FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
CytoSorbents (NASDAQ: CTSO) announced that the FDA has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. DrugSorb-ATR aims to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft (CABG) surgery. The device has received FDA Breakthrough Device Designation, making it eligible for priority review.
The company anticipates an FDA decision in 2025. The application is based on data from the 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial. CytoSorbents believes DrugSorb-ATR will allow patients to proceed with CABG surgery safely and timely, avoiding the current 3-5 day delay recommended for ticagrelor washout. The company also plans to submit DrugSorb-ATR for Health Canada Medical Device Licensure.
CytoSorbents (NASDAQ: CTSO) ha annunciato che la FDA ha accettato la sua domanda di dispositivo medico De Novo per il DrugSorb™-ATR e ha avviato una revisione sostanziale. DrugSorb-ATR mira a ridurre la gravità del sanguinamento perioperatorio nei pazienti trattenuti a ticagrelor che si sottopongono a chirurgia di bypass coronarico (CABG). Il dispositivo ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA, rendendolo idoneo per una revisione prioritaria.
La compagnia prevede una decisione da parte della FDA nel 2025. La domanda si basa su dati provenienti dallo studio pivotale STAR-T, randomizzato, in doppio cieco e controllato con placebo su 140 pazienti in Nord America. CytoSorbents crede che DrugSorb-ATR consentirà ai pazienti di affrontare la chirurgia CABG in modo sicuro e tempestivo, evitando l'attuale ritardo di 3-5 giorni raccomandato per il washout di ticagrelor. La società prevede inoltre di presentare DrugSorb-ATR per l'Autorizzazione all'Uso di Dispositivi Medici in Canada.
CytoSorbents (NASDAQ: CTSO) anunció que la FDA ha aceptado su solicitud de dispositivo médico De Novo para DrugSorb™-ATR y ha iniciado una revisión sustantiva. DrugSorb-ATR tiene como objetivo reducir la gravedad del sangrado perioperatorio en pacientes con ticagrelor que se someten a cirugía de bypass de arteria coronaria (CABG). El dispositivo ha recibido la Designación de Dispositivo Innovador de la FDA, lo que lo hace elegible para una revisión prioritaria.
La compañía anticipa una decisión de la FDA en 2025. La solicitud se basa en datos de un ensayo pivotal randomizado, doble ciego y controlado con placebo STAR-T de 140 pacientes en América del Norte. CytoSorbents cree que DrugSorb-ATR permitirá a los pacientes someterse a la cirugía CABG de manera segura y oportuna, evitando el retraso actual de 3-5 días recomendado para el lavado de ticagrelor. La compañía también planea presentar DrugSorb-ATR para la Licencia de Dispositivos Médicos de Salud Canada.
CytoSorbents (NASDAQ: CTSO)는 FDA가 DrugSorb™-ATR의 De Novo 의료기기 신청을 수락하고 본격적인 검토에 들어갔다고 발표했습니다. DrugSorb-ATR는 티카그렐로르를 복용 중인 환자에서 관상동맥 우회로 수술(CABG) 시 수술 전 출혈의 심각성을 줄이는 것을 목표로 합니다. 이 장치는 FDA 혁신 기기 지정을 받았으며, 우선 검토를 받을 수 있습니다.
회사는 2025년까지 FDA의 결정을 예상하고 있습니다. 이 신청은 북미에서 140명의 환자를 대상으로 한 STAR-T 무작위 double-blind 가짜 대조군 시험의 데이터를 기반으로 하고 있습니다. CytoSorbents는 DrugSorb-ATR가 환자들이 CABG 수술을 안전하고 적시에 진행할 수 있도록 하여, 티카그렐로르의 세척을 위한 현재의 3-5일 지연을 피할 수 있게 할 것이라고 믿고 있습니다. 이 회사는 또한 DrugSorb-ATR을 캐나다 보건 당국의 의료 기기 라이센스 신청을 위해 제출할 계획입니다.
CytoSorbents (NASDAQ: CTSO) a annoncé que la FDA a accepté sa demande de dispositif médical De Novo pour le DrugSorb™-ATR et a entamé un examen substantiel. DrugSorb-ATR vise à réduire la gravité des saignements périopératoires chez les patients sous ticagrelor qui subissent une chirurgie de pontage coronarien (CABG). Le dispositif a reçu la désignation de dispositif révolutionnaire de la FDA, ce qui le rend éligible pour un examen prioritaire.
L'entreprise prévoit une décision de la FDA en 2025. La demande est basée sur des données provenant de l'essai pivot randomisé, en double aveugle et contrôlé par placebo STAR-T impliquant 140 patients en Amérique du Nord. CytoSorbents pense que le DrugSorb-ATR permettra aux patients de procéder à la chirurgie CABG de manière sécurisée et en temps opportun, évitant le délai actuel de 3 à 5 jours recommandé pour le washout de ticagrelor. L'entreprise prévoit également de soumettre le DrugSorb-ATR pour l'autorisation de dispositif médical au Canada.
CytoSorbents (NASDAQ: CTSO) gab bekannt, dass die FDA seinen De Novo-Antrag für das medizinische Gerät DrugSorb™-ATR akzeptiert hat und eine substanzielle Überprüfung eingeleitet hat. DrugSorb-ATR zielt darauf ab, die Schwere perioperativer Blutungen bei Patienten, die Ticagrelor erhalten, die sich einer koronaren Bypass-Operation (CABG) unterziehen, zu reduzieren. Das Gerät hat von der FDA die Auszeichnung als Durchbruchgerät erhalten, was ihm Anspruch auf eine bevorzugte Überprüfung verleiht.
