Pharmaceutical company United Therapeutics Corporation (Nasdaq: UTHR) on Monday reported positive results from a phase 1 clinical trial of miroliverELAP, an external liver assist product, marking the world's first US Food and Drug Administration-cleared clinical study of a bioengineered liver. The company plans to initiate a phase 2 study following the outcome.

miroliverELAP, developed by Miromatrix Medical Inc, a wholly owned subsidiary of United Therapeutics Corporation (Nasdaq: UTHR), is designed to provide temporary liver support for patients with acute liver failure who are ineligible for transplant or unable to receive a donated organ. The product combines an external blood circuit with a single-use bioengineered liver manufactured from a decellularized porcine scaffold seeded with human endothelial and liver cells derived from non-transplantable donated human livers.

The phase 1 single-arm, open-label safety study treated five acute liver failure patients continuously for at least 44 hours. The trial met its primary endpoint of survival during treatment, with no unexpected serious adverse events reported during a subsequent 32-day follow-up period. Full results are expected to be presented and published in the second half of 2026.

Acute liver failure is a rapidly progressing condition with limited treatment options. Around 25% of patients receive a transplant and approximately 45% recover spontaneously, while about 30% die due to lack of transplant eligibility or organ availability, underscoring demand for organ alternatives.

United Therapeutics Corporation is advancing organ and organ-alternative manufacturing across xenotransplantation, allogeneic regenerative medicine and autologous regenerative medicine platforms, targeting heart, kidney, liver and lung replacement therapies. miroliverELAP remains investigational and is not approved for use in any country.