Portable Gas Perfusion System for Pancreas Preservation

DESCRIPTION (provided by applicant): Pancreatic islet transplantation (ITx) is an emerging treatment for a subset of Type 1 diabetics for which standard insulin therapies are insufficient. I is a promising alternative to pancreas transplantation, since ITxhas significantly less surgical risk and a less toxic immunosuppression regimen. Enhanced organ preservation via the proposed technology has the potential to increase the number of lifesaving ITx while improving outcomes. There have been 840 infusions in340 recipients performed in North America (most of them in Canada) and 1380 in 775 recipients in Europe. ITx is an approved standard of care in Canada, the UK and a number of European countries. In the US, islet centers are preparing to file for FDA biologics licenses based on the favorable outcomes in the North American clinical trials; once those are granted, the numbers of US ITx are expected to increase substantially. The Giner Portable Pancreas Preservation System (P3S) will be the first complete,