United Therapeutics (NASDAQ:UTHR) has cleared a primary safety hurdle in its ambitious effort to manufacture biological alternatives to human organs, reporting that its bioengineered external liver supported critically ill patients without serious adverse effects.
The Silver Spring, Maryland-based biotech announced Monday that its Phase 1 study of miroliverELAP met its primary endpoint of patient survival during treatment.
The device, developed by United’s subsidiary Miromatrix Medical, was tested on five patients suffering from acute liver failure (ALF) who were not candidates for traditional transplants.
Unlike a mechanical dialysis machine, miroliverELAP utilizes a "bioengineered" approach.
Scientists take a pig liver, strip it of its original cells to leave a scaffold, and then "re-seed" that scaffold with human liver and endothelial cells.
This external organ then functions as a temporary bridge, providing vital filtration and metabolic support to give a patient’s native liver time to recover.
The five participants in the open-label study were treated continuously for at least 44 hours.
United Therapeutics reported no unexpected serious adverse events attributable to the device during a 32-day follow-up period.