On April 25, 2025, the FDA issued a denial letter regarding CytoSorbents’ (NASDAQ:CTSO) De Novo Request for DrugSorb-ATR authorization. The agency identified remaining deficiencies that must be addressed before the De Novo Request can be granted and the device can be authorized for commercialization in the U.S. CytoSorbents has already met with the FDA subsequent to receiving the letter and continues to have interactive conversations with the agency to try to resolve the remaining issues. If needed, CytoSorbents plans to file a formal appeal within 60 days from the receipt of the letter and believes it can resolve the remaining issues in a timely manner. The company still anticipates a final regulatory decision from the FDA this year, which remains consistent with its prior guidance.
The company states that it remains extremely committed to bringing DrugSorb-ATR to market as an important solution to address the serious, unmet medical need of preventing life-threatening bleeding in CABG patients treated with Brilinta. There are no effective therapies currently available in the U.S., resulting in tens of thousands of patients facing this risk every year. FDA granted DrugSorb-ATR two separate Breakthrough Device designations, one for Brilinta and one for the direct oral anticoagulants such as Eliquis and Xarelto because of its potential to solve this major problem.
Additional Commentary on the FDA Letter and Appeals Process
CytoSorbents has not disclosed the specific remaining issues cited in the FDA’s denial letter. However, the company stated that, following a subsequent meeting with the FDA to clarify these issues, it believes they can be resolved promptly—potentially through the appeals process—which could lead to a final FDA decision later this year. This confidence in a short timeline suggests that the data from the STAR-T trial may be deemed sufficient, and that a new pre-approval study may not be required which is a significant positive outcome if accurate.
The appeals process is the most common and established pathway companies pursue following a denial of a De Novo request. It allows for a higher-level review within the FDA, during which the original decision can be upheld, reversed, or modified. The process includes a supervisory review of the appeal summary submitted by the sponsor, as well as a meeting involving FDA officials, the company, and relevant external experts. The typical timeline from submission to final decision is approximately 60 days.
The question arises why the outstanding issues were not resolved prior to the issuance of the denial letter. Under the Medical Device User Fee Amendments of 2022 (MDUFA V), the FDA is expected to reach a decision on 70% of De Novo applications within 150 days, excluding any time the application is placed on hold for additional data requests. The agency’s performance is closely tracked against these metrics. We believe these metrics may be under even greater scrutiny under the current administration.
Based on our analysis, we continue to believe that DrugSorb-ATR, as an FDA Breakthrough Device with the potential to safely mitigate the risk of serious perioperative bleeding caused by Brilinta in CABG patients, merits marketing approval. Its effectiveness has been demonstrated both in a randomized controlled trial and real-world data. The safety profile appears benign. Most importantly, the alternative—either doing nothing and accepting high rates of serious or life-threatening bleeding, or delaying surgery to allow drug washout while the patient remains at risk from an ongoing heart attack—is unacceptable when a viable therapeutic option exists.
Health Canada
CytoSorbents has not provided an update to its Health Canada submission for DrugSorb-ATR. This may be coming in the 1st quarter 2025 earnings release scheduled for May 14, 2025. According to prior statements, DrugSorb-ATR is under advanced review by Health Canada. We note that seven of the 32 adult cardiac surgery centers throughout Canada participated in the pivotal U.S. and Canadian STAR-T randomized controlled trial, representing nearly a quarter of the participating surgical institutions in the trial and contributing approximately a third of all patients into the trial. We believe these factors will be viewed favorably by Health Canada.
We maintain our price target of $4.00 per share and estimates at this time as we do not expect this delay to make a material change to our financial model. Our model does not project DrugSorb-ATR revenues until calendar year 2026.
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