Virtue SAB revolutionizes angioplasty with protected delivery of extended focal release sirolimus, while leaving nothing behind.
Dilates artery and restores blood flow without leaving a permanent implant behind.
Enables protected drug delivery to consistently deliver intended dose and to reduce potential downstream ischemia from large particulates.
Delivers sirolimus, the coronary gold standard anti-restenotic, cytostatic drug with a broad safety window.
Provides extended focal release of therapeutic levels of sirolimus during the critical healing period.
Enables angioplasty with protected drug delivery to overcome challenges of drug-coated balloons.
Supports extended focal release of therapeutic levels of sirolimus during the 30-day critical healing period.
Virtue SAB is supported by extensive published preclinical data and strong clinical data out to 3 years.
Virtue SAB achieves focal therapeutic sirolimus tissue concentrations through the critical healing period. Extended release through 30 days correlates to improved clinical outcomes as seen with drug-eluting stents.
Enables Therapeutic Arterial Tissue Concentrations
with Low Systemic Concentrations
126 pigs, N= 753 arterial segments
Virtue SAB demonstrated promising safety and efficacy in patients with coronary in-stent restenosis (ISR) in 50-patient prospective, multi-center SABRE Trial†.
TLF*, MI*, Death, Thrombosis at 30 days
LLL* at 6-month angiographic assessment
TLF at 1 year
new TLR* between 1 to 3 years
with Low 0.12mm Late Loss
1RVD reported using Internormal values; 2Trial primary performance endpoint; 3Trial secondary performance endpoint (binary restenosis = >50% lumen diameter stenosis)
with Low Event Rates Out to 3 Years
3-Year SABRE Trial Clinical Report on file at the company
†Revised per protocol analysis set meets the criteria of the proposed In-Stent Restenosis IDE study population
*Target lesion failure (TLF), late lumen loss (LLL), target lesion revascularization (TLR) and Myocardial Infarction (MI)
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."
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."
Chairman, CEO and Founder, Orchestra BioMed
About the Agreement
Virtue® SAB is not approved for commercial use in the US
© 2022 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.
SM-0020 Rev 01