Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO

Orchestra BioMed said yesterday that it received the CE Mark for its Moderato implantable pulse generator system for BackBeat cardiac neuromodulation therapy (CNT), just nine days after naming a new chief medical officer.

BackBeat therapy is a bioelectronic treatment designed to lower blood pressure while modulating the autonomic nervous system. The Moderato implantable device is designed to deliver BackBeat CNT and provide standard pacemaker functions.

In July, New Hope, Penn.-based Orchestra BioMed announced it had closed a $34 million Series B preferred stock funding round and said it could receive up to an additional $57 million in follow-on investments. At the time, the company said the proceeds would be used to accelerate and expand the development of its lead assets, namely BackBeat CNT.

Dr. Karl-Heinz Kuck, director of cardiology at the Lans Medicum, Hamburg, Germany, and principal investigator for the Moderato’s clinical trials, will present the latest study of BackBeat CNT, titled Moderato II, on Sept. 28 at the Transcatheter Cardiovascular Therapeutics 2019 conference in San Francisco.

“BackBeat CNT is an exciting new approach to device-based blood pressure management and has potential to be a primary treatment modality for the more than two-thirds of pacemaker patients at risk from hypertension,” Kuck said in a news release. “In the Moderato I clinical trial, BackBeat CNT demonstrated excellent efficacy and safety results, particularly given that 78% of the study patients had isolated systolic hypertension and that patients’ average baseline ambulatory systolic blood pressure (137 mmHg) was lower compared to patients in other device-based hypertension studies. I look forward to presenting the six-month primary endpoint results from the Moderato II study of BackBeat CNT as a late-breaker at TCT later this month.”

“CE Mark approval and selection for late-breaking science presentation at TCT validate the potential for BackBeat CNT to benefit targeted high-risk hypertensive patients, such as those already indicated for a pacemaker,” added Orchestra BioMed CEO David Hochman. “Effective treatment of these patients, the majority of whom have isolated systolic disease and persistent high blood pressure despite conventional pharmaceutical therapies, represents a significant market opportunity that could have substantial growth, value and market share implications for the field of cardiac rhythm management.”

The CE Mark approval came days after the company’s announcement that Dr. Dennis Donohoe would take over as chief medical officer.

Donohoe was worldwide vice president of clinical, regulatory and medical affairs for Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corporation a for 11 years. He has owned Donohoe Clinical Consultants for the past four years, previously serving as a part-time chief medical officer for Orchestra BioMed’s Focal Therapies group and its predecessor, Caliber Therapeutics, as a consultant.

“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,” Hochman said in a news release. “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 (sirolimus-eluting balloon) 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.”

“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,” added 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.”