Financing Will Support Orchestra BioMed's Product Pipeline Development
July 10, 2019—Orchestra BioMed, Inc. announced that financing will be used to accelerate and expand development of the company's lead and pipeline assets, including BackBeat cardiac neuromodulation therapy (CNT) for hypertension.
According to the company, a $34 million Series B-1 preferred stock financing was led by institutional investors Perceptive Advisors, RTW Investments, and Soleus Capital with participation from Terumo Corporation and existing investors from SternAegis Ventures. In addition, 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.
Funding 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 (SEB) for percutaneous coronary and peripheral vascular interventions.
In June, the company announced the partnership with Terumo, which included a $30 million up-front payment as well as future milestone payments from Terumo and revenue sharing.
The FDA granted Virtue SEB Breakthrough Device designation for coronary in-stent restenosis in April 2019. The companies are preparing to launch a United States registrational trial for this indication under an FDA investigational device exemption 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 United States, 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.
The company is also advancing its implantable BackBeat CNT, which has been shown in clinical studies to immediately, substantially, and chronically lower blood pressure. A randomized clinical study that is further investigating the efficacy and safety of BackBeat CNT for the treatment of hypertension recently completed enrollment, with 6-month data expected to be available later this year.
With this Series B-1 financing, Orchestra BioMed plans to accelerate additional global BackBeat CNT clinical trials. The company continues to evaluate additional product acquisition opportunities in line with its strategy of developing high-impact solutions that address major needs in key markets and forming partnerships with established commercial leaders, stated Orchestra BioMed.