CytoSorbents Provides DrugSorb-ATR Regulatory Update
CytoSorbents (NASDAQ: CTSO) provided a regulatory update on DrugSorb-ATR, its FDA Breakthrough Device for blood purification. Following FDA's previous De Novo application denial, the company has received constructive feedback and will submit a new De Novo application with additional real-world data supporting their desired label indication for patients on ticagrelor undergoing urgent CABG surgery.
The FDA found no safety issues with the device and has proposed an expedited path for market authorization. CytoSorbents plans to file a pre-submission meeting request in October 2025, with a formal FDA meeting expected in Q4 2025. A regulatory decision is anticipated by mid-2026. Additionally, the company has withdrawn its Health Canada reconsideration request, planning to submit a new application after gaining clarity from the FDA process.
CytoSorbents (NASDAQ: CTSO) ha fornito un aggiornamento regolatorio su DrugSorb-ATR, il suo dispositivo di Breakthrough FDA per la purificazione del sangue. Dopo il precedente rifiuto della De Novo da parte della FDA, l'azienda ha ricevuto feedback costruttivi e presenterà una nuova domanda De Novo con ulteriori dati reali a supporto dell'etichetta desiderata per i pazienti in trattamento con ticagrelor sottoposti a un intervento urgente di CABG. La FDA non ha riscontrato problemi di sicurezza con il dispositivo e ha proposto un percorso accelerato per l'autorizzazione sul mercato. CytoSorbents prevede di presentare una richiesta di incontro pre-sottomissione a ottobre 2025, con un incontro formale con la FDA previsto nel Q4 2025. Si prevede una decisione regolatoria entro metà-2026. Inoltre, l'azienda ha ritirato la richiesta di riesame presso Health Canada, pianificando di presentare una nuova domanda dopo aver ottenuto chiarimenti dal processo FDA.
CytoSorbents (NASDAQ: CTSO) proporcionó una actualización regulatoria sobre DrugSorb-ATR, su dispositivo de avance (Breakthrough) de la FDA para la purificación de la sangre. Tras la denegación previa de la solicitud De Novo por parte de la FDA, la empresa ha recibido comentarios constructivos y presentará una nueva solicitud De Novo con datos del mundo real adicionales que respaldan la indicación de etiqueta deseada para pacientes que toman ticagrelor y se someten a una cirugía urgente de CABG. La FDA no encontró problemas de seguridad con el dispositivo y ha propuesto un camino acelerado para la autorización de comercialización. CytoSorbents planea presentar una solicitud de reunión previa a la presentación en octubre de 2025, con una reunión formal de la FDA prevista para el cuarto trimestre de 2025. Se espera una decisión regulatoria para mediados de 2026. Además, la empresa ha retirado su solicitud de reconsideración ante Health Canada, planeando presentar una nueva solicitud tras obtener claridad del proceso de la FDA.
CytoSorbents (NASDAQ: CTSO)가 혈액 정화를 위한 FDA의 혁신적 장치 DrugSorb-ATR에 대한 규제 업데이트를 제공했습니다. FDA의 이전 De Novo 신청 거부 이후, 회사는 건설적인 피드백을 받았고 Ticagrelor를 복용 중인 환자들이 긴급 CABG 수술을 받는 경우를 지원하는 추가 실전 데이터를 포함한 새로운 De Novo 신청을 제출할 예정입니다. FDA는 장치에 안전성 이슈가 없다고 판단했으며 시판 허가를 위한 신속한 경로를 제안했습니다. CytoSorbents는 2025년 10월에 사전 제출 미팅 요청을 제출하고, 2025년 4분기에 FDA 공식 회의를 예상합니다. 규제 결정은 2026년 중반까지가 예상됩니다. 또한 Health Canada의 재심사를 철회했으며 FDA 절차에서 명확성을 얻은 후 새로운 신청을 제출할 계획입니다.
