Orchestra BioMed and Terumo Enter into New $30 Million Virtue SAB Strategic Agreements

Core Insights - Orchestra BioMed has entered into a termination and right of first refusal agreement with Terumo Corporation regarding the Virtue® Sirolimus AngioInfusion™ Balloon for coronary artery disease treatment, with Terumo making an upfront payment of $10 million [1] - Terumo will invest an additional $20 million in Orchestra BioMed through a new series of non-voting preferred stock, convertible into common stock at a minimum of $12 per share [1] - The new agreements highlight the clinical and commercial potential of Virtue SAB, which is positioned to become a leading therapy in the global coronary market [2] Agreement Details - The ROFR Agreement allows Orchestra BioMed to seek development and commercialization partnerships for Virtue SAB in any therapeutic indication, while Terumo has the first right to respond to third-party offers related to the global coronary market [3] - The ROFR period lasts for 90 days after the disclosure of primary endpoint data from the Virtue Trial [3] - The transactions are expected to close by November 7, 2025, subject to customary closing conditions [4] Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through strategic collaborations, with flagship products including AVIM Therapy and Virtue SAB, both targeting multi-billion-dollar global market opportunities [5] - Virtue SAB is a first-of-its-kind drug delivery angioplasty balloon system designed to deliver an extended-release formulation of sirolimus, showing positive clinical data in treating coronary in-stent restenosis [8] - The company has received FDA Breakthrough Device Designation for Virtue SAB for multiple indications, including coronary ISR and small vessel disease [7][8] Market Context - Coronary in-stent restenosis (ISR) is a significant complication affecting up to 10% of stented patients in the first year, leading to over 325,000 lesions annually that may require treatment [9] - Current FDA-approved treatments for coronary ISR are limited, with traditional balloon angioplasty having high retreatment rates, indicating a need for innovative solutions like Virtue SAB [9]