8-K: CytoSorbents Appeals FDA Denial for Breakthrough DrugSorb-ATR Device

CytoSorbents Corporation has filed an administrative appeal with the U.S. FDA regarding the denial of its De Novo Request for the DrugSorb-ATR device, aiming to resolve deficiencies and secure U.S. commercialization.

Summary

• CytoSorbents Corporation filed an administrative appeal with the U.S. Food and Drug Administration (FDA) on June 18, 2025, concerning the denial of its De Novo Request for the DrugSorb-ATR Device.
• The FDA's denial letter, issued on April 25, 2025, identified remaining deficiencies that must be addressed before the device can be authorized for U.S. commercialization.
• DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, 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 company believes that the administrative appeals process, which includes a formal hearing and engagement with senior FDA leadership and external experts, is the most effective path to resolve the remaining deficiencies.
• CytoSorbents expects a final regulatory decision on DrugSorb-ATR in 2025, both from the FDA and Health Canada.
• Health Canada's review of the DrugSorb-ATR application remains under advanced review but is experiencing delays beyond their target Market Authorization Times (MAT) due to a backlog.
• CytoSorbents' lead product, CytoSorb, is CE Marked 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 FDA denial is a significant setback for U.S. market entry, which is a negative. However, the company's immediate and confident appeal, coupled with the prior Breakthrough Device Designation and existing global product success (CytoSorb), mitigates some of the negative impact. The Health Canada delay adds a layer of uncertainty.

Positives

• DrugSorb-ATR previously received Breakthrough Device Designation from the FDA, indicating its potential importance for an unmet medical need.
• The company has a clear administrative appeals process (21 CFR 10.75) to engage with upper management of FDA's Center for Devices and Radiological Health (CDRH), including a formal hearing, with a final decision typically issued approximately 60 days after the appeal is filed.
• Management expresses strong confidence in the DrugSorb-ATR submission and believes that the FDA's remaining concerns can be addressed and resolved efficiently.
• CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review, with Health Canada reaffirming its commitment to issuing a decision at the earliest opportunity.
• The company remains confident in receiving a final regulatory decision in 2025 for both the FDA appeal and Health Canada application.
• CytoSorbents has a globally marketed product, CytoSorb, which is CE Marked in the EU and distributed in over 70 countries, with over 270,000 devices used cumulatively.

Negatives

• The U.S. FDA issued a De Novo Denial Letter for DrugSorb-ATR on April 25, 2025, preventing immediate U.S. commercialization.
• The denial letter identified remaining deficiencies that must be addressed before the device can be granted and authorized for U.S. commercialization.
• Health Canada's application reviews for DrugSorb-ATR are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog.

Risks

• The company's ability to resolve the identified deficiencies in the FDA denial letter through a successful administrative appeal.
• General risks discussed in the company's Annual Report on Form 10-K, filed with the SEC on March 31, 2025, and updated by Quarterly Reports on Form 10-Q.
• Risks associated with the restructuring of the company's direct sales team and strategy in Germany.

Future Outlook

CytoSorbents anticipates that the administrative appeals process with the FDA will efficiently resolve the remaining deficiencies for DrugSorb-ATR, leading to a final regulatory decision in 2025. Similarly, the company expects a final regulatory decision from Health Canada on DrugSorb-ATR in 2025, despite current review backlogs.

Management Comments

• "The appeals process allows us to work more directly and effectively with senior FDA leadership connecting them with the Company’s leading external experts, including cardiac surgeons, who can provide the FDA with critical insight and expert consultation." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.
• "We continue to have strong confidence in our DrugSorb-ATR submission and believe that the FDA’s remaining concerns can be addressed and resolved efficiently." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.
• "Our goal remains clear to make DrugSorb-ATR available to the thousands of U.S. patients on Brilinta who require urgent CABG surgery each year and to fill this expanding and critical unmet medical need." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.

Industry Context

This announcement highlights the significant regulatory hurdles faced by medical device companies, particularly for novel technologies like blood purification systems. The need for devices like DrugSorb-ATR addresses a critical unmet medical need in cardiac surgery, where managing bleeding risks from antiplatelet drugs is crucial. The FDA's Breakthrough Device Designation indicates the potential importance of the technology, but the denial underscores the rigorous review process. The company's strategy to appeal and engage senior FDA leadership is a common approach for innovative firms navigating complex regulatory pathways, reflecting the high stakes involved in bringing new medical technologies to market.

Stakeholder Impact

• Shareholders: Potential negative impact due to the FDA denial and associated uncertainty, but potential positive impact if the appeal is successful and U.S. market access is granted.
• Patients: Continued unmet medical need for patients on Brilinta requiring urgent CABG surgery in the U.S. until DrugSorb-ATR receives regulatory approval.
• Employees: Continued focus and effort required to navigate complex regulatory processes and resolve identified deficiencies for a key product.

Next Steps

• Engage with upper management of FDA's Center for Devices and Radiological Health (CDRH) through a formal hearing as part of the administrative appeals process.
• Address and resolve the remaining deficiencies identified by the FDA for DrugSorb-ATR.
• Await a final regulatory decision from the FDA on DrugSorb-ATR, expected in 2025.
• Await a final regulatory decision from Health Canada on DrugSorb-ATR, also expected in 2025.

Key Dates

Keywords

CytoSorbents, CTSO, DrugSorb-ATR, FDA, De Novo Request, administrative appeal, blood purification, medical device, antiplatelet, ticagrelor, Brilinta, CABG surgery, cardiac surgery, Health Canada, Breakthrough Device Designation, CytoSorb, critical care, intensive care unit, blood thinner removal