CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Business Update
CytoSorbents (NASDAQ: CTSO) has submitted a De Novo marketing application to the U.S. FDA for DrugSorb™-ATR, a device designed to reduce bleeding severity in heart bypass surgery patients on ticagrelor. The application, submitted on September 27, 2024, is eligible for FDA priority review due to its Breakthrough Device Designation. CytoSorbents is also preparing to submit a Medical Device License application to Health Canada, pending MDSAP certification.
The submission is based on data from the 140-patient North American STAR-T trial, which evaluated DrugSorb-ATR's safety and efficacy in removing ticagrelor and reducing perioperative bleeding complications in urgent CABG surgery patients. FDA and Health Canada decisions are expected in 2025. This milestone represents years of clinical, regulatory, and manufacturing efforts by CytoSorbents and its collaborators.
CytoSorbents (NASDAQ: CTSO) ha presentato una domanda di marketing De Novo alla FDA degli Stati Uniti per il dispositivo DrugSorb™-ATR, progettato per ridurre la gravità delle emorragie nei pazienti sottoposti a chirurgia di bypass cardiaco in terapia con ticagrelor. La domanda, presentata il 27 settembre 2024, è idonea per la revisione prioritaria da parte della FDA grazie alla sua Designazione di Dispositivo Innovativo. CytoSorbents si sta anche preparando a presentare una richiesta di licenza per dispositivi medici a Health Canada, in attesa della certificazione MDSAP.
La presentazione si basa su dati ottenuti dallo studio STAR-T, condotto su 140 pazienti in Nord America, che ha valutato la sicurezza e l'efficacia di DrugSorb-ATR nell'eliminazione del ticagrelor e nella riduzione delle complicanze emorragiche perioperatorie nei pazienti sottoposti a chirurgia CABG urgente. Le decisioni della FDA e di Health Canada sono attese nel 2025. Questo traguardo rappresenta anni di sforzi clinici, regolatori e di produzione da parte di CytoSorbents e dei suoi collaboratori.
CytoSorbents (NASDAQ: CTSO) ha presentado una solicitud de marketing De Novo a la FDA de EE. UU. para DrugSorb™-ATR, un dispositivo diseñado para reducir la gravedad de las hemorragias en pacientes de cirugía de bypass cardíaco tratados con ticagrelor. La solicitud, presentada el 27 de septiembre de 2024, es elegible para revisión prioritaria por parte de la FDA gracias a su Designación de Dispositivo Innovador. CytoSorbents también se está preparando para presentar una solicitud de licencia de dispositivo médico a Health Canada, a la espera de la certificación MDSAP.
La presentación se basa en datos del ensayo norteamericano STAR-T, que evaluó la seguridad y eficacia de DrugSorb-ATR para eliminar ticagrelor y reducir las complicaciones hemorrágicas perioperatorias en pacientes de cirugía CABG urgente. Se esperan decisiones de la FDA y de Health Canada en 2025. Este hito representa años de esfuerzos clínicos, regulatorios y de fabricación por parte de CytoSorbents y sus colaboradores.
CytoSorbents (NASDAQ: CTSO)는 미국 FDA에 DrugSorb™-ATR에 대한 De Novo 마케팅 신청서를 제출했습니다. 이 장치는 티카그렐러를 투여받고 있는 심장 우회 수술 환자의 출혈 심각성을 줄이기 위해 설계되었습니다. 2024년 9월 27일에 제출된 이 신청서는 혁신적인 의료기기 지정으로 인해 FDA 우선 리뷰 대상입니다. CytoSorbents는 또한 MDSAP 인증을 기다리는 상태에서 Health Canada에医療기기 라이센스 신청서를 제출할 준비를 하고 있습니다.
이 제출은 140명의 환자를 대상으로 한 북미 STAR-T 시험 데이터를 기반으로 하며, DrugSorb-ATR의 안전성과 유효성을 평가하여 긴급 CABG 수술 환자에서 티카그렐러를 제거하고 수술 전후 출혈 합병증을 줄였습니다. FDA와 Health Canada의 결정은 2025년으로 예상됩니다. 이 이정표는 CytoSorbents와 그 협력사들의 수년간의 임상, 규제 및 제조 노력을 나타냅니다.
CytoSorbents (NASDAQ: CTSO) a soumis une demande de marketing De Novo à la FDA des États-Unis pour DrugSorb™-ATR, un dispositif conçu pour réduire la sévérité des hémorragies chez les patients subissant une chirurgie de pontage cardiaque sous ticagrelor. La demande, soumise le 27 septembre 2024, est éligible à un examen prioritaire de la FDA en raison de sa désignation de dispositif innovant. CytoSorbents prépare également la soumission d'une demande de licence de dispositif médical à Santé Canada, en attente de la certification MDSAP.
Cette soumission est basée sur des données provenant de l'essai STAR-T mené sur 140 patients en Amérique du Nord, qui a évalué la sécurité et l'efficacité de DrugSorb-ATR pour éliminer le ticagrelor et réduire les complications hémorragiques périopératoires chez les patients nécessitant une chirurgie de pontage coronarien en urgence. Les décisions de la FDA et de Santé Canada sont attendues en 2025. Ce jalon représente des années d'efforts cliniques, réglementaires et de fabrication de CytoSorbents et de ses collaborateurs.
