CytoSorbents Corporation (CTSO)

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CytoSorbents Awarded an Approximately $4.3M Contract by the U.S. Department of Defense to Develop HemoDefend-BGA™ for Freeze-Dried Universal Plasma

October 06 2022 - 07:00AM
PR Newswire (US)


PRINCETON, N.J., Oct. 6, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the U.S. Army Medical Research Acquisition Activity (USAMRAA) has awarded the Company a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.

Dr. Maryann Gruda, PhD, Principal Investigator and Senior Director of Biology at CytoSorbents stated, "We are excited to begin this phase of our development program. The continued support and funding of our anti-A and anti-B blood group antibody (BGA) reduction technology by the Defense Health Agency and U.S. Army will be instrumental in bringing this technology to market. This award will fund the development and scale-up of a specialized HemoDefend-BGA filter that can be integrated with freeze-dried plasma technologies to generate a logistically superior, low titer plasma product that can be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity."

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Freeze-dried plasma is dry and lightweight, stable for up to 2 years at room temperature, and can be quickly reconstituted with sterile water when needed. However, it currently remains a blood-type specific product, complicating its use. HemoDefend-BGA can remove blood-type specific antibodies from single donor or pooled plasma prior to freeze-drying, with the goal of ultimately producing a 'one-size-fits-all' freeze-dried universal plasma – a major advance. Such a product would also eliminate the need for cold-chain storage – greatly simplifying battlefield logistics and enabling first responders to provide mobile/remote emergency resuscitation in civilian trauma."

The HemoDefend-BGA filter is not yet approved in the U.S. or elsewhere. This award was supported by the Defense Health Agency (DHA) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs/Joint Warfighter Medical Research Program (JWMRP) under U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract No. W81XWH-22-C-0046. The award is entitled "Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use." The outcome of this award is expected to be the large-scale manufacturing of the active polymer for subsequent integration of the device into the plasma freeze-drying process.

The content of this press release is solely the responsibility of the authors and any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of Defense, DHA, SBIR/STTR Programs, JWMRP, or USAMRAA.

About HemoDefend-BGA™

CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.

CytoSorbents Contact:
Kathleen Bloch
[phone]
[e-mail]

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
[e-mail]

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