FDA upholds De Novo denial for DrugSorb-ATR, proposes path forward.

CytoSorbents Corporation's appeal for De Novo market authorization of DrugSorb-ATR was denied by the FDA, but the agency found no safety issues with the device. The FDA cited the need for additional information to support the company's application. The FDA proposes a potential path forward for market authorization, although the specific details are not disclosed.

Title: CytoSorbents Corporation's FDA Appeal for DrugSorb-ATR Device

CytoSorbents Corporation (NASDAQ: CTSO) recently received an FDA appeal decision regarding its De Novo market authorization request for the DrugSorb™-ATR device. The FDA found no issues with the device's safety but upheld the De Novo denial, citing the need for additional information to support the company's desired label indication for this FDA Breakthrough Device [1].

The FDA proactively proposed a potential path forward for market authorization, suggesting further interactive discussions between CytoSorbents and the Agency to clarify this proposal. The company is currently evaluating another appeal avenue, specifically with the Director of the FDA's Center for Devices and Radiologic Health (CDRH), which must be filed within 30 days of the appeal decision [1].

CytoSorbents' Chief Executive Officer, Dr. Phillip Chan, stated, "The path to FDA approval frequently involves sequential, collaborative discussions with the Agency to address issues that arise during the review process. Although we are disappointed that the denial decision was upheld, we believe significant progress has been made with the resolution of the majority of outstanding issues previously raised by the FDA. Importantly, we have affirmed no issues of device safety on which the De Novo standard of a favorable benefit-to-risk profile is established" [1].

The DrugSorb-ATR device is designed to reduce the severity of perioperative bleeding in high-risk surgery due to blood-thinning drugs. It has received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOACs) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures [1].

CytoSorbents is also pursuing market authorization in Canada. In June 2025, Health Canada issued a Notice of Refusal for the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted [1]. The company has filed a Level 1 "Request for Reconsideration" and is pursuing the review following the completion of its review with the U.S. FDA.

References
[1] https://www.prnewswire.com/news-releases/cytosorbents-updates-us-fda-regulatory-status-of-drugsorb-atr-302534350.html