Das Unternehmen erwartet eine Entscheidung der FDA im Jahr 2025. Der Antrag basiert auf Daten aus der 140-Patienten umfassenden nordamerikanischen entscheidenden STAR-T randomisierten, doppelblinden, placebo-kontrollierten Studie. CytoSorbents ist der Ansicht, dass DrugSorb-ATR es den Patienten ermöglichen wird, sicher und rechtzeitig eine CABG-Operation durchzuführen und die derzeit empfohlene 3-5-tägige Verzögerung für das Absetzen von Ticagrelor zu vermeiden. Das Unternehmen plant außerdem, DrugSorb-ATR für die Lizenzierung von Medizinprodukten bei Health Canada einzureichen.
- FDA acceptance of De Novo application for DrugSorb-ATR
- FDA Breakthrough Device Designation granted, enabling priority review
- Potential to reduce perioperative bleeding in CABG patients on ticagrelor
- Completed 140-patient STAR-T pivotal trial for safety and efficacy data
- Planned submission for Health Canada Medical Device Licensure
- FDA decision not expected until 2025
- DrugSorb-ATR still an investigational medical device, not yet approved
Insights
The FDA's acceptance of CytoSorbents' De Novo application for DrugSorb-ATR is a significant milestone for the company. This device aims to address a critical issue in cardiac surgery by reducing bleeding complications in patients on ticagrelor undergoing CABG. Key points to consider:
- DrugSorb-ATR has Breakthrough Device Designation, indicating its potential to provide more effective treatment for a life-threatening condition.
- The De Novo pathway suggests the device is novel and potentially first-in-class, which could give CytoSorbents a competitive advantage.
- An FDA decision is expected in 2025, providing a clear timeline for potential market entry.
- The STAR-T trial with 140 patients forms the basis of the application, demonstrating the company's commitment to clinical evidence.
If approved, DrugSorb-ATR could significantly impact patient care by allowing timely CABG surgeries without the current 3-5 day delay, potentially reducing hospital stays and associated costs. This could translate to substantial market opportunity for CytoSorbents, especially considering the frequency of CABG procedures and ticagrelor use.
The FDA's acceptance of CytoSorbents' De Novo application for DrugSorb-ATR is a positive development for the company's financial outlook. Key financial implications include:
- Market Potential: With a
$54.4 million market cap, approval could significantly expand CytoSorbents' market opportunity in the lucrative cardiac surgery space. - Revenue Growth: If approved, DrugSorb-ATR could drive substantial revenue growth, potentially transforming the company's financial profile.
- Competitive Advantage: As a potential first-in-class device, it could command premium pricing and capture market share rapidly.
- Cost Savings: By reducing hospital stays and complications, the device could offer significant cost savings to healthcare systems, enhancing its adoption potential.
Investors should monitor the FDA review process closely, as approval could be a major catalyst for the stock. However, it's important to note that the relatively small market cap suggests high risk-reward potential and any setbacks in the approval process could have a significant negative impact on the stock price.
DrugSorb™-ATR is an FDA Breakthrough Device eligible for priority review with an FDA decision anticipated in 2025
PRINCETON, N.J., Oct. 22, 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 U.S. Food and Drug Administration (FDA) has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. The goal of DrugSorb-ATR, an investigational medical device, is to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery.
The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company anticipates an FDA decision in 2025.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “We are pleased to achieve this important milestone and to enter the substantive review phase with FDA of our De Novo application. We believe DrugSorb-ATR represents a breakthrough solution that will allow patients to proceed with their much-needed CABG surgery in a safe and timely manner rather than risking serious, potentially life-threatening complications and consuming costly hospital resources while waiting in the hospital for multiple days for ticagrelor to be naturally eliminated from their system. We are committed to working closely with FDA throughout the review process.”
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. These safety and efficacy data in CABG patients from STAR-T form the basis of our marketing approval submission.
CytoSorbents also expects to submit DrugSorb-ATR for Health Canada Medical Device Licensure soon for this same purpose, pending the expected receipt of MDSAP certification.
About the U.S. and Canadian Regulatory Pathways
The U.S. FDA De Novo process for medical devices provides a marketing pathway to classify novel medical devices for which special controls are established to provide reasonable assurance of safety and effectiveness but for which there is no legally marketed predicate device. Following application acceptance by FDA, De Novo submissions enter the substantive review phase where the FDA Breakthrough Device designation and an associated interactive priority review, can accelerate the process.
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, which the Company expects to receive shortly, at which point it will file its MDL application.
Final regulatory decisions on DrugSorb-ATR are expected from FDA and Health Canada in 2025. DrugSorb-ATR is not yet granted or approved in the U.S. or Canada, respectively.
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. Two important ones 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. The Company expects to submit its completed Health Canada Medical Device License (MDL) application, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near future. 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
What is the purpose of DrugSorb-ATR for CABG patients on ticagrelor (CTSO)?
When does CytoSorbents (CTSO) expect an FDA decision on DrugSorb-ATR?
What clinical trial supports CytoSorbents' (CTSO) DrugSorb-ATR application?
How might DrugSorb-ATR benefit CABG patients on ticagrelor (CTSO)?
