10-Q - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

SCHEDULE 13D/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)

DEFA14A - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

DEF 14A - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

8-K - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

10-K - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

8-K - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

8-K - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

S-8 - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

SCHEDULE 13G/A - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)

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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 ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline. Q1 2025 Highlights: U.S. Food and Drug Administration ("FDA") Breakthrough Device Design

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 patentsPatent 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 failureHeart failure pipeline program now protected by an additional 17 issued global patents FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk, including those at risk of heart fa

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 DesignationsThe 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 of coronary in-stent restenosis ("ISR")Robust non-inferiority trial is designed to provide a clear pathway to regulatory approval as well as potentially showcase clinical advantages of Virtue SABWith the amended IDE approved by the FDA, Orchestra BioMed is currently targeti

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 Capital's Trending Issues in Drug Development Conference – April 29, 2025 (Virtual) David Hochman, Orchestra BioMed's Chairman and Chief Executive Officer, will participate in a fireside chat with Keay Nakae, Senior Research Analyst, Chardan on the topic of "Data & Reg

FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular riskHRS 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 systolic blood pressure, as well as improve cardiac functionSymposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE:MDT) NEW HOPE, Pa., April 23, 2025 (GLOBE

First fully absorbable, sutureless closure system designed for large-bore procedures aims to improve procedural efficiency and patient outcomes in structural heart interventions Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced European CE mark approval of the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device. The company plans to launch the product in select European markets this summer. Leveraging Vivasure's PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore closure follow

Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular riskBDD 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 accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future NEW HOPE, Pa., April 22, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO) ("Orchestra

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 study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for

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 conferences are shown below. Presentations TD Cowen 45th Annual Healthcare ConferenceFormat: Corporate Presentation Date: March 3, 2025Time: 2:30 PM ETWebcast: https://wsw.com/webcast/cowen177/obio/2014707 Barclays 27th Annual Global Healthcare ConferenceFormat: Fire

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 indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine a

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4/A - Orchestra BioMed Holdings, Inc. (0001814114) (Issuer)

BTIG Research initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $12.00

Barclays initiated coverage of Orchestra BioMed with a rating of Overweight and set a new price target of $16.00

H.C. Wainwright initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $14.00

B. Riley Securities initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $15.00

Jefferies initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $14.00

Piper Sandler initiated coverage of Orchestra BioMed with a rating of Overweight and set a new price target of $15.00

Chardan Capital Markets initiated coverage of Orchestra BioMed with a rating of Buy and set a new price target of $20.00

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 study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for

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 indicationA globally recognized thought leader and innovator in cardiovascular technologies, including electrophysiology and cardiac rhythm management, Dr. Reddy currently serves as the Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, the Director of Electrophysiology for the Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine a

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 Orchestra BioMed and Medtronic for atrioventricular interval modulation ("AVIM") therapy in hypertension with increased cardiovascular riskEric A. Rose, M.D. to transition from Board Member to Board Member Emeritus and Strategic Advisor, continuing to provide invaluable expe

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 BioMed" or the "Company"))), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of John Mack to its Board of Directors, effective as of July 29, 2024. Mr. Mack brings over 30 years

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 VascularMr. 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 advisor during the formation of the company NEW HOPE, Pa., March 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 shar

FORT LAUDERDALE, Fla., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company focused on improving endoscopic outcomes and experiences, announced the appointment of Scott Durbin to the Company's Board of Directors (the "Board"). Mr. Durbin has more than 25 years of executive leadership, finance and clinical development experience, including the execution of over $5 billion in financings and merger transactions. In addition, the Company announced that David Hochman and Darren Sherman, independent members of the Board, have stepped down from the Board due to time requirements of their roles as Chief Executive Offi

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

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 were spent in the medical device sector NEW HOPE, Pa., June 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-rewa

Completed business combination and listing on Nasdaq generating gross proceeds of approximately $70 millionBackBeat CNT™ global pivotal study in hypertensive pacemaker patients on track for initiation in the second half of 2023 in collaboration with MedtronicVirtue 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, 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 first quarter 2023 financial r

Hypertension is the most common comorbidity in the pacemaker population, affecting over 70% of patients or approximately 750,000 people annually worldwideMedtronic 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 patientsBACKBEAT global pivotal study is expected to start before the end of 2023 IDE supported by data from the MODERATO II randomized pilot study that showed AVIM therapy drove significant and sustained reductions in blood pressure in hypertensive pacemaker patients Orc