CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR
CytoSorbents (NASDAQ: CTSO) received an FDA appeal decision regarding its DrugSorb-ATR device, following the April 2025 De Novo application denial. While the FDA found no safety issues with the device, they upheld the denial citing the need for additional information to support the label indication for this FDA Breakthrough Device.
The FDA has proactively proposed a potential path forward for market authorization, and the company continues discussions with the Agency. CytoSorbents has the option to file another appeal with the FDA's CDRH Director within 30 days. The device aims to help heart attack patients requiring urgent CABG surgery while on ticagrelor, addressing the critical issue of perioperative bleeding risk.
CytoSorbents (NASDAQ: CTSO) ha ricevuto una decisione di appello dalla FDA riguardo al dispositivo DrugSorb-ATR, a seguito del rigetto della sua domanda De Novo di aprile 2025. Sebbene la FDA non abbia riscontrato problemi di sicurezza con il dispositivo, ha confermato il diniego ritenendo necessarie ulteriori informazioni a supporto dell'indicazione riportata sull'etichetta per questo FDA Breakthrough Device.
La FDA ha proposto in modo proattivo un possibile percorso verso l'autorizzazione al mercato e la società prosegue le interlocuzioni con l'Agenzia. CytoSorbents ha la facoltà di presentare un nuovo ricorso al Direttore della CDRH della FDA entro 30 giorni. Il dispositivo è destinato ad aiutare i pazienti colpiti da infarto che necessitano urgentemente di CABG mentre assumono ticagrelor, affrontando il problema critico del rischio di sanguinamento perioperatorio.
CytoSorbents (NASDAQ: CTSO) recibió una decisión de apelación de la FDA sobre su dispositivo DrugSorb-ATR, tras la denegación de la solicitud De Novo en abril de 2025. Aunque la FDA no encontró problemas de seguridad con el dispositivo, confirmó la denegación al considerar que se requieren información adicional para respaldar la indicación en la etiqueta de este FDA Breakthrough Device.
La FDA ha propuesto de forma proactiva una posible vía para la autorización de mercado y la compañía mantiene conversaciones con la Agencia. CytoSorbents puede presentar otra apelación ante el Director de la CDRH de la FDA dentro de los 30 días. El dispositivo pretende ayudar a pacientes con infarto que necesitan una CABG urgente mientras toman ticagrelor, abordando el riesgo crítico de sangrado perioperatorio.
CytoSorbents (NASDAQ: CTSO)는 2025년 4월 De Novo 신청 거부에 따라 DrugSorb-ATR 장치에 대한 FDA 항소 결정을 받았습니다. FDA는 해당 장치에 대해 안전성 문제를 발견하지 않았다고 밝혔지만, 이 FDA Breakthrough Device의 라벨 적응증을 뒷받침할 추가 정보가 필요하다는 이유로 거부 결정을 유지했습니다.
FDA는 시장 허가를 위한 잠재적 진행 경로를 선제적으로 제안했으며 회사는 기관과의 논의를 계속하고 있습니다. CytoSorbents는 30일 이내에 FDA CDRH 국장에게 추가 항소를 제기할 수 있는 선택권이 있습니다. 이 장치는 티카그렐러를 복용 중인 상태에서 긴급 관상동맥우회술(CABG)이 필요한 심근경색 환자의 수술 전후 출혈 위험이라는 중대한 문제를 해결하는 데 목적이 있습니다.
CytoSorbents (NASDAQ: CTSO) a reçu une décision d'appel de la FDA concernant son dispositif DrugSorb-ATR, suite au refus de sa demande De Novo en avril 2025. Bien que la FDA n'ait relevé aucun problème de sécurité avec le dispositif, elle a maintenu le refus, estimant que des informations supplémentaires sont nécessaires pour étayer l'indication figurant sur l'étiquette de ce FDA Breakthrough Device.
La FDA a proposé de manière proactive une voie possible vers l'autorisation commerciale et la société poursuit ses échanges avec l'Agence. CytoSorbents peut déposer un nouvel appel auprès du directeur de la CDRH de la FDA dans les 30 jours. Le dispositif vise à aider les patients ayant subi un infarctus et nécessitant une CABG urgente tout en prenant du ticagrélor, en traitant le problème critique du risque d'hémorragie périopératoire.
CytoSorbents (NASDAQ: CTSO) erhielt eine FDA-Berufungsentscheidung bezüglich seines Geräts DrugSorb-ATR nach der Ablehnung des De Novo-Antrags im April 2025. Zwar hat die FDA keine Sicherheitsprobleme mit dem Gerät festgestellt, sie bestätigte jedoch die Ablehnung mit der Begründung, dass zusätzliche Informationen zur Untermauerung der Zulassungsangabe auf dem Etikett für dieses FDA Breakthrough Device erforderlich seien.
