• Orchestra BioMed set end of Q3 2026 target to finish enrollment for BACKBEAT global pivotal trial testing AVIM Therapy in pacemaker-indicated patients with uncontrolled hypertension.
• Primary endpoint results have not been presented; data slated for submission as a late-breaker at a major cardiology conference in Q2 2027.
• Timeline update follows FDA-backed reduction in trial size, aiming to keep study on track while maintaining strength of planned readout.
• Assuming trial meets safety and efficacy goals, Medtronic plans to file for FDA marketing approval once primary endpoint analyses and reports are completed, then pursue additional regulatory clearances globally.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Orchestra Biomed Holdings Inc. published the original content used to generate this news brief on May 12, 2026, and is solely responsible for the information contained therein.