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

Strategic Vision and Technology Advancements

• Plans to relocate to a new facility in Somerville within 12–18 months to support growth initiatives.

• Developed the OCS, a portable, multiorgan perfusion platform for heart, lung, liver, and kidney, maintaining organs in physiologic conditions and enabling real-time assessment.

• OCS Kidney, representing Gen-3 technology, will enter clinical trials by late 2024 or early 2025, with future upgrades planned for other organs and anticipated FDA approvals by 2029+.

• OCS platforms aim to overcome cold storage limitations, minimize ischemic damage, and improve transplant outcomes through ex-vivo optimization and real-time clinical assessment.

• Supported by extensive Level 1 FDA pivotal trials, ongoing clinical programs, and the largest body of prospective clinical evidence for both DBD and DCD organs.

Clinical and Operational Milestones

• Received unconditional FDA approval for the OCS Lung DENOVO trial, with enrollment to begin imminently.

• Heart and lung clinical trials are expected to enroll fully within 12–18 months, with heart progressing faster due to existing relationships.

• Liver program is supported by a registry of over 9,000 transplants, with major publications expected to drive further adoption.

• Achieved record-high organ utilization rates: liver 98%, heart 97%, lung 96% as of year-end 2024.

• NOP operates from 18 hubs, with over 50 surgeons, 200+ clinical specialists, 22 airplanes, and a 24/7 logistics command center, integrating logistics and aviation to maximize organ availability.

Market Expansion and Growth Targets

• U.S. transplant volume for heart, lung, and liver grew at mid-20% annually over three years, driven by OCS and NOP.

• DCD organ utilization increased over 500% since FDA approvals, significantly expanding the donor pool.

• Targets 10,000 U.S. transplants by 2028, 20,000 by 2030 (with kidney), and 30,000 globally by 2032, including European expansion.

• Launching EU NOP model in Italy with four hubs, dedicated staff, and a modern aviation network, aiming for meaningful results in late 2024 and early 2025.

• Plans to expand NOP internationally to Europe, Middle East, and potentially Australia by 2026.