Picard Medical (PMI) Investor presentation summary

Business and product

• SynCardia Total Artificial Heart (STAH) is the only commercially available FDA- and Health Canada-approved total artificial heart; approved for sale in the U.S. and Canada for indicated bridge-to-transplant use.

• STAH replaces both ventricles and all four valves, is available in 50cc and 70cc sizes, and can use hospital or portable home drivers.

• More than 2,100 implants have been performed across 27 countries; the longest reported patient support exceeded 8 years.

Clinical evidence and market need

• In the 2004 pivotal trial, survival to transplant was 79% with STAH versus 46% in controls; overall one-year survival was 70% versus 31%.

• At least 300,000 U.S. patients with advanced heart failure may benefit from durable mechanical circulatory support; the 2024 transplant waitlist exceeded 9,400 patients.

• More than 5,500 patients are added to the U.S. waitlist annually, while 4,636 donor hearts were transplanted in 2024.

Growth strategy and product pipeline

• Growth priorities include expanding Centers of Excellence, physician training and patient access, while scaling manufacturing and supply chains to improve capacity and gross margins.

• The Unicorn next-generation pneumatic driver is planned to progress through prototype completion in 2025, design freeze and bench testing in 2026, clinical evaluation in 2028, and a potential commercialization milestone in 2029; timelines may change.

• The Emperor program targets a fully implantable TAH platform: design lock and validation in 2027, GLP animal studies in 2028, clinical development from 2029+, and potential commercialization in 2032; milestones are projected and subject to change.

• NMPA timing is expected in Q4 2027; EU MDR certification and other international approvals remain pending or under evaluation.