Picard Medical (PMI) H.C. Wainwright 27th Annual Global Investment Conference summary

Key presentations and company overview

• Picard Medical recently listed on Nasdaq, raising $19.2 million in its IPO and is the parent of SynCardia, which focuses on heart replacement technology.

• SynCardia is the market leader with the only FDA-approved total artificial heart, over 2,100 implants in 27 countries, and 800 patient years of experience.

• The device is indicated as a bridge to transplant for end-stage heart failure patients, addressing a significant unmet need with only 4,000–4,200 heart transplants performed annually in the US.

• The system includes a pulsatile implant and two external drivers, enabling both in-hospital and home use, with the Freedom Driver allowing patients to live active lives.

• Clinical validation shows a 79% survival rate to transplantation and 70% one-year survival, nearly doubling outcomes versus standard care.

Strategic initiatives and growth plans

• Sales in 2023 were $4.4 million, with a focus on restructuring the sales organization and targeting growth in the US through physician education and improved reimbursement.

• International expansion is underway, with CE mark and China approvals targeted for late 2026 or early 2027.

• Discussions with the FDA are ongoing for label expansion to include long-term destination therapy, supported by strong device durability data.

• Long-term innovation centers on developing a fully implantable version, "Emperor," with FDA submission planned for late 2028 or early 2029.

• Driver development and production are being coordinated with a facility in China to serve global markets.

Competitive landscape and differentiation

• SynCardia's device is the only FDA-approved total artificial heart in the US, with a broader patient fit compared to competitors like CARMAT and BiVACOR.

• CARMAT's device is CE marked but heavier and less versatile, while BiVACOR is still in early feasibility stages.

• SynCardia's heart is simpler in design, with fewer moving parts, enhancing durability and reliability for long-term use.

• The device's pulsatile function and partial fill mechanism allow for auto-regulation, supporting patient activity and quality of life.

• Reimbursement in the US can reach up to $430,000, supporting commercial viability.