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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