8-K: CytoSorbents Faces Dual Regulatory Setbacks for DrugSorb-ATR in U.S. and Canada, Pursues Appeals

CytoSorbents Corporation announced regulatory setbacks for its DrugSorb-ATR device in both the U.S. and Canada, with the FDA scheduling an appeal hearing and Health Canada issuing a Notice of Refusal, though the company remains confident in its appeal processes.

Summary

• CytoSorbents Corporation provided a regulatory update for its DrugSorb-ATR device, which is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta (ticagrelor).
• The U.S. Food and Drug Administration (FDA) has scheduled an appeal hearing date for the company's requested supervisory review (administrative appeal) under 21 CFR 10.75, following a De Novo Denial Letter issued on April 25, 2025. The company expects this process to complete by the end of August 2025.
• Health Canada issued a Notice of Refusal of the company's Medical Device License application on June 26, 2025, citing non-compliance with certain Medical Devices Regulations.
• CytoSorbents intends to file a Level 1 Request for Reconsideration with Health Canada's Medical Devices Directorate Bureau Director by July 25, 2025.
• The company remains confident in the strength of its regulatory submissions and is committed to working through the appeals processes, expecting final regulatory decisions from both agencies by the end of 2025.
• DrugSorb-ATR has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of direct oral anticoagulants (DOAC) apixaban and rivaroxaban.
• CytoSorbents' lead product, CytoSorb, is approved in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used cumulatively to date.

Sentiment

Score: 4

Explanation: The sentiment is mixed to slightly negative. While the company expresses confidence and is actively pursuing appeals, the core news involves regulatory denials from two major markets (FDA and Health Canada) for a key product. The positive aspects are the Breakthrough Device designation and the existing success of CytoSorb internationally, but the immediate regulatory hurdles are significant and create uncertainty.

Positives

• DrugSorb-ATR has received two FDA Breakthrough Device Designations, one for ticagrelor removal and another for the removal of DOACs apixaban and rivaroxaban, indicating its potential to address unmet medical needs.
• The company's lead product, CytoSorb, is approved in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used cumulatively to date, demonstrating a proven technology platform and international market acceptance.
• CytoSorb has received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure.
• Management expresses confidence in the strength of regulatory submissions and commitment to working through the appeals processes.
• The company continues to expect final regulatory decisions from both FDA and Health Canada by the end of 2025, suggesting a defined timeline for resolution.

Negatives

• The U.S. FDA issued a De Novo Denial Letter on April 25, 2025, for DrugSorb-ATR, identifying remaining deficiencies that must be addressed for U.S. commercialization.
• Health Canada issued a Notice of Refusal on June 26, 2025, for the Medical Device License application for DrugSorb-ATR, citing non-compliance with certain Medical Devices Regulations.
• DrugSorb-ATR is not yet authorized for commercialization in the U.S. or Canada.

Risks

• Inability to resolve remaining deficiencies identified by the FDA in its De Novo Denial Letter for DrugSorb-ATR.
• Unsuccessful appeal of the FDA's decision regarding the De Novo Request for DrugSorb-ATR.
• Inability to successfully appeal Health Canada's Notice of Refusal for the Medical Device License application.
• General risks discussed in the company's Annual Report on Form 10-K filed with the SEC on March 31, 2025, and updated by risks reported in Quarterly Reports on Form 10-Q.

Future Outlook

The company expects to resolve remaining deficiencies through formal appeal processes with both the FDA and Health Canada, anticipating final regulatory decisions for DrugSorb-ATR by the end of 2025. The FDA supervisory review process is expected to complete by the end of August 2025.

Management Comments

• "We believe DrugSorb-ATR addresses a critical and growing need in cardiac surgery by helping to reduce the severity of perioperative bleeding in patients undergoing CABG surgery on Brilinta."
• "With no other approved therapies currently available to patients and cardiac surgeons in the U.S. and Canada, we believe DrugSorb-ATR offers a highly differentiated solution to this large and underserved market."
• "We remain confident in the strength of our regulatory submissions and are committed to working through the appeals processes in a timely manner with both FDA and Health Canada to bring this FDA Breakthrough Designated therapy to the tens of thousands of patients at risk and the surgical teams that operate on them each year in these countries."
• "We continue to expect final regulatory decisions by the end of this year."

Industry Context

The announcement highlights the rigorous and often challenging regulatory pathways for novel medical devices, even those with Breakthrough Device designations, in major markets like the U.S. and Canada. It underscores the high unmet medical need for effective solutions to manage perioperative bleeding in cardiac surgery, particularly for patients on antiplatelet drugs like ticagrelor, where currently no other approved therapies exist. The company's pursuit of appeals reflects the common industry practice of engaging regulatory bodies through established processes to address deficiencies and seek market authorization for innovative therapies.

Comparison to Industry Standards

• DrugSorb-ATR is positioned to address a critical and growing need in cardiac surgery, with no other approved therapies currently available to patients and cardiac surgeons in the U.S. and Canada for reducing perioperative bleeding in patients on Brilinta. This suggests a potential first-to-market advantage if regulatory approvals are ultimately secured.
• The company's existing product, CytoSorb, has a strong international presence, approved in the European Union and distributed in over 70 countries with over 270,000 devices used cumulatively. This demonstrates a proven technology platform and market acceptance outside North America, which could be leveraged for DrugSorb-ATR.
• The FDA Breakthrough Device Designation for DrugSorb-ATR signifies the agency's recognition of the device's potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, indicating its perceived clinical value compared to existing or non-existent alternatives in the market.

Stakeholder Impact

• Shareholders: Potential negative impact due to regulatory setbacks for a key product, leading to uncertainty regarding future commercialization and revenue streams in North America.
• Patients: Continued lack of an approved therapy in the U.S. and Canada for reducing perioperative bleeding in CABG patients on Brilinta, delaying access to a potentially beneficial treatment.
• Cardiac Surgeons/Medical Professionals: Continued absence of a specialized tool to manage a critical clinical challenge in CABG surgery.
• Employees: Potential impact on morale and strategic focus due to prolonged regulatory processes and uncertainty regarding product launch.

Next Steps

• CytoSorbents will pursue a supervisory review (administrative appeal) with the U.S. FDA, with a hearing scheduled and expected completion by the end of August 2025.
• CytoSorbents intends to file a Level 1 Request for Reconsideration with Health Canada by July 25, 2025.
• If marketing authorization is not received from Health Canada after the reconsideration process, the company can then file a formal Appeal with the Director General of the Medical Devices Directorate.
• The company expects final regulatory decisions from both FDA and Health Canada by the end of 2025.

Key Dates

Keywords

CytoSorbents, CTSO, DrugSorb-ATR, FDA, Health Canada, regulatory update, medical device, blood purification, ticagrelor, Brilinta, CABG surgery, antiplatelet, De Novo Request, Breakthrough Device, appeal, reconsideration, CytoSorb, critical care, cardiac surgery