FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Cytosorbents Corporation (CTSO)
Last cytosorbents corporation earnings: 11/5 04:15 pm
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Source: GlobeNewswire
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.
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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
- CytoSorbents to Report Third Quarter 2024 Operating and Financial ResultsGlobeNewswire
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
CTSO
Earnings
- 8/13/24 - Beat
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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