Presentation to provide comprehensive overview of AVIM Therapy clinical evidence demonstrating the potential to halt the progression of hypertensive heart disease Orchestra BioMed and Medtronic (NYSE: MDT) have a strategic collaboration to develop and commercialize AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, an estimated global population of over 750,000 patients... Read More

Results from long-term follow up of patients treated with atrioventricular interval modulation (“AVIM”) therapy show blood pressure-lowering effects are sustained for years after activation, reversible with no observed rebound hypertension upon deactivation of treatment, and reproducible upon reactivation following a washout period Simultaneous peer-reviewed publication of AVIM therapy mechanistic and clinical results... Read More

Data from acute and chronic pressure-volume loop studies support the mechanism of action and show a favorable impact of AVIM therapy on blood pressure and cardiovascular hemodynamics AVIM therapy drove statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no adverse impact on stroke volume or contractility. Orchestra BioMed and Medtronic... Read More

Echocardiographic data analysis demonstrated favorable impact of atrioventricular interval modulation (“AVIM”) therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failure with preserved ejection fraction (“HFpEF”) Hypertension is the leading cause of diastolic dysfunction and the most common comorbidity in older patients indicated for a pacemaker NEW HOPE, Pa., Aug.... Read More

Secured over $111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over $71 million in committed capital from Medtronic and Ligand Achieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue... Read More

FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocol Expanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™... Read More

$56.2 million in proceeds from completed public offering and concurrent private equity purchase by Medtronic and Ligand $55 million in proceeds and funding commitments from royalty-based, non-dilutive investments from Medtronic and Ligand Proceeds extend expected cash runway into the second half of 2027 and expected to fund completion of enrollment and follow up for the primary endpoint of the BACKBEAT study, as well as... Read More

NEW HOPE, Pa., Aug. 01, 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, announced today the pricing of an underwritten public offering of 9,413,637 shares of its common stock at a price to the public of $2.75 per share and, in lieu of common stock to... Read More

NEW HOPE, Pa., July 31, 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, announced today that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to... Read More

Ligand to invest $35 million in exchange for a tiered royalty on future sales of Orchestra’s AVIM therapy and Virtue SAB and an additional $5 million in an equity private placement Medtronic to invest $10 million in an equity private placement and an additional $20 million in a secured subordinated promissory note convertible to prepaid revenue share Medtronic and Orchestra BioMed expand strategic collaboration to provide... Read More

Presentation underscores unique potential for atrioventricular interval modulation (“AVIM”) therapy to manage blood pressure in older, high-risk patients who have indicators of diastolic dysfunction and progression to heart failure with preserved ejection fraction (“HFpEF”) Hypertensive heart disease represents over 7.7 million U.S. patients, the same population with hypertension and elevated cardiovascular risk cited in the... Read More

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