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

September has been a busy month already with more to come. We thought it was worth taking the time to review highlights that we believe reflect our Company executing across multiple fronts as we approach key pivotal-stage milestones.

Engaging the Investment Community: Wells Fargo and H.C. Wainwright

Chairman and CEO David Hochman presented at two major healthcare investor conferences this month: the Wells Fargo 21st Annual Healthcare Conference on September 10^th and the H.C. Wainwright 28^th Annual Global Investment Conference on September 16^th. Presenting an updated corporate deck, he walked shareholders and investors through the outlook for what is shaping up to be the most consequential stretch in our Company's history:

• A defined path from enrollment to data to potential regulatory submission. The BACKBEAT Trial, conducted in collaboration with Medtronic, is on track to reach completion of enrollment by the end of this month, now just days away. Orchestra BioMed and Medtronic intend to present primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by, subject to the results of the trial, Medtronic's marketing application submissions to the FDA and global regulatory agencies in the second half of 2027.

• Two pivotal programs advancing in parallel. Beyond AVIM Therapy, these presentations highlighted continued momentum in the Virtue pivotal trial, with ongoing site activations and patient enrollment.

• A balance sheet built to reach milestones. With an estimated $110 million in cash at the end of Q2 2026, bolstered by $35 million in strategic capital received from Medtronic and Ligand last quarter, our projected runway extends to the end of 2027.

• Our business model in action. These presentations also gave us the chance to reinforce what differentiates Orchestra BioMed: a risk-reward sharing partnership model that pairs our development capabilities with the commercial reach of market-leading strategic partners like Medtronic.

The webcast replay of the H.C. Wainwright presentation is available through our Investor Relations website.

Strategic Capital: Further Proceeds Received from Haemonetics for Vivasure PerQseal™ Milestone Payment

On September 14^th, we received a $6.1 million milestone payment in connection with the previously announced acquisition of Vivasure Medical by Haemonetics. This payment follows the approximately $5 million payment received in January 2026 and brings total cash proceeds received from the transaction to approximately $11 million, completing the proceeds we anticipated for 2026. We remain eligible to receive up to approximately $10 million in additional proceeds through future revenue-based earnouts, for total potential aggregate proceeds of up to $21 million.

As we shared earlier this year in our reflections on the Vivasure journey, this outcome followed more than a decade of collaboration with the Vivasure team through fundraising, clinical development, and the evolution of its strategic relationship with Haemonetics. The monetization of this holding provides non-dilutive capital to help drive our two pivotal-stage programs.

AVIM Therapy, the BACKBEAT Trial and the Medtronic – Orchestra BioMed Strategic Collaboration Featured at HRX Live 2026

This past weekend, AVIM Therapy was featured in two sessions at HRX Live 2026, the Heart Rhythm Society's annual innovation-focused meeting held September 18-20 in Atlanta.

A roundtable focused on our strategic collaboration with Medtronic as a model to accelerate the development and commercialization of high-impact, novel innovations like AVIM Therapy. The program was moderated by Vivek Reddy, MD, Director of Cardiac Arrhythmia Services, The Mount Sinai Fuster Heart Hospital; Director of Electrophysiology, Mount Sinai Health System, and featured Robert C. Kowal, MD, PhD, Vice President and General Manager of Cardiac Pacing Therapies, Medtronic Electrophysiology Therapies; Andrea Russo, MD, Academic Chief, Division of Cardiology, and Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital; Charles Love, MD, Professor of Medicine and Director of Cardiac Rhythm Device Services, Johns Hopkins Hospital; and David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. The session included discussion of the unmet need associated with uncontrolled hypertension in pacemaker-indicated patients, AVIM Therapy’s mechanism of action, clinical evidence on blood pressure reduction and cardiac function, as well as the outlook for the BACKBEAT Trial as it rapidly nears enrollment completion.

A second panel, "Permanent Pacing but not for Bradycardia," moderated by Robert C. Kowal, MD, PhD, from Medtronic, explored the expanding role of permanent cardiac pacing beyond bradycardia, with AVIM Therapy highlighted as the emerging pacing-based treatment for uncontrolled hypertension and hypertensive heart disease.

AVIM Therapy exemplifies the kind of innovation the event was created to showcase, building on the long-established pacemaker platform to expand cardiac pacing into hypertension, the leading risk factor for death worldwide and the most common comorbidity in pacemaker patients. As our CEO David Hochman shared, “The inclusion of AVIM Therapy in two HRX Live sessions reflects growing recognition within the electrophysiology community that AVIM Therapy can play a significant role in expanding the therapeutic value of cardiac pacing.”

David Hochman on the State of Medtech Podcast

David also joined the State of Medtech podcast this month for a wide-ranging conversation on all things Orchestra — from the partnership model behind our approach, to the state of medtech innovation, to what it really takes to bring high-impact therapies to patients.

In the episode, David breaks down how AVIM Therapy treats uncontrolled hypertension through a dual-chamber pacemaker, why partnerships are core to how Orchestra creates long-term value, and what separates the innovations strategic acquirers get excited about from the ones they pass on.

Listen to the full episode HERE.

Looking Ahead

The through-line across these updates is execution. Investor engagement keeps our stakeholders informed as we approach pivotal data. Milestone-based strategic capital strengthens our position to fund that execution. And clinical recognition at forums like HRX underscores the growing momentum behind AVIM Therapy as the BACKBEAT Trial nears enrollment completion.

—  Team OBIO

Published September 2026

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