NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) announced a new agreement with Japan’s Terumo Corporation (TYO: 4543) that grants Terumo a right of first refusal for the company’s Virtue Sirolimus AngioInfusion Balloon (SAB) in coronary artery disease applications. The deal, which replaces a prior distribution agreement, provides Orchestra BioMed with $30 million in new capital.
Under the Right of First Refusal (ROFR) Agreement, Terumo will pay $10 million upfront for the rights and invest an additional $20 million through a new series of preferred stock convertible into common shares at a minimum of $12 per share.
“Our new agreements with Terumo reflect the differentiated value of Virtue SAB for the treatment of atherosclerotic disease in the coronary arteries and provide strategic optionality for both companies,” said David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed. “This new arrangement highlights the strong clinical and commercial potential of Virtue SAB to become a best-in-class therapy in the global coronary market. The $30 million in proceeds from Terumo provides meaningful additional capital resources to advance both of our pivotal stage programs to key clinical and regulatory milestones.”
Orchestra BioMed retains all development and commercialization rights to Virtue SAB in every therapeutic indication. The company recently began enrolling patients in its U.S. pivotal IDE trial — the Virtue Trial — evaluating the device for treating coronary in-stent restenosis, a serious condition that can re-narrow previously stented arteries.
“We are very pleased to enter into a new strategic agreement with Orchestra BioMed that reflects the significant potential for Virtue SAB in the treatment of coronary artery disease,” said Ghada Farah, President of Terumo Interventional Systems.
The transactions are expected to close by November 7, 2025, pending customary conditions. Virtue SAB has received FDA Breakthrough Device Designation for coronary in-stent restenosis, coronary small vessel disease, and below-the-knee peripheral artery disease.
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