Three-Month Data from the Moderato-HTN Trial Published
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.
Abstract on BackBeat® CNT Awarded Best Abstract at the International Conference for Innovations
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.
Angiographic Results and 1-Year Clinical Outcomes from the SABRE Trial Published
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.
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).
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.
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.
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.
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.
BackBeat Medical Wins Top Honor in TCT 2016 Shark Tank Innovation Competition
November 4, 2016
Transcatheter Cardiovascular Therapeutics (TCT), Washington, DC.
NEW HOPE, Pa., Nov. 4, 2016 /PRNewswire/ -- 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."
Results of Multicenter Clinical Study Demonstrate BackBeat's Patented Technology Creates a Potential Breakthrough in Device-Based Treatment of Hypertension
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.