CytoSorbents (NASDAQ: CTSO) a fourni une mise à jour réglementaire sur DrugSorb-ATR, son dispositif breakthrough de la FDA pour la purification du sang. Suite au refus préalable de la demande De Novo par la FDA, l'entreprise a reçu des retours constructifs et déposera une nouvelle demande De Novo avec des données réelles complémentaires soutenant l’indication d’étiquette souhaitée pour les patients sous ticagrelor ayant besoin d’une chirurgie urgente de pontage aorto-coronarien (CABG). La FDA n’a identifié aucun problème de sécurité avec le dispositif et a proposé une voie accélérée pour l’autorisation de mise sur le marché. CytoSorbents prévoit de déposer une demande de réunion pré-soumission en octobre 2025, avec une réunion formelle de la FDA attendue au cours du 4e trimestre 2025. Une décision réglementaire est anticipée d’ici mi-2026. De plus, l’entreprise a retiré sa demande de réexamen auprès d’Health Canada et prévoit de soumettre une nouvelle demande après avoir obtenu des éclaircissements sur le processus de la FDA.
CytoSorbents (NASDAQ: CTSO) hat ein regulatorisches Update zu DrugSorb-ATR vorgelegt, seinem FDA-Breakthrough-Gerät zur Blutreinigung. Nach der früheren Ablehnung des De-Novo-Antrags durch die FDA hat das Unternehmen konstruktives Feedback erhalten und wird einen neuen De-Novo-Antrag mit zusätzlichen realen Daten einreichen, die die gewünschte Kennzeichnungsindikation für Patienten unterstützen, die Ticagrelor einnehmen und eine dringende CABG-Operation benötigen. Die FDA fand keine Sicherheitsprobleme mit dem Gerät und hat einen beschleunigten Weg zur Marktzulassung vorgeschlagen. CytoSorbents plant, im Oktober 2025 eine Voranfrage für ein Treffen einzureichen, mit einer formellen FDA-Besprechung im vierten Quartal 2025 erwartet. Eine regulatorische Entscheidung wird voraussichtlich bis Mitte 2026 getroffen. Zusätzlich hat das Unternehmen seinen Antrag auf Überprüfung durch Health Canada zurückgezogen und plant, nach Klarheit aus dem FDA-Prozess einen neuen Antrag zu stellen.
قامت CytoSorbents (المدرَجة في السوق بحروف CTSO) بتقديم تحديث تنظيمي بشأن DrugSorb-ATR، جهاز FDA الرائد لتنقية الدم. بعد رفض FDA السابق لطلب De Novo، تلقت الشركة تعليقات بناءة وستقدم طلب De Novo جديد مع بيانات واقعية إضافية تدعم المؤشر الملصق المرغوب للمصابين الذين يتناولون ticagrelor ويخضعون لعملية CABG طارئة. وجدت FDA لا مشكلات تتعلق بالسلامة مع الجهاز واقترحت مساراً معجلاً للموافقة على التسويق. تخطط CytoSorbents لتقديم طلب اجتماع ما قبل التقديم في أكتوبر 2025، مع اجتماع رسمي مع FDA متوقع في الربع الرابع من 2025. من المتوقع أن تكون القرار التنظيمي بحلول منتصف 2026. كما ألغت الشركة طلب إعادة النظر لدى Health Canada وتخطط لتقديم طلب جديد بعد توضيح من عملية FDA.
CytoSorbents (NASDAQ: CTSO) 就其用于血液净化的 FDA 突破性设备 DrugSorb-ATR 提供了监管更新。在 FDA 先前的 De Novo 申请被拒后，公司获得了建设性反馈，将提交一个新的 De Novo 申请，并提供额外的真实世界数据，以支持其针对正在使用替格瑞洛且需紧急 CABG 手术的患者的标签指示。FDA 未发现该设备有任何安全性问题，并提出一条加速上市的路径。CytoSorbents 计划在 2025 年 10 月提交一份预提交会谈请求，预计在 2025 年第四季度举行正式的 FDA 会议。监管决定预计在2026 年中前后。另公司已撤回对 Health Canada 的重新审议请求，计划在从 FDA 流程获得明确性后提交新申请。
- FDA found no safety issues with DrugSorb-ATR
- FDA proposed expedited path for market authorization
- New real-world data available to support clinical performance
- Device maintains Breakthrough Device Designation status
- Original De Novo application denial upheld by FDA
- Regulatory approval delayed until mid-2026
- Health Canada application withdrawn and delayed
- Additional clinical data and new submission required
Insights
CytoSorbents' new regulatory strategy for DrugSorb-ATR shows promise despite prior FDA denial, with potential approval by mid-2026.
