National Institute for Health and Care Excellence (NICE) Issues Medtech Innovation Briefing on CytoSorb for Reducing Risk of Bleeding During Cardiac Surgery
MONMOUTH JUNCTION, N.J., Feb. 4, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, highlights the recent release from the United Kingdom's internationally renowned National Institute for Health and Care Excellence (NICE) of a Medtech Innovation Briefing (MIB) on CytoSorb for reducing risk of bleeding during cardiac surgery.
Released as part of its "NICE advice" series to U.K. National Health Service (NHS) hospitals and clinical commissioning groups/payers, the briefing document includes the following quoted highlights:
- "The innovative aspects are that it is the first medical device that can be used to remove ticagrelor from the blood during urgent or emergency cardiac surgery. Using CytoSorb in emergency cardiac surgery could reduce resource use for management of bleeding complications, and in urgent cardiac surgery could reduce length of hospital stay before the procedure and the use of adjunctive bridging treatments.
- The intended place in therapy would be as an alternative to surgical management of bleeding in emergency surgeries (when ticagrelor is not removed) or as an alternative to a 5- to 7-day delay in urgent surgeries for natural ticagrelor washout.
- The cost of CytoSorb is £1,500 per unit (excluding VAT). The resource impact would be less than standard care for emergency cardiac surgery (a UK cost-utility analysis reported a cost saving of £3,941 for CytoSorb compared with no removal of ticagrelor), and less than standard care for urgent surgery (about £1,575)."
The MIB document incorporates the available evidence for the use of CytoSorb for the intraoperative removal of ticagrelor in patients undergoing cardiac surgery on cardiopulmonary bypass, invited commentary from clinical experts working in the field, and relevant patient organizations. Quoted from the MIB, "All experts agreed that CytoSorb has the potential to change the current pathway. It can reduce operating theatre occupancy time, and lengths of intensive care unit and hospital stays. Furthermore, there is less need to return to the theatre for re-exploration for bleeding and cardiac tamponade, and reduced need for blood products." Accordingly, CytoSorb use in this application is expected to produce significant cost savings and improve the operational efficiency of hospitals.
Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "NICE is considered the world's leading authority in evaluating the cost-effectiveness of novel therapies using a rigorous methodology that considers both clinical and economic outcomes. In today's cost sensitive healthcare environment, rapid adoption of any new technology requires evidence of this true value. We are thrilled with the recent advice issued by NICE that accurately captures the "game changing" potential of antithrombotic removal by CytoSorb in cardiac surgery patients. We believe this analysis will resonate well beyond the U.K. and sensitize health care organizations around the world to CytoSorb as a breakthrough solution to a critical unmet medical need. We remain steadfast in our commitment to high quality evidence generation and are pleased to announce the international, company-sponsored STAR Registry (Safe and Timely Antithrombotic Removal) that is scheduled to commence enrollment in Q2 2021."
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 67 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® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 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 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 U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), 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 ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, 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.
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, including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones, 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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