CytoSorbents (NASDAQ: CTSO) hat einen De Novo-Marketingantrag bei der FDA der USA für DrugSorb™-ATR eingereicht, ein Gerät, das entwickelt wurde, um die Schwere von Blutungen bei Herz-Bypass-Patienten, die Ticagrelor erhalten, zu reduzieren. Der Antrag wurde am 27. September 2024 eingereicht und ist aufgrund seiner Breakthrough Device Designation für eine vorrangige Überprüfung durch die FDA berechtigt. CytoSorbents bereitet auch die Einreichung eines Antrags auf medizinische Gerätezulassung bei Health Canada vor, die auf die MDSAP-Zertifizierung wartet.
Die Einreichung basiert auf Daten aus der nordamerikanischen STAR-T-Studie mit 140 Patienten, die die Sicherheit und Wirksamkeit von DrugSorb-ATR zur Entfernung von Ticagrelor und zur Verringerung perioperativer Blutungskomplikationen bei Patienten einer dringenden CABG-Operation bewertete. Entscheidungen der FDA und von Health Canada werden für 2025 erwartet. Dieser Meilenstein stellt Jahre klinischer, regulatorischer und herstellungsbezogener Anstrengungen von CytoSorbents und seinen Partnern dar.
- Submission of DrugSorb-ATR De Novo marketing application to FDA
- FDA Breakthrough Device Designation makes DrugSorb-ATR eligible for priority review
- Completed Health Canada Medical Device License application ready for submission
- Potential to address a major unmet medical need in CABG surgery patients on ticagrelor
- FDA and Health Canada decisions not expected until 2025
- Health Canada application submission pending MDSAP certification
Insights
The submission of DrugSorb-ATR's De Novo marketing application to the FDA represents a significant milestone for CytoSorbents. This device, designed to reduce bleeding severity in heart bypass patients on ticagrelor, addresses a critical unmet medical need. The FDA's Breakthrough Device Designation and eligibility for priority review could potentially accelerate the approval process.
Key points to consider:
- The STAR-T trial's data forms the foundation of this application, involving 140 patients in a rigorous study design.
- FDA and Health Canada decisions are expected in 2025, which could open significant market opportunities.
- The potential approval could reduce surgical delays and associated risks for patients requiring urgent CABG while on ticagrelor.
This development could positively impact CytoSorbents' market position in critical care and cardiac surgery, potentially driving future revenue growth. However, investors should be aware that regulatory approval processes can be unpredictable and success is not guaranteed.
From a financial perspective, this FDA submission is a pivotal event for CytoSorbents. Key financial implications include:
- Market Expansion: Potential FDA approval could open up the lucrative U.S. market, significantly expanding CytoSorbents' addressable market.
- Revenue Growth: If approved, DrugSorb-ATR could become a major revenue driver, especially given the high incidence of CABG surgeries and ticagrelor use.
- Competitive Advantage: Being first-to-market with an FDA-approved solution for this indication could provide a substantial competitive edge.
However, investors should note that the company's current market cap of
- The De Novo medical device application for DrugSorb™-ATR is eligible for FDA priority review as an FDA Breakthrough Designated Device for this indication
- The Health Canada Medical Device License application is ready for submission, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near future
- Expecting FDA and Health Canada decisions in 2025
PRINCETON, N.J., Oct. 01, 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, announces the submission of its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024, to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review.
“The DrugSorb-ATR De Novo submission to FDA is the culmination of multiple years of significant clinical, regulatory, and manufacturing accomplishments company-wide, centered on the execution and data analysis from the U.S. and Canadian pivotal STAR-T randomized controlled trial and the product development of DrugSorb-ATR,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “We are very proud of our dedicated CytoSorbents team and external clinicians, collaborators, and consultants who helped to achieve this major milestone. We look forward to interactions with FDA and the timely review of our application. Meanwhile, we have also completed our DrugSorb-ATR Health Canada Medical Device License (MDL) application, which will be submitted with the expected near-term receipt of MDSAP certification.”
Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering from 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 CABG surgery on ticagrelor to remove the drug and reduce the severity of perioperative bleeding complications compared with patients operated without the device. These safety and efficacy data from STAR-T form the basis of our marketing approval submissions.
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 general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Following application acceptance by FDA, De Novo submissions enter the substantive review phase where FDA Breakthrough Device designation and an associated interactive priority review, called “sprint discussions,” 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 approved or cleared in the U.S. or Canada.
Preliminary, Selected Third Quarter 2024 Financial Results and Business Update
- We estimate that our Q3 2024 Product Sales (excluding grant income) will be in the range of approximately
$8.3 million to$8.5 million , representing growth of7% to10% , versus$7.8 million in Q3 2023. - A planned temporary slowdown in production to rebalance inventory levels coupled with a short-term manufacturing issue resulted in a significantly lower number of CytoSorb devices produced in the quarter. Because of this, we estimate that our product gross margins for Q3 2024 will be in the range of approximately
50% -60% , compared to71% in Q3 2023. The Company believes the short-term manufacturing issue has been resolved and expects a return to more normalized production levels and product gross margins in Q4 2024. The Company continues to have sufficient inventory to meet demand.
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. 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 medical device application to the U.S. FDA requesting marketing approval to remove ticagrelor and reduce the severity of perioperative bleeding in CABG patients on the drug. 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 approved or cleared in the United States and Canada.
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.
Please Click to Follow Us on Facebook and X
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
Investor Relations, ICR-Westwicke
(443) 450-4191
ir@cytosorbents.com
FAQ
What is the purpose of CytoSorbents' DrugSorb-ATR device (CTSO)?
When did CytoSorbents submit the DrugSorb-ATR marketing application to the FDA?
What type of FDA designation has DrugSorb-ATR received for CTSO?
When are FDA and Health Canada decisions expected for CytoSorbents' DrugSorb-ATR (CTSO)?
