07:46 AM EDT, 06/24/2025 (MT Newswires) -- CytoSorbents ( CTSO ) said Tuesday it filed an appeal with the US Food and Drug Administration over the denial of its DrugSorb-ATR device on April 25.

The appeal will allow CytoSorbents ( CTSO ) to engage with the agency in a process that includes a formal hearing, where it will try to address the remaining deficiencies identified before its De Novo request is granted and the device is authorized for commercialization in the US, the company said.

A final decision is typically issued around 60 days after an appeal is filed, the company said.

CytoSorbents ( CTSO ) said its DrugSorb-ATR application with Health Canada remains under advanced review due to a backlog in the agency, but it expects a final regulatory decision within the year.

DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within two days of stopping the antiplatelet drug Brilinta, a commonly used blood thinner, the company said.