CytoSorbents: FDA issues denial letter for De Novo Request for DrugSorb-ATR

CytoSorbents (CTSO) provided a regulatory update for DrugSorb-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within 2 days of stopping the antiplatelet drug Brilinta, a commonly used blood thinner. On April 25, the U.S. FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. CytoSorbents has since met with the FDA and will continue to have interactive conversations with the agency to try to resolve the remaining issues. However, if these conversations do not lead to a resolution, a formal appeal will be filed within 60 days. “We remain deeply committed to bringing DrugSorb-ATR to market as an important solution to address the serious, unmet medical need of preventing life-threatening bleeding in CABG patients treated with Brilinta,” said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “With no therapies currently available in the U.S., tens of thousands of patients remain at risk every year. We will continue working closely with FDA and believe we can resolve the remaining issues in a timely manner and still anticipate a final regulatory decision in 2025.”