Cytosorbents (CTSO), Aferetica Launch PerSorb Adsorber and PerLife Organ Perfusion System in Italy

Cytosorbents (NASDAQ: CTSO) and Aferetica srl (Italy) announce the commercial launch of Aferetica's PerLife ex vivo organ perfusion system for kidney and liver transplant and CytoSorbents' PerSorb™ adsorber, based on the CytoSorbents ECOS-300CY™ sorbent technology to remove inflammatory mediators during ex vivo organ perfusion, at the European Society of Organ Transplantation (ESOT) Congress in Milan, Italy from August 29 – September 1, 2021.

Cytosorbents is a leader in blood purification to treat cytokine storm and deadly inflammation in life-threatening illnesses and during cardiac surgery with its flagship product, CytoSorb. CytoSorb is approved in the European Union and distributed in 67 countries worldwide. (PRNewsfoto/CytoSorbents Corporation)" alt="CytoSorbents Corporation (NASDAQ: CTSO) is a leader in blood purification to treat cytokine storm and deadly inflammation in life-threatening illnesses and during cardiac surgery with its flagship product, CytoSorb. CytoSorb is approved in the European Union and distributed in 67 countries worldwide. (PRNewsfoto/CytoSorbents Corporation)" />

The PerLife and PerSorb technologies will be showcased in Aferetica's Booth #26 in the main exhibit hall and highlighted at the company-sponsored symposium "From Organ Preservation to Organ Regeneration" on Tuesday, August 31, 2021 from 1:15-2:15PM CEST in Turquoise Room 1.

Chairs:

• L. De Carlis (University of Milan Bicocca, Italy) and F. D'Ovidio (Columbia University, USA)

Speakers:

• G. Remuzzi (Mario Negri Institute, Italy) Expanding the Organ Transplant Pool: The Role of Ex Vivo Perfusion
• S. Hosgood (University of Cambridge, U.K.)The Inflammatory Mediators and Graft Function: The Kidneys
• M. Boffini & M. Rinaldi (University of Turin, Italy)Cytokines, Transplantability, Primary Graft Dysfunction, Survival: The Lungs
• F. Dazzi (King's College, U.K.)Mesenchymal Stromal Cells: Should they be Integrated in Machine Perfusion Devices?

Dr. Mauro Atti, Chief Executive Officer of Aferetica stated, "Today is a significant step forward for the PerLife project with the commercial launch at the ESOT Congress, which sets the stage for the international launch of the combined PerLife and PerSorb system. We believe we can revolutionize the world of transplantation with the first system capable of supporting both hypothermic and normothermic organ support in one machine. We have reached this milestone thanks to many academic collaborations with leading national and international experts and our partnership with CytoSorbents. We take great pride and satisfaction in this accomplishment."

Dr. Atti continued, "At tomorrow's symposia, key opinion leaders will present studies with results showing the importance of ex vivo perfusion in the preservation and recovery of organs intended for transplantation. The PerLife™ platform for the ex vivo perfusion of livers and kidneys, integrated with the PerSorb™ sorbent that was developed in collaboration with CytoSorbents allows the removal of inflammatory mediators that can cause short- and long-term damage to organs. In doing so, the combined technologies provide a unique system to support and minimize damage to donated organs prior to transplant."

Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents stated, "We are excited to work with Aferetica to launch our combined solution for ex vivo perfusion of kidneys and livers. Demand for donated organs continues to increase in Europe, as well as around the world, which has been exacerbated by a decrease in donated organs due to the COVID-19 pandemic. In Europe, kidneys are the most transplanted organs, at 63% of all solid organ transplants, while liver transplants are the second highest at 23%. We believe utilization of the PerLife and PerSorb combined solution can improve the quality and viability of donated kidneys and livers, a life-saving innovation that can make a tremendous difference in the lives of patients requiring organ transplant."

PerLife is a revolutionary, integrated, therapeutic system for organ transplant that is the first to provide both perfusion and purification of the kidney and the liver, following organ retrieval and before organ implantation. The platform integrates innovative patented technologies creating an all-in-one machine capable of covering the broad range of temperature preservation techniques (hypothermic and normothermic) while incorporating CytoSorbents' PerSorb perfusion cartridge to remove inflammatory mediators that can compromise the health and quality of the organs. The main goal of combining these two European Union approved therapies is to increase successful solid organ transplants by helping to preserve good organs, rehabilitate sub-optimally functioning ones, and to increase the overall pool of viable organs to meet the growing worldwide demand for transplanted organs. Today, this need is being driven by record rates of kidney and liver failure caused by globally pervasive health crises such as the aging population, diabetes, hypertension, obesity, alcoholism, hepatitis, and non-alcoholic steatohepatitis (NASH), also called "fatty liver."

Viable organs for transplant are scarce, yet the number of patients awaiting transplant continues to grow globally, with more than 150,000 candidates waiting for transplants in Europe alone. In 2019, 41,000 patients received solid organ transplants in the E.U., while 48,000 new patients were added to the transplant list and approximately 4% (or 6,000) died awaiting a transplant. As demand for donor organs continues to outpace availability and as patients run out of options, transplant centers are now supplementing viable organs with marginal ones. However, some studies suggest organs from this expanded donor pool have a higher risk of primary graft failure and organ rejection compared to "ideal donors." Inflammatory mediators and cytokines, such as IL-6, appear to play a role in this progressive loss of function, and have been correlated with an increased risk of death in recipients. By providing perfusion and purification following kidney or liver donation and before transplant, the PerLife platform and PerSorb cartridge have the potential to significantly change how these organs are treated before transplant, and to increase successful transplant outcomes.

You May Also Be Interested In

• Cytosorbents (CTSO) Announces STAR-T Pivotal Trial Results to Be Featured as a Late-Breaking Presentation at AATS
• Alvotech (ALVO) signs U.S. agreement to expand access for adalimumab
• Ocugen (OCGN) Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy