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Orchestra BioMed and Terumo Enter New Strategic Agreements
OCEA
New Projects/Investments
Convertible Preferred Issuance
- 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.
- 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.
- Orchestra BioMed retains all development and distribution rights for Virtue SAB across all indications.
- 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.
Oct 28, 2025, 12:00 PM
Orchestra BioMed Initiates U.S. Pivotal Trial for Virtue® SAB
OCEA
Product Launch
New Projects/Investments
- 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.
- 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.
- 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.
- 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.
Oct 27, 2025, 1:00 PM
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