Portable Gas Perfusion System for Pancreas Preservation

Portable Gas Perfusion System for Pancreas Preservation

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK070400-05A1
Agency Tracking Number: R44DK070400
Amount: $2,000,201.00
Phase: Phase II
Program: SBIR
Awards Year: 2014
Solicitation Year: 2014
Solicitation Topic Code: NIDDK
Solicitation Number: PA13-234
Small Business Information
89 RUMFORD AVE, NEWTON, MA, 02466-1311
DUNS: 66594979
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 LINDA TEMPELMAN
 (781) 529-0514
 ltempelman@ginerinc.com
Business Contact
 ANTHONY VACCARO
Phone: (781) 529-0504
Email: avaccaro@ginerinc.com
Research Institution
 Stub
Abstract
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,

* Information listed above is at the time of submission. *

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