OBIO | AVIM Therapy Breakthrough Device Designation Shareholder Implications

This week marks a major milestone for Orchestra BioMed that has potentially significant implications for the commercial potential of AVIM therapy that OBIO is pursuing with its strategic partner, Medtronic.

• We’re proud to share that the FDA has granted Breakthrough Device Designation (BDD) to AVIM therapy for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk.
• The FDA Breakthrough Device program is reserved exclusively for devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions as well as meet other breakthrough technology requirements
• Breakthrough Designation for AVIM therapy reinforces our conviction in both the clinical need and the large, multi-billion-dollar end market which AVIM therapy is being developed to serve.

What does this mean for OBIO shareholders? We see five key potential benefits:

1. Validation of the broader addressable market opportunity for AVIM therapy - we estimate there are over 7.7M patients that meet the criteria for the FDA BDD.
   
   We believe there is a multi-billion-dollar US market opportunity for AVIM therapy to address the needs of these patients - FDA BDD enhances our and Medtronic’s position to pursue this opportunity
   
    
2. Enhanced initial “beachhead” market for AVIM therapy: patients who have uncontrolled hypertension and are already indicated for a pacemaker generally fit within the FDA BDD criteria
   
   Our BACKBEAT global pivotal study is focused on this population which we believe reflects the key attributes of the broader addressable market to which the BDD applies.
   
    
3. A faster track to impact.
   
   BDD gives us access to priority FDA review, interactive feedback on trial design, which could lead to potentially faster time to market.
   
    
4. Potential revenue upside through higher reimbursement
   
   BDD helps AVIM therapy qualify for additional, incremental reimbursement opportunities through CMS, which could enhance the commercial economics of AVIM-enabled systems for OBIO and Medtronic.
   
    
5. Potential future expansion of Medtronic partnership
   
   Medtronic is our exclusive partner for the commercialization of AVIM therapy for the treatment of pacemaker indicated patients. 
   
   Medtronic does not yet have rights for the broader AVIM therapy market opportunity but has a right of first negotiation to seek to expand its partnership with OBIO.

Importantly, this milestone comes as a result of effective execution of our unique business model, which focuses on optimizing and accelerating clinical and regulatory outcomes with major partners.

The bottom line: our opportunity is getting stronger in terms of both market and economic potential.

We remain laser-focused on execution—completing enrollment, advancing our pivotal trial, and building momentum with Medtronic—so that we can bring this potentially high-impact therapy to millions more patients who need it. Thanks for staying with us on this journey.
Orchestra is just warming up. Stay tuned!

—Team OBIO