Here are a few analogies to describe TransMedics (TMDX):

• SpaceX for organ transplants: TransMedics is using groundbreaking, high-tech innovation to revolutionize and expand the possibilities within the critical field of organ transplantation, much like SpaceX has done for space travel.
• Tesla for organ preservation technology: They are disrupting traditional methods of organ preservation and transport with advanced, integrated technology, similar to how Tesla has revolutionized the automotive industry.
• Medtronic or Stryker focused on advanced organ transplant systems: TransMedics is establishing itself as a specialized leader in sophisticated medical device technology, specifically for organ care, akin to how Medtronic and Stryker lead in their respective med-tech areas.

• TransMedics Organ Care System (OCS™) Heart: A portable device designed to maintain donor hearts in a near-physiologic, warm, and continually perfused state during transportation for transplantation.
• TransMedics Organ Care System (OCS™) Lung: A portable device designed to maintain donor lungs in a near-physiologic, warm, and continually perfused state during transportation for transplantation.
• TransMedics Organ Care System (OCS™) Liver: A portable device designed to maintain donor livers in a near-physiologic, warm, and continually perfused state during transportation for transplantation.

TransMedics (symbol: TMDX) primarily sells its advanced medical devices, specifically the Organ Care System (OCS) platform, to other companies and institutions within the healthcare sector. Therefore, it does not serve individual customers directly.

Its major customers are:

• Transplant Centers at Hospitals: These institutions are the primary users of TransMedics' OCS devices (OCS Heart, OCS Lung, OCS Liver). The OCS is utilized by transplant surgeons, procurement teams, and hospital administration for the preservation and assessment of donor organs during transportation prior to transplantation.
• Organ Procurement Organizations (OPOs): These organizations play a crucial role in the organ donation and recovery process. OPOs work in conjunction with transplant centers and may utilize TransMedics' technology as part of their efforts to optimize organ viability and logistics.

It is important to note that the vast majority of hospitals and Organ Procurement Organizations are not publicly traded companies and, therefore, do not have stock symbols. TransMedics' customer base is distributed across numerous such institutions globally, rather than concentrated in a few publicly listed entities.

null

Waleed H. Hassanein, President, Chief Executive Officer, and Director

Dr. Waleed H. Hassanein founded TransMedics, Inc. in August 1998, and has served as its President, Chief Executive Officer, and Director since that time. He is a physician and the inventor of the Organ Care System technology. Prior to founding TransMedics, he completed a three-year cardiac surgery research fellowship at West Roxbury VA Medical Center and Brigham and Women's Hospital, a Harvard Medical School affiliate, and two years of general surgery residency. Dr. Hassanein earned his M.D. degree from Georgetown University in 1993. Since founding TransMedics, he has raised over $35 million in private equity capital to commercialize the Organ Care System. The company has also received approximately EUR 280 million in venture capital and private equity.

Gerardo Hernandez, Chief Financial Officer and Treasurer

Gerardo Hernandez was appointed Chief Financial Officer of TransMedics Group, Inc. effective December 2, 2024. He is an accomplished finance leader with over 25 years of experience in the healthcare and consumer packaged goods sectors. Most recently, he served as Vice President Finance, Head of Corporate Financial Planning and Analysis at Alnylam Pharmaceuticals, Inc. from February 2020 until September 2024. Prior to Alnylam, Mr. Hernandez spent nearly a decade at Shire, where he led corporate financial planning and analysis. During his tenure at Shire, the company was acquired by Takeda in a $62 billion transaction, and he was instrumental in the integration efforts. He began his career at Unilever, holding various finance roles. Mr. Hernandez holds a Bachelor of Science degree in Finance from the University of Wisconsin, La Crosse, and an MBA in Strategy and Economics.

Tamer Khayal, Chief Commercial Officer

Dr. Tamer Khayal serves as the Chief Commercial Officer at TransMedics Group, Inc.

Nicholas Corcoran, Senior Vice President, Supply Chain and Operations

Nicholas Corcoran holds the position of Senior Vice President, Supply Chain and Operations at TransMedics Group, Inc.

Anil P. Ranganath, Senior Vice President, General Counsel and Corporate Secretary

Anil P. Ranganath is the Senior Vice President, General Counsel, and Corporate Secretary for TransMedics Group, Inc.

The public company TransMedics (TMDX) faces several key risks to its business, primarily centered around legal challenges, operational complexities related to its National OCS Program, and competitive pressures within its niche market. These risks are presented in order from most significant to least significant based on available information.

1. Legal and Regulatory Challenges: TransMedics is currently facing a class-action lawsuit filed in March 2025, alleging fraudulent practices, including kickbacks, overbilling, and coercive tactics, along with the concealment of safety issues. Such allegations pose significant risks to the company's financial health, potentially leading to costly legal battles, regulatory fines, and a substantial loss of investor confidence. Historically, the company has also faced scrutiny from the FDA regarding its Organ Care System (OCS) Liver System, with past concerns raised about potential device malfunctions, organ damage, and a lack of demonstrated survival improvement compared to traditional cold storage methods. The heavily regulated nature of the medical technology industry means that changes in healthcare policies or economic conditions could also impact demand for its products.
2. Operational Complexities and Margin Pressures: A significant challenge stems from the complexities and cost-intensive nature of TransMedics' National OCS Program (NOP), which involves transitioning into an aviation logistics company. This shift towards lower-margin service offerings, particularly aviation logistics, has led to mounting gross margin pressure and an increasingly unfavorable revenue mix, eroding overall profitability. Scaling these logistics operations effectively while maintaining financial health is a complex task, with increased operational costs due to inflation, rising fuel, parts, and maintenance expenses further exacerbating margin challenges.
3. Competition and Market Saturation: TransMedics operates in a highly competitive medical technology industry that demands continuous innovation to maintain market leadership and avoid losing market share. The company's heavy reliance on its OCS technology could be a double-edged sword, as a lack of diversification in product offerings exposes it to risks if market dynamics shift or if competitors introduce superior or more cost-effective technologies. The emergence of alternatives like Normothermic Regional Perfusion (NRP), which is often considered a much cheaper solution, poses a competitive threat. Furthermore, the overall market for organ transplantation is relatively limited, and TransMedics' solutions are perceived as niche due to their cost, suggesting potential market saturation, particularly in its core liver market.

