The U.S. Department of Defense Awards $1.1 Million to CytoSorbents to Optimize Development of HemoDefend-BGA™ for Life-saving Universal Plasma

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) has been awarded a two-year SBIR Sequential Phase II contract valued at $1,098,588 by the U.S. Army Medical Research Acquisition Activity. The funding aims to optimize the development of the HemoDefend-BGA™ adsorber, capable of removing over 99% of blood group antibodies to create a 'universal plasma' for emergency treatment. This follows prior contracts totaling approximately $7.5 million to enhance their blood purification technologies, which are crucial for treating critically ill patients.

Positive

• Award of $1,098,588 contract for HemoDefend-BGA development.
• Technology could significantly enhance emergency treatment speed and efficiency.
• Total funding from U.S. Army research activities exceeds $7.5 million.

Negative

• HemoDefend-BGA not yet approved for use in the U.S.
• Dependency on government contracts raises funding sustainability concerns.

MONMOUTH JUNCTION, N.J., Oct. 9, 2020 /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 two-year SBIR Sequential Phase II contract valued at $1,098,588 to optimize development of the HemoDefend-BGA™ adsorber. The HemoDefend-BGA adsorber can rapidly remove >99% of anti-A and anti-B antibodies from plasma to create a "universal plasma" that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity. Plasma is the liquid portion of blood, used to resuscitate critically-ill patients such as those with massive blood loss from trauma, and contains important proteins and other substances responsible for vital functions such as blood clotting, protecting the body against infections, and communicating biochemical messages throughout the body. 

Dr. Maryann Gruda, PhD, Principal Investigator and Director of Biology for CytoSorbents stated, "We are grateful for the U.S. Army's ongoing support and funding of our blood group antibody (BGA) adsorber technology. Widespread availability of universal plasma is expected to help save lives through faster emergency treatment that does not require blood typing, while providing substantial cost savings with simpler storage and distribution logistics.  This award is focused on optimizing materials and manufacturing methods to rapidly achieve a commercially desirable product."

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "We thank the U.S. Army and Department of Defense for their continued support of our HemoDefend-BGA program.  These funds are expected to help us accelerate development of this product to make universal plasma a reality."  

The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. This award is in support of the US Army Medical Research and Development Command (USAMRDC)/Congressionally Directed Medical Research Programs (CDMRP)/Combat Casualty Care Research Program (CCCRP/JPC-6) under Contract No. W81XWH20C0087. This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Development Command (USAMRDC). This award is in addition to two recently awarded contracts to develop HemoDefend-BGA for universal plasma and whole blood transfusions announced earlier this year, including a $4.4 million contract from U.S. Army Medical Research Acquisition Activity (USAMRAA) and the Congressionally Directed Medical Research Programs (CDMRP), and a $2.9 million contract from the Defense Health Agency STTR Program/U.S. Army Medical Research and Development Command (USAMRDC) and CDMRP. 

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 USAMRDC/CDMRP/CCCRP/JPC-6) or the US Army Medical Research Acquisition Activity (USAMRAA).    

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 65 countries around the world, as an 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. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 100,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted U.S. FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

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 of more than $38 million from DARPA, the Defense Health Agency, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC), the U.S. Department of Health and Human Services, and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K⁺ontrol™, 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.

Forward-Looking Statements

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, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. 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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CytoSorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

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SOURCE CytoSorbents Corporation

FAQ

What recent contract did CytoSorbents (CTSO) receive?

CytoSorbents was awarded a $1,098,588 SBIR Sequential Phase II contract to develop the HemoDefend-BGA adsorber.

How does the HemoDefend-BGA adsorber work?

It removes over 99% of blood group antibodies from plasma, enabling the creation of universal plasma for transfusions.

What is the purpose of the funding received by CytoSorbents?

The funding aims to optimize materials and manufacturing methods for the HemoDefend-BGA adsorber, accelerating its development.

Has CytoSorbents had previous funding for their projects?

Yes, they have received prior contracts totaling approximately $7.5 million for the development of blood purification technologies.

Is the HemoDefend-BGA adsorber currently approved for use?

No, the HemoDefend-BGA is not yet approved for use in the U.S. or elsewhere.