic medicine entrepreneur panel at the 2019 Bioelectronic Medicine Forum on Thursday, April 4, 2019 at 2:00 p.m. ET in New York, NY.
As part of his panel presentation, Mr. Hochman will discuss Orchestra BioMed’s innovative business model as well as provide a detailed overview of the Company’s Bioelectronic Therapies group’s flagship product, BackBeat Cardiac Neuromodulation Therapy (CNT). Orchestra BioMed is focused on advancing high impact therapeutic solutions through development and plans to leverage strategic partnerships with established global market leaders to optimize commercialization and profitability.
BackBeat CNT is a patented intelligent biolectronic cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure while simultaneously modulating autonomic nervous system to maintain blood pressure higher. Clinical results from the European MODERATO I clinical trial demonstrated that BackBeat CNT can reduce 24-hour ambulatory systolic blood pressure by an average of 14.2 mm/Hg and in-office systolic blood pressure by an average of 23.8 mm/Hg at 3-month follow up. Two-year follow-up from MODERATO I showed sustained reduction of in-office systolic blood pressure by 23.4 mm/Hg, an amount that has the potential to reduce risk of heart attack and stroke by at least 50% based on established blood pressure risk statistics. BackBeat CNT can be readily incorporated into existing cardiac rhythm management devices such as pacemakers, making it rapidly adaptable to the existing paradigm of care for hypertensive patients that already require a pacemaker. In addition, it can also be used to treat refractory hypertensive patients that do not require a pacemaker but have significant blood pressure disease despite multi-drug daily treatment. Effective treatment of both of these patient populations represents an estimated annual global market opportunity of over $6 billion.
Orchestra BioMed is also seeking to develop a pipeline of additional treatments for development and future licensing based on its patented CNT technology. The Company believes these products may have clinical applications in heart failure as well as other indications related to sympathetic neurohormonal regulation.
About the 2019 Bioelectronic Medicine Forum
This second annual meeting represents the premier management and investment conference for the new and emerging bioelectronic medicine industry. Attendees will have an exclusive opportunity to interact with some of the key leaders driving this field forward. The schedule of presentations and panel discussions features a host of experts with a wealth of information on the neuroscience industry and the investment community.
Sessions will cover a range of technologies and indications for bioelectronic medicine, including applications in cardiovascular medicine, inflammation, gastrointestinal disorders, and many other clinical specialties. Attendees will hear from some of the leading researchers and entrepreneurs developing clinically and commercially promising products such as implanted vagus nerve stimulation systems to treat hypertension, and surface stimulation devices to treat a range of disorders. For more information, please visit the conference website.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact therapeutic solutions to address significant unmet needs in healthcare. The Company advances promising therapies through clinical development and aims to leverage strategic partnerships with established global leaders to optimize commercialization. This strategy positions Orchestra BioMed to generate long-term, high-margin cash flow from revenue sharing, royalty, licensing and product development agreements.
With a primary focus on the treatment of cardiovascular health issues that affect tens of millions of people worldwide, the Orchestra BioMed pipeline includes BackBeat® Cardiac Neuromodulation Therapy, a patented implantable cardiac stimulation-based treatment for hypertension, and Virtue® Sirolimus-Eluting Balloon, a novel, first-in-class drug/device combination product that delivers programmed-release bioabsorbable particle encapsulated Sirolimus to the artery during balloon angioplasty for treatment of atherosclerosis. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies, including FreeHold Surgical (a wholly-owned subsidiary), Motus GI and Vivasure Medical.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
March 13, 2019
- Presentation with live audio webcast on Tuesday, March 19, 2019 at 3:20 p.m. ET -
Webcast Link: https://www.veracast.com/webcasts/opco/healthcare2019/82115698694.cfm
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet medical needs, announced today that David Hochman, Chairman and Chief Executive Officer, will present at Oppenheimer’s 29th Annual Healthcare Conference on Tuesday, March 19, 2019 at 3:20 p.m. ET in New York, NY.
A live audio webcast of the presentation will be accessible on the News and Events page on the Company's website at www.orchestrabiomed.com. The webcast replay will be available approximately two hours after the presentation ends and will be accessible for 90 days.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact therapeutic solutions to address significant unmet needs in healthcare. The Company advances promising therapies through clinical development and aims to leverage strategic partnerships with established global leaders to optimize commercialization. This strategy positions Orchestra BioMed to generate long-term, high-margin cash flow from revenue sharing, royalty, licensing and product development agreements.
With a primary focus on the treatment of cardiovascular health issues that affect tens of millions of people worldwide, the Orchestra BioMed pipeline includes BackBeat® Cardiac Neuromodulation Therapy, a patented implantable cardiac stimulation-based treatment for hypertension, and Virtue® Sirolimus-Eluting Balloon, a novel, first-in-class drug/device combination product that delivers programmed-release bioabsorbable particle encapsulated Sirolimus to the artery during balloon angioplasty for treatment of atherosclerosis. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies, including FreeHold Surgical (a wholly-owned subsidiary), Motus GI and Vivasure Medical.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
December 4, 2018
- Industry veteran brings over 25 years of financial and operational management experience with a proven track record of developing and implementing successful strategies to drive growth and build shareholder value -
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet medical needs, announced today that it has appointed Evan Ballantyne as its Chief Financial Officer (CFO). Mr. Ballantyne is an experienced financial and strategic leader in the biotech, medical device and information services industries with a proven track record of building and strengthening a company’s financial position during his career of more than 25 years.
David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, commented, “Over the course of his career, Evan has played key roles in successfully leading companies in the full range of strategic options in financing including private equity and public offerings. His proven track record, business acumen, and established network of relationships will be a critical resource for Orchestra BioMed as we plan for rapid progress in our innovative product development and value creation strategy in the years ahead.”
Prior to joining Orchestra BioMed, he most recently served as the CFO at Accera, Inc., an Alzheimer’s disease focused company backed by Nestlé Health Sciences. Mr. Ballantyne previously served as Executive Vice President and CFO of Clinical Data, Inc. (NASDAQ: CLDA), a biopharmaceutical company that was acquired by Forest Labs for $1.6 billion. He was also CFO of Synthetic Biologics, Inc. (NYSE: SYN), a microbiome-focused company where he led the company’s re-structuring effort, and CFO at Agenus, Inc. (NASDAQ: AGEN), an immuno-oncology company where he helped complete several acquisitions and partnerships as well as monetize a GlaxoSmithKline royalty-stream for gross proceeds of $115 million. He also served as CFO of the private medical technology companies Avedro, Inc. and ZymeQuest, Inc. Before entering the healthcare industry, Mr. Ballantyne served as CFO of Knowledge Impact, Inc., a software company whose technology was ultimately acquired by Oracle, Inc., and as COO and CFO at the ACNielsen Corporation. He also held positions in finance at IMS Health (d.b.a. IQVIA NYSE: IQV) and Dun & Bradstreet Corp. Mr. Ballantyne holds a BA from the University of Western Ontario and a post-graduate degree in business administration from the University of Windsor.
