Our Innovations

Virtue^® SAB

Aims to be the first-in-class Sirolimus AngioInfusion Balloon (SAB) for the treatment of artery disease

Virtue SAB is designed to enable protected drug delivery and extended focal release of therapeutic levels of sirolimus over the critical healing period, revolutionizing drug delivery while leaving nothing behind.

AngioInfusion™ Balloon

Designed to...

Dilate artery and restore blood flow without leaving a permanent implant behind.

Enable protected drug delivery to consistently deliver the intended dose and to reduce potential downstream ischemia from large drug coating particulates.

SirolimusEFR™

Designed to...

Deliver sirolimus, a proven anti-restenotic, cytostatic drug with a broad safety window.

Provide extended focal release of therapeutic levels of sirolimus during the critical healing period of approximately 30 days.

Novel AngioInfusion Balloon

Designed to enable angioplasty with protected drug delivery to overcome challenges of drug-coated balloons.

Provides consistent delivery of intended dose. No drug lost in transit

Enables standard navigation and deployment technique

Reduces potential downstream ischemia from large coating particulates

Protected Delivery Design (Non-Drug Coated)

No drug loss in transit
No time constraints on positioning
No drug coating particulates

SirolimusEFR

Designed to support extended focal release of therapeutic levels of sirolimus through the critical healing period.

The clinically proven, anti-restenotic, cytostatic drug with a broad safety window

Overcomes the challenges of leaving a stent behind

Focal therapeutic sirolimus tissue concentrations >= 30 days correlate to improved outcomes

Virtue SAB is supported by encouraging published preclinical data and clinical data out to 3 years.

Clinical

Virtue SAB preliminarily promising safety and efficacy results in patients with coronary in-stent restenosis (ISR) in the prospective, multi-center SABRE Trial.^1,2,3

0.12mm

LLL⁴ at 6-month angiographic assessment

2.8%

TLF⁴ at 1 year

0%

new TLR⁴ between 1 to 3 years

Preliminarily Demonstrated Efficacy
with Low 0.12mm Late Loss

Preliminarily Demonstrated Safety
with Low Event Rates Out to 3 Years

Angiographic results and 1-year clinical outcomes published in JACC: Cardiovascular Interventions, October 2017

3-Year Clinical Results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2018

Preclinical

Virtue SAB achieved focal therapeutic sirolimus tissue concentrations through the critical healing period of approximately 30 days.⁸

Enabled Therapeutic Arterial Tissue Concentrations
with Low Systemic Concentrations

Enables Therapeutic Arterial Tissue Concentrations with Low Systemic Concentrations chart

126 pigs, N= 753 arterial segments

Granada J, et al. EuroIntervention 2016;12:740-747

¹Verheye et al. JACC Cardiovasc Interv 2017 Oct 23;10(20):2029-2037. DOI: 10.1016/j.jcin.2017.06.021.

²Granada 3-Year Clinical Results TCT 2018. 3-Year SABRE Trial Clinical Report on file.

³Revised per protocol analysis set meets the criteria of the proposed In-Stent Restenosis IDE study population

⁴Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Target Vessel Myocardial Infarction (TV-MI)

⁵RVD reported using Internormal values

⁶Trial primary performance endpoint

⁷Trial secondary performance endpoint (binary restenosis = >50% lumen diameter stenosis)

⁸Granada J, et al. EuroIntervention 2016;12:740-747

Strategic partnership with Terumo Corporation for the development and commercialization of Virtue SAB.

In June 2019, Orchestra BioMed entered into a collaborative agreement with Terumo Corporation, one of the largest medical device companies in the world with corporate headquarters in Tokyo, Japan, pursuant to which Terumo secured global commercialization rights for Virtue SAB in coronary and peripheral vascular indications.

"We are excited to partner with Orchestra BioMed and secure global rights to Virtue SAB, which we intend to make a flagship therapeutic product…The unique design of Virtue SAB 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."

James Rushworth,
CEO, Terumo Medical Corporation (North America)

"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."

David Hochman,
Chairman, CEO and Founder, Orchestra BioMed

About the Agreement

Terumo made a one-time, up-front payment and an equity commitment to Orchestra BioMed and will potentially make additional future clinical and regulatory milestone payments to Orchestra BioMed
Terumo will assume financial and execution responsibility for substantially all of future clinical and regulatory development with the exception of the Virtue ISR-US trial. Terumo will also be responsible for device manufacturing, commercial sales, marketing and distribution for Virtue SAB for coronary and peripheral vascular indications globally
Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SAB through royalties and per unit payments as the exclusive supplier of the proprietary SirolimusEFR formulation used in Virtue SAB
Orchestra BioMed retains the rights to develop and license technology used in Virtue SAB for clinical applications outside of coronary and peripheral vascular intervention

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Virtue® SAB