CytoSorbents Corporation (CTSO)

[techxen]

Renewed interest in whole blood transfusions

Interesting that Hemodefend, which had disappeared into the background the last couple of years, has quietly been moving forward and appears as a focal point again for the company in terms of their trial strategy here in the U.S. From what I remember back in 2015 the ABLE trial that was conducted in Canada and Europe did not demonstrate the negative impact on 90-day mortality from aged blood transfusions that they were expecting. However the company continued to build out the prototype for their inline filter for the bag and kept moving this product forward through the R&D cycle and working with the NIH on the SBIR contract behind the scenes.

Saw this blog article the other day which was about the renewed interest in blood centers for 'whole blood transfusions': "Blood centers across the country are seeing a renewed interest in whole blood transfusions. The main fuel to this fire appears to be the recent change from AABB and the forthcoming 31st edition of Standards for Blood Banks and Transfusion Services which allows for the use of low titer group O whole blood in emergent situations for recipients of unknown blood type (AABB News, 2017)."

https://www.bloodbuy.com/blog/2018/2/28/whole-blood-industry-replicated-but-not-duplicated

Back in 2015 when the NIH awarded the company the $1.5M Phase 2 SBIR contract and this was mentioned in the press release and the fact they are fine tuning the beads for various blood transfusion scenarios (emphasis mine):

"This contract follows the successful completion of a $203K Phase I SBIR contract for HemoDefend™ awarded in September 2013, and is designed to bring the HemoDefend™ in-line blood filter to human testing, a required major step towards commercialization. In addition, the contract will also fund development of new polymers that could enable safer whole blood transfusions, a potentially life-saving advance in the treatment of trauma and military combat casualty victims. CytoSorbents will again collaborate with Dr. Larry J. Dumont, MBA, PhD, Director of the Center for Transfusion Medicine Research and Associate Professor of Pathology at the Geisel School of Medicine at Dartmouth.Dr. Dumont stated, “The HemoDefend technology was easy to use and performed well in the Phase I SBIR program, removing a wide range of contaminants from packed red blood cells that are implicated in transfusion reactions and adverse clinical events. We plan to work with CytoSorbents in this Phase II SBIR to further optimize the technology and advance it to the next phases of human testing and potential commercialization.”

Hemodefend, IMO could be the sleeper product and it has a significant revenue potential for the company should they choose to develop it or in most likely out-license it to a prospective partner.

From Zack's report: "According to the World Health Organization (WHO), there are more than 80 million blood donations each year worldwide with each donation generating multiple blood transfusion products such as packed red blood cells (pRBCs), platelets, fresh frozen plasma, and cryoprecipitate. Every year there is an estimated 150 - 200 million transfusions administered worldwide with, according to the American Red Cross, more than 30 million in the U.S. alone. CytoSorbents target market for the technology are pRBCs, platelets, and whole blood, which represent more than half of all blood transfusions annually. HemoDefend can be configured either as an in-line filter design or what the company has termed "Beads in a Bag". About one-half of all transfusions use "packed red blood cells" (pRBC)"