TransMedics Group (TMDX) 44th Annual J.P. Morgan Healthcare Conference summary

Strategic Vision, Technology Innovation, and Conference Insights

• Relocation to a new Somerville facility is planned within 12–18 months to support growth initiatives.

• OCS platforms for lung, heart, and liver are FDA-approved, with kidney entering clinical trials by late 2024 or early 2025; Gen-3 OCS and kidney expected by 2029+.

• OCS is the only multiorgan, portable warm perfusion system, supporting heart, lung, liver, and kidney transplants.

• Gen-3 OCS Kidney introduces smaller, automated, remotely monitored technology with real-time viability assessment; upgrades for other organs will follow.

• The digital ecosystem and command center provide real-time logistics, clinical, and financial transparency for transplant centers.

Clinical Evidence and Market Expansion

• OCS platforms are supported by Level 1 FDA pivotal trials and the largest body of prospective clinical evidence for DBD and DCD organs.

• ENHANCE (heart) and DENOVO (lung) trials are underway, aiming for superiority claims over cold storage; DENOVO trial received unconditional FDA approval.

• Heart trial enrollment is progressing, with full enrollment expected in 12–18 months; lung may take closer to 18 months.

• Liver adoption is expected to accelerate with upcoming publications from a registry of over 9,000 transplants.

• OCS technology minimizes ischemic damage, enables ex-vivo organ optimization, and provides real-time clinical assessment.

Operational Scale, NOP, and Logistics Integration

• The National OCS Program (NOP) operates from 18 U.S. hubs, with 50+ transplant surgeons, 200+ clinical specialists, 22 airplanes, and a digital ecosystem.

• TransMedics Aviation manages 22 aircraft and 130+ pilots, enabling rapid, long-range organ transport.

• NOP operates a 24/7 logistics command center with advanced routing technology and 90 full-time employees.

• NOP and OCS have driven mid-20% annual growth in U.S. heart, lung, and liver transplant volumes over three years, with high utilization rates.

• DCD organ utilization has increased over 500% since OCS FDA approvals.