X-Therma has announced the successful completion of multiple transatlantic organ transports using its novel subzero preservation technology. A pig kidney, preserved at subzero temperatures using X-Therma's proprietary solutions, was transported across the Atlantic Ocean multiple times, demonstrating the potential to significantly extend organ storage and make long-distance organ transplantation a clinical reality.
The preserved kidney was transported on a commercial aircraft from Johns Hopkins University School of Medicine in Baltimore, Maryland, to the Medical University of Innsbruck in Austria. The surgical and research team, led by Dr. Gerald Brandacher, assessed the kidney after roughly 48 hours of subzero preservation using a clinical-grade machine perfusion device, confirming its viability and functionality.
Key Findings and Implications
The team repeated the process five times over the past year, with preservation times ranging from 48 to 72 hours. As a proof of concept, a life-supporting transplant was performed in a pig, with the kidney maintaining normal renal function for 200 days post-transplant after 72 hours of ice-free subzero preservation.
"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.
X-Therma's Preservation Technology
The kidneys were preserved using X-Therma's XT-ViVo solution in the TimeSeal device. 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. TimeSeal allows for precise monitoring of temperature, storage duration, and location without requiring external power, blood, or oxygen. The FDA granted Breakthrough Device status to XT-ViVo and TimeSeal in 2022 for human kidney preservation up to 120 hours for transplant.
Addressing the Organ Shortage
Currently, the gold standard for organ preservation is static cold storage at 2-8°C using ice coolers, which can lead to tissue and cell damage. X-Therma's technology overcomes these limitations by extending preservation times beyond the current standards of 24 hours for kidneys and 4 hours for hearts. This could significantly enhance transplantation outcomes and increase the number of transplants performed.
Dr. David Mulligan, past president of UNOS/OPTN and Professor of Surgery at Yale University, stated, "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, improve patient outcomes, and, someday, end the waiting list."
Presentation of Results
The results were presented at the Society of Cryobiology's 61st annual meeting and The Transplantation Society in Istanbul. The findings have been validated through extensive pre-clinical studies in various organ systems.
