During our recent public business update call, Chairman & CEO David Hochman discussed a number of key developments achieved over the last several months, including why Orchestra BioMed believes Virtue SAB represents a fundamentally different approach to the treatment of coronary artery disease and a major long-term value driver for our Company and shareholders.
This post summarizes that part of the discussion and explains what differentiates Virtue SAB — and why it matters for investors, especially in connection with the recent strengthening of the Company’s balance sheet and strategic partnership positioning.
Drug delivery balloons are rapidly becoming an accepted “leave-nothing-behind” treatment option for coronary artery disease, an annual global market estimated at approximately $7.5 billion. Yet, every such balloon device is a drug-coated balloon or “DCB” with the exception of Orchestra’s Virtue SAB.
All DCB — whether paclitaxel- or sirolimus-based — faces the same inherent limitations: restricted drug-loading capacity, a thin and fragile surface coating that sheds during navigation to the target lesion, and large particulate release that has the potential to cause downstream micro-embolization. These constraints seem to cap efficacy and create procedural challenges for physicians.
Virtue SAB is different by design. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) is the only non-coated balloon-based drug-delivery system in development for coronary indications.
Engineered specifically to deliver Orchestra BioMed’s proprietary SirolimusEFR™ (Extended Focal Release) formulation, Virtue SAB enables optimized uptake and extended release of sirolimus, the proven “gold standard” drug class used on all currently available drug-eluting stents, with targeted vessel delivery through our patented microporous balloon delivery system.
These data underpin the recently launched Virtue Trial, the first U.S. pivotal IDE study to compare a sirolimus-eluting balloon head-to-head with an approved paclitaxel-coated balloon for coronary ISR.
Virtue SAB embodies the kind of disruptive, de-risked innovation that can redefine an established medical market. It addresses the key limitations of coated balloons while preserving the procedural simplicity physicians want — and it does so within a strong reimbursement and adoption framework that already supports premium pricing.
For shareholders, this means exposure to a large, visible market and a clear, data-driven pathway toward potential U.S. approval that could materially expand Orchestra BioMed’s long-term value creation potential.
— Team OBIO Published November 2025
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risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2024, and under the heading “Item 1A. Risk Factors” in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of the Content. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made in the Content, except as required by law.