“Our business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of our technologies designed to address major unmet clinical needs primarily in the area of cardiovascular disease. By successfully executing this innovative approach, we expect to generate long-term, high margin cash flow from royalties, revenue sharing, as well as licensing and development payments from strategic partners. Evan’s expertise is perfectly aligned with our unique strategy, and we look forward to benefitting from his insights, experience and contributions as we seek to establish Orchestra BioMed as a premier biomedical innovation company,” added Mr. Hochman.
“I firmly believe Orchestra BioMed’s innovative business model will accelerate market access to groundbreaking treatments for major unmet needs like artery disease and hypertension. I am especially pleased to join the leadership team at what I believe is a pivotal stage in the Company's growth,” stated Mr. Ballantyne. “I am eager to leverage my broad experience as a member of the Orchestra BioMed team and to contribute to the Company’s success in the near- and long-term.”
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact therapeutic solutions to address major medical conditions where options for patients are limited or inadequate. The Company advances promising therapeutic solutions through late-stage development based on rigorous clinical research and then leverages partnerships with established global leaders in product commercialization to bring new treatment options to patients quickly and efficiently. This strategy aims to maximize the commercial potential of novel therapies while positioning Orchestra BioMed to generate long-term, high-margin cash flows from revenue sharing, royalty, licensing and product development agreements. With a primary focus on the treatment of cardiovascular health issues that affect tens of millions of people worldwide, the Orchestra BioMed pipeline includes BackBeat® Cardiac Neuromodulation Therapy, a patented implantable cardiac stimulation-based treatment for hypertension, and Virtue® Sirolimus-Eluting Balloon, a novel, first-in-class drug/device combination product that delivers delayed-release bioabsorbable particle encapsulated Sirolimus to the artery during balloon angioplasty for treatment of atherosclerosis. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies, including FreeHold Surgical (a wholly-owned subsidiary), Motus GI and Vivasure Medical.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
November 20, 2018
Event: Piper Jaffray Healthcare Conference
Date: Thursday, November 29, 2018 at 9:30 a.m. EST
Webcast Link: https://event.webcasts.com/starthere.jsp?ei=1222275&tp_key=5bdf221dd0
November 20, 2018
New Hope, PA – Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet medical needs, today announced that David Hochman, Chairman and Chief Executive Officer, will present a corporate overview at the Piper Jaffray Healthcare Conference on Thursday, November 29, 2018 at 9:30 a.m. EST in New York, NY.
A live audio webcast of the presentation will be accessible on the News and Events page on the Company's website at www.orchestrabiomed.com. The webcast replay will be available approximately two hours after the presentation ends and will be accessible for 90 days.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence-based therapeutic solutions for procedures that address major medical conditions. The Company’s core innovation and product development expertise are in the areas of drug delivery, interventional devices, bioelectronics and neuromodulation with a primary focus on cardiovascular disease. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products, with potential for long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments. The Company’s lead product candidates include Virtue® Sirolimus-Eluting Balloon® (SEB), a novel, first-in-class drug-eluting angioplasty balloon that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, and BackBeat® Cardiac Neuromodulation Therapy (CNT), a patented implantable cardiac neuromodulation treatment for hypertension. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies that were originally founded, financed and developed with the assistance from the principals of Orchestra BioMed. These include one wholly-owned subsidiary (FreeHold Surgical®) and two large minority interests in other therapeutic device companies (Motus GI®, Vivasure® Medical).
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
November 15, 2018
Capital proceeds to support late-stage clinical development of lead cardiovascular product candidates for artery disease and hypertension
Financing structure provides for up to an additional $23 million in follow-on financing from existing investors
New Hope, PA – Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet medical needs, today announced the successful final closing of a $41 million private equity financing, which also included the conversion of outstanding debt to equity. Proceeds from the financing will support continued late-stage clinical development of Orchestra BioMed’s lead product candidates, which include the Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease and the BackBeat® Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension.
“This successful financing marks a significant milestone for Orchestra BioMed as we look to implement our innovative business model which aims to more efficiently advance high impact, high value, evidence-based therapeutic device solutions for large, established, procedure-based medical markets like interventional cardiology and electrophysiology,” commented David Hochman, Chairman and Chief Executive Officer of Orchestra. “Within these mature markets, we believe the key to continued product improvements is for technology innovators to forge and leverage long-term strategic partnerships with global market leaders to optimize clinical impact, commercial penetration and the health-economic value of their products. Orchestra BioMed’s mission is to be a leader in creating products and partnerships that help shape the future of medicine.”
Orchestra BioMed‘s lead product candidates target significant areas of unmet cardiovascular need that also represent large potential commercial market opportunities. BackBeat CNT is a patented implantable cardiac stimulation-based treatment for hypertension that has been shown to substantially and chronically reduce systolic blood pressure to levels associated with significantly reduced risk of heart attack and stroke. BackBeat CNT can be readily incorporated into existing cardiac rhythm management devices such as pacemakers, making it rapidly adaptable to the existing paradigm of care for hypertensive patients that already require a pacemaker as well as applicable to patients with severe hypertension that do not require a pacemaker. These target patient populations represent an annual global market opportunity for BackBeat CNT of over $5 billion. Virtue SEB is a novel, first in-class drug/device combination product that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, the proven gold-standard drug for preventing restenosis, to the artery during balloon angioplasty for treatment of atherosclerosis without the need for a permanent implant. Key target clinical indications for Virtue SEB such as coronary in-stent restenosis, small vessel disease, below-the-knee lesions and others, represent an aggregate annual global market opportunity of over $4 billion.
“Our Virtue SEB and BackBeat CNT technologies each offer an exciting new way to treat some of today’s most challenging medical conditions while taking full advantage of techniques and technologies that are familiar and broadly acceptable by interventionalists in cardiology and electrophysiology,” said Darren R. Sherman, President and Chief Operating Officer of Orchestra BioMed. “This recent financing will help support the final stages of development of these promising programs while also allowing us to explore many new options to expand our product pipeline.”
In addition to the Virtue SEB and BackBeat CNT product platforms, Orchestra BioMed operates a wholly-owned subsidiary, FreeHold Surgical, a commercial-stage advanced surgical accessory device product line. Orchestra BioMed also owns significant strategic equity positions in other therapeutic device companies that were originally founded, financed and developed with assistance from the principals of Orchestra BioMed. These include large minority interests in Motus GI® Holdings, Inc. (NASDAQ:MOTS), which is currently focused on the commercial launch of its Pure-Vu® System for intraprocedural cleansing during colonoscopy, and Vivasure Medical Ltd., which recently initiated the commercial launch of PerQSeal®, the world’s first fully absorbable, patch-based large-bore percutaneous closure device.
