Blood purification specialists CytoSorbents and Aferetica are joining forces to improve the transplantation of solid organs, such as the kidney, liver and heart. The pair inked a deal to develop a perfusion system that cleans donor organs before they are transplanted.
Traditionally, donor organs are rapidly cooled and kept in cold, ischemic storage until surgery. But the longer an organ is kept under ice, the less likely it will be viable for transplant. Because the organ has no blood circulation in cold storage, it sustains tissue damage and eventually becomes unusable.
New Jersey’s CytoSorbents and Mirandola, Italy-based Aferetica aim to improve the viability of donor organs, while also reducing the risk of organ rejection, the companies said in a statement. Under the agreement, they will jointly develop Aferetica’s PerLife ex-vivo organ perfusion system, which will use CytoSorbents’ absorption technology. The company markets the CytoSorb device, an extracorporeal cytokine absorber, in Europe. It contains porous polymer beads that absorb cytokines, thereby “purifying” the blood.
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“This may help to recondition marginal organs that are typically discarded, expand the availability of scarce, suitable organs, and ensure the success of costly transplantation procedures,” they said in the statement.
The duo expects to bring the product to market in Italy later this year, before expanding to other European countries in 2018. This collaboration expands on their existing relationship—Aferetica already distributes the CytoSorb device in Italy.
Transplanted kidneys account for approximately two-thirds of all transplants, yet based on research performed by UNOS, the United Network for Organ Sharing, nearly 20 percent of all deceased donor kidneys are discarded, mainly because they do not meet kidney donor quality criteria,” said CytoSorbents CEO Philip Chan, in the statement. “For example, cytokine storm and severe inflammation in organ donors who die of traumatic injury can damage and reduce the functioning of these organs, resulting in a higher risk of graft failure after transplant, and even decreased long-term survival. By reconditioning organs prior to transplant, the PerLife System, utilizing CytoSorbents' sorbent technology, has the potential to positively impact the field, by improving the quality and supply of harvested organs, while reclaiming many marginal organs that would otherwise be discarded."
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TransMedics also makes a perfusion system for donor organ transport. In May, an FDA panel voted favorably on the company’s Organ Care System for the transportation of lungs for transplant. The device comprises a portable platform, a perfusion module, a solution set that delivers blood and nutrients to the organ, and a sterile chamber that protects the organ and keeps it at the right temperature. TransMedics’ OCS systems are CE-marked for the transportation of donor hearts and lungs.