Orchestra BioMed Holdings, Inc. operates as an innovative company in the biomedical sector. Its leading product candidates are BackBeat Cardiac Neuromodulation Therapy (CNT), designed to manage hypertension, and the Virtue Sirolimus AngioInfusion Balloon (SAB), aimed at treating atherosclerotic artery disease. The company's offerings also encompass FreeHold retractors, which are solutions for minimally invasive surgical procedures. Orchestra BioMed has formed key alliances to advance its products: a strategic collaboration with Medtronic focuses on developing and commercializing BackBeat CNT for pacemaker-indicated patients suffering from hypertension. Additionally, a partnership with Terumo Corporation is dedicated to the development and market introduction of Virtue SAB for artery disease. The company's headquarters are located in New Hope, Pennsylvania.
Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy
Orchestra BioMed surpassed full enrollment in the BACKBEAT Global Pivotal Trial of AVIM Therapy, randomizing 330 patients as of September 30, 2026 versus a target of 316.
The trial is running across 81 sites in 13 countries in collaboration with Medtronic, which holds commercialization rights pending regulatory approval.
Primary endpoint data will be submitted for late-breaking presentation at a major cardiovascular conference in Q2 2027; positive results would support Medtronic's FDA and global marketing applications.