OrganOx Enrols First US Patient for Post-Approval Study
Oxford, United Kingdom, 10 January 2023: OrganOx Ltd (“OrganOx” or the “Company”), a world-leading medical technology company committed to making every donated organ count with metra®, a fully automated normothermic machine perfusion (NMP) device for liver transplantation, today announces the successful recruitment of the first patient into its Post Approval Study (PAS).
The PAS will collect data on the occurrence of biliary-related complications, subject survival and graft survival of 315 liver transplant patients transplanted using NMP on metra. During the multi-site, single arm, unblinded post-approval study, donation after brain death (DBD) and donation after circulatory death (DCD) donor livers will be transplanted into adult liver transplant recipients according to the indications for use of metra.
The first patient enrolment occurred at MedStar Georgetown University Hospital on 18 November 2022. Raffaelle Girlanda, MD successfully performed the transplant procedure after the donor liver was perfused for five hours using metra.
Thomas Fishbein, MD, Executive Director of MedStar Georgetown University Hospital, added: “Being able to transplant the first patient on the OrganOx PAS is a significant milestone for NMP in the US. Using the metra, we were able to successfully complete the transplant procedure after five hours of perfusion enabling us to ascertain the health of the donor liver pre-transplant, and at the same time schedule the transplant procedure and manage hospital personnel and patient logistics. We are looking forward to enrolling more patients to the Study and helping to reduce the liver transplant waiting list.”
Craig Marshall, Chief Executive Officer of OrganOx said: “As we continue with our mission to save more lives by increasing utilisation of organs in the US, we are pleased to announce the enrolment of our first patient into the PAS.
Of the >11,500 patients currently on the US liver transplant waiting list, more than 10% die waiting for an organ and over 23% are removed from the list for reasons including becoming too sick to go through with a transplant procedure. A further 9% are still waiting for a transplant after three years.1
With the OrganOx metra, we aim to make more livers available for transplantation ensuring that more patients with end-stage liver failure can benefit from this life saving procedure, and overall improve population health in the US, as we are in Europe. We look forward to supporting the US healthcare system by improving outcomes and experiences for both patients and healthcare providers.”
For more information about OrganOx, please contact:
David Bond T: +44 (0) 1865 362 386
Marketing Manager E: Marketing@organox.com
About OrganOx and metra
Based in Oxford, UK, OrganOx is a world leader in normothermic machine perfusion with a mission to save more lives by increasing utilisation of organs.
metra is a fully automated NMP device for the preservation and transport of donor livers destined for transplantation from both donation after brain death and donation after circulatory death. metra is commercially available in Europe (CE Mark) and the United States (FDA Approved: P200035).
For more information, please visit our website: organox.com.
About MedStar Georgetown Transplant Institute
MedStar Georgetown Transplant Institute, a systemwide program that is part of MedStar Health, the region’s largest health care system, is a multi-organ transplant program performing liver, and kidney, pancreas, and small bowel transplant. It is a leader within all these specialized groups, performs large numbers of living donor transplants, and operates the second largest paired kidney exchange program (through the National Kidney Registry) in the country. MedStar Georgetown University Hospital, the base of operations for transplant surgery, is a large, not-for-profit, tertiary-care teaching hospital located in Northwest Washington, D.C. Founded in the Jesuit principle of cura personalis, caring for the whole person, MedStar Georgetown is committed to offering a variety of innovative diagnostic and treatment options in a trusting and compassionate environment.