TransMedics at Oppenheimer Conference: Strategic Expansion Unveiled

On Monday, 16 March 2026, TransMedics Group Inc (NASDAQ:TMDX) presented at the Oppenheimer 36th Annual Healthcare MedTech & Services Conference. The company, led by CEO Waleed Hassanein and CFO Gerardo Hernandez-Omana, outlined its strategic initiatives, including European expansion and integration into the national transplant ecosystem. While optimistic about future growth, the company acknowledged challenges from competitive dynamics and operational costs.

TransMedics remains committed to its strategic goals and invites readers to refer to the full transcript for more detailed insights.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Good morning, everyone. Suraj Kalia, Senior Medical Devices Analyst at Oppenheimer. I know a lot of you are very anxious for this fireside chat. We’re pleased to have today CEO Waleed Hassanein and CFO Gerardo Hernandez-Omana from TransMedics with us this morning. Gentlemen, always a pleasure to discuss with you about the space. Thank you so much for taking the time this morning.

Waleed Hassanein, CEO, TransMedics: Thank you so much, Suraj, for the opportunity. We’re excited to be here.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Waleed, let me start out first with a comment, and then we’ll jump into questions. Despite the noise, I do want to congratulate you and the team. Been following you for what? 5, 6 years now, and you guys have delivered on what you all have set out originally, and you all have consistently hit your target. I do want to congratulate you guys on the impact you all have had on the organ transplantation space. Kudos to you guys. Waleed, let’s start out with the topic du jour, right? One of the things that you had said on the Q4 call was TransMedics is exploring to become, you know, more of an integrated contributor to the national transplant ecosystem.

If you could dissect it a little bit more, there is a lot of chatter about CMS meetings. Any additional color that you can fill in the blanks for us?

Waleed Hassanein, CEO, TransMedics: Sure. Suraj, first of all, thank you for your kind comment. This is a reflection of a team effort by the TransMedics team. We are excited about where we are, but we think that these are just the early innings, and there’s a lot more that’s coming from TransMedics to help grow organ transplantation and tackle bigger and higher peaks in organ transplant. One of which is that topic that you are asking me about. We started as a medical device company. We did the largest number of trials and the largest size trials in the history of organ transplant. We got five FDA indications for three organ transplant market segments.

We came out from FDA approval process, and we decided that the device alone is not enough, and we need to reinvent ourselves. We built the first of its kind national organ procurement infrastructure and created the NOP. That really delivered significant success for organ transplantation patients in the U.S. as well as TransMedics. 18 months into it, we identified another opportunity to further expand our NOP reach into vertically integrating transplant logistics and creating the first 100% dedicated air and ground transplant logistics in the nation and frankly, around the world. That generated significant momentum for TransMedics and significant momentum for organ transplantation. Two years into it became very obvious to us that we need to invest even further and build a very sophisticated digital ecosystem.

We call it the NOP Connect and NOP Access, and that generated significant success and momentum. Now we’re sitting here with the first and only fully operational national network for organ procurement that includes 50+ world-class transplant surgeons, 240+ clinical specialists, operating out of 18 hubs across the nation, surrounded with a very sophisticated digital ecosystem to manage organ transplantation for approximately nearly 30% of the nation’s volume. All that gave us the confidence and the interest to do more. For us to do more, we have to be an integral part of the national federal transplant ecosystem as a member of OPTN.

That’s what we are trying to pursue today to do more for organ transplant, generate more organ transplants to save more American lives and deliver it in the most cost-effective fashion, as we have proven throughout the NOP system over the last several years. That’s really where it’s coming from, Suraj. We are building off of the foundation that we built and the infrastructure that we built and the success that we built. We believe this is gonna be, if given the opportunity by the regulators, this could be a huge win-win-win-win to everybody involved. It’s gonna be a win for the patients, win for transplantation, win for the U.S. transplant system, and win for other OPOs, and win for TransMedics.

