OrganOx is pleased to announce that the University of Wisconsin, led by Principal Investigator Dr Anthony D’Alessandro, has transplanted the first patients in OrganOx’s pivotal US clinical study using the metra®. This study, operating under an Investigational Device Exemption (IDE) from the FDA, involves the transplant of up to 266 donor livers and is intended to test the safety and effectiveness of the OrganOx metra for preserving human livers prior to liver transplantation against the current standard of static cold storage.
Dr Les Russell, CEO of OrganOx commented “I’m delighted that Dr D’Alessandro and the University of Wisconsin have transplanted the first livers in our major study. The University of Wisconsin has a long history in pioneering novel approaches in transplantation and indeed, UW solution remains the most widely used organ preservation solution after more than 20 years in use.”
The OrganOx metra is a fully automated and transportable device for ex-vivo normothermic perfusion of donor livers prior to transplantation. The metra is the result of 20 years of research and is based on the pioneering work of Professors Peter Friend and Constantin Coussios at the University of Oxford. The CE marked metra has been used to transplant more than 170 livers in 6 countries. The device was recently used in a pivotal European study (COPE, Consortium for Organ Preservation) funded by the European Union under Framework 7 and the full results of this study are expected to be released shortly.
The US study will involve up to 15 major liver transplant centres in the US and is funded by a grant from Innovate UK, under the Biomedical Catalyst Award.