OrganOx Phase 2 Clinical Investigation

A portable machine that keeps donated human livers alive outside the body is about to enter a phase II clinical trial in the United States, a key step toward getting it approved for sale there. The problem is stark: thousands of people die each year waiting for a liver transplant because not enough usable organs are available. Currently, donated livers must be rushed to a recipient on ice, which gives surgeons only a few hours to assess and transplant the organ. Many livers are discarded because their condition is unclear. The OrganOx metra™ device changes this by pumping warm, oxygenated blood through the liver, keeping it functioning outside the body for much longer. This allows surgeons to objectively test whether the organ is viable, turning emergency transplant procedures into planned, scheduled operations. If the US trial succeeds and the FDA grants marketing authorisation, the device could double the company’s market and bring revenue back to the UK, supporting further product development and new jobs. More importantly, it could save thousands of additional lives each year by making more livers available for transplant—a direct, measurable improvement to a system that quietly determines who lives and who stays on the waiting list.