Orchestra BioMed reported cash and marketable securities of $94.4 million as of March 31, 2026, and used $22.4 million in net cash for operating activities and fixed asset purchases during Q1. Revenue declined to $0.1 million due to termination of a prior distribution agreement, while R&D and trial expenses rose from increased clinical activities.

The company aims to complete enrollment of the BACKBEAT Global Pivotal Trial by the end of Q3 2026 with a reduced sample size of 284 evaluable subjects (316 enrolled accounting for dropouts). Plans include a late-breaking primary endpoint presentation at a major cardiology conference in Q2 2027 and potential FDA and global regulatory submissions thereafter.

FDA granted a second Breakthrough Device Designation for AVIM Therapy, covering patients with uncontrolled hypertension despite medication and those with a pacemaker indication, representing over 7.7 million U.S. patients. This designation can facilitate enhanced reimbursement pathways like New Technology Add-on Payment and Transitional Pass-Through.

Orchestra BioMed received $20 million from Medtronic under a secured subordinated promissory note and $15 million from Ligand via a royalty purchase agreement, bringing total contributions to $82 million and $40 million respectively. These funds support completion of pivotal-stage trials for AVIM Therapy and Virtue SAB and extend the company’s cash runway.