SternAegis Ventures acted as the exclusive Placement Agent for Orchestra BioMed’s financing, which was fully oversubscribed as well as expanded beyond its original maximum target amount. “We believe the strong investor response to this heavily oversubscribed offering speaks volumes about the enormous potential of Orchestra BioMed’s product pipeline as well as its innovative business model which applies proven value creation strategies from the biotech sector to the medtech arena,” said Adam Stern, CEO of SternAegis Ventures. “The innovative structure of this round provides strong investor incentives to provide an additional $23 million in future follow-on capital, further complementing Orchestra BioMed’s business strategy and growth plans.”
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence-based therapeutic solutions for procedures that address major medical conditions. The Company’s core innovation and product development expertise are in the areas of drug delivery, interventional devices, bioelectronics and neuromodulation with a primary focus on cardiovascular disease. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products, with potential for long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments. The Company’s lead product candidates include Virtue® Sirolimus-Eluting Balloon® (SEB), a novel, first-in-class drug-eluting angioplasty balloon that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, and BackBeat® Cardiac Neuromodulation Therapy (CNT), a patented implantable cardiac neuromodulation treatment for hypertension. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies that were originally founded, financed and developed with the assistance from the principals of Orchestra BioMed. These include one wholly-owned subsidiary (FreeHold Surgical®) and two large minority interests in other therapeutic device companies (Motus GI®, Vivasure® Medical).
About SternAegis Ventures
SternAegis Ventures is the management team within Aegis Capital Corp. that is responsible for venture capital and private equity financing. For additional information, please visit: www.sternaegis.com.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
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Source: Orchestra BioMed, Inc.
November 8, 2018
Novel Treatment Delivers Immediate, Substantial, and Sustained Reduction in Blood Pressure
Potential to Become a Broadly Applicable Therapy for Device-Based Hypertension Management
New Hope, PA – Orchestra BioMed, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing advanced therapeutic solutions to address major unmet medical needs, announced today that Professor Petr Neuzil, M.D., Head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic, was invited to present on BackBeat CNT and its impact on device-based hypertension management during a Scientific Session at American Heart Association meeting to take place on November 10th in Chicago, IL. Dr. Neuzil’s presentation will highlight 2-year clinical results from the European Moderato I study of BackBeat CNT which demonstrate strong safety profile of the therapy as well as its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension (office BP > 150mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.
"In the Moderato I study, BackBeat CNT demonstrated an impressive 14.2 mmHg reduction in 24-hour ambulatory systolic blood pressure at 3 months as well as a substantial and sustained 23.4 mmHg reduction in office cuff systolic blood pressure out to 2 years. These statistically significant results are very exciting as they support the potential for BackBeat CNT to become a broadly applicable therapy for device-based hypertension management” said Professor Neuzil, one of the Principal Investigators of the study. “We are looking forward to Moderato II randomized, controlled trial results next year as well as to the long-term potential of this exciting therapy to benefit high-risk patients with uncontrolled high blood pressure.”
To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is currently enrolling patients into Moderato II, a prospective, 1:1 randomized double-blind active treatment (BackBeat® CNT) versus standard medical therapy trial in pacemaker-indicated patients with uncontrolled blood pressure and treated with at least one anti-hypertension medication. The primary efficacy and safety endpoints will be assessed at 6 months. The Company is expecting results on the first cohort of patients in 2019.
About BackBeat® CNT
BackBeat's CNT, a flagship product of Orchestra BioMed, is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers. BackBeat CNT is applicable to a wide range of hypertensive patients, inclusive of Isolated Systolic Hypertension, who are also indicated for a pacemaker and patients with uncontrolled hypertension despite multi-drug medical management. Orchestra BioMed is currently working to obtain regulatory approval for BackBeat CNT in Europe. In addition, the Company is nearing completion of its first cohort of patients in a prospective, randomized, double-blind study, Moderato II, to further evaluate the clinical benefits of the therapy.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence-based therapeutic solutions for procedures that address major medical conditions. The Company’s core innovation and product development expertise are in the areas of drug delivery, interventional devices, bioelectronics and neuromodulation with a primary focus on cardiovascular disease. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products, with potential for long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments. The Company’s lead product candidates include Virtue® Sirolimus-Eluting Balloon® (SEB), a novel, first-in-class drug-eluting angioplasty balloon that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, and BackBeat® Cardiac Neuromodulation Therapy (CNT), a patented implantable cardiac neuromodulation treatment for hypertension. Orchestra BioMed also has significant strategic ownership in other therapeutic device companies that were originally founded, financed and developed with the assistance from the principals of Orchestra BioMed. These include one wholly-owned subsidiary (FreeHold Surgical®) and two large minority interests in other therapeutic device companies (Motus GI®, Vivasure® Medical).
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward- looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
October 10, 2018
Ron Dadino appointed Vice President, Pharmaceutical Development & Operations, Cardiovascular Interventions
Greg Kopia, Ph.D., CMPP appointed Director, Pre-Clinical Development, Cardiovascular Interventions
Ziv Belsky appointed Vice President, Research & Development, Cardiac Neuromodulation
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing high impact, high value, evidence-based therapeutic solutions for medical procedures that address major medical conditions, announced today that it has appointed three key members to its management team. Joining the Company are Ron Dadino as Vice President, Pharmaceutical Development & Operations, Cardiovascular Interventions; Gregory Kopia, Ph.D., CMPP as Director, Pre-Clinical Development, Cardiovascular Interventions; and Ziv Belsky as Vice President, Research & Development, Cardiac Neuromodulation.
“We have been working diligently to ensure we have the right team in place as we continue to advance the development of our pipeline of highly differentiated late-stage products. We are pleased to welcome Ron, Greg and Ziv and believe that their experience and expertise in their respective fields will be instrumental in advancing our two lead programs, the Virtue® Sirolimus-eluting Balloon (SEB) for coronary artery disease and BackBeat® Cardiac Neuromodulation Therapy (CNT) for hypertension,” commented Darren R. Sherman, President and Chief Operating Officer of Orchestra BioMed.
Mr. Dadino joins Orchestra BioMed with more than 30 years of pharmaceutical experience and having commercialized over 20 pharmaceutical and combination products. Mr. Dadino most recently served as Vice President of Pharmaceutical Development and Manufacturing for Aclaris Therapeutics, Inc. (Nasdaq:ACRS), where he assisted in bringing the company’s first product to market. Prior to Aclaris, Mr. Dadino was President of Dadino Consulting, LLC, where he provided product development, technical operations, manufacturing and commercialization consulting services to pharmaceutical, biotechnology and medical device companies. During his career, Mr. Dadino spent 13 years with Johnson & Johnson (NYSE: JNJ), where he served as Vice President, Development and Technical Operations from 2011-2013, and as Vice President, Pharmaceutical Development, Technical Operations and CMC from 2001-2011, where he was responsible for development of pharmaceutical attributes for drug/device combination products including the CYPHER® Sirolimus-eluting stent. Prior to J&J, Mr. Dadino served as Senior Director, Technical Operations, for Rhone-Poulenc Rorer Pharmaceuticals. Mr. Dadino holds an M.S. in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University and a B.S. in Pharmacy from University of the Sciences in Philadelphia.
