United Therapeutics and Intermountain Health Announce the First Patient Treated With External Liver Support Using a Bioengineered Liver

A phase 1 study of miroliverELAP for the treatment of acute liver failure is currently underway;¹ first patient in the study underwent the procedure at Intermountain Medical Center in Murray, Utah

Approximately 30% of acute liver failure (ALF) patients die without access to a liver transplant.²

EDEN PRAIRIE, Minn. & MURRAY, Utah--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, and Intermountain Health, one of the nation’s top health systems and the largest nonprofit health system in the Intermountain West, today announced the world’s first patient treated in a clinical study of a bioengineered external liver assist product called miroliverELAP®.

This study is the first human clinical trial of a manufactured organ alternative.

The procedure was performed on a patient experiencing liver failure who was not eligible for a liver transplant. The procedure was performed by the team at Intermountain Medical Center in Murray, Utah, led by Christopher J. Danford, MD, a transplant hepatologist at Intermountain Health.

Developed by Miromatrix Medical Inc., a United Therapeutics subsidiary, miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver and an extracorporeal blood circuit.

The bioengineered liver is made up of a decellularized porcine liver scaffold to which allogeneic³ human endothelial⁴ and liver cells have been added.

“This first of its kind treatment represents a historic achievement for United Therapeutics and Miromatrix in advancing the potential of bioengineered human organs to help save and improve patients’ lives,” said Jeff Ross, Ph.D., President of Miromatrix. “We’re grateful to the patient and their family, in addition to the scientists and caregivers at Intermountain Health and Intermountain Medical Center who helped make this breakthrough possible. Looking ahead, we’re excited to continue progressing our ongoing phase 1 clinical trial.”

“This groundbreaking procedure – the first of its kind in the world – represents everything Intermountain Health stands for in providing innovative, cutting-edge high-quality care for our patients,” said Ralph Jean-Mary, president of Intermountain Medical Center. “We are profoundly thankful to this patient for their participation in this pioneering study, and to our exceptional Intermountain medical team, as well as our partners at United Therapeutics and Miromatrix. This procedure reinforces our unwavering commitment to leading in clinical excellence and helping people live the healthiest lives possible.”

United Therapeutics’ organ and organ alternative manufacturing efforts consist of three platforms – xenotransplantation,⁵ allogeneic regenerative medicine, and autologous⁶ regenerative medicine – encompassing four different organs: hearts, kidneys, livers, and lungs. These revolutionary programs are intended to address the ongoing shortage of transplantable organs for patients with end-stage organ disease.

The investigational miroliverELAP system is not approved for any use in any country. More information about the phase 1 study of miroliverELAP for the treatment of acute liver failure is available on clinicaltrials.gov.

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. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

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

About Intermountain Health

Headquartered in Utah with locations in six states and additional operations across the western U.S., Intermountain Health is a nonprofit system of 33 hospitals, approximately 400 clinics, medical groups with some 4,600 employed physicians and advanced care providers, a health plans division called Select Health with more than one million members, and other health services. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes at sustainable costs.

About ALF and miroliverELAP

Developed by Miromatrix, a subsidiary of United Therapeutics, miroliverELAP® is an external liver assist product (ELAP) designed to provide liver support for acute liver failure patients. The ELAP system consists of an external perfusion system and a bioengineered liver that resides outside of the human body to provide temporary liver support to patients with acute liver failure. The bioengineered liver is manufactured by recellularizing a decellularized porcine liver with human endothelial cells and human liver cells obtained from donated human livers. Miromatrix works with organ procurement organizations to obtain donated human livers that were unable to be transplanted.

Approximately 86,000 patients are hospitalized in the U.S. each year with acute forms of liver failure, acute on chronic liver failure and severe acute alcoholic hepatitis, collectively called acute liver failure (ALF).^7,8,9 ALF refers to a rapid loss of liver function – over days or weeks – often in a person who has no history of preexisting liver disease. Common causes include hepatitis viruses, drugs such as acetaminophen, and excessive alcohol use. ALF can cause serious complications including excessive bleeding and pressure on the brain, making it a medical emergency that requires hospitalization. The outcomes for ALF patients are estimated to be 45% spontaneous recovery, 25% liver transplantation and 30% death without transplant.¹⁰

A phase 1 study of ELAP was initiated in 2024, and in June 2025, the world’s first external liver support treatment using a bioengineered liver was conducted on an ALF patient at Intermountain Medical Center in Murray, Utah. The phase 1 study is open for enrollment of patients with ALF at eight sites in the United States.

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, statements regarding the future progress of the phase 1 clinical trial of the miroliverELAP product; our plans to develop manufactured organ and organ alternative products with the intent of addressing the ongoing shortage of transplantable organs for patients with end-stage organ disease; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders and furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs, and our expectations for a future where organ shortages no longer cost lives. 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. In particular, our plans to commence clinical studies of one or more xenotransplantation products in 2025 are subject to regulatory clearance, including the completion of preclinical studies to the satisfaction of the FDA, and many other factors that we cannot control. 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 June 24, 2025, 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.

MIROLIVERELAP is a registered trademark of United Therapeutics Corporation and its subsidiaries.

1 More information on the study is available at https://clinicaltrials.gov/study/NCT06285253. 2 Lee, W. M., Squires, R. H., Jr, Nyberg, S. L., Doo, E., & Hoofnagle, J. H. (2008). Acute liver failure: Summary of a workshop. Hepatology (Baltimore, Md.), 47(4), 1401–1415. https://doi.org/10.1002/hep.22177 3 Allogeneic cells come from a donor who is genetically different from the recipient, but of the same species. 4 Endothelial cells form the inner lining of blood vessels. 5 Xenotransplantation is the process of transplanting living cells, tissues, or organs from one species into another—most commonly from animals into humans. United Therapeutics is developing technologies to enable transplantation of whole organs from gene-edited pigs into humans. 6 Autologous cells are cells collected from and then used in the same individual. 7 Allen, A.M., Kim, W.R., Moriarty, J.P., Shah, N.D., Larson, J.J. and Kamath, P.S. (2016), Time trends in the health care burden and mortality of acute on chronic liver failure in the United States. Hepatology, 64: 2165-2172. https://doi.org/10.1002/hep.28812 8 Liangpunsakul S. (2011). Clinical characteristics and mortality of hospitalized alcoholic hepatitis patients in the United States. Journal of clinical gastroenterology, 45(8), 714–719. https://doi.org/10.1097/MCG.0b013e3181fdef1d 9 Pathikonda, M., & Munoz, S. J. (2010). Acute liver failure. Annals of Hepatology, 9(1), 7–14. https://doi.org/10.1016/S1665-2681(19)31673-4 10 Lee, W. M., Squires, R. H., Jr, Nyberg, S. L., Doo, E., & Hoofnagle, J. H. (2008). Acute liver failure: Summary of a workshop. Hepatology (Baltimore, Md.), 47(4), 1401–1415. https://doi.org/10.1002/hep.22177

 

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United Therapeutics

Dewey Steadman at (202) 919-4097 (media/investors)

Harry Silvers at (301) 578-1401 (investors)

https://ir.unither.com/contact-uthr/

Intermountain Health

Jess Gomez: jess.gomez@imail.org / 801-718-8495

Source: United Therapeutics Corporation