CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
CTSO 11.04.2024
About Gravity Analytica
- 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 andU.S. FDA quality management system requirements, replacing FDA audit and inspection if required Health Canada andU.S. FDA regulatory decisions expected in 2025
“We are excited to have now submitted DrugSorb-ATR for marketing approval in both the
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
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
A final regulatory decision on a DrugSorb-ATR MDL is expected from
About
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 forticagrelorandrivaroxabanremoval in cardiothoracic surgery procedures. CytoSorb has also receivedFDA Emergency Use Authorizationin 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
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-XLTM, HemoDefend-RBCTM, HemoDefend-BGATM, VetResQ®, K+ontrolTM, DrugSorbTM, ContrastSorb, and others. For more information, please visit the Company’s website atwww.cytosorbents.comor follow us onFacebookandX.
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
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Source: CytoSorbents