Unique centralized service helps increase the supply of lungs for transplant, addressing a critical unmet need

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, and its subsidiary Lung Bioengineering Inc. (LBE) announced that the 500^th lung transplant utilizing LBE’s centralized ex vivo lung perfusion (EVLP) service was completed last month. These 500 transplants were the result of evaluating over 800 donated lungs using centralized EVLP since 2014.

The 500th transplant was completed in Jacksonville at Mayo Clinic in Florida. “We are honored to work with United Therapeutics in this important collaboration that continues to increase the number of lungs that can be transplanted and is a significant step forward for transplant patients,” said John Haney, M.D., M.P.H., Chair of the Department of Cardiothoracic Surgery at Mayo Clinic in Florida. “Mayo Clinic is committed to using and developing the latest medical advances and innovations that will have tremendous benefits not only for our patients, but other patients at institutions throughout the U.S.”

“At United Therapeutics, our founding purpose has always been to save and improve lives through innovative technologies like those that expand the availability of transplantable organs and organ alternatives,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “We are proud of the groundbreaking accomplishments at LBE, and this important milestone serves as a testament to directly fulfilling our public benefit purpose by providing life-changing opportunities for those in need. This critical effort would not be possible without the tireless dedication of the LBE staff, the skilled physicians and hospital teams with whom we partner, and the patients and families we serve. Together, we are making a profound difference in the lives of so many, and we are deeply grateful for the trust placed in us.”

Lungs are among the most fragile and difficult organs to transplant. They are susceptible to injuries and infections, with only about 20 percent of donor lungs in the U.S. initially meeting the standard for transplant. About 300 people die every year waiting for a lung transplant – and this number only includes patients who can get on the waiting list. Close to 1,400 people are waiting for a lung transplant, and many thousands more could benefit from a transplant if more viable lungs were available, according to the United Network for Organ Sharing, the organization that oversees the nation's organ transplant system.

EVLP is a technique used to evaluate donor lungs outside of the human body. It has emerged as an important tool for transplant physicians to increase the number of lungs available for transplant. EVLP involves flushing, ventilating, and heating donor lungs to normal body temperatures while gathering data on the lungs for real-time transmission for review by transplant physicians and other transplant program team members. For example, when lungs do not meet standard direct-to-transplant criteria, they are often discarded. With the help of EVLP, lungs can be monitored and clinically assessed to help transplant centers determine transplant suitability.

In each case, LBE clinical specialists review donor information with transplant centers and organ procurement organizations to determine whether the proposed organ is suitable for EVLP. LBE clinical specialists then use an FDA-approved EVLP device, or alternatively as part of a clinical trial, an EVLP device under development by LBE called the Centralized Lung Evaluation System (CLES), to gather data. LBE transmits EVLP data and communicates with transplant practitioners in real time using its proprietary OrganVue™ software.

LBE’s staff of more than 30 professionals provide EVLP services at facilities located in Silver Spring, Maryland, and Jacksonville, Florida. Since 2014, LBE has received lungs from donor institutions as far afield as Alaska and Puerto Rico for centralized EVLP evaluation. Following EVLP, lungs have been accepted for transplant at 25 centers in North America spanning from a southernmost point of Miami to Toronto to the north, and St. Louis to the west.

Added Dr. Rothblatt: “As we look ahead at the unmet need, we are committed to building on the success of our centers of excellence in Maryland and Florida and are planning to open additional centralized EVLP centers in North America.”

LBE’s centralized EVLP service is part of the broader xeno and organ alternative development platform at United Therapeutics. This platform consists of four key technologies – xenotransplantation, bio-artificial organ alternatives, regenerative medicine, and 3D bioprinting – providing manufactured alternatives for four human organs – heart, kidney, liver, and lung. United Therapeutics’ Miromatrix subsidiary recently initiated a phase 1 study of miroliverELAP™, the first bioengineered organ alternative to enter human clinical studies. United Therapeutics plans to initiate the first clinical study of the UKidney™ xenokidney in 2025, contingent on satisfactory FDA review of an investigational new drug application and concurrent investigational new animal drug application.

About Lung Bioengineering

Lung Bioengineering Inc. (LBE) owns and operates the first and only full-service ex-vivo lung perfusion (EVLP) centers in the United States. The company was formed as a subsidiary of United Therapeutics in 2014 to be a leading provider of EVLP services. Our EVLP centers are driven by data and powered 24/7, 365 days a year, by the expertise of our LBE clinical specialists. LBE’s integrated EVLP service aims to reduce resource burdens from donation to transplant and increase organ utilization. LBE’s vision is a world where no one waits for a lifesaving transplant to become a reality. The organization is dedicated to achieving this vision one organ at a time. www.lungbioengineering.com

United Therapeutics: Enabling Inspiration

At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.

You can learn more about what it means to be a PBC here: unither.com/pbc.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, our goals for LBE’s integrated EVLP service to reduce resource burdens from donation to transplant and increase organ utilization; our plans to open additional centralized EVLP centers in North America; our plan to initiate the first clinical study of the UKidney™ xenokidney in 2025, and future regulatory activities related to these plans; and our efforts to innovate for the unmet medical needs of our patients, to benefit our other stakeholders, and to pursue our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of October 23, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

ORGANVUE, MIROLIVERELAP, and UKIDNEY are trademarks of United Therapeutics Corporation and its subsidiaries.

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