Business
Orchestra BioMed Reports Second Quarter 2023 Financial Results and Provides Business Update
U.S. Food and Drug Administration (“FDA”) granted Investigational Device Exemption (“IDE”) approval with conditions for Virtue SAB® coronary in-stent
About this update from Orchestra Biomed Holdings, Inc.
[{"type":"text","content":"U.S. Food and Drug Administration (“FDA”) granted Investigational Device Exemption (“IDE”) approval with conditions for Virtue SAB® coronary in-stent restenosis (“ISR”) U.S. pivotal study (in collaboration with Terumo Corporation (“Terumo”)); study expected to start before the end of 2023BackBeat CNT™ global pivotal study in hypertensive pacemaker patients (in collaboration with Medtronic) on track for initiation in the second half of 2023 NEW HOPE, Pa., Aug. 10, 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 second quarter 2023 financial results and provided a business update. “We are excited about this week’s announcement of the FDA’s IDE approval for our Virtue ISR-US pivotal study. This latest milestone kicks off what is expected to be a busy second half of 2023 for Orchestra BioMed, which we believe will feature the initiation of pivotal studies for both of our flagship partnered development programs. These two studies are key next steps toward realizing the substantial potential clinical and commercial value of BackBeat CNT and Virtue SAB,” commented David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “We are focused on delivering on these milestones and continuing to build upon the significant momentum from the first half of the year. To support our growth strategy, we recently entered the public markets as a Nasdaq-listed company and strengthened our leadership team with the appointments of several highly skilled senior executives. Looking ahead, we are well-funded, have outstanding partners and are well-positioned to accomplish our mission of accelerating high impact medical innovations to physicians and patients.” Pipeline highlights BackBeat Cardiac Neuromodulation Therapy (CNT™) – Hypertension in Pacemaker Patients Global pivotal study evaluating the efficacy and safety of BackBeat CNT in adult patients with hypertension who are indicated for a pacemaker on track to start in the second half of 2023 Virtue® Sirolimus AngioInfusion™ Balloon (SAB) – Coronary Indications FDA granted IDE approval with conditions of U.S. pivotal study evaluating Virtue SAB in adult patients with coronary ISR, expected ...