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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. 14, 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 announced the publication

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 LigandAchieved 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 SAB trial versus commercially available paclitaxel-coated balloon NEW HOPE, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO, "Orchestra BioMed" or the "Company")), a biomedical company accelerating high-impact technologies to patients t

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 protocolExpanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements NEW HOPE, Pa., Aug. 08, 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 sh

$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 LigandProceeds 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 substantial enrollment of the Virtue Trial NEW HOPE, Pa., Aug. 05, 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 shari

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 certain investors, pre-funded warrants to purchase 5,136,363 shares of its common stock at a price to the public of $2.7499 per pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $0.0001 per share exercise pric

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 purchase shares of its common stock (the "Offering"). All of the securities are being offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock and pre-funded warrants so

• 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 pathway for development of AVIM therapy-enabled leadless pacemakers 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

Regulatory progress underscores global momentum for PerQseal Elite in transforming large-bore vascular closure Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its PerQseal® Elite vascular closure system for arterial procedures. The submission builds upon the successful results of the PATCH study as well as positive clinical use in Europe, reinforcing the system's potential safety and performance profile. In addition, the company received European CE mark approval for an expanded indication for PerQseal Elite

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 recent FDA Breakthrough Device Designation ("BDD") for AVIM therapy NEW HOPE, Pa., June 18, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO, "Orchestra BioMed" or the "Company")), a biomedical company accelerating high-impact technologies to pat

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

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

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

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

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

424B5 - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

424B5 - Orchestra BioMed Holdings, Inc. (0001814114) (Filer)

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

144 - Orchestra BioMed Holdings, Inc. (0001814114) (Subject)

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

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

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

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

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

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

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

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