TransMedics to Provide Update on Ongoing Clinical Programs at the International Society of Heart and Lung Transplantation 2026 Annual Meeting

Rhea-AI Summary

TransMedics (Nasdaq: TMDX) unveiled the Controlled Hypothermic Organ Preservation System (CHOPS) at ISHLT 2026 to expand its product portfolio and support control arms in ENHANCE Heart Part B and DENOVO Lung trials.

CHOPS is an active cooling device intended to provide stable, adjustable cold storage. TransMedics will submit an IDE amendment to permit CHOPS as the control arm. The FDA granted full IDE approval for the Next-Generation OCS ENHANCE Heart trial in February 2026 and for the Next-Generation OCS DENOVO Lung trial in January 2026.

Positive

• Unveiled CHOPS, a new active cooling organ preservation device
• IDE for Next-Generation OCS ENHANCE Heart granted in February 2026
• IDE for Next-Generation OCS DENOVO Lung granted in January 2026
• Planned IDE amendment to allow CHOPS as control arm in two trials

Negative

• CHOPS is a new, stand-alone device requiring FDA review and clearance
• IDE amendment to use CHOPS as control arm is pending FDA approval
• Regulatory review timing uncertain despite company expectation of near-term conclusion

News Market Reaction – TMDX

-1.26%

1 alert

-1.26% News Effect

On the day this news was published, TMDX declined 1.26%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ENHANCE Heart IDE approval: February 2026 DENOVO Lung IDE approval: January 2026 ENHANCE Heart Part B: Part B +1 more

4 metrics

ENHANCE Heart IDE approval February 2026 FDA granted full IDE approval for Next-Generation OCS ENHANCE Heart trial

DENOVO Lung IDE approval January 2026 FDA granted full IDE approval for Next-Generation OCS DENOVO Lung trial

ENHANCE Heart Part B Part B Designed to assess superiority of OCS Heart perfusion versus static cold storage

DENOVO Lung trial DBD and DCD cases Assesses OCS Lung perfusion versus static cold storage in DBD and DCD

Market Reality Check

Price: $100.01 Vol: Volume 778,506 is below t...

normal vol

$100.01 Last Close

Volume Volume 778,506 is below the 20-day average of 871,895, suggesting modest participation. normal

Technical Price 114.65 is trading below the 200-day MA of 123.1, despite the positive news.

Peers on Argus

TMDX gained 5.27% while key peers were mixed: ITGR -1.13%, GKOS -1.5%, BRKR -2.2...

TMDX gained 5.27% while key peers were mixed: ITGR -1.13%, GKOS -1.5%, BRKR -2.22%, INSP +2.65%, LIVN +0.59%. The move appears stock-specific rather than sector-driven.

Historical Context

5 past events · Latest: Apr 21 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 21	Earnings date notice	Neutral	+4.0%	Scheduled Q1 2026 results and conference call announcement.
Feb 27	Tax allowance detail	Positive	+7.9%	Clarified impact of $103.3M tax valuation allowance release on Q4 results.
Feb 24	Earnings results	Positive	-4.3%	Reported strong Q4 and FY 2025 growth and 2026 revenue guidance.
Feb 20	Inducement grants	Neutral	+0.3%	Disclosed equity awards to new employees under inducement plan.
Feb 17	Conference appearances	Neutral	+1.3%	Announced March 2026 investor conference presentations and webcasts.

Pattern Detected

Recent fundamental and corporate updates often saw positive price reactions, though one strong earnings release drew a negative move.

Recent Company History

Over recent months, TransMedics highlighted strong growth and expanding clinical and commercial activity. Q4 2025 revenue was $160.8M with FY 2025 revenue of $605.5M (+37% YoY), and guidance for 2026 at $727M–$757M. Earnings-related updates in late February 2026 produced mixed reactions, including a -4.3% move on strong results and a 7.94% gain on tax-allowance detail. Routine corporate news, such as inducement grants and conference presentations, saw small positive moves, providing context for today’s clinically focused update.

