TransMedics Group (NASDAQ:TMDX) CEO Waleed Hassanein and CFO Gerardo Hernandez-Omana provided updates on the company’s strategy, clinical trial planning, and operational initiatives during a fireside chat hosted by Oppenheimer senior medical devices analyst Suraj Kalia.
Expanding TransMedics’ role in the U.S. transplant ecosystem
Hassanein said TransMedics began as a medical device company and emphasized the company’s history of conducting large-scale trials in organ transplantation, resulting in “five FDA indications for three organ transplant market segments.” He said the company later concluded that “the device alone is not enough,” prompting TransMedics to build a national organ procurement infrastructure, which he referred to as the National OCS Program (NOP).
Looking ahead, Hassanein said the company is pursuing becoming “an integral part of the national federal transplant ecosystem as a member of OPTN,” framing the effort as a way to generate more transplants, save lives, and deliver services “in the most cost-effective fashion.” When asked about the mechanics and whether TransMedics might pursue becoming an organ procurement organization (OPO), Hassanein said he could not comment, calling the topics sensitive and in the hands of regulators, while noting that “becoming an OPO is just one mechanism” and “there’s other opportunities.”
On timing, Hassanein cited public statements from CMS and HRSA indicating decisions on the topic could come by the end of 2026, but said he views it as “more of a 2027 event” if TransMedics is involved.
Clinical trial updates: ENHANCE and De Novo
Hassanein addressed questions about competitive dynamics affecting the control arm of Part B in the ENHANCE trial. He said he viewed the situation as a signal that competitors are reluctant to have their results compared to TransMedics’ Organ Care System (OCS). He reiterated TransMedics’ emphasis on “level one evidence” and prospective randomized trials, and said the company intends to take “full control” of the study, including a control arm “under FDA oversight.”
When asked how competitors could slow progress, Hassanein described what he said occurred: a competitor raised concerns with transplant centers about comparing its technology to OCS, which created friction. He said TransMedics did not want to place transplant programs in “tough situations” and pursued a “creative way of solving the problem” to generate the evidence needed. He said Part A was “on track,” and added the company plans to discuss its solution at ISHLT, while noting he did not want to share details while in active dialogue with the FDA.
Regarding the De Novo lung initiative, Hassanein said it “falls in the same category as Part B of ENHANCE,” adding that the De Novo program was still in IRB processes after being approved “earlier in sort of the late January timeframe.” He said the company is talking to the FDA about both trials.
Europe and international initiatives; fuel cost considerations
On Europe, Hassanein said he does not see geopolitics currently playing a major role in the company’s European expansion and noted TransMedics’ origins in Europe. He said the company is investing in Europe, including building a dedicated air and ground transportation network, and cited ongoing partnerships, including a relationship with Mercedes-Benz.
He also pointed to an upcoming trip to Italy, where he said he planned to appear alongside Italian government officials to announce “the OCS budget approval to cover OCS cases across Italy.” Beyond Europe, Hassanein said the company has initiatives across the GCC region, which he noted is impacted by geopolitical developments, but characterized it as not a near-term event like Europe.
On fuel prices, Hassanein said transplantation has long dealt with fuel surcharges. He said TransMedics aims to manage fuel-related costs carefully, emphasizing it wants to be a partner to transplant programs and avoid “gouge[ing] the system,” adding the company believes it can operate more cost-efficiently because it owns and operates its fleet and considers itself “a transplant entity” rather than a logistics contractor.
Kidney program planning and upcoming protocol details
Hassanein said the kidney program could become the largest program TransMedics has sponsored, citing demand and interest in the kidney device. He said the company is “actively investigating” releasing the kidney product for clinical trials in both the U.S. and Europe at the same time, rather than prioritizing the U.S.
He described kidney transplantation in the U.S. as “an OPO kinda controlled therapy,” which he said adds complexity and requires close work with OPOs, while noting Europe may be different. Hassanein said TransMedics expects to be in a position to discuss the clinical protocol more fully by the Q3 earnings call or later in the year.
Operational updates: double shifting and the Somerville facility
Hernandez-Omana provided an update on the company’s “double shifting” initiative for its aviation fleet. He said TransMedics expects a better view on outcomes by the end of Q2 or early Q3. Currently, he said “around 20%-30% of our fleet”—approximately “four to six planes, depending on the time”—is already double shifting. He said early numbers suggest increased productivity, but emphasized it is still early and the company needs more flights to assess the impact.
On the Somerville facility, Hernandez-Omana described the next couple of years as “transition years,” noting the building is still at the core-and-shell stage and must be prepared for occupancy. He said part of the organization could move at the end of the year, with the remainder moving through 2027 and potentially early 2028. He added that lease accounting could create P&L impacts, potentially beginning with charges in Q1, and said he planned to provide further explanation on the Q1 earnings call.
In closing remarks, Hassanein said he believes TransMedics is still in “early to mid-innings,” and highlighted ENHANCE and De Novo as critical near-term priorities. He also pointed to ongoing liver growth, the potential for kidney to be a “game changer,” international expansion, and future technology development, including what he called “Gen III technology,” while emphasizing a continued focus on execution amid market “noise.”
About TransMedics Group (NASDAQ:TMDX)
TransMedics Group, Inc is a medical device company headquartered in Andover, Massachusetts, that specializes in advanced organ preservation and transport systems for transplantation. The company’s flagship technology, the Organ Care System (OCS), maintains donor organs in a near-physiologic, warm, beating state during transportation, with the aim of extending preservation times and improving post‐transplant outcomes. TransMedics’ solutions address a critical need in transplantation by reducing ischemic injury and expanding the donor organ pool.
TransMedics currently markets two commercially available OCS platforms.
