• 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.
• "This first of its kind treatment represents a historic achievement for United Therapeutics and Miromatrix in advancing the potential of bioengineered human organs to help save and improve patients' lives," said Jeff Ross, Ph.D.,President of Miromatrix. "We're grateful to the patient and their family, in addition to the scientists and caregivers at Intermountain Health and Intermountain Medical Center who helped make this breakthrough possible. Looking ahead, we're excited to continue progressing our ongoing phase 1 clinical trial."
• "This groundbreaking procedure – the first of its kind in the world – represents everything Intermountain Health stands for in providing innovative, cutting-edge high-quality care for our patients," said Ralph Jean-Mary, president of Intermountain Medical Center. "We are profoundly thankful to this patient for their participation in this pioneering study, and to our exceptional Intermountain medical team, as well as our partners at United Therapeutics and Miromatrix. This procedure reinforces our unwavering commitment to leading in clinical excellence and helping people live the healthiest lives possible."
• United Therapeutics' organ and organ alternative manufacturing efforts consist of three platforms – xenotransplantation,5 allogeneic regenerative medicine, and autologous6 regenerative medicine – encompassing four different organs: hearts, kidneys, livers, and lungs. These revolutionary programs are intended to address the ongoing shortage of transplantable organs for patients with end-stage organ disease.
• The investigational miroliverELAP system is not approved for any use in any country.

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