OrganOx announced today that it received FDA approval for the use of its normothermic machine perfusion (NMP) device during air transport.
The company said approval supports the broader utilization of donor organs that might otherwise be discarded. Reasons for discarding could include time, geographic distance or marginal liver function. This milestone comes as Terumo works toward completing its planned acquisition of OrganOx in a deal announced last month.
NMP and other ex-vivo machine perfusion (EVMP) technologies can preserve organs longer by circulating oxygen and nutrient-rich perfusate through the organ at near-body temperature, Terumo says. They also enable real-time monitoring of organ condition during storage and transport. This can help prevent the transplantation of organs with impaired function and lead to more effective use of organs from marginal donors.
The OrganOx liver NMP device, Metra, won FDA approval in 2021, then the company launched it in the U.S. in 2022. It also has regulatory approval in Europe, the UK, Australia and Canada as commercialization efforts continue in those regions. To date, the company touts the use of Metra in more than 6,000 liver transplant procedures worldwide.
OrganOx also has a kidney NMP device under development, with eyes on commercialization around 2030.
According to a news release, the latest approval enables transplant centers and organ procurement organizations to safely transport donor livers on the Metra via chartered aircraft. This significantly extends the reach of the company’s technology from coast to coast. OrganOx anticipates increased adoption among U.S. transplant programs seeking to optimize outcomes while managing cost and operational complexity.
The company said Metra now aligns with the logistical flexibility of leading transplant systems. Meanwhile, it retains its advantages in extended preservation times and enabling functional liver assessment.
“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.”
