OrganOx Enrols First US Patient for Post-Approval Study

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.”

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