September Highlights: A Defined Path from Enrollment to Data to Regulatory Submission, Medtronic & Orchestra at HRX, A Milestone Payment, Healthcare Investor Conferences and More
Orchestra BioMed Investor Relations Blog | September 2026
Q2 2026 Progress Brings Key Pivotal Milestones Into View
Orchestra BioMed Investor Relations Blog | August 2026
Orchestra BioMed recently announced financial results for the second quarter of 2026 and provided a business update across our two pivotal-stage cardiovascular programs. The quarter delivered meaningful clarity on the timeline for primary endpoint results from the BACKBEAT global pivotal trial (“BACKBEAT Trial”) as well as planned regulatory submissions for AVIM Therapy, assuming endpoints are met. We also continued to advance the Virtue SAB in the Treatment of Coronary In-Stent Restenosis Trial (“Virtue Trial”), our investigational device exemption (IDE) randomized pivotal trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis. At the same time, we strengthened our financial foundation to support both programs through their next major milestones.
BACKBEAT Timeline Update Reinforces Momentum to Pivotal Trial Data Presentation and Regulatory Submissions by Medtronic
Orchestra BioMed Investor Relations Blog | May 2026
Orchestra BioMed recently announced updates to the target timeline for the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”). These important updates provide clarity on the plan for pivotal data presentation as well as Medtronic’s FDA marketing application for Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension despite anti-hypertensive medications in patients who are also indicated for a pacemaker.
Strategic Capital Supports Pivotal-Stage Execution
Orchestra BioMed Investor Relations Blog | May 2026
The receipt of $35 million in strategic capital from Medtronic and Ligand reflects continued partner alignment behind Orchestra BioMed’s pivotal-stage cardiovascular pipeline.
Strengthening AVIM Therapy’s Regulatory Pathway: A Second FDA Breakthrough Device Designation
Orchestra BioMed Investor Relations Blog | April 2026
The second Breakthrough Device Designation awarded to AVIM Therapy underscores its potential in a defined high-risk population and supports an accelerated development pathway.
From Blood Pressure Reduction to Cardiac Function: What New AVIM Therapy Data Signal
Orchestra BioMed Investor Relations Blog | April 2026
Recently presented clinical and mechanistic findings reinforce the potential of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) to immediately reduce blood pressure and have a favorable cardiac hemodynamic impact, expanding its potential therapeutic relevance beyond hypertension into hypertensive heart disease.
Our Clinical Vision: AVIM Therapy for Hypertensive Heart Disease
Orchestra BioMed recently announced multiple scientific presentations highlighting the robust body of existing clinical findings from the Atrioventricular Interval Modulation (“AVIM”) Therapy program at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings. These discussions reinforce growing clinical interest in our novel, device-based approach to treating hypertension and reducing associated cardiovascular risk.
When Partnership Drives Progress: Reflections on the Vivasure Journey
The recent acquisition of Vivasure Medical by Haemonetics follows over a decade of collaboration between Vivasure and Orchestra BioMed. Over that time, Orchestra worked alongside the Vivasure team through early-stage fundraising, clinical development and next-generation advancement of the PerQseal® technology, including during the formation and evolution of Vivasure’s strategic relationship with Haemonetics.
