OrganOx Ltd. 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, marking a significant advancement in organ transplant logistics. This approval addresses critical challenges in organ utilization by enabling the safe transport of donor livers that might otherwise be discarded due to time constraints, geographic distance, or marginal liver function.
Expanding Geographic Reach
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. This capability aligns the metra® with the logistical flexibility of leading transplant transport systems while retaining its advantages in extended preservation times and enabling functional liver assessment.
OrganOx anticipates increased adoption among U.S. transplant programs seeking to optimize outcomes while managing cost and operational complexity. The air transport capability removes key logistical barriers that have previously limited the broader utilization of donor organs.
Strategic Partnership for Nationwide Coverage
The expansion is supported by a partnership with Strata Critical Medical, which provides 24/7, device-to-donor support across the United States. "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."
Clinical Impact and Technology Background
The metra® normothermic machine perfusion platform, approved in the U.S., Europe, Canada, and Australia, has been utilized in over 6,000 liver transplants to date. The technology keeps donor livers in a metabolically active state outside the body, enabling longer preservation times and functional assessment of the organ prior to transplant. This approach has led to an increased number of organs available for transplant.
"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."
Addressing Transplant Challenges
The approval represents a significant development in addressing the world's toughest transplant challenges, particularly the utilization of marginal donor organs that might otherwise be unsuitable for transplantation. The technology's ability to maintain organ viability during extended transport times could potentially increase the donor pool and improve access to life-saving liver transplants across broader geographic regions.