This regulatory update reveals meaningful progress for CytoSorbents' DrugSorb-ATR, a Breakthrough Device designed to remove ticagrelor from blood during urgent cardiac surgery. After receiving an FDA denial on their original De Novo application, the company has strategically opted not to pursue a final appeal, instead choosing a potentially expedited path forward based on constructive feedback from FDA upper management.
The FDA found no safety issues with DrugSorb-ATR but required additional information for the desired label indication. Critically, CytoSorbents now plans to include new real-world data from patients on ticagrelor undergoing urgent CABG surgery – data unavailable during their original submission. This approach strengthens their position since this real-world population matches their intended use case.
The regulatory timeline appears reasonable: a pre-submission meeting request next month, formal FDA meeting in Q4 2025, followed by the new De Novo submission, with a potential decision by mid-2026. The FDA's willingness to focus only on remaining open items from the initial submission (not safety concerns) and maintain the product's Breakthrough Device status for priority review suggests a more streamlined path.
Regarding Canada, CytoSorbents has withdrawn their reconsideration request with Health Canada, planning to resubmit after gaining clarity from the FDA process – a sensible sequencing of regulatory efforts. While continuing this regulatory work, management emphasizes their focus on core business growth, margin improvement, and cost control, targeting near breakeven as they exit 2025.
On August 20, 2025, the Company announced that it had received a
The Company recently completed a constructive meeting with the FDA to review the content of the appeal decision and to align on a path forward, with several key outcomes.
- The Company has decided to not file a final appeal with CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the Company's original desired label indication.
- Based on this updated feedback, the Company plans to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication. This information was not available at the time of the original De Novo submission a year ago and therefore was not part of the administrative record, nor technically eligible to be submitted and reviewed, for the appeal meeting and decision. The Company believes these new real-world data, drawn from a population consistent with the intended DrugSorb-ATR use population (patients on ticagrelor undergoing urgent coronary artery bypass graft [CABG] surgery), reiterate the device's robust clinical performance in everyday medical practice. Combined with the previously submitted clinical data on DrugSorb-ATR, the Company believes it further strengthens the favorable benefit-to-risk profile on which De Novo devices are evaluated.
- Based on discussions with the FDA, it is the Company's understanding that the review of the new submission will focus only on the remaining open items from the initial De Novo submission. Again, the FDA found no safety issues in its prior review. The Company expects the new application to be reviewed in an expedited fashion under the auspices of the Breakthrough Device Designation previously granted for the device, which provides for priority and interactive review.
- As part of the resubmission process, the Company plans to file a pre-submission meeting request with supporting documentation to the FDA next month. A formal meeting with the Agency is anticipated in Q4 2025 to confirm the requirements for the new De Novo submission. Notwithstanding expected opportunities to accelerate the timeline, a standard regulatory decision is expected in mid-2026 following a timely De Novo submission and a typical 150-day review process.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "We are encouraged by the continued constructive dialogue with the FDA to define a clear and expedited path forward. We plan to move as quickly as possible to have our pre-submission meeting with the FDA to finalize alignment and to file our new De Novo application, which is expected to heavily leverage our original filing. We continue to have confidence in the performance and clinical value of DrugSorb-ATR for this major unmet medical need and the importance of making this FDA Breakthrough Designated Device available to the American public."
Additionally, the Company had previously disclosed that it had filed a Level 1 "Request For Reconsideration" with Health Canada. However, following interactive discussions with the Medical Devices Directorate Bureau Director and the Company's Canadian regulatory counsel, it was recommended that any subsequent review of DrugSorb-ATR in
Dr. Chan continued, "We remain committed to working collaboratively with both the FDA and Health Canada to secure marketing authorization for DrugSorb-ATR. Meanwhile, we continue to be focused on driving growth in our core business with key, high impact clinical applications, improving product gross margins, controlling costs, and driving efficiencies to manage our core business to near breakeven as we exit 2025."
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 extracorporeal 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 to reduce inflammatory cytokines. 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. The company is actively pursuing regulatory approval of DrugSorb-ATR with the
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 ability to successfully obtain
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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FAQ
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