Dr. Donohoe brings nearly 30 years of successful clinical and regulatory experience advancing medical devices in the cardiology and endovascular space
NEW HOPE, Pa., Aug. 27, 2019 (GLOBE NEWSWIRE) — Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced the appointment of Dennis Donohoe, M.D., as full-time chief medical officer. Dr. Donohoe is a leading clinical development expert with an outstanding track record of success in steering high-impact therapeutic devices through clinical trials and regulatory approvals, including the CYPHER® sirolimus-eluting stent, the first 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 proven 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 chief executive officer 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 twenty years prior to that, Dr. Donohoe worked in various clinical leadership roles within Johnson & Johnson: for eleven 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 also 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 holds a medical degree from the 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.”
About Orchestra BioMed™
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. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.
Forward-Looking Statements
Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.
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LifeSci Advisors
646-597-6989
Bob@lifesciadvisors.com
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LifeSci Public Relations
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