Initiated enrollment of the BACKBEAT global pivotal study evaluating AVIM therapy (also known as BackBeat Cardiac Neuromodulation Therapy) in hypertensive pacemaker patients in collaboration with Medtronic, plc (NYSE: MDT) in December 2023 Orchestra BioMed and Terumo remain actively engaged to update operational plans and financial arrangements for Virtue ® Sirolimus AngioInfusion TM Balloon (“SAB”) development and... Read More

David Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers; formerly Division Vice President of U.S. Commercial Operations, Sales, and Marketing at Abbott Vascular Mr. Pacitti brings nearly 30 years of experience in cardiovascular device and procedural imaging experience to the Orchestra BioMed Board of Directors after previously serving as a strategic... Read More

New pharmacokinetic data demonstrate Virtue ® SAB enables extended release of sirolimus above required tissue concentrations in target arterial sites without polymer degradation or detectable remaining polymer within 90 days of balloon delivery AVIM therapy presentation highlighted recent clinical results showing favorable hemodynamic effects and long-term reduction in 24-hour ambulatory systolic blood pressure, as well as... Read More

NEW HOPE, Pa., March 07, 2024 (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 announced that company management will present and be available for one-on-one meetings at multiple conferences throughout March 2024. Details on the presentations are shown... Read More

Clinical study evaluated impact of AVIM therapy as compared to standard pacing using invasive pressure-volume loop analysis in 16 hypertensive pacemaker-indicated patients Results demonstrate statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no significant changes in stroke volume or contractility. AVIM therapy showed consistent favorable... Read More

8.9 mmHg mean reduction in 24-Hour ambulatory systolic blood pressure at average of 3.6 years from initiation of AVIM therapy in patients who participated in the MODERATO II study Orchestra BioMed is actively enrolling patients in the BACKBEAT pivotal study of AVIM therapy in hypertensive pacemaker patients NEW HOPE, Pa., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or... Read More

Orchestra BioMed and Medtronic, Inc., have an exclusive strategic collaboration for development and commercialization of AVIM therapy for hypertensive pacemaker population, which is estimated to be more than 750,000 patients annually worldwide NEW HOPE, Pa., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact... Read More

U.S. FDA granted Investigational Device Exemption (“IDE”) approval to initiate the BACKBEAT pivotal study evaluating AVIM therapy (BackBeat CNT) in hypertensive pacemaker patients BACKBEAT 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... Read More

NEW HOPE, Pa., Nov. 09, 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 announced that company management will present and be available for one-on-one meetings at multiple conferences throughout November and Deccember. Details on the... Read More

Hypertension is the most common comorbidity in the pacemaker population, affecting over 70% of patients or approximately 750,000 people annually worldwide Medtronic plc and Orchestra BioMed have an exclusive strategic collaboration for global development and commercialization of BackBeat Cardiac Neuromodulation Therapy™ (CNT), now also known as Atrioventricular Interval Modulation (“AVIM”) therapy, for hypertensive pacemaker... Read More

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 2023 BackBeat CNT™ global pivotal study in hypertensive pacemaker patients (in collaboration with Medtronic) on track for initiation in the... Read More

Virtue® Sirolimus AngioInfusion Balloon (“SAB”) is the only non-coated angioplasty system providing protected delivery of extended release sirolimus under clinical investigation worldwide Virtue ISR-US pivotal study focused on coronary in-stent restenosis (“ISR”), a difficult-to-treat and serious complication of coronary stenting, currently expected to start before the end of 2023 Strategic partnership with Terumo... Read More

NEW HOPE, Pa., June 26, 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 announced that it is set to join the broad-market Russell 3000 ® Index, the small-cap Russell 2000 ® Index, and the Russell Microcap ® index at the conclusion of the 2023... Read More

Bill Little, previously Chief Operating Officer (COO) of Neovasc, Inc. through its acquisition by Shockwave Medical in April 2023, will lead efforts to forge further strategic collaborations in newly created Executive Vice President (EVP) of Corporate Development and Strategy role Andrew Taylor joins as Chief Financial Officer (CFO) with over 20 years of CFO experience with emerging growth companies, the last 15 of which... Read More

NEW HOPE, Pa., June 01, 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 announced that company management will present and be available for one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York, NY, June 7-9,... Read More

Completed business combination and listing on Nasdaq generating gross proceeds of approximately $70 million BackBeat CNT™ global pivotal study in hypertensive pacemaker patients on track for initiation in the second half of 2023 in collaboration with Medtronic Virtue SAB® U.S. pivotal study in coronary in-stent restenosis (“ISR”) start planned for the second half of 2023 in collaboration with Terumo NEW HOPE, Pa., May 12,... Read More

NEW HOPE, Pa., March 07, 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 announced that company management will present and be available for one-on-one meetings at Oppenheimer’s 33 rd Annual Healthcare Conference, which is taking place virtually... Read More