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New Hope-based Orchestra BioMed Inc., a biomedical innovation company working in procedure-based medicine, has completed a $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.

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 commercialization of the Virtue® Sirolimus-Eluting Balloon for percutaneous coronary and peripheral vascular interventions.

Orchestra BioMed’s June 2019 partnership with Terumo included a $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 program for Virtue SEB, 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 U.S. registrational trial for this indication under an Investigational Device Exemption 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 U.S., Japan, China, and other markets.

Orchestra BioMed retained the rights to develop and license technology used in Virtue SEB in clinical applications outside of peripheral and coronary interventions. Proceeds from the Series B-1 financing will be used to develop additional clinical product candidates using sustained-release sirolimus in other large, procedure-based medical markets.

Orchestra BioMed is also advancing its implantable cardiac neuromodulation therapy for hypertension, BackBeat CNT, shown in clinical studies to immediately, substantially and chronically lower blood pressure. A randomized clinical study to further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension recently completed enrollment and is on track to report six-month data later this year. With this Series B-1 financing, Orchestra BioMed plans to accelerate additional global BackBeat CNT clinical trials.