TransMedics Group (TMDX) investor relations material

OCS Kidney program and clinical need

• OCS Kidney aims to address high rates of delayed graft function (DGF) and low kidney utilization, with DGF rates rising from 20-25% in 1998 to 55-60% today and utilization dropping from 90% to 60% since 1990.

• OCS Kidney could reduce DGF by 50% and add up to 9,000 kidneys annually by eliminating ischemia, targeting a late 2026 or early 2027 clinical rollout.

• The technology offers benefits for both DBD and DCD kidneys, improving outcomes and reducing costs for CMS.

• The program is positioned for simultaneous U.S. and international launches, with milestones including device demonstrations at major transplant meetings and FDA submission in early 2025.

Next-generation OCS system and margin expansion

• The next-gen OCS device will be smaller, with fewer parts and more automation, reducing assembly costs.

• Remote clinical assessment via a command center will lower human resource needs and increase operating leverage.

• The new system will be rolled out across all organ indications by the end of the decade.

Clinical trial progress and guidance

• Key OCS Kidney milestones include device demonstrations in June and FDA dossier submission by early 2025, with clinical trials expected to start in the first half of 2025.

• Clinical endpoints will focus on DGF incidence and dialysis needs within 30 days post-transplant.

• OCS Lung de novo trial enrollment pace will be a key indicator, with results reflected in quarterly reports; no incremental trial revenue is included in 2026 guidance.

• ENHANCE heart trial is expected to complete in 12-18 months, with control arm details to be announced at ISHLT.