Orchestra BioMed Holdings Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a significant protocol update for the BACKBEAT global pivotal study, which evaluates AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension. This update expands patient eligibility criteria, now including hypertensive patients with Medtronic Azure™ or Astra™ dual-chamber pacemakers, significantly increasing the eligible patient pool by more than 24-fold compared to the original protocol. This expansion is expected to enhance the study's relevance and potential impact, aligning with the characteristics of the FDA Breakthrough Device Designation for AVIM therapy. The full implementation of the updated protocol is anticipated by the fourth quarter of 2025, supporting Orchestra BioMed's target to complete enrollment by mid-2026.