We’re very excited about this potential opportunity when we hope we’re fortunate enough to be successful in this endeavor.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Waleed, if I could and feel free, I respect, you know, some of the confidentialities surrounding discussions, so I don’t want to breach any of those. Logic tells you that such an endeavor as a CMO would not be part of TransMedics, right? It’s probably gonna be set as a nonprofit arm’s length entity. I presume that’s potentially on the one of the paths that any additional color you could provide on how if the regulators give you all approval, the mechanics of something like this, or you would say for competitive reasons, or you don’t want to get the spike the ball just yet, you don’t want to go there.

Waleed Hassanein, CEO, TransMedics: Yeah, yeah. I’m not sure I follow, Suraj. What do you mean by CMO?

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Like a contract organization, right? For organs. Would the nonprofit be set up?

Waleed Hassanein, CEO, TransMedics: Oh, you mean OPOs.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: For OPOs.

Waleed Hassanein, CEO, TransMedics: OPOs. Yeah, yeah.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: right?

Waleed Hassanein, CEO, TransMedics: Yeah.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Would it be set up as a nonprofit arm? Just any additional color.

Waleed Hassanein, CEO, TransMedics: Sure. I really cannot comment on that. These are very sensitive topics. It’s in the hands of the regulators, but they’re, you know. Becoming an OPO is just one mechanism of being a part of the OPTN system. There’s other opportunities. I’ll leave it at that, but it’s really in the hands of the regulators, and we wanna work very closely with the regulators and make sure that we do the right thing. We’ll have to wait and see.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Fair enough. I won’t press you on that. Waleed, at the best you can guess today, whatever decision happens, would this be a 2026 event, or do you think it could be later in 2027, just given the idiosyncrasies of regulatory approvals and whatnot?

Waleed Hassanein, CEO, TransMedics: I think, again, it’s up to the regulators, but the public statements made by CMS and HRSA that they indicated that they will be in a position to make decisions on this topic by end of 2026. For me, it’s more of a 2027 event if TransMedics would even be in the mix here. It will be a 2027 event.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Fair enough. Okay. Let’s switch gears. Waleed, one of the things, again, from the Q4 call that generated a lot of questions from clients was about the competitive dynamics for the control arm of Part B in ENHANCE. You know, how should we think about from that time to now what has happened? You know, how are you navigating any additional color you all can present us?

Waleed Hassanein, CEO, TransMedics: Sure. Suraj, that competitive dynamic that I referred to in the last earnings call, we actually are very excited about that, because it sent to me personally a clear signal that competition is shaking in their boots to compare their results to TransMedics or to OCS. For me, we are just focusing on doing the highest level evidence, collecting the highest level clinical evidence that is much needed in the field. That competitor does not have a single prospective randomized clinical trial. All their data is retrospective. The community are criticizing them for being cherry-picked. The control arm was handpicked by whoever was analyzing at the time using data from the COVID era.

It’s really noisy at best. When they created this tempest in a teacup for us, again, that’s a question that should be for them. TransMedics will never shy away from competing fairly. TransMedics will never shy away from building level one evidence. That’s our calling card. That’s our game plan from day one, and we are going to take full control of our study, including a control arm that is FDA, is gonna be FDA under FDA oversight and will generate the level one evidence that we’re hoping to deliver from this trial. We hope the results will speak for themselves and validate our excitement about the value of OCS and standard criteria DBD hearts for transplantation.

Suraj Kalia, Senior Medical Devices Analyst, Oppenheimer: Waleed, one of the questions that came up through many clients post Q4 was: How can the competitors throw a wrench? How can they slow down the process? You know, part of my explanation, and I won’t go into that, is just in terms of the software and, you know, the IRBs, what they sign up for. Maybe in your own words, you could articulate if somebody could slow things down, how they would, and what are the mechanisms to counter that, intrinsic or extrinsic mechanisms.

Waleed Hassanein, CEO, TransMedics: Sure. I’ll tell you what actually happened, rather than me kinda philosophizing about what the mechanisms. They basically raised serious concern for their technology to be compared to OCS. They shared that with the cent