By Xiaoxi Wei, Ph.D., CEO and Co-Founder, X-Therma
“There is no way that widespread organ transplants will ever be possible without major new developments in organ preservation,” Thomas E. Starzl, M.D., “the father of modern transplantation,” once said. “Progress in this direction has been relatively minor.”
That’s changing with a breakthrough in organ storage and transportation logistics. In October 2024, X-Therma announced the world’s first successful transport of pig kidneys across the Atlantic using subzero preservation technology. This achievement—completed five times during the past year—signals steps toward actualizing the long-desired end of the organ waitlist and addressing the supply-demand gap in organ transplants.
“Running Out of Time”: The Biggest Challenge Facing Organ Transplant
Time is of the utmost essence in organ transport. Current preservation methods on wet ice (just above freezing) only allow for a 4- to 16-hour window of survival, resulting in significant numbers of organs never successfully making it to the recipient. For hearts, this figure is shockingly over 80%–and one life expires on the waitlist every single hour.
This time crunch causes enormous stress on patients, hospital staff, and transporters. Limited preservation time restricts the pool of available organs to those located within a few hundred miles, reducing potential matches and, at times, prioritizing proximity over the best genetic fit. Patients in remote or underserved regions often face reduced access to transplants, further exacerbating disparities in healthcare.
This is where X-Therma’s advancement in subzero preservation could play a role in redefining the logistics of organ storage and transport.
Landmark 48-Hour Subzero Preservation Across 4,000 Miles
On November 15, 2023, surgeons at Johns Hopkins University Medical School, led by Dr. Gerald Brandacher, removed a kidney from a pig and transported it 4,000 miles on a commercial aircraft to the Medical University of Innsbruck in Austria. The kidney was preserved for approximately 48 hours at subzero and showed full viability when perfused in Innsbruck. This journey was accomplished five times in the subsequent year.
Perhaps more exciting, the team performed several successful life-supporting kidney transplantations in pigs with the most strenuous model, demonstrating normal kidney recovery and function for the entire post-transplant monitoring time of 200 days after ice-free subzero preservation of 72 hours.
Emulate Nature to Rewrite the Time Equation
“Look deep into nature, and then you will understand everything better.” – Albert Einstein. Image: Xiaoxi Wei, Ph.D., Co-founder and CEO of X-Therma, with the TimeSeal® during the trans-Atlantic kidney journey at Frankfurt Airport
This advancement was made possible with X-Therma’s XT-ViVo® solution and smart, portable transporter TimeSeal®, which together received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2022 for a potential 120-hour preservation of kidneys, which is approximately five times longer than the current standard.
Inspired by the anti-freeze proteins found in Arctic species, XT-ViVo® prevents the formation of ice crystals with fully synthetic, non-toxic molecule peptoids, enabling extended organ survival at a previously inconceivable temperature below zero Celsius without any ice damage.
TimeSeal® is a smart, lightweight, and easy-to-use transporter that allows for precise tracking of temperature, storage duration, and location without requiring intensive monitoring, external power, blood, or oxygen for active perfusion—and possible to carry on a commercial aircraft.
The combined turnkey solution blends seamlessly within current transplant workflows and effectively extends organ life. 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.
The Transplant Community’s Positive Reaction
X-Therma’s innovations have sparked the attention of the global transplant community.
“The 2am or 3am phone call and rush to an overnight surgery could be a thing of the past. Instead, transplants could be elective procedures scheduled during the day,” explains Dr. Brandacher. “It reduces risks and boosts team performance—with no change to the pari-transplant workflow.”
“With the ability to extend preservation times far beyond the current 24-hour window for kidneys, X-Therma’s technology could allow for advanced genetic matching and more transplants, aligning with the U.S. Department of Health and Human Services’ goal of 60,000 transplants by 2026,” adds David Mulligan, M.D., immediate past president of UNOS and Chair of Yale Transplant Center. “It’s exciting to explore new platforms that will be game changers for extending organ preservation times by days and add to the advantages of organ perfusion when needed.”
“Our airport closes by 6pm. If you can take time out of the equation in getting an organ to the East Coast, that would be huge,” commented Paul Lange, M.D., Medical Director of Donor Alliance of Colorado.
What’s Next?
These results have been shared at major transplantation and biology congresses in 2024, including a keynote by Dr. Brandacher at the Society of Cryobiology’s annual meeting and The Transplantation Society conference in Istanbul, where the work presented by Dr. Amanda Loftin was recognized as one of the top four presentations from the United States (among 5,600 submissions). X-Therma continues to validate the platform through rigorous pre-clinical studies across various organ systems.
I am immensely proud that this groundbreaking innovation not only brings us closer to reducing the organ waitlist but also paves the way for planned, high-precision transplants, which could drastically improve patient outcomes and make global organ sharing a reality. This world-first demonstration is a testament to the tremendous teamwork and dedication of over 100 individuals who have contributed generously over the years to make this possible.
Looking ahead, X-Therma’s mission extends beyond preservation. We envision a sustainable, reliable, and accessible network for organ sharing worldwide, shaping a future where life-saving transplants are within reach for all. By addressing the critical time constraints in transplantation, it opens new opportunities to expand access to organs, improve matching for better outcomes, and enable surgeries to be scheduled at optimal times.
This innovation has far-reaching implications beyond just extending preservation times. Beyond transplantation, our platform paves the way for other groundbreaking “living” therapies, including cell and gene therapies, IVF, and vaccines. The result is a transformative shift in patient care, creating a more equitable and efficient system for saving lives—because you have time.
