An Italian startup has teamed with critical-care immunotherapy company CytoSorbents Corporation (NASDAQ: CTSO) on an integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded.
Aferetica srl (Mirandola, Italy) designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and organ rejection. PerLife incorporates CytoSorbents’ PerSorb sorbent cartridge, which uses adsorptive porous polymer technology to reduce a broad range of toxins that can compromise organ function from the perfusate.
One major targeted use is the reconditioning of unusable or sub-optimally functioning “marginal” organs that are typically discarded. This may increase the availability of scarce, suitable organs and improve the clinical outcomes of complex and expensive transplantation procedures, according to a statement from both companies. Aferetica and CytoSorbents (Monmouth Junction, New Jersey) announced the system’s debut with a scientific presentation at the 27thInternational Congress of the Transplantation Society (TTS 2018) in Madrid, Spain last week.
PerLife includes a fluid-handling system with specially designed disposables and cannulas and proprietary perfusate solutions. Its active thermoregulation allows tight yet flexible control of temperatures (4-37oC) during perfusion, and its design allows the same equipment and disposables to perfuse either kidneys or livers, according to Aferetica.
Approximately 84,347 kidney transplants and 27,759 liver transplants were performed globally in 2015, representing 89% of the 126,670 solid organ transplants that year, according to the Global Observatory on Donation and Transplantation. While the number of solid organ transplants continues to increase, it still represents less than 10% of the global organ transplantation need due to the severe shortage of available and viable organs, said CytoSorbents CEO Phillip Chan, MD in the statement.
“We are eager to see how the combined PerLife and PerSorb technologies may improve clinical outcomes on current kidney and liver transplants performed today,” Chan said. “And longer term, we believe the platform has the potential to significantly expand the overall numbers of transplant procedures by making more organs available to those in need.”
“The PerLife organ preservation and rehabilitation platform was designed and built from the ground up by Aferetica over the past four years,” said Aferetica CEO Mauro Atti in the statement. “The key addition of CytoSorbents’ PerSorb cartridge was the result of a partnership with the company announced just 10 months ago. The system, conceived in cooperation with many prestigious Italian clinicians, has performed very well in preliminary tests.”
Aferetica is working on obtaining the CE Mark for PerLife by the end of 2018 and launching in multiple countries in 2019. It is CytoSorbents’ distributor for CytoSorb in Italy.