Home > Boards > US Listed > Medical - Equipment > Cytosorbents Corporation (CTSO)

Easy question pearsby. We just need FDA approval

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
biotech48 Member Profile
 
Followed By 1
Posts 567
Boards Moderated 0
Alias Born 03/22/12
160x600 placeholder
Statement of Changes in Beneficial Ownership (4) Edgar (US Regulatory) - 11/26/2021 6:11:44 PM
CytoSorbents to Present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum and Jefferies London Healthcare Conference PR Newswire (US) - 11/15/2021 4:30:00 PM
Cytosorbents EPS misses by $0.03, beats on revenue Seeking Alpha - 11/4/2021 4:29:11 PM
Quarterly Report (10-q) Edgar (US Regulatory) - 11/4/2021 4:15:41 PM
CytoSorbents Reports Full Third Quarter 2021 Financial and Operational Results PR Newswire (US) - 11/4/2021 4:15:00 PM
Cytosorbents Q3 2021 Earnings Preview Seeking Alpha - 11/3/2021 5:35:41 PM
CytoSorbents Comments on REMOVE Study Presentation PR Newswire (US) - 10/20/2021 7:05:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 10/15/2021 6:26:17 AM
First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery PR Newswire (US) - 10/14/2021 7:05:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 10/13/2021 7:01:40 AM
CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery PR Newswire (US) - 10/12/2021 4:38:00 PM
CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance PR Newswire (US) - 10/12/2021 4:35:00 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 10/8/2021 7:31:48 AM
CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference PR Newswire (US) - 10/7/2021 3:11:00 PM
Merus, Nutriband leads healthcare gainers; Osmotica Pharmaceuticals, Prelude Therapeutics among major losers Seeking Alpha - 10/7/2021 10:59:16 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 9/14/2021 5:01:28 PM
CytoSorbents to Host International Webinar on the Worldwide Experience Using CytoSorb® in Critically Ill Patients with COVID-19 PR Newswire (US) - 9/14/2021 9:25:00 AM
CytoSorbents Commemorates World Sepsis Day and Sepsis Awareness Month with Key Sepsis-Related Events, Sponsorships and Studies PR Newswire (US) - 9/13/2021 7:08:00 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 9/10/2021 4:33:48 PM
CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery PR Newswire (US) - 9/10/2021 7:08:00 AM
CytoSorbents Announces Webinar Discussing Topline Results from the U.S. CTC Registry using CytoSorb® in Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO) PR Newswire (US) - 9/8/2021 4:15:00 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 9/1/2021 5:28:08 PM
SKLZ, RUN and AMBA among pre market gainers Seeking Alpha - 9/1/2021 8:19:50 AM
Topline Results from CytoSorbents' U.S. CTC Multicenter Registry Demonstrate High Survival using CytoSorb® in Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO) PR Newswire (US) - 9/1/2021 7:08:00 AM
CytoSorbents and Aferetica Announce the Commercial Launch in Italy of the PerSorb™ Adsorber and PerLife™ Organ Perfusion System, respectively, at the European Society of Organ Transplantation Congress PR Newswire (US) - 8/30/2021 7:08:00 AM
biotech48   Saturday, 09/25/21 11:15:20 AM
Re: kjpcrna post# 26714
Post # of 26888 
Easy question pearsby. We just need FDA approval after our trials. We are already approved in the EU for the same thing. HemoDefend will be the icing on the cake. "Dr. David Cox, Vice President of Global Regulatory Affairs of CytoSorbents remarked, “The U.S. Prescribing Information for apixaban and rivaroxaban, two leading DOACs taken to reduce the risk of blood clots and associated complications, clearly warns that dosing should be stopped prior to a surgical procedure to reduce the risk of bleeding. Unfortunately, in unexpected urgent cardiothoracic surgery, this is often not possible, posing the risk of life-threatening bleeding in these patients. We are pleased that the FDA has recognized the potential of our DrugSorb-ATR Antithrombotic Removal System to reduce levels of these drugs in a patient’s blood, potentially decreasing the risk of life-threatening perioperative bleeding. The achievement of two Breakthrough Designations in these situations where no approved or cleared alternatives exist is a major Company milestone that is expected to expedite our regulatory and clinical goals.”

Public Reply | Private Reply | Keep | Last ReadPost New MsgReplies (1) | Next 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist
Consent Preferences