Orchestra BioMed (OBIO) Chardan Capital’s Trending Issues in Drug Development Conference summary

Strategic partnerships and business model

• Focuses on advancing medical device therapies through partnerships, notably with Medtronic and Terumo, targeting hypertension and coronary/peripheral artery disease.

• Business model emphasizes capital efficiency, clinical execution, and revenue sharing via royalties.

• Both platform technologies address large, unmet market needs and rely on pivotal trial data for advancement.

AVIM therapy and BACKBEAT pivotal study

• AVIM therapy uses pacemaker firmware to lower blood pressure in high-risk patients, showing over 11 mmHg reduction in 24-hour systolic BP in phase 2 trials.

• No major adverse cardiac events were observed in the treatment group.

• Protocol changes in the pivotal study, supported by the FDA, expanded patient eligibility and improved enrollment predictability.

• FDA granted breakthrough device designation to AVIM, broadening addressable patient population and potential reimbursement.

• Partnership with Medtronic provides regulatory expertise and market access, enhancing trial execution and future commercialization.

Regulatory interactions and breakthrough designation

• Close collaboration with FDA and Medtronic ensured protocol amendments maintained statistical integrity.

• Breakthrough designation applies to a U.S. population of about 7.7 million with uncontrolled hypertension and high cardiovascular risk.

• Designation may facilitate add-on reimbursement, potentially increasing per-device revenue share.