Business
Orchestra BioMed Reports Third Quarter 2023 Financial Results and Provides Business Update
U.S. FDA granted Investigational Device Exemption (“IDE”) approval to initiate the BACKBEAT pivotal study evaluating AVIM therapy (BackBeat CNT) in
About this update from Orchestra Biomed Holdings, Inc.
[{"type":"text","content":"U.S. FDA granted Investigational Device Exemption (“IDE”) approval to initiate the BACKBEAT pivotal study evaluating AVIM therapy (BackBeat CNT) in hypertensive pacemaker patientsBACKBEAT pivotal study on track to start enrollment before the end of 2023, with a mid-2025 target for completion of enrollment Expected operating cash runway sufficient into 2H 2026, beyond anticipated BACKBEAT top-line results readout, based on internal forecastFDA also granted conditional IDE approval for pivotal study of Virtue® SAB in coronary in-stent restenosis (“ISR”) patients; Virtue ISR-US study initiation targeted for 2024, pending Terumo partnership restructuring NEW HOPE, Pa., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its third quarter 2023 financial results and provided a business update. “This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB. We are excited to initiate enrollment of the BACKBEAT pivotal study imminently, taking a critical step closer to enabling Medtronic, our strategic partner, to deliver this highly innovative blood pressure treatment to patients,” stated David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “We believe the design of the BACKBEAT pivotal study positions us to report topline data from this landmark study within the timeframe of our anticipated operating cash runway.” “We are actively engaged with our colleagues at Terumo with the goal of updating our Virtue SAB strategic agreement and aligning our plans to advance this differentiated technology through pivotal studies and to the market,” Mr. Hochman continued. “As the only non-coated balloon angioplasty system that enables protected delivery of extended release sirolimus directly to target arterial lesions, Virtue SAB has the potential to redefine the class of drug-eluting balloons, which are emerging as a preferred solution for the treatment of coronary artery disease.” Lead Program BackBeat CNTTM (atrioventricular interval modulation (AVIM) therapy): large global opportunity for treating hypert...