World's First Subzero Organ Transports: Multiple 48-Hour Transatlantic Journeys Support First Steps Toward Tackling Organ Waitlist

Surgeons successfully transported pig kidneys between Baltimore and Innsbruck five times using X-Therma's FDA Breakthrough-designated subzero preservation technology

SAN FRANCISCO, Oct. 23, 2024 /PRNewswire/ -- In a world first, a pig kidney preserved at subzero temperatures was successfully transported across the Atlantic Ocean multiple times, demonstrating the potential for a novel technology to greatly extend organ storage and preservation, and make long-distance organ transportation a clinical reality.

Extending organ preservation time could bridge the organ supply-and-demand gap, avoid high-risk, time-critical emergency surgeries, and potentially achieve advanced genetic matching, ultimately leading to more transplants and saving more lives.

Dr. Gerald Brandacher led a surgical and research team that removed a kidney from a pig at the Johns Hopkins University School of Medicine in Baltimore, Maryland, and transported the kidney on a commercial aircraft to the Medical University of Innsbruck in Austria. Preserved for roughly 48 hours at subzero temperatures, the kidney was assessed in Innsbruck on a clinical-grade machine perfusion device and demonstrated viability and functionality.

The team repeated the process five times in the past 12 months with preservation times ranging from 48-72 hours. As proof of concept of the technology, the team performed a life-supporting transplant in a pig, with the kidney maintaining normal renal function during the entire observation period for 200 days post-transplant after 72 hours ice-free subzero preservation.

Dr. Brandacher is Professor of Translational and Experimental Transplant Surgery, Co-Director and Executive Vice Chair for Research of the Department of Visceral, Transplant, and Thoracic Surgery, and Scientific Director of the Daniel Swarovski Transplantation Research Laboratory at Medical University of Innsbruck. He is also a professor in the Departments of Surgery and Plastic and Reconstructive Surgery at the Johns Hopkins University School of Medicine and Scientific Director of the reconstructive transplantation program.

The kidneys were preserved in X-Therma's XT-ViVo® solution in X-Therma's TimeSeal® device. X-Therma is a biotechnology company developing a biopreservation platform for regenerative medicines and organs for transplant. Inspired by naturally occurring anti-freeze proteins found in Arctic species, XT-ViVo® is a non-toxic, serum- and protein-free organ preservation solution that uses peptoids to prevent damaging ice crystal formation, enabling ice-free preservation of organs between 0°C and -20°C. Therefore, the temperature is reduced, and time extends. With the ability to be carried on a commercial aircraft, TimeSeal® allows for precise monitoring of temperature, storage duration, and location without requiring external power, blood, or oxygen. In 2022, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device status to XT-ViVo® and TimeSeal® for human kidney preservation up to 120 hours for transplant.

"By dismantling the traditional barriers of distance and time, our technology heralds a transformative era in organ transplantation, potentially making organs more accessible and saving more lives," said Xiaoxi Wei, Ph.D., CEO and co-founder of X-Therma. "With recent legislation permitting organ transport in commercial aircraft cabins, X-Therma is at the forefront of flexible global sharing of organs, tissues, and cells, with pioneering technology that seamlessly integrates into existing peri-transplant workflows and ensures time is on our side."

Since 1954, the gold standard for organ preservation has been static cold storage at 2-8°C using ice coolers, often leading to tissue and cell damage. X-Therma technology demonstrates incredible potential to overcome storage limitations with no additional steps and no additional perfusion instrument, blood, or oxygen. By extending preservation times beyond current standards—24 hours for kidneys, 4 hours for hearts—we could significantly enhance transplantation outcomes and open access to more transplants.

"The U.S. Department of Health and Human Services (HHS), in collaboration with the White House, has set an ambitious goal of 60,000 transplants in the United States by 2026, while we currently perform 27,000 kidney transplants yearly today. Extending the time that we can preserve an organ for transplantation is a game changer for the entire transplant community, with the potential to reduce costs, improve quality of life for transplant staff by scheduling surgeries during the normal workday, improve patient outcomes, and, someday, end the waiting list," said Dr. David Mulligan, past president of UNOS/OPTN and Professor of Surgery at Yale University.

The results were presented to peers at several events, including by Dr. Brandacher on July 25, 2024, at the Society of Cryobiology's 61^st annual meeting in Bethesda, Maryland, and by Amanda Loftin, DVM, Ph.D. Candidate at the Johns Hopkins University School of Medicine, on September 25, 2024, at The Transplantation Society in Istanbul. Dr. Loftin's presentation was selected as one of the TSS meeting's top four abstracts in the United States. The results have been validated through extensive pre-clinical studies in various organ systems.

Images and video are available for press use.

About X-Therma Inc.
X-Therma Inc. (www.x-therma.com) is pioneering breakthrough cold chain technology via a convergent biopreservation platform, to advance regenerative medicine and make available safe and on-demand organs, engineered tissues, cell and gene therapies, vaccines, and beyond to patients in need. X-Therma is headquartered in Hercules, part of the San Francisco Bay Area. The company has an expanding presence in Austria, with parts of the TimeSeal® being developed and manufactured in Tyrol.

Contacts:
Media: [email protected]
Investor Relations: [email protected]

SOURCE X-Therma Inc.