Dr. Kopia joins the Orchestra BioMed team with more than 20 years’ experience in the preclinical evaluation of local therapies for cardiovascular disease encompassing both drugs and devices. Dr. Kopia most recently worked in medical communications at PharmaWrite, LLC and served as the Principal of Kopia Consulting LLC, where he provided preclinical development consulting services to companies developing cardiovascular drugs and devices. Since 2009, Dr. Kopia has provided consulting services to Caliber Therapeutics related to the development of Virtue® SEB. Prior to this, he was a Research Fellow for Cordis, a Johnson & Johnson company which was subsequently sold to Cardinal Health for $1.9 billion. As a Research Fellow at the Cordis Corporation, Dr. Kopia was involved in extensive work in the area of safety and efficacy of vascular devices used for post-angioplasty restenosis including stents, balloon delivery catheters, and drug-device combinations. He is one of the recognized inventors of CYPHER®, the first commercially successful drug-eluting stent, and was deeply involved with the early research and development of this milestone therapeutic device. As a result of this work, Dr. Kopia was co-recipient of the prestigious Johnson Medal for the discovery and development of the CYPHER® sirolimus-eluting coronary stent. Prior to Cordis, he served as Director of Pharmacology from 1989 to 1995 for Zynaxis Cell Science, Inc., a localized drug delivery development company, as well as Assistant Director, Pharmacology for GlaxoSmithKline from 1987 to 1989. He completed his postdoctoral fellowship in Pharmacology at the University of Michigan Medical School, received his Ph.D. in Pharmacology from the University of Medicine and Dentistry of New Jersey, and B.A. in Biology from Gettysburg College.
Mr. Belsky joins Orchestra BioMed having most recently served as Chief Technology Officer for NewPace Ltd., a cardiac rhythm management company based in Israel. Over the course of his career, Mr. Belsky has established a strong track record as a serial entrepreneur helping to found, and serving as Chief Executive Officer for, a number of start-up medical innovation companies in Israel including: Novogate Medical Ltd., a company focused on development of novel means of enabling thoraco-apical access for beating heart procedures; Juvenis, a biomaterials company focused on aesthetic and reconstructive surgical procedures; SphinxTech Ltd., a research and development company focused on medical devices for the treatment of fecal incontinence; and E-Pill Pharma Ltd., a company developing an oral drug delivery platform to administer peptides and large molecules, small molecules, as well as low bioavailability drugs. Mr. Belsky has also served as Director, Business Development from for Wavion Ltd., and Product Manager for Impulse Dynamics Ltd., a medical device company developing an implantable cardiac stimulator for the treatment of heart failure that was co-founded by Yuval Mika, Ph.D., Orchestra BioMed’s General Manager and CTO of Cardiac Neuromodulation. Mr. Belsky received his MBA from Heriot-Watt University, his MSc in Electrical Engineering from Tel Aviv University, and his BSc in Physics and Mathematics from Hebrew University in Jerusalem.
“As we execute on our business strategy to optimize the clinical impact and commercial value of our products, it is critical that we leverage key relationships and work closely with established leaders in the industry. Each of these individuals have proven to have a strong track record and will bring key leadership and direction as we advance our products and drive Orchestra BioMed through its next phase of growth,” added David Hochman, Chairman of the Board and Chief Executive Officer of Orchestra BioMed.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence-based therapeutic solutions for medical procedures address major medical conditions, such as cardiovascular disease and hypertension, affect large patient populations and drive a significant portion of healthcare costs. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products. Orchestra BioMed expects to generate long-term, high margin cash flow from royalties, revenue sharing, as well as licensing and development payments from strategic partners that secure commercial rights to Orchestra BioMed-developed products. Orchestra BioMed’s core innovation and development expertise are in the areas of drug delivery, interventional devices, bioelectronics and neuromodulation. The Company’s lead cardiovascular therapies, which were developed from concept stage by Orchestra BioMed’s wholly- owned subsidiaries, are highly proprietary and have demonstrated promising clinical results in addressing specific high-need patient populations with artery disease and hypertension. The Virtue® Sirolimus-Eluting Balloon (SEB), is a novel, first-in-class device that delivers delayed-release Sirolimus, the proven gold-standard drug for preventing restenosis of treated arteries, to the vessel wall during balloon angioplasty without the need for a permanent implant. BackBeat® Cardiac Neuromodulation Therapy (CNT), is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward- looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
October 9, 2018
Eric A. Rose, M.D., biotech and medical device business leader as well as world-renowned cardiac surgeon and scientist who performed the landmark achievement of the first successful pediatric heart transplant
Jason Aryeh, life sciences industry expert, investment fund manager, and Director of licensing juggernaut Ligand Pharmaceuticals
Gary J. Pruden, former Worldwide Chairman for Johnson & Johnson Medical Devices Group and Executive Vice President of Johnson & Johnson
Expanded Strategic Advisory Board offers exceptional industry, product development, commercialization, and capital markets strategic insight and expertise
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformational therapeutic devices targeting major medical conditions, announced today the appointment of three new members to its Strategic Advisory Board (“SAB”). Joining the Company’s SAB is Gary J. Pruden, former Worldwide Chairman for Johnson & Johnson Medical Devices Group; Eric A. Rose, M.D., Executive Chairman of SIGA Technologies (Nasdaq: SIGA) and world-renowned cardiac surgeon and scientist; and Jason Aryeh, a life sciences investment fund manager and pharmaceutical industry expert who serves on the Board of Directors of Ligand Pharmaceuticals, Inc. (Nasdaq: LGND).
“Our core business objective is to fully realize the clinical and commercial value of our high impact, evidence-based product innovations through strategic collaborations with established market leaders. Our Strategic Advisory Board is a key extension of Orchestra’s knowledge, perspective and relationships with the medical device and biopharma industries. We are honored to welcome these distinguished individuals to the ranks of an already outstanding group,” stated David Hochman, Chairman of the Board and Chief Executive Officer of Orchestra BioMed. “We firmly believe that the experience and expertise that Gary, Eric and Jason have amassed over the course of their careers will be essential to our near- and long-term success as we execute on our development plans of our portfolio, specifically Virtue® SEB and BackBeat® CNT, two products that have the potential to address significant unmet medical needs in cardiovascular disease and hypertension.”
