CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
CytoSorbents has submitted its DrugSorb™-ATR Medical Device License application to Health Canada while receiving Medical Device Single Audit Program (MDSAP) certification. DrugSorb-ATR aims to enable safe and timely coronary artery bypass graft surgery in patients on ticagrelor blood thinner. The submission follows the U.S. FDA De Novo filing, with both regulatory decisions expected in 2025. The 140-patient STAR-T trial data supports these submissions. The device addresses a critical need in Canada, where ticagrelor is the preferred treatment for acute coronary syndrome patients, who currently face 3-5 day surgery delays for drug washout to prevent bleeding complications.
CytoSorbents ha presentato la sua domanda di licenza per il dispositivo medico DrugSorb™-ATR a Health Canada, ricevendo anche la certificazione del Medical Device Single Audit Program (MDSAP). DrugSorb-ATR punta a consentire interventi chirurgici sicuri e tempestivi di bypass coronarico in pazienti in trattamento con il farmaco anticoagulante ticagrelor. La presentazione segue la richiesta De Novo dell'U.S. FDA, con entrambe le decisioni normative attese per il 2025. I dati della prova STAR-T, che coinvolge 140 pazienti, supportano queste presentazioni. Il dispositivo risponde a un bisogno critico in Canada, dove il ticagrelor è il trattamento preferito per i pazienti con sindrome coronarica acuta, i quali attualmente affrontano ritardi chirurgici di 3-5 giorni per l'eliminazione del farmaco, al fine di prevenire complicazioni emorragiche.
CytoSorbents ha presentado su solicitud de licencia para el dispositivo médico DrugSorb™-ATR a Health Canada, mientras recibe la certificación del Programa de Auditoría Única de Dispositivos Médicos (MDSAP). DrugSorb-ATR tiene como objetivo permitir una cirugía de derivación de arteria coronaria segura y oportuna en pacientes que están en tratamiento con el anticoagulante ticagrelor. La presentación sigue la solicitud De Novo ante la FDA de EE. UU., con ambas decisiones regulatorias esperadas para 2025. Los datos del ensayo STAR-T, que involucra a 140 pacientes, respaldan estas presentaciones. El dispositivo aborda una necesidad crítica en Canadá, donde el ticagrelor es el tratamiento preferido para pacientes con síndrome coronario agudo, los cuales enfrentan actualmente demoras quirúrgicas de 3 a 5 días para la eliminación del medicamento y prevenir complicaciones hemorrágicas.
CytoSorbents는 Health Canada에 DrugSorb™-ATR 의료 기기 라이센스 신청서를 제출했으며, 의료 기기 단일 감사 프로그램(MDSAP) 인증을 받았습니다. DrugSorb-ATR는 티카그렐러 항응고제를 사용하고 있는 환자들이 안전하고 시기적절한 관상동맥 우회 수술을 받을 수 있도록 하는 것을 목표로 합니다. 이 신청서는 미국 FDA의 De Novo 제출에 이어지며, 두 가지 규제 결정은 2025년으로 예상됩니다. 140명의 환자가 참여한 STAR-T 시험 데이터는 이러한 제출을 지원합니다. 이 기기는 캐나다에서의 중요한 필요를 충족시키며, 티카그렐러는 급성 관상동맥 증후군 환자에게 선호되는 치료법으로, 현재 이들은 약물 세척을 위한 3-5일의 수술 지연을 겪고 있어 출혈 합병증을 예방하고 있습니다.
CytoSorbents a soumis sa demande de licence de dispositif médical DrugSorb™-ATR à Health Canada tout en obtenant la certification du Programme d’audit unique des dispositifs médicaux (MDSAP). DrugSorb-ATR vise à permettre une chirurgie de pontage coronarien sûre et rapide chez des patients sous anticoagulant ticagrelor. Cette soumission fait suite à l'enregistrement De Novo auprès de la FDA américaine, avec les deux décisions réglementaires attendues en 2025. Les données de l'essai STAR-T impliquant 140 patients soutiennent ces soumissions. Le dispositif répond à un besoin critique au Canada, où le ticagrelor est le traitement préféré pour les patients souffrant de syndrome coronarien aigu, qui font actuellement face à des retards chirurgicaux de 3 à 5 jours pour l'élimination du médicament et pour prévenir les complications hémorragiques.
CytoSorbents hat seinen Antrag auf eine medizinische Gerätezulassung für DrugSorb™-ATR bei Health Canada eingereicht und gleichzeitig die Zertifizierung des Medical Device Single Audit Program (MDSAP) erhalten. DrugSorb-ATR zielt darauf ab, eine sichere und zeitnahe koronare Bypass-Operation bei Patienten zu ermöglichen, die mit dem Blutverdünner Ticagrelor behandelt werden. Der Antrag folgt auf die De Novo-Einreichung bei der US FDA, von der beide regulatorischen Entscheidungen für 2025 erwartet werden. Die Daten der STARD-T-Studie mit 140 Patienten unterstützen diese Einreichungen. Das Gerät adressiert einen kritischen Bedarf in Kanada, wo Ticagrelor die bevorzugte Behandlung für Patienten mit akutem Koronarsyndrom ist, die derzeit mit 3-5-tägigen chirurgischen Verzögerungen für das Absetzen des Medikaments konfrontiert sind, um Blutungskomplikationen zu vermeiden.
