FDA Breakthrough Device Designation Awarded to AVIM Therapy FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch NEW HOPE, Pa., May 12, 2025 (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 financial results for the first quarter... Read More

Secured ten new fully-issued patents related to hypertension treatment during last 12 months, bringing global issued patent estate total for this condition to 120 patents Patent estate covering atrioventricular interval modulation (“AVIM”) therapy now includes 46 issued U.S. patents and 91 patents outside the U.S. that collectively comprise over 2100 claims related to the treatment of hypertension as well as heart failure... Read More

Orchestra BioMed’s Virtue ® Sirolimus AngioInfusion Balloon™ (“Virtue SAB”) is the only non-coated drug-eluting balloon system under clinical investigation worldwide and has been awarded multiple FDA Breakthrough Device Designations The Virtue Trial will be the first U.S. IDE head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) for the treatment... Read More

NEW HOPE, Pa., April 28, 2025 (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 participate in multiple upcoming institutional investor conferences. Details on the Company’s participation appear below: Chardan... Read More

FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure Presentations will detail clinical results from prior studies demonstrating AVIM therapy’s ability to immediately, substantially and persistently reduce... Read More

Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT) BDD status provides... Read More

NEW HOPE, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its full year 2024 financial results and provided a fourth quarter business update. "We remain highly focused on execution of the BACKBEAT global pivotal... Read More

NEW HOPE, Pa., Feb. 20, 2025 (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 upcoming investor conferences. Details on the Company’s presence at these... Read More

The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy for patients who have uncontrolled hypertension and a pacemaker indication A globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of... Read More

Late-breaking oral presentation features echocardiographic data analysis showing favorable impact of AVIM therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failure Hypertension is the leading cause of diastolic dysfunction; both conditions are common in older patients and contribute to the development of heart failure NEW HOPE, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) --... Read More

Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development (“R&D”) collaborations aligned with Orchestra BioMed’s partnership-enabled business model Mr. Cleary previously served as Senior Vice President (“SVP”) of Corporate Development at Medtronic plc (NYSE: MDT) (“Medtronic”), where he played a key role in establishing the strategic collaboration between... Read More

NEW HOPE, Pa., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced two presentations at the 2024 Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv, Israel. The presentations will provide insights on the... Read More

NEW HOPE, Pa., Nov. 26, 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 the Piper Sandler 36 th Annual Healthcare Conference being held in New York, NY from... Read More

NEW HOPE, Pa., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its third quarter 2024 financial results and provided a business update. "The Orchestra BioMed team is focused on execution of the BACKBEAT global pivotal... Read More

NEW HOPE, Pa., Nov. 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 the Jefferies London Healthcare Conference being held in London, UK from November... Read More

NEW HOPE, Pa., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its second quarter 2024 financial results and provided a business update. "Our work in hypertension and coronary artery disease aligns with a renaissance... Read More

John Mack brings over 30 years of diverse medical device and healthcare technology experience to the Orchestra BioMed Board of Directors Most recently, Mr. Mack served as Medtronic’s President of Cardiac Surgery; Previous Medtronic roles include Vice President, Business Development, Strategy & Portfolio Management NEW HOPE, Pa., July 30, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra... Read More

NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Precision Neuroscience Corporation (Precision), a leader in developing brain–computer interface technology to restore function and autonomy for millions of people with neurological disorders, today announced the expansion of its executive team with the addition of Jayme Strauss, RN, MSN, MBA, as Chief Clinical and Commercial Officer and Mike Kaswan as Chief Financial Officer. The... Read More

NEW HOPE, Pa., June 04, 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 further details on its in-person R&D day at the Lotte New York Palace Hotel on Tuesday, June 11, 2024, at 10:00 AM ET. To register, click here . The R&D day will... Read More

NEW HOPE, Pa., May 22, 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 the Jefferies Global Healthcare Conference being held in New York, NY, June 4-6,... Read More

Company hosting in-person R&D day event, focused on atrioventricular interval modulation (“AVIM”) therapy, including the unmet need in hypertension, mechanism of action, clinical results and design of the BACKBEAT study in New York City on June 11, 2024 NEW HOPE, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating... Read More

Patent estate covering atrioventricular interval modulation (“AVIM”) therapy includes 37 issued U.S. patents and 73 patents outside the U.S. that collectively comprise over 1,800 claims related to the treatment of hypertension AVIM therapy is currently being studied in the BACKBEAT global pivotal study in collaboration with Medtronic Orchestra BioMed to provide detailed overview of AVIM therapy and the BACKBEAT global... Read More

NEW HOPE, Pa., April 30, 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 it will host an in-person R&D day at the Lotte New York Palace Hotel on Tuesday, June 11, 2024 at 10:00 AM ET. To register, click here . The event will feature... Read More

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