“I am honored and excited to work with Orchestra BioMed’s exceptional executives and esteemed board of advisors,” said Mr. Aryeh. “Orchestra’s late-stage programs, Virtue® SEB and BackBeat® CNT, have the potential to save many lives, offer profound health economic benefits, and be transformational and disruptive in two of the largest, most established medical device markets. I look forward to bringing my perspective, particularly my strategically relevant experience from Ligand, to Orchestra’s cuttingedge innovation, strategic partnering and high-margin, cash flow focused business model.”
New Strategic Advisor Biographies
Gary Pruden is a proven industry leader with a broad background in technology and pharmaceutical innovation and M&A transactions. Over the course of his 32-year career at Johnson and Johnson (NYSE: JNJ), Mr. Pruden held numerous senior leadership positions across both the medical devices and pharmaceutical sectors. As the Worldwide Chairman of the Medical Device group, he led a global business where new technologies, global expansion and focus on the patient were keys to success. He currently serves as a member of the Board of Directors of Motus GI Holdings, Inc. (Nasdaq: MOTS), an Orchestra-founded company. During his career at J&J, Mr. Pruden led a large global business with a significant portion of sales coming from outside of the United States including a strong focus on emerging markets. During his time at J&J, Mr. Pruden also helped lead the strategic collaboration with Google that was established for the advancement of surgical robotics. He has extensive experience in portfolio management including two large divestitures (Cordis Corporation and Codman Neurosurgery) and exits of non-strategic businesses, quality and compliance, as well as global regulatory experience. Additionally, Mr. Pruden serves as an Independent Director of Lantheus Holdings, Inc. (Nasdaq: LNTH).
Eric A. Rose, M.D. is a world-renowned innovative surgeon and scientist, best known for making history in 1984 when he performed the landmark achievement of the first successful pediatric heart transplant. Over the course of his career, he has continued to study and improve cardiac surgical care in children and adults. He currently serves as the Executive Chairman of the Board of Directors of SIGA Technologies, Inc. (Nasdaq: SIGA), a commercial-stage pharmaceutical company focused on serious unmet medical needs and biothreats. Previously, he had served as Chairman and CEO of SIGA. Dr. Rose chaired the Department of Health Evidence & Policy at the Mount Sinai School of Medicine from 2008 to 2012. From 1994 through 2007, he served as Chairman of the Department of Surgery and Surgeon-in-Chief of the Columbia Presbyterian Center of New York Presbyterian Hospital. In addition to his roles at SIGA, Dr. Rose holds a position as Executive Vice President – Life Sciences at MacAndrews & Forbes Incorporated, the holding company of Ronald O. Perelman and a related party to SIGA. In 2010, Dr. Rose became a director of Abiomed, Inc. (Nasdaq: ABMD), a leading provider of medical devices that provide circulatory support. In April 2013, he became a director for Mesoblast Inc. (Nasdaq: MESO), an advanced cellular medicine company, where he serves as Chairman of the Scientific and Technology Committee. Over the course of his career, Dr. Rose has authored or co-authored more than 300 peer-reviewed publications on topics such as cardiovascular surgery, ventricular assist devices, and cardiac transplantation, and he is the author of two books: Management of End-Stage Heart Disease and Second Opinion: The Columbia Presbyterian Guide to Surgery. Throughout his career, he has been involved in grants totaling more than $25 million in funding, including, a large National Heart, Lung, and Blood Institute project, the Human Biology of Long-Term Mechanical Circulatory Support.
Jason Aryeh is a life sciences investment fund manager and pharmaceutical industry expert with over twenty years of equity investment experience in the life sciences sector. Mr. Aryeh is the Founder and managing General Partner of JALAA Equities, LP, a private hedge fund focused on the biotechnology and medical device sectors and has served in such capacity since 1997. He has also served as a member of the Board of Directors of Ligand Pharmaceuticals, Inc. (Nasdaq: LGND), a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines and has served as Ligand’s Chairman of its Nominating and Governance Committee since September 2006. Mr. Aryeh is also a member of the Advisory Board of the Accreditation Council for Medical Affairs (ACMA), an internationally recognized accrediting body which focuses on properly educating, training and credentialing pharmaceutical and medical device industry sales representatives and medical science liaisons. As a shareholder-focused advocate, Mr. Aryeh has served on ten corporate or charitable foundation boards.
Existing Strategic Advisory Board Members
John R. Barr has spent his career in medical devices and most recently served as Chief Executive Officer at Surgical Specialties Inc., a privately held medical device firm specializing in wound closure and surgical knives that was sold to a private equity investor group in March 2017. Prior to that, he served as Executive Vice President and President of Global Surgical at Bausch & Lomb Holdings Incorporated until its acquisition by Valeant Pharmaceuticals in August 2013.
Eric S. Fain, M.D. is the President and Chief Executive Officer of Procyrion, a company focused on the treatment of heart failure through the development of a safe and innovative percutaneous mechanical circulatory support (pMCS) device. He is the former Senior Vice President and Group President, Cardiovascular and Neuromodulation at Abbott following its acquisition of St. Jude Medical. Dr. Fain became Group President of St. Jude Medical in 2014 where he was responsible for global sales, marketing and clinical affairs across the entire St. Jude Medical portfolio worldwide.
David Pacitti is President of Siemens Medical Solutions, Inc. and Head of Siemens Healthineers North America. Mr. Pacitti is responsible for leading the marketing, sales, service, and support functions in the U.S., with additional oversight of Canada, across the entire Healthcare portfolio, including medical imaging, laboratory diagnostics, therapy solutions, and services. Prior to joining Siemens in 2015 in his current role, Mr. Pacitti was Division Vice President of U.S. Commercial Operations, Sales, and Marketing at Abbott Vascular for two years, overseeing the company’s business in North America.
Louis Shapiro is President and CEO of Hospital for Special Surgery (“HSS”). He has served in this role since October 2006, overseeing all strategic and operational aspects of HSS and fulfilling its mission to advance the field of musculoskeletal medicine through world-class patient care, research and education. Under Mr. Shapiro’s leadership, HSS has experienced significant growth, expansion of facilities and recognition as the world leader in its specialty areas of orthopedics, rheumatology and their related disciplines. Mr. Shapiro has more than 30 years of healthcare experience, including as Executive Vice President and Chief Operating Officer of Geisinger Health System in Pennsylvania, and as a leader in the healthcare practice at McKinsey & Company.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence based therapeutic solutions for medical procedures that address major medical conditions, such as cardiovascular disease and hypertension, that affect large patient populations and drive a significant portion of healthcare costs. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products. Orchestra BioMed expects to generate long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments from strategic partners that secure commercial rights to Orchestra BioMed-developed products. Orchestra BioMed’s core innovation and development expertise is in the areas of drug delivery, interventional devices, bioelectronics and neuromodulation. The Company’s lead cardiovascular therapies, which were developed from concept stage by Orchestra BioMed’s whollyowned subsidiaries, are highly proprietary and have demonstrated promising clinical results in addressing specific high-need patient populations with artery disease and hypertension. The Virtue® Sirolimus-Eluting Balloon (SEB), is a novel, first in-class device that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, the proven gold-standard drug for preventing restenosis of treated arteries, to the vessel wall during balloon angioplasty without the need for a permanent implant. BackBeat® Cardiac Neuromodulation Therapy (CNT), is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forwardlooking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
October 8, 2018
Ms. Wheeler brings an extensive track record in marketing, strategy and commercial program development
New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing high impact, high value, evidence-based therapeutic solutions for medical procedures that address major medical conditions, announced today that it has appointed Inessa Wheeler, MBA, as Vice President of Strategy and Marketing.