- MDSAP certification received, eliminating need for separate FDA inspections
- Regulatory submissions completed in both US and Canadian markets
- Market concentrated in just 20 cardiac surgery centers, enabling efficient commercialization
- Strong Canadian market potential due to ticagrelor's preferential recommendation in treatment guidelines
- Regulatory decisions not expected until 2025
- Product still in investigational phase without current revenue generation
- to specific patient population requiring both CABG surgery and ticagrelor treatment
Insights
The submission of DrugSorb-ATR for Health Canada approval, coupled with MDSAP certification, represents a significant regulatory milestone for CytoSorbents. The device addresses a critical unmet need in cardiac surgery, specifically targeting patients on ticagrelor requiring urgent CABG procedures. The MDSAP certification streamlines regulatory processes across multiple major markets and strengthens the company's quality management credentials.
The Canadian market opportunity is particularly compelling due to ticagrelor's preferred status in national treatment guidelines. With just 20 cardiac surgery centers to target, the concentrated market structure could enable efficient commercialization. The timing advantage of potential Health Canada approval before FDA decision could provide valuable real-world evidence and early revenue generation.
The completed 140-patient STAR-T trial provides the clinical foundation for regulatory submissions. Strong enrollment from Canadian sites suggests high physician interest and validates the market need, potentially supporting rapid adoption if approved.
- Targets the reduction in CABG-related bleeding severity due to the blood thinning drug, ticagrelor – a major unmet medical need in heart attack patients requiring surgery
- Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if required
- Health Canada and U.S. FDA regulatory decisions expected in 2025
PRINCETON, N.J., Nov. 04, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced the submission of its DrugSorb™-ATR Medical Device License (MDL) application to Health Canada on November 1, 2024, concurrent with receipt of its Medical Device Single Audit Program (MDSAP) certification. DrugSorb-ATR, an investigational medical device, targets the ability to allow safe and timely coronary artery bypass graft (CABG) surgery in patients with acute coronary syndromes (ACS) on the blood thinning drug ticagrelor (Brilinta®, AstraZeneca). The Canadian MDL application follows the Company's DrugSorb-ATR U.S. Food and Drug Administration (FDA) De Novo filing which is now under substantive review.
“We are excited to have now submitted DrugSorb-ATR for marketing approval in both the U.S. and Canada. We are also pleased to have received MDSAP certification from our Notified Body, a single audit program that certifies medical device manufacturer compliance of its quality management system with the standard and regulatory requirements of Canada, the United States, Brazil, Japan, and Australia. Successful MDSAP certification is a key regulatory milestone and pre-requisite for filing our MDL application to Health Canada. In addition, U.S. FDA accepts MDSAP certification and audit reports as a substitute for routine Agency inspections, if required,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents.
Dr. Chan continued, “National treatment guidelines in Canada preferentially recommend ticagrelor over other antiplatelet agents, resulting in its near universal adoption in acute coronary syndrome (ACS) treatment protocols. Because of this, a future Health Canada approval of DrugSorb-ATR has the potential to improve the standard of care in heart attack patients requiring CABG surgery by enabling safe and timely surgery while eliminating treatment delays that expose patients to additional risk and consume valuable hospital resources. We believe the high rates of enrollment from Canadian sites in the STAR-T trial have helped to validate the unmet medical need and strong interest in DrugSorb-ATR among cardiac surgeons for this application. Meanwhile, the market for DrugSorb-ATR, if approved, is concentrated in approximately 20 cardiac surgery centers in Canada where we believe our team can quickly launch and support our therapy in this important market. We expect regulatory decisions in 2025, with Health Canada likely preceding FDA.”
Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering a heart attack. If patients are not eligible for a coronary stent, they will often require CABG surgery to restore blood flow to heart muscle. Current guidelines recommend the delay of surgery by three to five days to allow “washout” or natural elimination of the drug to reduce the high risk of serious and potentially fatal perioperative bleeding from the use of the blood thinner. The 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial evaluated the safety and efficacy of DrugSorb-ATR in patients undergoing urgent cardiac surgery on ticagrelor to reduce the severity of perioperative bleeding complications compared with patients operated without the device. The safety and efficacy data in CABG patients from STAR-T form the basis of our marketing approval submissions.
About the Canadian Regulatory Pathway
The Health Canada Medical Device License (MDL) authorizes manufacturers to import or sell Class II, III, and IV medical devices in Canada. The license ensures that these devices meet the necessary safety, quality, and efficacy standards as per the Medical Devices Regulations. MDL requires MDSAP certification.
MDSAP is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions, including Canada and the U.S.
A final regulatory decision on a DrugSorb-ATR MDL is expected from Health Canada in 2025. DrugSorb-ATR is not yet granted or approved in the U.S. or Canada.
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 in the hospital (e.g. dialysis, ECMO, heart-lung machines). 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 in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death. 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 76 countries worldwide, with more than 250,000 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, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved 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 medical device application 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. In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.
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 www.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, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, 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.
U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA
ICR-Westwicke
ir@cytosorbents.com
FAQ
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