Liver graphics
United Therapeutics Corporation (NASDAQ: UTHR), a public welfare corporation, and Intermountain Health, one of the nation's largest health systems and the largest non-profit health system at Intermountain West, today announced the world's first patient treated in a clinical study of a bioengineering external liver assist product called Miroliver.Elap®.
This study is the first human clinical trial of manufactured organ replacements.
This procedure was performed on patients experiencing liver failure who were not eligible for liver transplants. The procedure was carried out by a team at Intermountain Medical Center in Murray, Utah, led by Intermountain Health's transplant liver specialist Christopher J. Dunford.
Developed by Miromatrix Medical Inc., a subsidiary of Miroliver's United TherapeuticsELAP is a single-use Milo-001 bioengineering product that combines external liver auxiliary material, consisting of an extracorporeal blood circuit.
The bioengineered liver consists of a decellularized pig hepatic scaffold supplemented with allogeneic 3 human endothelial 4 and liver cells.
“This initial treatment represents the historical achievements of United Therapeutics and Milomatrix in advancing the potential of bioengineering human organs to save and improve patients' lives,” says Dr. Jeffros of Milomatrix. “We are grateful to our patients and their families, as well as the scientists and caregivers at Intermountain Health and Intermountain Medical Center who helped make this breakthrough possible. We are excited to continue our ongoing Phase 1 clinical trials with a look ahead.”
“This groundbreaking procedure – the world's first step represents everything Intermountain Health represents in providing innovative, cutting-edge, high-quality care to patients,” said Ralph Jean-Mary, president of Intermountain Medical Center. “We are deeply grateful to this patient and our exceptional Intermountain Medical team for participating in this pioneering research and our partners at United Therapeutics and Milomatrix. This procedure reinforces our unwavering commitment to leading clinical excellence and helping people lead healthier lives.”
United Therapeutics' organ and alternative manufacturing operations consist of three platforms: xenograft, five allogeneic regenerative medicine, and Autocous6 regenerative medicine. These innovative programs aim to address the ongoing shortage of transplantable organs in patients with terminal organ disease.
Research Milo RiverELAP The system is not approved for use in any country. Details of Miroliver's Phase 1 ResearchELAP Treatment of acute liver failure is available at ClinicalTrials.gov.
About Alf and MiroliverELAP
Developed by Miromatrix, a subsidiary of Miroliver's United TherapeuticsELAP® is an external liver support product (ELAP) designed to provide liver support to patients with acute liver failure. The ELAP system consists of an external perfusion system and a bioengineered liver located outside the human body to provide temporary liver support to patients with acute liver failure.
Bioengineering liver is produced by rechlorination of small dechlorinated pig liver with human endothelial cells and human hepatocytes obtained from donated human liver. Miromatrix works with organ procurement organizations to obtain donated human livers that cannot be transplanted.
In the United States, approximately 86,000 patients are hospitalized each year with liver failure, chronic liver failure, and severe acute alcoholic hepatitis. This is collectively called acute liver failure (ALF). 7,8,9ALF refers to the rapid loss of liver function.
Common causes include hepatitis virus, drugs such as acetaminophen, and excessive alcohol use. ALF can cause serious complications, including excessive bleeding and brain pressure, resulting in a medical emergency that requires hospitalization. Results for ALF patients are estimated to be voluntary recovery in 45%, 25% liver transplantation, and 30% deaths without transplantation.
The ELAP phase 1 study began in 2024, and in June 2025, the world's first external liver-assisted treatment using bioengineered liver was conducted in ALF patients at Intermountain Medical Center in Murray, Utah. Phase 1 studies are open for registration of ALF patients at eight US sites.
Forward-looking statements
The statements contained in this press release, which are not inherently historic, are “forward-looking statements” in the meaning of the Private Securities Litigation Reform Act of 1995.ELAP Products; Plans to develop manufactured organs and organ alternative products aimed at addressing the continued shortage of transplantable organs in patients with terminal organ disease. and our goal of developing new pharmaceutical therapies and technologies that innovate patients' unmet medical needs, benefit other stakeholders, and expand the availability of transplantable organs, and to promote expectations for a future where organ shortages are no longer costly. These forward-looking statements are subject to certain risks and uncertainties as set forth in periodic reports filed with the Securities and Exchange Commission, and actual results may differ materially from those expected. Therefore, such forward-looking statements are qualified by caution, warning language and risk factors as set forth in periodic reports and documents filed with the Securities and Exchange Commission, including the most recent annual report on Form 10-K, the quarterly report on Form 10-Q, and the current reports on Form 8-K. Plans to commence clinical research on one or more xenograft products in 2025 will be subject to regulatory clearance, including completion of preclinical studies to FDA satisfaction and many other factors that we cannot control. For a forward-looking statement, it advocates the protection of safe harbors included in the Private Securities Litigation Reform Act of 1995. As of June 24, 2025, we are providing this information and have no obligation to update or revise the information contained in this press release, whether there are new information, future events, or other reasons.
Mirolivelap is a registered trademark of United Therapeutics Corporation and its subsidiaries.
More information about 1 research is available at https://clinicaltrials.gov/study/NCT06285253.
2 Lee, Wm, Squires, Rh, Jr, Nyberg, SL, Doo, E. , & Hoofnagle, J. H. (2008). Acute liver failure: Workshop overview. Hepatics (Baltimore, Maryland), 47(4), 1401–1415. https://doi.org/10.1002/hep.22177
Three-radiating cells come from genetically different donors of the same species as recipients.
4 Endothelial cells form the inner lining of the blood vessels.
5xenoTransplantation is the process of transplanting live cells, tissues, or organs from one species to another. This is from animals to humans. United Therapeutics is developing technologies that allow for gene-edited pig-to-human organ transplantation.
6autologous cells are cells that are collected from the same individual and subsequently used.
7 Allen, Am, Kim, WR, Moriarty, JP, Shah, ND, Larson, JJ and Kamath, PS (2016), Time trends in healthcare burden and acute mortality for 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 rates 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. , and Munoz, S. J. (2010). Acute liver failure. Chronicles of Hepatology, 9(1), 7–14. https://doi.org/10.1016/S1665-2681(19)31673-4
10 Lee, Wm, Squires, Rh, Jr, Nyberg, SL, Doo, E. , & Hoofnagle, J. H. (2008). Acute liver failure: Workshop overview. Hepatics (Baltimore, Maryland), 47(4), 1401–1415. https://doi.org/10.1002/hep.22177
contact address:
United Therapeutics:
Dewey Steadman at (202) 919-4097 (Media/Investor)
(301) 578-1401 (Investor) Harry Silver
Inter Mountain Health:
Jess Gomez: jess.gomez@imail.org / 801-718-8495
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