OBIO | Strategic Recaps: The Power of Partnership and Future of AVIM Therapy

Fellow Shareholders:

Throughout the year, we’ve amplified in our blogs and shareholder emails a variety of important milestones, insights, and behind-the-scenes information. Following our recent financing news, we’re pleased to revisit some highlights from the first half of the year. Whether you missed them the first time or just want a second listen, OBIO’s video-briefing “Encore Moments” reviews impactful progress.

Earlier this year, Chris Eso, VP and Global Head of Corporate and Business Development, M&A and Ventures at Medtronic joined Orchestra BioMed CEO, David Hochman at the LSI Emerging Medtech Summit to reflect on our strategic collaboration for the development and commercialization of AVIM therapy and how it’s positioned to reshape hypertension care.

The conversation offered insight into why both companies believe AVIM therapy has the potential to transform blood pressure management for patients worldwide suffering from uncontrolled hypertension and increased cardiovascular risk. You can watch the full “Encore Moments” video here: OBIO Encore Moments - LSI Chris Eso Session

Below are three key takeaways from the discussion that outline the clinical rationale for AVIM therapy, global market opportunity, and unique synergy between OBIO and Medtronic:

1. The BACKBEAT Study is a Global Pivotal Study Designed to Enable Commercialization
2. “Always On” Therapies Like AVIM Can Redefine Treatment of Uncontrolled Hypertension
3. OBIO’s Collaboration with Medtronic is Built to Leverage Established Commercial Strength

Deeper Dive: What Was Said and Why It Matters

1. The BACKBEAT Study is a Global Pivotal Study Designed to Enable Commercialization | Timestamp: 0:06–0:45

Key Quote: David Hochman (Orchestra BioMed) 
“We're running the BACKBEAT study… a 500-patient global double-blind randomized study, which we think is going to allow Medtronic to commercialize broadly [if AVIM therapy is approved].”

Hochman makes clear that the BACKBEAT trial is intended to drive potential commercialization of AVIM therapy-enabled devices. OBIO, with Medtronic’s support, is now actively a rigorous, global pivotal study that builds on prior prospective studies in which AVIM therapy demonstrated double-digit reductions in ambulatory systolic blood pressure as well as favorable safety data.

The BACKBEAT study is structured to enable future FDA and international regulatory approvals for the treatment of uncontrolled hypertension in pacemaker-indicated patients, in collaboration with the world’s leader in pacemakers and cardiac rhythm devices.

2. “Always On” Therapies Like AVIM Can Redefine Treatment of Uncontrolled Hypertension | Timestamp: 0:56–1:47

Key Quote: Chris Eso (Medtronic) 
“Medication, you know, wears off over time. When you're asleep, it goes off and it goes away, right? And so with both the AVIM therapy as well as renal denervation, it's a treatment algorithm that is actually always there and on and treating the patient and maintaining control.”

Eso draws an important contrast between pharmacological therapy and device-based solutions: drugs are intermittent and patient-dependent, while device-based treatments like AVIM therapy are continuously delivered. Once programmed and activated, AVIM therapy is designed to automatically control blood pressure all day, every day.

For older patients with increased cardiovascular risk from common conditions like isolated systolic hypertension and diastolic dysfunction, as well as other comorbidities, a continuous, always on treatment like AVIM therapy is designed to provide more effective results and overcome the limitations of the current standard of care.

3. OBIO’s Collaboration with Medtronic is Built to Leverage Established Commercial Strength | Timestamp: 2:30–3:15

Key Quote: David Hochman (Orchestra BioMed) 
“When you're the market leader in pacemakers, the FDA wants to have a standing monthly call with your regulatory team just to check in on topics. When you're the partner developing a new therapy, that's very powerful.”

Medtronic is the global leader in pacemakers and other cardiac rhythm management devices. Its established market position, scale, credibility, and infrastructure represent major advantages for the commercial potential of AVIM therapy, if and when approved. OBIO can leverage Medtronic’s market leadership in many ways, including its relationship with the FDA, its sales and distribution networks, and its deep clinical, technological and commercial expertise in this large, existing market.

For OBIO, this all leads to more efficient problem-solving, more robust clinical trial capabilities, and broader strategic support all in service of bringing AVIM therapy to market efficiently.

Looking Ahead

The 2025 LSI session made clear: AVIM therapy is not just a novel hypertension treatment, it represents a foundational shift in how pacing systems can be used to improve patient outcomes in hypertensive heart disease broadly, worldwide.

With strong clinical evidence, aligned regulatory strategy, and a defined path to commercialization, the collaboration between OBIO and Medtronic for AVIM therapy has the potential to be transformational.

— Team OBIO

Forward-Looking Statements

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