What's Happening?
CytoSorbents Corporation has received a decision from the FDA regarding its appeal for the De Novo market authorization of DrugSorb-ATR. The FDA upheld its previous denial, citing the need for additional information to support the desired label indication. Despite finding no issues with device safety, the FDA proposed a potential path forward for market authorization. CytoSorbents is engaged in ongoing discussions with the FDA to clarify this proposal and is considering further appeal options within the FDA's hierarchy.
Why It's Important?
The FDA's decision impacts CytoSorbents' ability to market DrugSorb-ATR in the U.S., a device aimed at reducing perioperative bleeding in heart attack patients undergoing coronary artery bypass graft surgery. This decision affects the company's strategic plans and could delay access to potentially life-saving technology for patients on blood thinners. The outcome of these discussions and potential appeals could influence the company's market position and financial health, as well as the availability of innovative medical solutions in the U.S.
What's Next?
CytoSorbents is evaluating the possibility of appealing to a higher level within the FDA, specifically the Director of the FDA's Center for Devices and Radiologic Health. This appeal must be filed within 30 days of the decision. The company is committed to resolving outstanding issues and continues to engage in collaborative discussions with the FDA to bring DrugSorb-ATR to market.
