TransMedics Group (TMDX) investor relations material

Heart and lung programs

• OCS 2.0 targets cardiothoracic concerns around edema, overnight preservation and improving organ function; heart and lung markets are busier and more crowded than liver.

• ENHANCE Part A enrolled 175 patients in 7–8 months; ENHANCE Part B and DENOVO are intended to improve transplant outcomes and increase donor heart and lung utilization.

• If successful, the programs could open access to ~5,000–5,500 additional U.S. cases annually; daytime heart transplantation is a secondary benefit, not the primary objective.

• ENHANCE Part B’s primary effectiveness endpoint combines severe PGD and survival; the trial compares OCS 2.0 with CHOPS, and management aims to demonstrate OCS superiority.

• ENHANCE Part B’s 400 OCS and 200 CHOPS cases, plus DENOVO’s 150 OCS and 150 CHOPS cases, were described as incremental because they address indications not currently served in the U.S.

Europe and transplant logistics

• European launches are NOP Europe and Transplant Logistics Europe; OCS has been available in Europe for several years, with reimbursement work progressing country by country and, in some areas, region by region.

• Logistics is expected to help establish NOP in new European geographies and centers; meaningful European revenue contribution is expected to begin in H2 2027 and continue into 2028.

• Europe represents 50% of global transplant volume; the Emilia-Romagna tender win is an initial step, with other tenders underway in Italy and elsewhere.

• 2027 guidance will map the expected revenue ramp; management expects it to start in H2 2027, while PAD charter activity is expected to slow in H1 as the business transitions toward organ-transplant services.

Kidney opportunity

• Kidney is described as the largest transplant market globally; management cited 9,000 U.S. kidneys lost last year due to prolonged ischemic time and sees OCS as a way to expand utilization.

• Management estimates kidney transplants could increase by 5,000–8,000 annually; HHS estimated that adding 2,000 annual kidney transplants could affect the CMS budget by $250 billion in 2040.

• NOP infrastructure will support the kidney launch, developed collaboratively with OPOs; management sees potential benefits for recipients, transplant programs, OPOs and CMS.