Orchestra BioMed Inc., a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, has appointed Dennis Donohoe, M.D., as full-time chief medical officer. Dr. Donohoe is a clinical development expert with a track record of success in steering high-impact therapeutic devices through clinical trials and regulatory approvals, including the CYPHER sirolimus-eluting stent, the first U.S. Food and Drug Administration (FDA)-approved drug-eluting stent, for which he oversaw global registrational clinical development during his tenure as worldwide vice president of clinical, regulatory and medical affairs for Cordis Corporation (a Johnson & Johnson Company).
 
“Dennis Donohoe is a leader with extensive clinical and regulatory experience directly relevant to our therapeutic device product pipeline. We are thrilled that Dennis has agreed to join our management team on a full-time basis,” said David Hochman, chairman and CEO of Orchestra BioMed. “We could not ask for a more qualified leader as we prepare to initiate a global clinical and regulatory development program focused on multiple coronary and peripheral indications for Virtue SEB in collaboration with Terumo, our strategic partner. His extensive knowledge and expertise will also be vital to further our clinical and regulatory plans for BackBeat CNT for hypertension, our other flagship product, as well as additional pipeline development initiatives we expect to embark on in the future.”
 
Dr. Donohoe previously served as a part-time chief medical officer for Orchestra BioMed’s Focal Therapies group and its predecessor, Caliber Therapeutics Inc., under a consulting agreement. For the last four years, Dr. Donohoe has been the owner of Donohoe Clinical Consultants LLC, a clinical and regulatory advisory firm that provided services to a number of companies developing innovative products in the field of interventional cardiovascular devices. For 20 years prior to that, Dr. Donohoe worked in various clinical leadership roles within Johnson & Johnson: for 11 years, he was with Cordis, serving as the worldwide vice president of clinical, regulatory and medical affairs, where he was responsible for the clinical development of cardiology, neurovascular and endovascular devices, including the CYPHER stent. He also served as a board member of the Cordis franchise; he was the director of medical affairs for Ethicon Inc., working on the clinical development of a variety of surgical devices used in laparoscopic surgery; he was also the director of clinical research at the Pharmaceutical Research Institute where he worked on clinical trials, including an antidepressant, oral hypoglycemic, a non-sedating antihistamine and a recombinant Hepatitis B vaccine. While at Johnson & Johnson, Dr. Donohoe received the Johnson Medal, the highest scientific recognition awarded by Johnson & Johnson in recognition for the clinical development of a topical growth factor for the treatment of chronic wounds. Prior to Cordis/Johnson & Johnson, Dr. Donohoe served as director of clinical research in the gastrointestinal therapeutic group at Glaxo Pharmaceutical. Before joining the industry, he practiced family medicine in the Philadelphia area.

Dr. Donohoe has a medical degree from Penn State Hershey Medical Center.
 
“I am excited to assume a full-time role as part of Orchestra BioMed’s leadership team during this critical growth period when I can help advance the development of Virtue SEB for coronary and peripheral artery disease as well as BackBeat CNT for targeted high blood pressure patient populations,” said Dr. Donohoe. “As a physician, I was impressed by how these therapies have the potential to improve outcomes in areas of high unmet medical need while seamlessly integrating into existing clinical workflows within interventional cardiology and cardiac rhythm management. I truly believe that eventual regulatory approval and adoption of these technologies could have a lasting impact for patients, physicians and hospital systems worldwide.”
 
Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and includes Virtue Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value.