TransMedics’ DENOVO Trial: New Lung Preservation Study Could Shape Future Growth for TMDX

Transmedics Group (TMDX) announced an update on their ongoing clinical study.

Study Overview: The “Decreasing Edema With a Novel OCS Solution (DENOVO) Trial” is a new TransMedics study that will compare two ways of preserving donor lungs for transplant. The goal is to see whether TransMedics’ Organ Care System (OCS) solution can improve early patient and graft survival and reduce severe early complications after surgery. For investors, this trial matters because strong results could support broader adoption of OCS technology in lung transplants and reinforce TransMedics’ position in the organ preservation market.

Intervention/Treatment: The study tests two preservation methods. The first is the OCS Lung System, a device that keeps donor lungs functioning outside the body before transplant. The second is standard static cold storage, where lungs are kept on ice. The aim is to see if the OCS approach can better protect lungs and reduce early damage compared with the long‑standing cold storage method.

Study Design: This is an interventional clinical trial in lung transplant recipients. Patients will be randomly assigned to receive lungs preserved either with the OCS Lung System or with static cold storage. There is no masking, meaning doctors and care teams know which method is used. The main purpose is treatment-focused: to test if using OCS leads to better short‑term outcomes after transplant compared with the current standard of care.

Study Timeline: The study was first submitted on September 10, 2025, and is listed as “not yet recruiting,” so enrollment has not started. Primary completion and full completion dates have not yet been posted, which means data readouts are likely several years away. The most recent update to the record was filed on January 13, 2026, signaling that TransMedics is actively maintaining the trial plan and moving toward launch.

Market Implications: For TransMedics (TMDX), this trial is a strategic effort to deepen clinical proof for its OCS Lung platform beyond earlier studies. Positive outcomes could support higher utilization of the system, stronger pricing power, and greater share in lung transplant centers, which may bolster revenue visibility and investor confidence. The study directly challenges static cold storage, the long‑time standard, and fits within a broader industry trend toward “warm” organ perfusion platforms. While commercial impact will depend on results several years out, the update confirms management’s commitment to building a larger evidence base, which can be a medium‑term catalyst for sentiment relative to more traditional device players in transplant care.

The DENOVO study is currently in the setup phase and remains ongoing in planning, with further details and updates available on the ClinicalTrials.gov portal under identifier NCT07340710.