TransMedics Group (TMDX) TD Cowen 46th Annual Health Care Conference summary

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.

• Kidney utilization in the US has dropped to about 60%, down from over 90% in 1990, representing a significant opportunity for improvement.

• OCS Kidney could add 9,000 donor kidneys annually by eliminating ischemia, with rollout targeted for late 2025 or early 2027.

• The technology offers benefits across both DBD and DCD kidneys, aiming to reduce DGF by 50% and improve economics for CMS.

• The program is positioned for both US and international launches, with milestones including device demonstrations and FDA submissions in 2024-2025.

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 is planned, reducing the need for on-site specialists and increasing operating leverage.

• The next-gen platform will extend to other organ indications by the end of the decade.

Clinical trial progress and guidance

• OCS Kidney design was presented at ASTS in January, with further data to be shared at the American Transplant Congress in June.

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

• Initial 2026 revenue guidance does not include incremental contributions from ongoing lung or heart trials, leaving room for upside.

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