Ms. Wheeler is a proven healthcare strategic marketing executive with over 15 years of experience in marketing strategy and commercial program development. Prior to joining Orchestra BioMed, Ms. Wheeler served since 2010 as President of D&E Strategy, LLC, a business strategy and marketing consulting firm that worked with established as well as start-up medical device and pharmaceutical companies. Prior to D&E Strategy, Ms. Wheeler was Group Marketing Manager for LifeCell Corporation, a regenerative medicine company that was acquired in 2017 by Allergan plc for $2.9 billion. Prior to LifeCell, Ms. Wheeler was a Product Director for Cordis, (a Johnson & Johnson company, subsequently sold to Cardinal Health for $1.9 billion), where she worked on marketing strategy and commercial programs for cardiovascular, neurovascular and endovascular interventional products. Ms. Wheeler earned an M.B.A. from Columbia Business School and a B.S. in Chemistry from The College of New Jersey.
Starting in 2013, Ms. Wheeler was engaged through D&E Strategy by the predecessor companies that were acquired to form Orchestra BioMed (Caliber Therapeutics®, BackBeat Medical® and FreeHold Surgical®) in May 2018. In this capacity, she provided strategy and marketing guidance toward the development and market positioning of Orchestra BioMed’s lead development products, the Virtue® Sirolimus-eluting Balloon and BackBeat® Cardiac Neuromodulation Therapy, as well as to the Company’s commercial-stage surgical devices, FreeHold Duo® and FreeHold Trio®. She has also provided strategy and marketing services to Motus GI (Nasdaq:MOTS) in which Orchestra BioMed is major strategic equity holder.
“We are delighted that Inessa agreed to join our leadership team on full-time basis. Her track record and her extensive prior experience with Orchestra BioMed’s product portfolio makes her ideally suited to drive strategy and marketing for these exciting products,” commented David Hochman, Chief Executive Officer and Chairman of the Board of Orchestra BioMed. “Her appointment is another important step in ensuring we have the right core expertise in place to execute our business strategy focused on the development of high impact, high value, evidence-based product innovations that are optimally positioned for clinical and commercial realization through partnerships with established market leaders.”
“Orchestra BioMed is working to differentiate itself as a leader in the development of innovative solutions that can transform critical areas of procedure-based medicine and help address major unmet needs such as artery disease and hypertension,” Ms. Wheeler stated. “Having already spent years working as an advisor to help advance and position what I believe is an extraordinary pipeline of products, I am truly excited to join the team that will help drive these important therapies to market.”
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing high impact, high value, evidence based therapeutic solutions for medical procedures that address major medical conditions, such as cardiovascular disease and hypertension, that affect large patient populations and drive a significant portion of healthcare costs. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products. Orchestra BioMed expects to generate long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments from strategic partners that secure commercial rights to Orchestra BioMed-developed products. Orchestra BioMed’s core innovation and development expertise is in the areas of drug delivery, bioelectronics and neuromodulation, as well as interventional, robotic and other minimally-invasive therapeutic devices. The Company’s lead cardiovascular therapies, which were developed from concept stage by Orchestra BioMed’s wholly-owned subsidiaries, are highly proprietary and have demonstrated promising clinical results in addressing specific high-need patient populations with artery disease and hypertension. The Virtue® Sirolimus-Eluting Balloon (SEB), is a novel, first in-class device that delivers delayed-release bioabsorbable particle encapsulated Sirolimus, the proven gold-standard drug for preventing restenosis of treated arteries, to the vessel wall during balloon angioplasty without the need for a permanent implant. BackBeat® Cardiac Neuromodulation Therapy (CNT), is a patented implantable cardiac stimulation-based treatment for hypertension that immediately and substantially lowers blood pressure while simultaneously modulating autonomic nervous system responses that normally drive and maintain blood pressure higher.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
September 25, 2018
Immediate, Substantial, and Sustained Reduction in Blood Pressure Demonstrates Potential to Offer Highly Differentiated, Breakthrough Treatment for Hypertension
San Diego, CA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformational therapeutic devices targeting major medical conditions, presented positive 2-year clinical results from its multicenter clinical trial for BackBeat® Cardiac Neuromodulation Therapy (CNT) at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 in San Diego, CA. Daniel Burkhoff, M.D., Ph.D., Director, Heart Failure, Hemodynamics and Mechanical Circulatory Support Research for the Cardiovascular Research Foundation, presented clinical outcomes of the Moderato I Study, which demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat CNT was used in patients with persistent hypertension (office BP > 150mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.
"The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70% of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Professor Petr Neuzil, M.D., Head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the Principal Investigators of the study.
The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato™ dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:
“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Dr. Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”
To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat® CNT) versus standard medical therapy trial, Moderato II, in patients with uncontrolled blood pressure (office Systolic > 140, Day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control. The Company is expecting results on the first cohort of patients in 2019.
About BackBeat® CNT
BackBeat's CNT, a flagship product of Orchestra BioMed, is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating Autonomic Nervous System (ANS). Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers. BackBeat CNT is applicable to a wide range of hypertensive patients inclusive of Isolated Systolic Hypertension, hypertensive patients who are also indicated for a pacemaker and uncontrolled hypertensive patients. Orchestra BioMed is currently working to obtain regulatory approval for BackBeat CNT in Europe. In addition, the Company is nearing completion of its first cohort of patients (~50 patients) in a prospective, randomized, double-blind study, Moderato II, to further substantiate the clinical benefits of therapy.
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing transformational therapies for major medical conditions, such as cardiovascular, gastrointestinal and metabolic disease, that affect a significant portion of the population and drive a majority of healthcare costs. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products. Orchestra BioMed expects to generate long-term, high margin cash flow from royalties, revenue sharing, and licensing and development payments from strategic partners that secure commercial rights to Orchestra BioMed-developed products. Orchestra BioMed’s core innovation and development expertise is in the areas of drug delivery, bioelectronics and neuromodulation, as well as interventional, robotic and other minimally-invasive therapeutic devices.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
obio@jtcir.com
Source: Orchestra BioMed, Inc.