Die FDA hat proaktiv einen möglichen Weg zur Marktzulassung vorgeschlagen und das Unternehmen führt weiterhin Gespräche mit der Behörde. CytoSorbents hat die Möglichkeit, innerhalb von 30 Tagen erneut Berufung beim Direktor der CDRH der FDA einzulegen. Das Gerät soll Patienten nach Herzinfarkt helfen, die dringend eine CABG benötigen und Ticagrelor einnehmen, indem es das schwerwiegende Problem des perioperativen Blutungsrisikos adressiert.
- FDA confirmed no safety issues with DrugSorb-ATR device
- FDA proactively proposed a potential path forward for market authorization
- Device maintains FDA Breakthrough Device designation
- Company has option for higher-level FDA appeal within 30 days
- FDA upheld the De Novo application denial
- Additional information required to support label indication
- Market entry in US remains delayed pending resolution
Insights
FDA upheld DrugSorb-ATR denial but found no safety issues and offered potential path forward; regulatory uncertainty continues despite progress.
CytoSorbents has received mixed news regarding its DrugSorb-ATR device, classified as an FDA Breakthrough Device. The FDA has upheld its April 2025 De Novo application denial but importantly found no issues with device safety, which is critical for the De Novo pathway that relies on a favorable benefit-to-risk profile. This represents partial progress despite the continued market authorization delay.
The FDA has proactively proposed a potential path forward for market authorization, suggesting the agency sees merit in the technology despite current documentation insufficiencies. The company has two apparent options: pursue the FDA's proposed path or file another appeal to a higher level within the FDA—specifically with the Director of the FDA's Center for Devices and Radiologic Health within 30 days.
The regulatory context is particularly significant as DrugSorb-ATR addresses a critical unmet medical need in cardiac surgery. Patients requiring urgent coronary artery bypass graft (CABG) surgery while on ticagrelor (a blood thinner) currently face a difficult choice: delay needed surgery while actively experiencing a heart attack or risk severe perioperative bleeding. The company indicates its technology is already addressing this issue internationally, highlighting the potential market opportunity if approved.
While this represents a setback in timeline, the resolution of safety concerns and the FDA's willingness to propose alternative paths suggest the company has made meaningful progress in the regulatory process rather than facing a terminal rejection.
FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forward for market authorization
On August 14, 2025, the Company received an FDA appeal decision following its July 2025 in-person supervisory administrative review (appeal) meeting with FDA under 21 CFR 10.75. The appeal was in response to an April 25, 2025 FDA denial letter of the Company's De Novo application for DrugSorb-ATR. In the appeal decision, the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company's desired label indication for this FDA Breakthrough Device. The FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR and the Company continues interactive discussions with the Agency to seek further clarity on this proposal. The FDA also noted another avenue for appeal to a higher level within the FDA, specifically with the Director of the FDA's Center for Devices and Radiologic Health (CDRH), that must be filed within 30 days of the appeal decision, which the Company is currently evaluating.
"The path to FDA approval frequently involves sequential, collaborative discussions with the Agency to address issues that arise during the review process," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "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. We appreciate the Agency's offer to find a path forward to market authorization that we plan to discuss with them further. We remain committed to continuing our collaborative interaction with the FDA to bring DrugSorb-ATR, an FDA Breakthrough Device, to the tens of thousands of heart attack patients in the
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already found in hospitals (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure, and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis, as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with nearly 300,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States.
In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, 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 (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying 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. In July 2025, the Company had an in-person administrative appeal meeting with FDA under 21 CFR 10.75. The appeal hearing included FDA senior leadership and review team, Company management, its FDA regulatory counsel, and its external cardiac surgical experts. On August 14, 2025, the FDA issued a response to the Company's appeal that found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company's desired label indication for this FDA Breakthrough Device. FDA proactively proposed a potential path forward for market authorization of DrugSorb-ATR and the Company continues interactive discussions with the Agency to seek further clarity on this proposal. The FDA also noted another avenue for appeal to a higher level within the FDA, specifically with the Director of the FDA's Center for Devices and Radiologic Health (CDRH) that must be filed within 30 days of the appeal decision, which the Company is currently evaluating.
In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. On June 26, 2025, Health Canada issued a Notice of Refusal of the Company's Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. As part of Health Canada's prescribed reconsideration process, and after discussions with Health Canada, the Company has filed a Level 1 "Request for Reconsideration" and with agreement from the Medical Devices Directorate Bureau Director, will pursue the review following the completion of the Company's review with the U.S. FDA.
DrugSorb-ATR is not yet granted or approved in either
The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others.
For more information, please visit the Company's website at https://ir.cytosorbents.com/ or follow us on Facebook and X.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA appeal decision and to identify a path forward for market authorization, our ability to resolve deficiencies in the Health Canada Notice of Refusal and/or successfully appeal Health Canada's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Peter J. Mariani, Chief Financial Officer
305 College Road East
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
ir@cytosorbents.com
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SOURCE CytoSorbents Corporation
FAQ
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