United Therapeutics Corporation announced that its Phase 1 clinical study of miroliverELAP®, an external bioengineered liver assist product, produced positive results in patients with acute liver failure (ALF) who were not eligible for liver transplantation, the company said. The study, described as the first FDA-cleared clinical trial involving a manufactured bioengineered liver alternative, met its primary endpoint of patient survival during treatment with no unexpected serious adverse events reported during a 32-day follow-up period after treatment.
Developed by Miromatrix Medical Inc., a wholly owned United Therapeutics subsidiary, miroliverELAP comprises a single-use bioengineered liver maintained outside the body and connected via an extracorporeal blood circuit to provide temporary liver support. The bioengineered organ is engineered by seeding a decellularized porcine scaffold with allogeneic human endothelial and liver cells sourced from donated livers unsuitable for transplant.
In the open-label study, five ALF patients received continuous miroliverELAP support for at least 44 hours, and survival during treatment was achieved in all participants. United Therapeutics said that no unexpected serious adverse events were attributed to the device, suggesting a favourable safety profile in this first-in-human setting.
According to the company, these interim data support the advancement of miroliverELAP into a Phase 2 clinical trial, with more detailed results expected to be presented and published later in 2026. Acute liver failure—a rapid loss of liver function—has limited treatment options beyond spontaneous recovery and transplantation, and miroliverELAP is being developed as a potential bridge to recovery for patients facing critical liver dysfunction.
United Therapeutics said that the positive Phase 1 results mark a key step in its broader organ alternative and regenerative medicine strategy, which includes multiple programmes aimed at addressing shortages of transplantable organs and expanding therapeutic options for patients with severe organ failure.
