TransMedics Group Stock

TransMedics Group, Inc. (TransMedics) operates as a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states.

The company developed the OCS to replace a decades-old standard of care that is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. The company’s OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. The company has also developed its NOP, a turnkey solution to provide outsourced organ retrieval, OCS organ management and logistics services, to provide transplant programs in the United States with a more efficient process to procure donor organs with the OCS. The company’s logistics services include aviation transportation, ground transportation, and other coordination activity. The use of the OCS combined with the NOP has the potential to significantly increase the number of organ transplants and improve post-transplant outcomes.

The company designed the OCS to be a platform that allows the company to leverage core technologies across products for multiple organs. As of December 31, 2023, the company developed three OCS products, one for each of heart, lung and liver transplantations, making the OCS the only FDA approved, portable, multi-organ, warm perfusion technology platform. All three of the company’s products, OCS Heart, OCS Lung and OCS Liver, have received Pre-Market Approval, or PMA, from the Food and Drug Administration, or FDA, for both organs donated after brain death, or DBD organs, and organs donated after circulatory death, or DCD organs.

The company developed the OCS to comprehensively address the major limitations of cold storage. The OCS is a portable organ perfusion, optimization and monitoring system that utilizes the company’s proprietary and customized technology to replicate near-physiologic conditions for donor organs outside of the human body. The company designed the OCS technology platform to perfuse donor organs with warm, oxygenated, nutrient-enriched blood, while maintaining the organs in a living, functioning state; the lung is breathing, the heart is beating and the liver is producing bile. Because the OCS significantly reduces injurious ischemic time on donor organs as compared to cold storage and enables the optimization and assessment of donor organs, it has demonstrated improved clinical outcomes relative to cold storage and offers the potential to significantly improve donor organ utilization.

The company developed the NOP to provide additional capabilities to transplant centers for the complicated organ procurement process that often requires resources and logistics beyond a transplant center’s existing capabilities and capacity, thereby limiting the number of organs the transplant center may be able to retrieve. The company’s NOP provides trained organ procurement surgeons, clinical specialists and transplant coordinators that provide an end-to-end clinical solution using the company’s OCS technology. In 2023, the company enhanced its NOP offering to include logistics services with the addition of a logistics team to expand the company’s transportation logistics capabilities. The company’s logistics services include aviation transportation, ground transportation, and other coordination activity. The company’s NOP provides transplant centers with the ability to utilize the OCS to procure and transplant more organs for their patients than they would otherwise be able to do without increasing their own staff.

On August 16, 2023, the company acquired Summit Aviation, Inc. and Northside Property Group, LLC, or together Summit. Summit was a charter flight operator based in Bozeman, Montana. The acquisition enabled the company to add aircraft transportation services to the company’s NOP and become a comprehensive national provider of donor organ retrieval and delivery in the United States. The company has also acquired 13 fixed-wing aircraft to transport donor organs as part of the services offered under the company’s NOP. The company intends to acquire additional fixed-wing aircraft as the company scales its fleet of aircraft to reduce the company’s dependence on third party transportation providers.

The company’s OCS products and NOP services are reimbursed in the United States through existing, standard commercial transplant billing mechanisms. The Medicare program and private payors had been providing reimbursement for the OCS Lung, OCS Heart and OCS Liver during the U.S. pivotal trials and have continued providing reimbursement for the company’s products and services following FDA approval. The company is in the process of seeking long-term reimbursement for the company’s products outside of the United States.

Technology and Solution

The company developed the OCS to comprehensively address the major limitations of cold storage. The OCS is a portable organ perfusion, optimization and monitoring system that utilizes the company’s proprietary and customized technology to replicate near-physiologic conditions for donor organs outside of the human body. The OCS was designed to perfuse donor organs with warm, oxygenated and nutrient-enriched blood, while maintaining the organs in a living, functioning state; the lung is breathing, the heart is beating and the liver is producing bile. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment.

