CTSO: CytoSorbents Announces Submission of DrugSorb-ATR Application to the FDA [Yahoo! Finance]
Cytosorbents Corporation (CTSO)
Last cytosorbents corporation earnings: 11/5 04:15 pm
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Source: Yahoo! Finance
On October 1, 2024, CytoSorbents (NASDAQ:CTSO) announced 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. The goal of this product is to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) who are 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 which makes it eligible for priority review. Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “ 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. “We are very proud of our dedicated Cyt
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News
- CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP CertificationGlobeNewswire
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive ReviewGlobeNewswire
- CytoSorbents to Report Third Quarter 2024 Operating and Financial ResultsGlobeNewswire
CTSO
Earnings
- 8/13/24 - Beat
CTSO
Analyst Actions
- 8/14/24 - HC Wainwright
CTSO
Sec Filings
- 10/8/24 - Form 4
- 10/8/24 - Form 4
- 10/1/24 - Form 8-K
- CTSO's page on the SEC website