Market Pulse Summary

This announcement details rollout of the CHOPS preservation system and its planned role as the contr...

Analysis

This announcement details rollout of the CHOPS preservation system and its planned role as the control arm in ENHANCE Heart Part B and DENOVO Lung trials, both supported by recent FDA IDE approvals in January and February 2026. In the past six months, TransMedics has paired strong financial performance with continued trial investment. Investors may watch enrollment progress, FDA review outcomes, and subsequent clinical data as key markers for how this expanded platform evolves.

Key Terms

controlled hypothermic organ preservation system, static cold storage, investigation device exemption, ide, +4 more

8 terms

controlled hypothermic organ preservation system medical

"the Controlled Hypothermic Organ Preservation System (CHOPS), aimed at"

A controlled hypothermic organ preservation system is a medical device that cools and gently circulates preservation fluid around a donated organ outside the body to slow cell activity and reduce damage, acting like a mobile refrigerator and life-support system for the tissue. Investors care because improved preservation increases the window for successful transplants, raises demand for the technology, and affects reimbursement, regulatory approval and adoption — all key drivers of market value for manufacturers and hospitals.

static cold storage medical

"when compared to DBD cases using static cold storage methods."

Static cold storage is the long-term keeping of temperature-sensitive materials—such as vaccines, biologic drugs, or frozen samples—in fixed freezers or cryogenic tanks rather than during transport. It matters to investors because the quality, regulatory compliance and shelf life of those assets depend on reliable, constant temperatures; inadequate storage can destroy product value, trigger recalls, or raise ongoing capital and operating costs much like leaving perishable food out of a refrigerator.

investigation device exemption regulatory

"submit an Investigation Device Exemption (IDE) amendment to allow CHOPS"

A investigational device exemption is a regulatory permission that lets a company legally test an unapproved medical device in human clinical trials so safety and effectiveness can be evaluated. For investors it matters because receiving this temporary 'road-test' permit is a crucial milestone that reduces regulatory uncertainty, moves a product closer to market approval, and helps forecast development timelines, costs and potential future revenue.

ide regulatory

"The FDA granted full approval of TransMedics' IDE for the Next-Generation"

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

u.s. food and drug administration regulatory

"will be regulated by the U.S. Food and Drug Administration (FDA) as a new,"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"With FDA review expected to conclude in the coming months, we anticipate"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

donation after brain death medical

"perfusion in donation after brain death (DBD) cases when compared to"

Donation after brain death is the medical practice of recovering organs or tissues for transplant after a person has been declared brain-dead—meaning the brain has permanently stopped working even if the heart may still be maintained by machines. For investors, it affects the supply of transplantable organs and therefore demand for related medical devices, hospital services, and biotech treatments; changes in regulations, technology, or donation rates can influence revenue and risk for companies in those sectors.

donation after circulatory death medical

"in DBD and donation after circulatory death (DCD) cases when compared"

Donation after circulatory death is the process of recovering organs for transplant from a person whose heart and breathing have permanently stopped. It matters to investors because expanding use of this approach creates demand for specialized preservation technologies, transport logistics, monitoring equipment and hospital services, and can change regulatory and reimbursement landscapes that affect companies supplying the transplant ecosystem — similar to how a new delivery route opens markets for related businesses.

AI-generated analysis. Not financial advice.

Unveils New Controlled Hypothermic Organ Preservation System (CHOPS) to Expand its Product Portfolio and to Facilitate Enrollment in Control Arms of OCS ENHANCE Heart Part B and OCS DENOVO Lung Clinical Trials

ANDOVER, Mass., April 23, 2026 /PRNewswire/ -- TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, is today providing an update on its ongoing clinical programs at the International Society of Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting in Toronto, Canada. At the meeting, TransMedics will unveil its new controlled, active cooling preservation device, the Controlled Hypothermic Organ Preservation System (CHOPS), aimed at facilitating the enrollment of the control arms of the OCS ENHANCE Heart Part B and OCS DENOVO Lung clinical trials.