The OCS Technology Platform

The company developed the OCS, the first and only FDA approved portable, multi-organ, warm perfusion platform, to leverage proprietary core technologies across multiple organs. For each OCS product, the company supplement the platform with organ-specific, customized and proprietary technologies. As of December 31, 2023, the company developed three OCS products, one for each of lung, heart and liver transplantation. The company has initiated the development of the next generation multi-organ platform to improve the usability, incorporate new technology and automation, and facilitate the use of OCS in the company’s NOP.

Each OCS product consists of three primary components customized for each organ:

OCS Console: The OCS Console is a highly portable electromechanical medical device that houses and controls the function of the OCS and is designed to fit in the current workflow for organ transplantation.

OCS Perfusion Set: The OCS Perfusion Set is a sterile, biocompatible single-use disposable set that stores the organ and circulates blood. The OCS Perfusion Set includes all accessories needed to place the organ on the system.

OCS Solutions: The OCS Solutions are a set of nutrient-enriched solutions used with blood to replenish depleted nutrients and hormones needed to optimize the organ’s condition outside of the human body.

The OCS technology platform is equipped with the following core technologies that the company designed to comprehensively address the limitations of cold storage and improve transplant outcomes: proprietary pulsatile blood pump to simulate beating heart perfusion in organs outside of the human body; proprietary software-controlled titanium blood warmer to maintain blood at body temperature while maximizing portability; gas exchanger to maintain organ oxygenation outside of the human body; customized hemodynamics sensors to monitor and assess organ function outside of the human body; proprietary software-controlled, miniaturized, electromechanical system with universal power supply and hot-swappable batteries to maximize portability and travel distance for organ retrieval; proprietary wireless monitor and control software to provide an intuitive user interface for monitoring critical organ function; and customized carbon fiber OCS console structure to reduce the overall weight of the system and maximize portability.

Strategy

The key elements of the company’s strategy are to grow the adoption of the OCS at existing transplant center customers and expand the number of centers utilizing OCS and NOP; grow the company’s NOP, a turnkey solution to provide outsourced organ retrieval, OCS organ management and logistics services, to provide transplant programs with a more efficient process to procure donor organs with the OCS; develop the next generation OCS technology platform to improve user experience and facilitate the company’s NOP; and expand internationally by accessing national reimbursement for OCS in key European countries.

Commercialization

The company commercializes its products through two channels: the company’s NOP and a direct acquisition model. The company’s NOP enables transplant centers to outsource the retrieval, organ management and transportation logistics process to the company’s trained organ procurement surgeons, clinical specialists and transplant and logistics coordinators using the company’s OCS products. The company’s offering allows the transplant center to focus their internal resources on the transplant surgery and patient care. Utilizing the company’s NOP saves the transplant center from investing in additional resources to support higher volumes and longer distance retrievals. Since the launch of the NOP, the company’s sales of the OCS have primarily been through the NOP.

The company’s direct acquisition model is provided to transplant centers to train their own teams for retrieval and organ management on the OCS. Customer users are certified on the use of OCS at the company’s training facility. Customers in the direct acquisition channel keep inventory of OCS disposables available and order replenishment as they are used. All of the company’s international customers and a small number of the company’s U.S. customers purchase its OCS products through the direct acquisition model.

Clinical Evidence

The lead transplant surgeons at transplant centers are clinically focused and rely primarily on clinical evidence to drive changes in their practice of organ transplantation. The company has developed a substantial body of global clinical evidence to support the company’s FDA PMA approvals and PMA submissions for the OCS for lung, heart and liver transplantation. Many of these clinical trials and studies have been published in peer-reviewed clinical journals. The company’s clinical trials have evaluated the use of the OCS for transplantation of organs that meet the current criteria for organ transplantation, as well as organs that would otherwise go unutilized from DBD and DCD donors. The results of the company’s clinical trials across lung, heart and liver transplantation may support the potential of the OCS in improving clinical outcomes and increasing utilization of available donor organs.

