Orchestra BioMed logo

Close

  • Who We Are
    • Our Approach
    • Our People
    • Careers
  • Our Innovations
    • Pipeline
    • Therapeutic Areas
    • Virtue® SAB
    • BackBeat CNT™
    • FreeHold Retractors
  • Investor Relations
    • Overview
    • News & Events
    • Stock Information
    • Corporate Governance
    • Financial & Filings
    • IR Resources
  • Contact Us

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.

  • Technology
  • Data
  • Partner
AngioInfusion™ Balloon

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™

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.

Close

Novel AngioInfusion Balloon

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

Novel AngioInfusion Balloon Novel AngioInfusion Balloon
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.

SirolimusEFR Formulation SirolimusEFR Formulation
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
data-icon

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

Virtue SAB Clinical Data

 

Preliminarily Demonstrated Safety
with Low Event Rates Out to 3 Years

Low Event Rates chart

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

data-icon

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

Orchestra BioMed logoTerumo 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.

quote icon

"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)

quote icon

"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

Virtue® SAB is not approved for commercial use in the US

Orchestra BioMed logo
  • Who We Are
    Our Approach
    Our People
    Careers
  • Our Innovations
    Pipeline
    Therapeutic Areas
    Virtue® SAB
    BackBeat CNT™
    FreeHold Retractors
  • Investor Relations
    Overview
    News & Events
    Stock Information
    Corporate Governance
    Financial & Filings
    IR Resources
  • Contact Us

© 2023 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

Disclaimer