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.
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.
2025 Reflections from OBIO CEO
Dear Fellow Shareholders,
As 2025 comes to a close, I want to take the opportunity to reflect on a year of important achievements that puts Orchestra BioMed in a very strong position for the year to come. This year saw our Company make substantive clinical, strategic, and financial progress: we advanced execution of both of our pivotal trial-stage programs, we strengthened and clarified our strategic partnerships, and we secured nearly $150 million in capital and capital commitments on favorable terms.
Shareholder Call Series: Part 3 — Key Themes from the Analyst Q&A
Dear Shareholders,
To complement our two-part summary of Orchestra BioMed’s recent shareholder update call, we are highlighting the Q&A session that followed the prepared remarks. Given strong shareholder interest in the types of questions asked - and the additional clarity provided by management during the discussion - we believe a concise summary of the major themes will be helpful.
Shareholder Call Series: Part 1 — Building a Strong Capital Base and Strategic Alignment for Long-Term Growth
Dear Shareholders,
This blog is the first of a two-part summary from Chairman and CEO David Hochman’s recent shareholder update call, which offered a detailed perspective on Orchestra BioMed’s progress through what has been a highly productive and strategically defining year.
While the Company’s third-quarter financial results reflect disciplined execution, the call focused not on quarterly numbers, but on how Orchestra BioMed’s financing, partnerships, and pivotal-stage programs are shaping long-term value creation.
In this first part, we summarize the discussion of recent financing success and strategic alignment — how Orchestra BioMed has strengthened its capital foundation and optimized partnerships to advance its flagship programs, AVIM Therapy and Virtue SAB, from a position of operational and financial strength.
Unlocking the Value of Virtue SAB with the Achievement of Two Major Milestones - Why Investors Should Take Notice
