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Our Innovations

Virtue® SAB

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

Virtue SAB revolutionizes angioplasty with protected delivery of extended focal release sirolimus, while leaving nothing behind.

  • Technology
  • Data
  • Partner
AngioInfusion™ Balloon

AngioInfusion™ Balloon

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.

SirolimusEFR™ Formulation

SirolimusEFR™ Formulation

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.

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Novel AngioInfusion Balloon

Enables 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

SirolimusEFR Formulation

Supports extended focal release of therapeutic levels of sirolimus during the 30-day 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 extensive published preclinical data and strong clinical data out to 3 years.

Preclinical

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

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

Clinical

Virtue SAB demonstrated promising safety and efficacy in patients with coronary in-stent restenosis (ISR) in 50-patient prospective, multi-center SABRE Trial†.


0.0%

TLF*, MI*, Death, Thrombosis at 30 days


0.12mm

LLL* at 6-month angiographic assessment


2.8%

TLF at 1 year


0%

new TLR* between 1 to 3 years


Demonstrated Efficacy
with Low 0.12mm Late Loss

Virtue SAB Clinical Data


1RVD reported using Internormal values; 2Trial primary performance endpoint; 3Trial secondary performance endpoint (binary restenosis = >50% lumen diameter stenosis)

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

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)

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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.

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"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)

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"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 also make substantial 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 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 interventions

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

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© 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.
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