Intellectual Property

Patents and Trade Secrets

As of December 31, 2023, the company’s owned and licensed patent portfolio consisted of approximately 400 issued patents and pending patent applications worldwide, including in the United States, Australia, Europe, Canada, China, Israel, New Zealand and Japan. The company’s owned portfolio includes patents and applications related to one or more of the OCS Lung, OCS Heart, OCS Liver and solutions. In the United States, the company’s owned portfolio includes about 45 issued patents and 13 pending applications. Outside the United States, the company’s owned portfolio includes about 288 issued patents and 54 pending applications. Issued patents in the company’s portfolio are expected to expire between 2025 and 2038, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. If granted, the pending U.S. and foreign patent applications in the company’s portfolio are expected to expire between 2025 and 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

As of December 31, 2023, the company’s patent portfolio relating to the OCS Lung or lung transplantation technology included families consisted of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a lung ex vivo using both perfusion and ventilation. Such patents are issued in the United States, Australia, Belgium, Canada, China, Denmark, Europe, France, Germany, Ireland, Israel, Italy, Japan, Hong Kong, the Netherlands, New Zealand, Spain, Sweden, and United Kingdom, and patent applications are pending in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, Japan and New Zealand. These patents, and any patents issued from pending patent applications, are expected to expire in 2043, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

As of December 31, 2023, the company’s patent portfolio relating to the OCS Heart or heart transplantation technology included families consisted of patents and patent applications with claims that are generally directed to certain methods and systems for preserving a heart ex vivo. Such patents are issued in the United States, Australia, Belgium, Canada, China, Denmark, Europe, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, the Netherlands, New Zealand, Spain, Sweden, and the United Kingdom; and patent applications are pending in the United States, Australia, Canada, China, Europe, Hong Kong, Israel, Japan, and New Zealand. These patents, and any patents issued from pending patent applications, are expected to expire in 2038, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. The company has requested patent term extension for one patent relating to the OCS Heart, U.S. Patent No. 7,651,835, which, if granted, would expire in 2032.

As of December 31, 2023, the company’s patent portfolio relating to the OCS Liver or liver transplantation technology included a family of issued and pending patent applications with claims that are generally directed to certain systems, including perfusion circuits for perfusing a liver ex vivo. Such patents are issued in the United States and Australia, and applications are pending in the United States, Australia, Canada, China, Hong Kong, Israel, Japan, and New Zealand. This patent and any patents issued from pending patent applications are expected to expire in 2035, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable. The company has requested patent term extension for one patent relating to the OCS Liver, U.S. Patent No. 10,076,112, which, if granted, would expire in 2035.

As of December 31, 2023, the company’s patent portfolio relating to the OCS Solutions or other solutions for transplantation systems included families consisted of patents and patent applications with claims that are generally directed to compositions of certain perfusion fluids. Such patents are issued in the United States, Australia, China, Israel, Japan, and New Zealand; and patent applications are pending in the United States, Canada, China, Europe, Hong Kong, and New Zealand. These patents, and any patents issued from pending patent applications, are expected to expire in 2035, excluding any potential additional patent term for patent term adjustments or patent term extensions, if applicable.

Research, Development and Clinical Trial Operations

For the year ended December 31, 2023, the company’s research, development and clinical trials expenses were $36.1 million.

Manufacturing and Supply Chain Operations

Fresenius (Fresenius Kabi Austria GmbH and Fresenius Kabi AB) is the company’s single-source supplier of OCS Solutions for the OCS Lung and OCS Heart. The company’s agreement with Fresenius for the supply of OCS Lung Solution was previously through April 2024 and was automatically extended for 24 months through April 2026.

Product Regulation

The company’s OCS products and its operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in the European Union and other countries.

The company’s products are subject to regulation as medical devices under the Federal Food, Drug and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.

In addition to U.S. regulations, the company is subject to a variety of regulations in the European Union and other countries, governing medical devices, clinical investigations and commercial sales and distribution of the company’s products.

