MONMOUTH JUNCTION, N.J., Dec. 1, 2016 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its European Union approved CytoSorb® cytokine adsorber to treat deadly inflammation in critically-ill and cardiac surgery patients worldwide, announced the publication of a MedTech Innovation Briefing (MIB) on CytoSorb® for the treatment of sepsis, by the National Institute for Health and Care Excellence (NICE) in the United Kingdom (U.K.).
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “The selection of CytoSorb by NICE as an innovative therapy worthy of MIB review is a significant step towards potential future NICE recommendation for broader clinical use in the U.K. Only 88 such MIBs have been published since 2014, increasing the prominence of our therapy in the medical community. With our distribution partner LINC Medical, we plan to update NICE with new CytoSorb efficacy and cost-effectiveness data from numerous ongoing studies as they become available to strengthen our position as one of the most promising therapies for sepsis today. Our goal is to become standard therapy for sepsis and other life-threatening conditions in the U.K – the third largest medical device market in Europe – and the rest of the world.”
NICE is an independent organization established by the U.K. government to provide national guidance and advice on medical treatments to improve healthcare. NICE recommendation is generally needed for therapies to gain widespread adoption and reimbursement in the U.K. publicly-funded healthcare system, or National Health Service (NHS).
MIBs are commissioned by the NHS and produced in support of the NHS 5-Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics. According to the MIB frequently asked questions (FAQ) document, new technologies are selected by the NICE Medical Technologies Evaluation Programme (MTEP) for MIBs based on:
- Regulatory status, current availability, and degree of innovation
- The level of NHS interest in the technology
- The relevance to existing, in-development, or future NICE guidance
- The proposed patient or system benefits
- Whether there is sufficient evidence publicly available to summarize and critically appraise the technology
The MIB is intended to provide clinicians with an up-to-date summary of new innovative technologies, how they are used, and what their potential role is in the treatment pathway. A MIB also includes a review of relevant published evidence, opinions from clinical experts in the field, and the likely costs of using the technology. A MIB is not a treatment guidance document from NICE and does not constitute a guidance recommendation. MIBs are updated periodically, and are designed to be fast, flexible, and responsive to the needs of clinicians for information on promising technologies.
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 42 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 17,000 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 and contract funding in excess of $18 million from DARPA, the U.S. Army, the U.S. Air Force, 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™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites: http://www.cytosorbents.com and http://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 9, 2016, 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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