Orchestra BioMed has completed a US$34 million Series B-1 Preferred Stock financing—led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation and existing investors from SternAegis Ventures. Additionally, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on the structure of its Series B-1 and Series B Preferred Stock financings.

Proceeds from the financing will be used to accelerate and expand development of Orchestra BioMed’s lead and pipeline assets, including BackBeat Cardiac Neuromodulation Therapy (CNT) for hypertension. Proceeds will also support Orchestra BioMed’s commitments to its global strategic partnership with Terumo for the development and commercialisation of the Virtue sirolimus-eluting balloon (SEB) for percutaneous coronary and peripheral vascular interventions.

Orchestra BioMed’s June 2019 partnership with Terumo included a US$30 million up-front payment as well as significant future milestone payments from Terumo and meaningful revenue sharing through sales royalties and exclusive drug formulation supply payments. Terumo, one of the world’s leading medical device manufacturers, and Orchestra BioMed are executing a global clinical programme for the Virtue SEB; the balloon, a press release reports, the first and only non-coated angioplasty balloon to deliver a sustained-release formulation of sirolimus during balloon angioplasty without the need for a coating or permanent implant. The FDA granted Virtue SEB Breakthrough Device Designation for coronary in-stent restenosis in April 2019 and the companies are preparing to launch a US registrational trial for this indication under an Investigational Device Exemption (IDE) from the FDA within the next year.

Terumo and Orchestra BioMed also plan to expand Virtue SEB clinical trials into additional indications including small coronary vessels and peripheral artery disease below-the-knee in the USA Japan, China, and other markets. This strategic partnership with Terumo illustrates the long-term value of Orchestra BioMed’s business model and potential for collaboration with market leaders to accelerate development and commercialisation of products like Virtue SEB to address large established medical procedure markets.

David Hochman, chairman, chief executive officer and founder of Orchestra BioMed, comments: “This financing round, together with our recent global development and commercialization partnership with Terumo, validates our differentiated business strategy and unique approach for the development of high-impact therapeutic device solutions. Since the start of 2019, successful execution has generated over $64 million in capital inflows, including a significant upfront payment and strategic investment from our Virtue SEB global partnership. We are grateful to our investors and to Terumo, who’ve helped us achieve significant momentum and positioned us for meaningful value inflection as we seek to achieve key clinical milestones and expand our product development pipeline.”