Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents’ executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities
PRINCETON, N.J., Jan. 17, 2023 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs. Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others. She will serve as a member of CytoSorbents’ executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.
Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc., a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices. She has also worked for major U.S. and international life science corporations such as Johnson & Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and BioSphere Medical. She has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices. Dr. Kulinets has also provided executive strategic and operational leadership to help launch new products in the U.S., E.U., China, Japan, and many other Asian and Latin American markets.
Dr. Kulinets also has extensive experience as a regulator and worked for TUV America, Product Service – Medical Division and was appointed as a third-party FDA Inspector and 510(k) reviewer on behalf of the FDA to review, assess and approve new technologies.
Dr. Kulinets stated, “I am excited to join CytoSorbents at such an important time in the Company’s history as it nears the completion of the STAR-T pivotal trial, evaluating the ability of the DrugSorb®-ATR system to reduce the risk of perioperative bleeding in cardiothoracic surgery caused by the antithrombotic drug, Brilinta®. During my career I have led the regulatory approval of many cardiovascular and neurovascular medical devices. I believe the DrugSorb®-ATR system is a unique breakthrough therapy that can reduce bleeding complications in this setting and we will be working diligently to bring this product to help clinicians and patients as the Company’s first commercialized product in the U.S. and Canada. Meanwhile, CytoSorbents has so many other compelling technologies, such as CytoSorb® and HemoDefend®-BGA. I look forward to leveraging my U.S. and international regulatory and clinical expertise to help rapidly advance these programs around the world.”
Mr. Vincent Capponi remarked, “I am excited that Irina is joining the CytoSorbents team to lead Global Regulatory Affairs. She comes to us with a wealth of regulatory experience in medical devices, tissue products, and drugs and has received numerous FDA approvals. In addition to U.S. approvals, Irina has led international approvals in Europe, China, Japan, South Korea, Latin America, Australia, and Canada.”
Mr. Capponi continued, “First and foremost, Irina’s focus will be to help drive FDA marketing approval of DrugSorb-ATR for our initial indication of Brilinta® removal, currently under study in the STAR-T trial, and then later for direct oral anticoagulant (DOAC) removal under the STAR-D trial. Irina’s regulatory experience with cardiovascular devices aligns well with this intended use. Meanwhile, her background will no doubt be useful in expanding the DrugSorb-ATR market to hospital-wide applications where preoperative removal of antithrombotics could be helpful, as before emergency orthopedic or neurologic surgeries. At the same time, Irina is well-suited to help refine our global regulatory strategy for CytoSorb, HemoDefend-BGA (universal plasma), and other technologies currently under development. We are fortunate to have a regulatory professional of Irina’s caliber to join our team and look forward to her future success.”
Dr. Kulinets holds an M.S. in Mechanical Engineering from Belarus Polytechnic Academy, M.S. in Quality Systems from California State University, and a Ph.D. in Health Science from Trident University. She is RAPS (Regulatory Affairs Professionals Society) certified RAC (Regulatory Affairs Certification) and Board Certified in Medical Affairs. Irina also has strong ties to Academia. She served as a Faculty Director and lecturer for the Master of Science in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in Regulatory Science and Clinical Research program in Georgetown University, Washington DC. She has authored or co-authored 3 books and has multiple peer-reviewed publications in areas of her expertise.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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 marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, 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.
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SOURCE CytoSorbents Corporation