CHOPS is a true active cooling device that provides a consistent and stable controlled cold storage environment for donor organs at a variety of temperature ranges that are established based on the recipient transplant program's preferences. In comparison, other current cold storage techniques use phase changing material that makes it difficult to control or adjust temperatures. CHOPS will be regulated by the U.S. Food and Drug Administration (FDA) as a new, stand-alone device for controlled hypothermic preservation. Importantly, TransMedics will submit an Investigation Device Exemption (IDE) amendment to allow CHOPS to serve as the control arm for both Part B of ENHANCE Heart and DENOVO Lung Trials. 

The FDA granted full approval of TransMedics' IDE for the Next-Generation OCS ENHANCE Heart trial in February 2026 and of the company's IDE for its Next-Generation OCS DENOVO Lung trial in January 2026. Part B of the ENHANCE trial is designed to assess the superiority of OCS Heart perfusion in donation after brain death (DBD) cases when compared to DBD cases using static cold storage methods. The OCS DENOVO trial is designed to assess the superiority of OCS Lung perfusion in DBD and donation after circulatory death (DCD) cases when compared to cases using static cold storage methods.

"Our commitment to building the highest level of prospective clinical evidence is what is driving us to conduct these two major clinical programs for heart and lung transplantation," said Waleed Hassanein, M.D., President and Chief Executive Officer. "With FDA review expected to conclude in the coming months, we anticipate being well positioned to support rigorous, FDA-acceptable comparisons in both the ENHANCE Heart Part B and DENOVO Lung trials. Importantly, if approved, this approach would also expand TransMedics' product offerings to include true controlled active cooling preservation devices to serve a broader segment of heart and lung transplant patients globally, based on prospective level 1 evidence."

About TransMedics Group, Inc. 
TransMedics is the world's leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure.

Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements address various matters, including, among other things, future results and events, including the potential safety, efficacy, regulatory review or approval and commercial success of TransMedics' products and product candidates and those relating to the company's product development, pre-clinical testing, clinical studies, clinical and regulatory milestones and timelines, plans for TransMedics' Controlled Hypothermic Organ Preservation System, the company's IDE amendment submission, comparability in TransMedics' ENHANCE Heart Part B and DENOVO Lung trials, and the potential expansion of TransMedics' product offerings. For this purpose, all statements other than statements of historical facts are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "could," "target," "predict," "seek" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties. Our management cannot predict all risks, nor can we assess the impact of all factors or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in or implied by any forward-looking statements we may make. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated in or implied by the forward-looking statements. Some of the key factors that could cause actual results to differ include: the fluctuation of our financial results from quarter to quarter; our ability to attract, train and retain key personnel; our dependence on the success of the Organ Care System ("OCS"); our ability to expand access to the OCS through our National OCS Program ("NOP"); our ability to improve the OCS platform, including by developing the next generation of the OCS products or expanding into new indications, and the development, and potential commercialization of our OCS Kidney device and CHOPS; the timing or results of clinical trials for the OCS, including pre- and post-approval studies; our ability to sustain profitability; our need to raise additional funding and our ability to obtain it on favorable terms, or at all; our ability to use net operating losses and research and development credit carryforwards; that we have identified a material weakness in our internal control over financial reporting, and that we may identify additional material weaknesses in the future; our ability to scale our manufacturing and sterilization capabilities to meet increasing demand for our products; the rate and degree of market acceptance of the OCS; our ability to educate patients, surgeons, transplant centers and private and public payors on the benefits offered by the OCS; our dependence on a limited number of customers for a significant portion of our revenue; our ability to obtain or maintain regulatory approvals or clearances for our OCS products in the United States, the European Union, and other select jurisdictions worldwide as well as other product candidates, including CHOPS; our ability to adequately respond to the Food and Drug Administration ("FDA"), or other competent authorities, follow-up inquiries in a timely manner; the impact of healthcare policy changes, including recently enacted or potential future legislation or administrative actions affecting or reforming the U.S. healthcare system, Organ Procurement and Transplantation Network ("OPTN"), or the FDA; the performance of our third-party suppliers and manufacturers; our use of third parties to transport donor organs and medical personnel for our NOP and our ability to maintain and grow our transplant logistics capabilities to support our NOP to reduce dependence on third party transportation, including by means of attracting, training and retaining pilots, and the acquisition, maintenance or replacement of fixed-wing aircraft for our aviation transportation services or other acquisitions, joint ventures or strategic investments; our ability to maintain Federal Aviation Administration or other regulatory licenses or approvals for our aircraft transportation services; price increases of the components of our products and maintenance, parts and fuel for our aircraft; our manufacturing, sales, marketing and clinical support capabilities and strategy; attacks against our information technology infrastructure; the economic, political and other risks associated with our foreign operations; our ability to protect, defend, maintain and enforce our intellectual property rights relating to the OCS and avoid allegations that our products or services infringe, misappropriate or otherwise violate the intellectual property rights of third parties; the pricing of the OCS, as well as the reimbursement coverage for the OCS in the United States and internationally; regulatory developments in the United States, European Union and other jurisdictions; the impact of a shutdown of the U.S. government; the extent and success of competing products or procedures that are or may become available; our ability to service our 1.50% convertible senior notes, due 2028; our existing and any future indebtedness, including our ability to comply with affirmative and negative covenants under our credit agreements to which we will remain subject until maturity; the impact of any product recalls or improper use of our products; our international expansion plans and the costs related thereto; our estimates regarding revenue, expenses and needs for additional financing; and other factors that may be described in our filings with the Securities and Exchange Commission (the "SEC"). Additional information will be made available in our annual and quarterly reports and other filings that we make with the SEC. The forward-looking statements in this press release speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and we are not able to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

Investor Contact:
Brian Johnston
Hannah Jeffrey
Investors@transmedics.com  

View original content to download multimedia:https://www.prnewswire.com/news-releases/transmedics-to-provide-update-on-ongoing-clinical-programs-at-the-international-society-of-heart-and-lung-transplantation-2026-annual-meeting-302751622.html

SOURCE TransMedics Group, Inc.

FAQ

What is CHOPS and how does TransMedics (TMDX) describe its purpose?

CHOPS is a controlled, active cooling organ preservation device for donor organs. According to the company, it provides stable, adjustable cold storage to facilitate enrollment of control arms in ENHANCE Heart Part B and DENOVO Lung trials.

Has the FDA approved the trials related to TransMedics' OCS ENHANCE Heart and DENOVO Lung programs?

Yes, the FDA granted full IDE approval for both next-generation trials. According to the company, IDE approval was granted in January 2026 for DENOVO Lung and February 2026 for ENHANCE Heart.

Will TransMedics use CHOPS as the control arm in OCS ENHANCE Heart Part B and DENOVO Lung trials?

TransMedics plans to submit an IDE amendment to allow CHOPS as the control arm. According to the company, the amendment is intended to permit CHOPS for both ENHANCE Heart Part B and DENOVO Lung.

What do the ENHANCE Heart Part B and DENOVO Lung trials compare for transplantation outcomes?

Both trials are designed to assess OCS perfusion versus static cold storage. According to the company, ENHANCE Part B targets DBD heart cases and DENOVO targets DBD and DCD lung cases.

What is the regulatory status and next step for CHOPS under TransMedics (TMDX)?

CHOPS will be regulated as a new, stand-alone device and requires FDA review. According to the company, TransMedics will submit an IDE amendment and expects FDA review to conclude in the coming months.