Tag: Orchestra BioMed

Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients

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 […]

Orchestra BioMed Reports Third Quarter 2023 Financial Results and Provides Business Update

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 […]

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

NEW HOPE, Pa., Sept. 19, 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 the U.S. Food and Drug Administration (“FDA”) granted approval of an investigational device exemption (“IDE”) to […]

Orchestra BioMed Reports Second Quarter 2023 Financial Results and Provides Business Update

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, today reported its second quarter 2023 financial results and provided a business update. “We are excited about this […]

Orchestra BioMed™ Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue® Sirolimus AngioInfusion Balloon™ in Patients with Coronary In-Stent Restenosis

NEW HOPE, Pa., Aug. 08, 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 the U.S. Food and Drug Administration (the “FDA”) granted investigational device exemption (“IDE”) approval with conditions […]

Orchestra BioMed Set to Join Russell 3000® and other FTSE Russell Indexes

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 […]

Orchestra BioMed Appoints Bill Little as Executive Vice President of Corporate Development and Strategy and Andrew Taylor as Chief Financial Officer

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 […]

Orchestra BioMed Reports First Quarter 2023 Financial Results and Provides Business Update

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 […]

Orchestra BioMed Debuts as Nasdaq-Traded Company with Lead Programs Targeting Hypertension and Artery Disease and Novel Partnership-Enabled Business Model

Business combination with Health Sciences Acquisitions Corporation 2, a special purpose acquisition company sponsored by an affiliate of RTW Investments, LP, completed on January 26, 2023 The combination was announced simultaneously with Orchestra’s strategic collaboration with Medtronic to develop BackBeat Cardiac Neuromodulation Therapy™ as potential integrated hypertension treatment for cardiac […]