TransMedics' primary products and services center around its Organ Care System (OCS) platform, which includes OCS Heart, OCS Lung, and OCS Liver, along with its National OCS Program (NOP) that offers a comprehensive "organs as a service" solution encompassing organ procurement, logistics, and management for transplantation.

Addressable Market Sizes:

• Overall U.S. Organ Transplant Market (Heart, Lung, and Liver):
  • In 2024, the immediate organ transplant market in the U.S. was estimated to be approximately $2.2 billion.
  • TransMedics aims to facilitate 10,000 U.S. transplants annually by 2028, potentially capturing over 60% of the estimated 16,000 transplant-eligible organs available each year in the U.S.
• U.S. Liver Transplant Market:
  • In 2023, there were 10,660 liver transplants performed in the U.S.
• U.S. Heart Transplant Market:
  • In 2023, there were 4,545 heart transplants performed in the U.S.
• U.S. Lung Transplant Market:
  • In 2023, there were 3,026 lung transplants performed in the U.S.
• Global Organ Transplant Market (Overall):
  • The global transplantation market is approximately $10 billion and is growing at an 8.5% Compound Annual Growth Rate (CAGR).
  • The organ preservation solutions segment, where TransMedics is a key player, was valued at roughly $300 million in 2023 and is projected to grow at a 21% CAGR through 2030.
  • Globally, about 160,000 organ transplants are performed annually, against an estimated demand of 1.6 million (combining waitlists and emergency cases).
• U.S. Kidney Transplant Market (Future Product):
  • TransMedics plans to introduce a Kidney OCS. Management suggests this market could more than double its 2028 projections for total transplants supported.

Here are 3-5 expected drivers of future revenue growth for TransMedics (TMDX) over the next 2-3 years:

1. Increased Utilization and Penetration of the Organ Care System (OCS™) and National OCS Program (NOP™) in the U.S. for Existing Organs: TransMedics anticipates continued revenue growth from the expanding adoption and increased utilization of its OCS™ platform across heart, lung, and liver transplants within the U.S. National OCS Program. This involves deeper penetration into existing transplant centers and maximizing the use of available donor organs through their differentiated technology and comprehensive service offering.

2. Expansion into New Organ Markets: A significant driver for future revenue growth is the strategic expansion into new organ types, most notably kidney transplantation. The kidney transplant market represents a substantial addressable market, and TransMedics' plans to enter this segment are expected to materially grow its total addressable market.

3. Launch and Adoption of Next-Generation OCS™ Technologies: The development and planned commercialization of next-generation OCS™ Heart and Lung technologies are expected to fuel future growth. These advanced systems aim to improve clinical outcomes, potentially extend organ preservation times up to 24 hours, and facilitate more efficient transplant logistics. The company received conditional FDA approval to initiate its Next-Gen OCS™ Lung trial, with next-gen heart and lung programs expected to launch in the second half of 2025.

4. Expansion of Transplant Logistics Services and Aviation Infrastructure: The continued build-out and increased utilization of TransMedics' integrated transplant logistics network, including its dedicated aviation fleet, is a key component of its National OCS Program and a direct contributor to service revenue. The company plans to add more aircraft to optimize fleet utilization and operational efficiency, thereby supporting increased transplant volumes.

Share Issuance

• TransMedics granted inducement equity awards to 15 new employees on October 27, 2025, which included non-qualified stock options to purchase an aggregate of 27,582 shares and 18,299 restricted stock units.
• Stock-based compensation, which often results in share issuance, was approximately $38.23 million for the trailing twelve months ending September 30, 2025, $33.22 million in fiscal year 2024, and $19.79 million in fiscal year 2023.
• The number of shares outstanding increased from 35.2 million at the end of December 2024 to 40.7 million by September 30, 2025.

Outbound Investments

• TransMedics is focused on fueling growth through continued research and development investments and targeted expansion into selected international markets.
• The company announced a strategic collaboration with Mercedes-Benz Group AG to deploy a dedicated organ transportation ground network in Italy, expected to launch its first European National OCS Program (NOP) in 2026.
• Investments are also being made to build a stronger foundation by implementing systems to simplify and optimize processes, and enhancing infrastructure, including a planned new global headquarters.

Capital Expenditures

• TransMedics reported capital expenditures of approximately $57.34 million for the trailing twelve months ending September 30, 2025, $129.74 million in fiscal year 2024, and $151.85 million in fiscal year 2023.
• The primary focus of capital expenditures includes ongoing upgrades to expand manufacturing, enhancing infrastructure to support long-term scalability, and a planned move to a new global headquarters to accommodate growth.
• The company has expanded its owned and operated aircraft fleet for organ transport, owning 21 aircraft as of September 30, 2025, and adding a twenty-second aircraft in October 2025.