FDA Clears Orchestra BioMed's Virtue SAB Trial To Treat Coronary ISR

(RTTNews) - Orchestra BioMed Holdings, Inc. (OBIO), a biomedical company focused on advancing high-impact technologies, announced that the U.S. Food and Drug Administration or FDA has approved an Investigational Device Exemption or IDE amendment for its Virtue SAB in the Treatment of Coronary ISR Trial.

This regulatory clearance allows the company to proceed with a pivotal U.S. clinical trial comparing its Virtue Sirolimus-AngioInfusion Balloon (Virtue SAB) to Boston Scientific's AGENT paclitaxel-coated balloon—the only drug-coated balloon (DCB) currently FDA-approved for coronary use. Data from the trial will support potential U.S. approval of Virtue SAB.

Virtue SAB, designated as an FDA Breakthrough Device, is engineered to deliver a proprietary extended-release sirolimus formulation (SirolimusEFR™) using a non-coated, microporous AngioInfusion™ Balloon. This design protects the drug during transit and ensures effective tissue delivery, surpassing limitations of conventional DCBs. It maintains therapeutic sirolimus levels in the tissue for 30 days—the critical healing period—making it suitable for treating coronary ISR, coronary small vessel disease, and below-the-knee peripheral artery disease.

Dr. Dean Kereiakes, Co-Principal Investigator, highlighted Virtue SAB's unique ability to optimize both sirolimus uptake and retention, achieving drug performance comparable to or better than limus-eluting stents. He noted that the technology addresses the shortcomings of traditional DCBs, such as limited drug dose and risk of emboli, and could redefine care standards in interventional cardiology.

Dr. Allen Jeremias, also a Co-Principal Investigator, emphasized the significance of Virtue SAB's novel mechanism of action. Unlike paclitaxel-based DCBs, it delivers a high liquid dose of sirolimus with anti-restenotic, anti-inflammatory, and cytostatic effects, making it a strong candidate for shifting the coronary treatment paradigm.

CEO David Hochman explained that the head-to-head trial with the AGENT balloon reflects confidence in Virtue SAB's clinical and market potential. He underscored sirolimus' superiority over paclitaxel, supported by stent meta-analyses, and noted Virtue SAB's ability to match the drug delivery profile of high-performing drug-eluting stents—without leaving a permanent implant. He praised the team and collaborators for reaching this significant milestone.

The Virtue Trial is a prospective, randomized, multi-center study involving 740 patients across up to 75 U.S. centers. It compares Virtue SAB to the AGENT paclitaxel DCB in treating coronary ISR, with the primary goal of proving non-inferiority in 12-month Target Lesion Failure (TLF). The trial is set to begin in the second half of 2025.

About Coronary ISR: Coronary in-stent restenosis (ISR) involves the re-narrowing of a previously stented coronary artery segment, posing serious health risks. It affects up to 10% of patients within the first year post-stenting and around 3% annually thereafter, resulting in over 325,000 ISR lesions globally each year.

About Virtue SAB: Virtue SAB uses a unique balloon-based delivery of extended-release sirolimus, maintaining drug concentrations above therapeutic levels for the entire 30-day healing period. It has shown promising outcomes in preclinical studies and the SABRE pilot trial in Europe and holds FDA Breakthrough Device Designations for multiple coronary and peripheral indications.

OBIO is currently trading at $2.58 or 1.15% lower on the Nasdaq Global Market.