September 24, 2018
Excellent Long-Term Safety and Efficacy Profile Demonstrate Potential to Offer Valuable New Treatment for Coronary In-Stent Restenosis
San Diego, CA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformational therapeutic devices targeting major medical conditions, announced the 3-year clinical results from its Sirolimus Angioplasty Balloon for In-Stent Restenosis (SABRE) Trial at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 in San Diego, CA. Juan Granada, M.D., Associate Professor of Medicine at the Columbia University College of Physicians and Surgeons and President and CEO of Cardiovascular Research Foundation, presented the outcomes of SABRE trial, which demonstrated excellent efficacy and safety performance of the Virtue® Sirolimus-Eluting Balloon (SEB) in a very challenging patient population with predominantly long, diffuse restenosis lesions within stents that had been implanted an average of nearly 4 years prior to the study enrollment. The primary safety and efficacy per protocol endpoint results of the study were as follows:
“The clear biological efficacy demonstrated by this study, despite complex and challenging cases, was consistent with the effective therapeutic delivery of sirolimus during angioplasty. The results with Virtue SEB compare favorably to proven drug-eluting stents (DES) and Paclitaxel-coated balloons (PCB) and outperform PCBs in some key safety metrics observed in other coronary in-stent restenosis trials,” commented Stefan Verheye M.D., Senior Interventional Cardiologist at Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium and Principal Investigator in the SABRE study.
“We still do not have a perfect solution for the treatment of late stent failures and the 3- year results of the SABRE trial are very encouraging in the search to find a ‘leave nothing behind solution’ with a favorable safety profile and biological efficacy comparable to proven drug-eluting stents,” said Dr. Granada.
The SABRE trial was a prospective, 50-patient multi-center study conducted in European centers. Twelve-month follow-up data from the SABRE study was published in JACC: Cardiovascular Interventions, October 2017. Clinicians in the study had 100% procedural success rate (per patient) with Virtue® SEB, indicating the ease of use of the system. By enabling the simultaneous delivery of a full therapeutic dose of sirolimus during angioplasty, Virtue® SEB aims to address long-term issues associated with late adverse events following treatment of coronary arteries with stents, which are permanent implants.
Unmet Clinical Needs Associated with Coronary In-Stent Restenosis
Although the original introduction of bare metal stents (BMS) significantly improved short- term outcomes observed with plain balloon angioplasty, extensive data shows late adverse events occur at an annual rate of approximately 2.1% following the year after implantation. Drug-eluting stents (DES), which currently exclusively utilize sirolimus or chemical analogs, were introduced to further advance the treatment of coronary restenosis. While the presence of a drug immediately following the implantation dramatically improved the TLF rates in the first year after implantation over BMS, longer term TLF rates are higher (2-4%/year) even with 2nd generation DES. It is believed that the long-term events are driven by the permanent presence of a metal stent in the artery. Bioabsorbable stents, led by Absorb GT1 Bioabsorbable Vascular Scaffold (Abbott), were designed to overcome the permanent implant issue by dissolving over 24-36 months following implantation and showed promising short-term outcomes. However, at 3 years, Absorb GT1 Bioabsorbable Vascular Scaffold was associated with statistically significant higher rates of late stent-related thrombosis than DES and Abbott has halted commercial sales of the product.
Clinical interest to eliminate the need for a permanent stent is perhaps strongest in cases of coronary in-stent restenosis (ISR) where the off-label placement of an additional stent on top of the original stent has been shown to drive an increase in long-term TLF. While angioplasty balloons coated with the cytotoxic agent paclitaxel have been approved in the US for the treatment of the superficial femoral artery, a large peripheral vessel in the upper leg, and have shown promise outside the US for the treatment of coronary ISR, sirolimus is the gold-standard pharmaceutical agent used in conjunction with coronary stenting to prevent restenosis (reclogging) of an artery following percutaneous coronary intervention (PCI), as extensive clinical data demonstrated clinical superiority to paclitaxel. Further, drug-coated balloons present potential concerns associated with the safety risk of creating large size particulate from the coating that block smaller vessels distal to treated lesions.
About Virtue® SEB
The Virtue® Sirolimus-Eluting Balloon (SEB), a flagship product of Orchestra BioMed, is a balloon angioplasty system that allows for delivery and controlled-release of therapeutic dose of sirolimus without the need for coating. Virtue SEB performs balloon angioplasty using a patented microporous balloon and allows simultaneous, full-dose drug delivery to the lesion without the need for coating thereby eliminating safety concerns of dislodging large emboli and removing concerns associated with drug and coating loss during navigation to the target lesion. Virtue SEB delivers and controls the release of a full therapeutic dose of sirolimus using a proprietary bioabsorbable particle technology. Drug elution kinetics have been shown to be consistent with the pharmacokinetic profiles for the proven DES (EuroIntervention, August 2016).
About Orchestra BioMed™
Orchestra BioMed, Inc. is a biomedical innovation company focused on developing transformational therapies for major medical conditions, such as cardiovascular, gastrointestinal and metabolic disease, that affect a significant portion of the population and drive a majority of healthcare costs. Orchestra BioMed’s business strategy is to leverage partnerships with established global market leaders to optimize the clinical impact and commercial value of its products. Orchestra BioMed expects to generate long- term, high margin cash flow from royalties, revenue sharing, and licensing and development payments from strategic partners that secure commercial rights to Orchestra BioMed-developed products. Orchestra BioMed’s core innovation and development expertise is in the areas of drug delivery, bioelectronics and neuromodulation, as well as interventional, robotic and other minimally-invasive therapeutic devices. For more information about Orchestra BioMed, please visit www.orchestrabiomed.com.
Forward Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward- looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Jenene Thomas
(833) 475-8247
OBIO@jtcir.com
Source: Orchestra BioMed, Inc.
December 23, 2017
American Heart Association Journal
3-months data from Moderato-HTN first-in-human clinical study was published in the American Heart Association Journal. The study was an open-label, single-arm, multicenter, prospective trial investigating the safety and efficacy of BackBeat PHC pacing therapy in patients with persistent hypertension indicated for implantation or replacement of a dual-chamber pacemaker.
Twenty seven (27) patients with persistent oSBP>140 mmHg after 1-month of conventional pacing were included in the study. Compared with pre-PHC therapy activation measurements, office systolic blood pressure decreased by 16 mmHg at 3 months, which corresponded to a 24 mmHg drop from baseline values. No device-related serious adverse effects were noted. The paper concluded that initial indications are that this therapy is a safe and promising therapy for pacemaker patients with persistent hypertension.
December 5, 2017
International Conference for Innovation (ICI), Tel Aviv, Israel
BackBeat’s abstract entitled “Two-Year Experience with Programmable Hypertension Control Therapy: A Novel Treatment for Hypertension” was awarded best abstract at the International Conference for Innovation (ICI) that took place in Tel Aviv, Israel on December 3-5, 2017 and helped create a lot of buzz throughout the conference about this transformational therapy.
