OrganOx Ltd., the organ technology company tackling the world's toughest transplant challenges, announced that its metra^® normothermic machine perfusion (NMP) device has received approval from the U.S. Food and Drug Administration (FDA) for operation during air transport. This marks a major milestone in the company’s mission to make every organ count by supporting the broader utilization of donor organs that might otherwise be discarded due to time, geographic distance or marginal liver function^1,2.

The FDA approval enables transplant centers and organ procurement organizations to safely transport donor livers on the metra^® via chartered aircraft, significantly extending the reach of OrganOx’s technology to recipients from coast to coast. OrganOx anticipates increased adoption among U.S. transplant programs seeking to optimize outcomes while managing cost and operational complexity. With this capability, OrganOx metra^® now aligns with the logistical flexibility of leading transplant transport systems while retaining its advantages in extended preservation times and enabling functional liver assessment.^3,4

"This FDA approval is a major step forward for the transplant community," said Craig Marshall, CEO of OrganOx. "By enabling air transport of donor livers on the metra^®, we're removing key logistical barriers to broader organ utilization and expanding access to our technology nationwide through our collaboration with Strata Critical."

"We are proud to be partnering with OrganOx, a recognized leader in organ perfusion technology,” said Scott Wunsch, CEO of Trinity Medical Solutions, the logistics division of Strata Critical. “By providing dedicated air and ground transportation support for the OrganOx metra^® device coupled with Strata’s other services, we are creating a turnkey solution for transplant centers and OPOs to leverage this game-changing technology."

1. Mergental, H., Laing, R. W., Kirkham, A. J., Perera, M. T. P. R., Boteon, Y. L., Attard, J., Barton, D., Curbishley, S., Wilkhu, M., Neil, D. A. H., Hübscher, S. G., Muiesan, P., Isaac, J. R., Roberts, K. J., Abradelo, M., Schlegel, A., Ferguson, J., Cilliers, H., Bion, J., Adams, D. H., … Mirza, D. F. (2020). Transplantation of discarded livers following viability testing with normothermic machine perfusion. Nature Communications, 11(1), 2939. https://doi.org/10.1038/s41467-020-16251-3
2. Olumba, F. C., Zhou, F., Park, Y., Chapman, W. C., & RESTORE Investigators Group (2023). Normothermic Machine Perfusion for Declined Livers: A Strategy to Rescue Marginal Livers for Transplantation. Journal of the American College of Surgeons, 236(4), 614–625. https://doi.org/10.1097/XCS.0000000000000555   
3. Chapman WC, et al. Normothermic Machine Perfusion of Donor Livers for Transplantation in the United States: A Randomized Controlled Trial. Ann Surg. 2023 Nov 1;278(5):e912-e921. doi: 10.1097/SLA.0000000000005934. Epub 2023 Jun 26. PMID: 37389552.d.
4. Nasralla, D., Coussios, C. C., Mergental, H., Akhtar, M. Z., Butler, A. J., Ceresa, C. D. L., Chiocchia, V., Dutton, S. J., García-Valdecasas, J. C., Heaton, N., Imber, C., Jassem, W., Jochmans, I., Karani, J., Knight, S. R., Kocabayoglu, P., Malagò, M., Mirza, D., Morris, P. J., Pallan, A. Consortium for Organ Preservation in Europe (2018). A randomized trial of normothermic preservation in liver transplantation. Nature, 557(7703), 50–56. https://doi.org/10.1038/s41586-018-0047-10.

About OrganOx

OrganOx is a commercial stage organ technology company, spun out of the University of Oxford in 2008, dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The OrganOx metra^® is a normothermic machine perfusion (NMP) platform approved in the U.S., Europe, Canada, and Australia. It has been utilized in over 6,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Learn more at www.organox.com.

About Strata Critical Medical

Strata Critical Medical provides time critical logistics and specialized medical services to healthcare providers across the United States using an asset-light model prioritizing efficiency and reliability. As a recognized leader in air and ground transportation of human organs for transplant and now with expanded capability to provide perfusion services, Strata is committed to helping make the life-sustaining gift of organ transplant a reality for those at the greatest need.

Contacts

OrganOx Investor Relations:
Steve Deitsch
Chief Financial Officer, OrganOx
investorrelations@organox.com

OrganOx Media:
Emma Yang
Health+Commerce
emma@healthandcommerce.com