Virtue® SAB

Potential 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.

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Technology

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.

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.

Novel AngioInfusion Balloon

1

Precise dose is loaded and protected in dose unit (DU)

No drug loss in transit

2

Balloon positioned using standard PCI technique no 'rush to target' as dose is protected inside DU

No time constraints on positioning

3

Virtue® SAB inflated to simultaneously dilate the vessel and deliver intended dose through the micropores.

No drug coating particulates

SirolimusEFR

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

Delivers Sirolimus
Provides extended release of sirolimus through the critical healing period
Eliminated leaving nothing behind

Virtue® SAB is investigational and not commercially approved.

Sirolimus illustration

Data

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

0.12mm

LLL at 6-month angiographic assessment

2.8%

TLF4 at 1 year

0%

new TLR between 1 to 3 years

Preliminarily Demonstrated Efficacy
with Low 0.12mm Late Loss
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Preliminarily Demonstrated Safety
with Low Event Rates Out to 3 Years
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Preclinical

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

Enabled Therapeutic Arterial Tissue Concentrations
with Low Systemic Concentrations
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Partner

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

Orchestra Logo
Medtronic Logo

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.

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

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)
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.