- 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
