MONMOUTH JUNCTION, N.J., Jan. 21, 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, announces the immediate appointment of David D. Cox, Ph.D., M.B.A., as Vice President – Global Regulatory Affairs.
Dr. Cox was most recently Vice President of Regulatory Affairs for tissue and regenerative technologies at Integra LifeSciences Corporation. He was responsible for successful regulatory approvals of new products and product extensions for the $480 million orthopedics and tissue technologies division. Dr. Cox led efforts to develop U.S. FDA Premarket Approvals (PMA), 510(k)s, and Investigational New Drugs (IND), as well as international registrations under the European Union (E.U.) Medical Device Directive (MDD) and the new Medical Device Regulation (MDR). In addition, he effectively integrated the product lines of the Derma Sciences and BioDlogics acquisitions, expanding his regulatory responsibilities to include advanced wound care and human tissue products.
Prior to Integra LifeSciences, Dr. Cox held regulatory positions at several medical device companies, including Terumo BCT, where he was responsible for Class II and Class III submissions in the Center for Devices and Radiologic Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) branches of the FDA related to pathogen reduction and blood processing technologies. Earlier experiences include authoring numerous regulatory submissions for the U.S., E.U., Canada, and Japan for Medtronic's Cardiac Surgery division.
Dr. Cox received Regulatory Affairs Certification (RAC) for the U.S., Europe, and Canada. He received his Ph.D. in Bio-inorganic Chemistry from the University of Minnesota, his M.B.A. from Carnegie Mellon University, and his B.A. in Chemistry from Bethel College where he graduated magna cum laude.
Dr. Cox stated, "I am excited to join the CytoSorbents team and look forward to working with the FDA to achieve multiple product approvals for CytoSorb and other technologies. The FDA has recognized the potential of CytoSorb as a Breakthrough Device to remove the blood thinner ticagrelor, or Brilinta® (AstraZeneca), during emergent and urgent cardiothoracic surgery. Breakthrough Designation has the associated benefits of expedited development and prioritized reviews. The Company's rich development programs in critical care, cardiac surgery, blood transfusion, and military applications create numerous regulatory opportunities. I expect that solid clinical evidence, which is being gathered in various clinical trials, will be the cornerstone of multiple U.S. regulatory submissions in the future."
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, remarked, "I am pleased to have David join the Company as VP of Global Regulatory Affairs. His first priority is to expedite U.S. FDA regulatory approval of CytoSorb for ticagrelor removal, with the goal of targeting other antithrombotic drugs, as well as other critical care and cardiac surgery applications in the future. Meanwhile, David's international regulatory experience is an added plus as we prepare for MDR in the coming years. We believe David will also be instrumental in shaping the regulatory strategy for our robust pipeline of civilian and military use products under development. For example, his extensive experience at Terumo BCT with CBER and pathogen reduction technologies for blood product transfusions, will undoubtedly benefit our HemoDefend-RBC and HemoDefend-BGA/Universal Plasma development programs – also in the blood transfusion space. As a veteran regulatory professional with an outstanding chemistry background, David will greatly augment our regulatory capabilities and is expected to be an excellent fit for CytoSorbents."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents added, "David has established a solid reputation as a solutions-oriented, practical, and creative regulatory expert, with an extensive track record of successful FDA approvals in medical devices and biologics, and a wealth and breadth of industry experience in navigating the regulatory landscapes in both the U.S. and Europe. The added firepower and focus that he brings to our regulatory efforts is expected to speed the opening of the massive and lucrative U.S. market."
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.