United Therapeutics Corporation and Intermountain Health announced the world's first patient treated in a clinical study of a bioengineered external liver assist product called miroliverELAP®?. This study is the first human clinical trial of a manufactured organ alternative. The procedure was performed on a patient experiencing liver failure who was not eligible for a liver transplant.
The procedure was performed by the team at Intermountain Medical Center in Murray, Utah, led by Christopher J. Danford, MD, a transplant hepatologist at Intermountain Health. Developed by Miromatrix Medical Inc., a United Therapeutics subsidiary, miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver and an extracorporeal blood circuit. The bioengineered liver is made up of a decellularized porcine liver scaffold to which allogeneic3 human endothelial4 and liver cells have been added.
The phase 1 study is open for enrollment of patients with ALF at eight sites in the United States.
United Therapeutics Corporation is a pharmaceutical company. It markets and sells commercial therapies to treat pulmonary arterial hypertension (PAH): Tyvaso DPI (treprostinil) Inhalation Powder (Tyvaso DPI); Tyvaso (treprostinil) Inhalation Solution (nebulized Tyvaso), which includes the Tyvaso Inhalation System; Remodulin (treprostinil) Injection (Remodulin); Orenitram (treprostinil) Extended-Release Tablets (Orenitram); and Adcirca (tadalafil) Tablets (Adcirca). Tyvaso DPI and nebulized Tyvaso are also approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). It also markets and sells an oncology product, Unituxin (dinutuximab) Injection (Unituxin) for treatment of high-risk neuroblastoma, and the Remunity Pump for Remodulin (Remunity). Tyvaso DPI is a drug-device combination product that incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza (insulin human) Inhalation Powder.
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