October 23, 2017
JACC: Cardiovascular Interventions
Angiographic results and 1-year clinical outcomes of the SABRE (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) trial were published in JACC: Cardiovascular Interventions, October 2017.
ABSTRACT.
Objectives
The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).
Background
Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue® angioplasty balloon (delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.
Methods
In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.
Results
Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.
Conclusions
This first-in-human study showed excellent procedural success for the Virtue Sirolimus-eluting balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.
November 4, 2016
Transcatheter Cardiovascular Therapeutics (TCT), Washington, DC.
New Hope, PA – BackBeat Medical Inc. today announced that the company's patented Programmable Hypertension Control (PHC) therapy received first place in the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference in Washington, DC.
"The Shark Tank Innovation Competition is designed to select and highlight the most innovative new concepts in cardiovascular medicine today," said Juan F. Granada, MD, Executive Director and Chief Innovation Officer of the Skirball Center for Innovation at the Cardiovascular Research Foundation (CRF). "Seven companies were selected to present at TCT this year from over 60 submissions we received as part of the competition. BackBeat's novel treatment for hypertension was a standout because of its potential to benefit patients in an area with enormous unmet clinical needs. It was selected as the winner by a highly accomplished panel of judges including physician innovators, physician investors, and physicians involved in building companies and developing innovative, high impact therapies."
BackBeat's PHC therapy employs a patented method of cardiac pacing to substantially lower blood pressure while modulating the response of the baroreflex to prevent activation of the autonomic nervous system. Data presented at TCT demonstrated a continued significant reduction in blood pressure of 13.9 mmHg over a one year period in 25 patients who received BackBeat's PHC-enabled Moderato™ pacemaker using standard commercially available leads and standard lead placement. PHC therapy can also be readily incorporated into marketed pacemakers and could be added to already implanted pacemakers as a software download performed in the clinic.
Darren Sherman, co-founder of BackBeat Medical, added, "We are honored to receive this award. TCT is one of the premier forums for showcasing innovation in interventional and vascular medicine. We are humbled to have our technology recognized by such an esteemed panel of judges. Even more, we are excited to continue to deliver on the promise of PHC therapy as we look to realize its significant clinical and commercial promise in the future."
August 28, 2016
The Journal of Innovation in Cardiac Rhythm Management
BackBeat Medical Inc. today announced the presentation of data demonstrating a significant and sustained reduction in blood pressure in patients with hypertension using the company's patented cardiac pacing-based treatment.
The focus of an oral late-breaking clinical trial presentation by study investigator Petr Neuzil, M.D., Ph.D., at the European Society of Cardiology's annual scientific meeting, ESC Congress, in Rome, the data consisted of detailed results from a multicenter clinical trial of BackBeat's Programmable Hypertension Control (PHC) therapy.
In the study that enrolled 35 hypertensive patients indicated for implantation of a permanent dual-chamber pacemaker at 10 sites worldwide, participants received a pacemaker developed by BackBeat, called the Moderato™, that incorporates the company's proprietary PHC algorithm. During the first month of treatment, only the standard pacing functions were activated to allow estimation of the expected effect of participation in a study on blood pressure. After the first month, 27 patients met the strict study inclusion criteria at the end of the run-in period. However, PHC therapy was successfully activated in all patients with therapeutic benefit. In this study group that met all of the study inclusion criteria, 24-hour ambulatory systolic pressure significantly decreased by 11 mmHg immediately after PHC activation and was maintained low during the study period. After three months, ambulatory pressure had decreased by 10 mmHg from pre-activation (p=0.004; 14 mmHg from baseline, p<0.001). Office cuff pressure data were also collected on these patients and showed an average reduction of 16mmHg from pre-activation levels (p<0.001, 24 mmHg from baseline) after three months of therapy. This effect was maintained in patients who have so far reached later follow-up time points, with a significant reduction of 20 mmHg (p<0.001) from the pre-activation pressure after 12 months of therapy and 21 mmHg (p=0.02) after 24 months.
"By reducing ventricle filling and modulating the baroreflex response in hypertensive patients with a unique algorithm in a standard pacemaker, we were able to quickly reduce systolic blood pressure and sustain the response throughout the three-month study period," said Dr. Neuzil, one of the study's investigators and the head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic. "Additionally, these results have been maintained in patients beyond two years following the activation of the therapy. This is a highly differentiated approach to treating hypertension that provides a significant reduction in blood pressure with relatively no additional risk because the pacemaker implants are already required for these patients. BackBeat's PHC therapy has the potential to offer significant clinical benefits and help address the known side effects and compliance challenges associated with hypertension medications."
BackBeat's PHC algorithm reduces ventricular filing to lower blood pressure while modulating the response of the baroreflex to prevent activation of the autonomic nervous system. This technology can be readily incorporated into marketed pacemakers using standard leads and standard lead placement. It also could be added to already implanted pacemakers as a software download performed in the clinic. Hypertension affects over 70% of pacemaker patients and is uncontrolled in approximately 38% of the total pacemaker population. These patients could benefit substantially from a potent hypertension therapy such as PHC that could be included in their already necessary pacemaker.
Yuval Mika, Ph.D., CEO and co-founder of BackBeat Medical, said, "PHC therapy potentially represents an entirely new field of hypertension treatment that will leverage the use of pacemakers for a significant new market just as biventricular pacing has been used to treat heart failure. Incorporating BackBeat's PHC pacing algorithm into standard pacemakers would provide significant differentiation to increase the commercial value of a combination pacemaker. Furthermore, it could drive market share gains in the large population of the patients who could benefit substantially from a hypertension therapy that could be included in their pacemaker. With the data from our study, we believe that this device-based treatment of hypertension is now a reality, and we are actively pursuing plans to make this therapy broadly available first for patients already requiring pacemakers and, in the future, for other hypertensive patients struggling to keep blood pressure under control despite medication."
BackBeat is currently working to obtain regulatory approval in Europe for PHC therapy using data generated to date with BackBeat's Moderato™ device. In addition, the first patients have been enrolled in another European BackBeat-sponsored 170-patient, randomized, double-blind study designed to further investigate the benefit of PHC therapy in hypertensive pacemaker patients. This study, which will involve up to 30 clinical sites, will be used to drive adoption and gain reimbursement in Europe as well as support future regulatory approval of PHC therapy in the U.S. and other countries.
Virtue® SAB is investigational and not commercially approved.
BackBeat CNT™ (also known as AVIM therapy) is investigational and not commercially approved.
© 2024 Orchestra BioMed Inc. Virtue®, BackBeat CNT™ FreeHold Duo®, FreeHold Trio® and Orchestra BioMed™ are trademarks of Orchestra BioMed.
All other trademarks are trademarks of their respective owners.
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