FDA Premarket Clearance and Approval Requirements

The company received 510(k) clearance for the OCS Lung Solution for cold flush, storage and transportation of donor lungs in July 2021, for the OCS Lung Donor Flush Set in November 2022, and for the OCS Heart Leukocyte Reducing Filter in October 2023.

Each of the company’s OCS warm perfusion products is a Class III device. The company has received a PMA for each of the following:

OCS Lung for the preservation of standard criteria donor lungs for double-lung transplantation;

OCS Lung for the preservation of donor lungs initially deemed unsuitable due to limitations of cold storage for double-lung transplantation;

OCS Heart for the preservation of DBD donor hearts deemed unsuitable due to limitations of cold storage (e.g. >4 hours of cross-clamp time);

OCS Heart for the ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death (DCD) hearts; and

OCS Liver for the preservation of DBD and DCD donor livers < 55 years old, macrosteatosis < 15% and with < 30 minutes of warm ischemia time.

Post-market Regulation

The company’s manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. As a manufacturer, the company’s facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA.

Regulation of Medical Devices in the European Union

In the European Union, the company’s products are regulated as medical devices. Regulation of the company’s medical devices in the European Union is harmonized through Regulation (EU) 2017/745, or the MDR, which repealed and replaced the Medical Devices Directive (93/42/EEC) with effect from May 26, 2021.

All of the company’s products that were previously certified under the EU Medical Devices Directive, including OCS Heart, OCS Lung, and OCS Liver systems, which includes the OCS Console, the OCS disposables, and the OCS solution additives, have now been recertified under the MDR. The company received the CE Mark for the OCS Liver combined with the company’s solution additives under the MDR in May 2023, with an effective date of April 2023.

Regulation in Other Countries

The company received a Class II Medical Device License from Health Canada for the company’s OCS Liver combined with the company’s solution additives in October 2023 to complement the company’s existing Health Canada licenses for OCS Heart and OCS Lung.

Federal, State and Foreign Fraud and Abuse and Physician Payment Transparency Laws

In addition to FDA restrictions on marketing and promotion of drugs and devices, other federal, state, international laws, as well as laws with extra-territorial effect and market practices restrict the company’s business practices.

The U.S. federal healthcare fraud and abuse laws generally apply to the company’s activities because the company’s products are covered under federal healthcare programs, such as Medicare and Medicaid. The principal U.S. federal healthcare fraud and abuse laws applicable to the company and its activities include: (1) the Anti-Kickback Statute, which prohibits the knowing and willful offer, solicitation, payment or receipt of anything of value in order to generate business reimbursable by a federal healthcare program; (2) the False Claims Act, which prohibits the submission of false or otherwise improper claims for payment to a federally-funded healthcare program, including claims resulting from a violation of the Anti-Kickback Statute; and (3) healthcare fraud statutes that prohibit false statements and improper claims to any third-party payor.

The advertising and promotion of the company’s products is subject to EU Directives concerning misleading and comparative advertising and unfair commercial practices, as well as other EU member state legislation governing the advertising and promotion of medical devices.

Many countries in which the company operates have laws with extra-territorial effect—those laws apply to the company’s operations outside the relevant country, to the extent they are breached. Examples of such laws include the Foreign Corrupt Practices Act, or the FCPA; the U.K. Bribery Act 2010; and the General Data Protection Regulation, or the GDPR.

Data Privacy and Security Laws

The company is neither a ‘covered entity’ nor a ‘business associate’ directly under the Health Insurance Portability and Accountability Act of 1996.

The company depends on third parties in relation to provision of the company’s services, a number of which process personal data on the company’s behalf. With such providers the company is legally required to enter into contractual arrangements which contain the minimum terms set out in the GDPR (and the U.K. GDPR), including to ensure that they process personal data only according to the company’s instructions, and that they have adequate technical and organizational security measures in place.

History

Transmedics Group, Inc. was founded in 1998. The company was incorporated in the Commonwealth of Massachusetts in 2018.