- Orchestra BioMed and Terumo Corporation have entered into a new termination and right of first refusal (ROFR) agreement for Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for coronary artery disease, which supersedes a prior distribution agreement.  **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_0]** **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_1]** 
- Terumo will provide Orchestra BioMed with a total of **$30 million**, including a **$10 million** upfront payment for the ROFR and an additional **$20 million** investment in non-voting preferred stock.  **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_0]** **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_1]** 
- Orchestra BioMed retains all development and distribution rights for Virtue SAB across all indications.  **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_0]** 
- Orchestra BioMed recently **initiated patient enrollment for the Virtue Trial**, its U.S. pivotal IDE trial of Virtue SAB in the treatment of coronary in-stent restenosis.  **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_0]** **[1869974_f74d1d83a1ae44458cd83b65cd6cc0ff_1]**

Orchestra BioMed and Terumo Enter New Strategic Agreements

- Orchestra BioMed announced the **first patient enrollments** in its U.S. pivotal Virtue Trial for the **Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB)** on **October 27, 2025**.  **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_1]** 
- The Virtue Trial is a **head-to-head randomized coronary pivotal trial** evaluating Virtue SAB against the AGENT paclitaxel-coated balloon for **coronary in-stent restenosis (ISR)**, a condition affecting an estimated **100,000 patients in the U.S. annually**.  **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_0]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_1]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_3]** 
- Virtue SAB, which has **FDA Breakthrough Device Designation**, is the **first non-coated drug-eluting balloon system** designed to deliver a large liquid dose of proprietary extended-release sirolimus.  **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_0]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_3]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_4]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_5]** 
- The trial aims to enroll **740 patients** across up to **75 U.S. centers**, with enrollment completion anticipated by **mid-2027**, to support U.S. regulatory approval.  **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_1]** **[1869974_1c1f0586ace64d84b50ca4f2cae7f01e_3]**

Ocean Biomedical (OCEA)