MONMOUTH JUNCTION, N.J., April 24, 2017 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that it was awarded a two-year $999,996 Small Business Innovation Research (SBIR) Phase II contract to continue development of CytoSorb® for fungal mycotoxin blood purification. This follows the successful completion of its previously announced $150,000 Phase I SBIR contract for mycotoxin removal. This contract is funded through the Chemical and Biological Defense (CBD) SBIR Program which represents a component of the Joint Chemical and Biological Defense Science & Technology Program. This SBIR project is being managed by the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), the U.S. Department of Defense focal point for research, development, acquisition, fielding, & life-cycle support of Chemical, Biological, Radiological, Nuclear (CBRN) equipment and medical countermeasures.
Mycotoxins derived from naturally-occurring fungi can be weaponized as highly toxic biological warfare agents. Accidental or intentional exposure to mycotoxins, such as aflatoxin and T-2 toxin, can lead to acute liver failure, severe end-organ injury, bleeding, neurologic damage, coma, and death. The Phase II SBIR program will focus on demonstrating the ability of CytoSorb to adsorb mycotoxins in vivo and improve survival in animals.
“We greatly appreciate the support of JPEO-CBD and are excited to accelerate the development of CytoSorb as a countermeasure for mycotoxin exposure,” stated Dr. Phillip P. Chan, Chief Executive Officer of CytoSorbents. “If successful, this could represent a significant advance in the protection of our troops and civilians against these deadly toxins. In addition, it would provide key data supporting the use of CytoSorb to help treat fungal infections, a dreaded cause of approximately a quarter of all hospital-acquired infections that are extremely difficult to treat and where death is common. Anti-fungal therapeutics have a global market of over $10 billion annually.”
Dr. Thomas D. Golobish, PhD, Co-Principal Investigator and Senior Director of Polymer Development at CytoSorbents added, “In the Phase I SBIR program, we demonstrated the rapid and robust reduction of aflatoxin and T-2 mycotoxin from whole blood in vitro. Coupled with the ability of CytoSorb® to reduce a broad range of pathogenic toxins and inflammatory mediators such as cytokines from blood, as well as toxins such as bilirubin that can accumulate in acute liver failure, we believe CytoSorb may have a synergistic benefit in mycotoxin exposure and fungal sepsis.”
CytoSorbents’ advanced development program is entitled “Mycotoxin Adsorption with Hemocompatible Porous Polymer Beads,” and funded under JPEO-CBD contract number W911QY-17-C-0007.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 43 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety of intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 20,000 human treatments to date.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding in excess of $18 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL, HemoDefend™, VetResQ™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 3, 2017, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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