Tag: CytoSorbents

CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance

Preliminary third quarter 2021 total revenue was $9.7 million, including product sales of $8.9 million. Preliminary core non-COVID-19 product sales increased 4% Y-Y to approximately $7.8 million. MONMOUTH JUNCTION, N.J., Oct. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood […]

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

MONMOUTH JUNCTION, N.J., Sept. 10, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the filing of an Investigational Device Exemption (IDE) application to gain FDA approval to conduct the clinical study, “Safe and Timely Antithrombotic Removal […]

CytoSorbents Reports Second Quarter 2021 Financial and Operational Results

Total revenue increased 23% to $12.0 million. Core non-COVID-19 product sales increased 38% Y-Y, driving overall Q2 2021 product sales to $11.4 million versus $9.5 million a year ago MONMOUTH JUNCTION, N.J., Aug. 3, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery […]

CytoSorbents Receives Full FDA Approval of Investigational Device Exemption (IDE) for U.S. STAR-T Trial on Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., July 6, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized, controlled trial (RCT) in the United States to support FDA regulatory clearance.  This study is being performed under the previously announced FDA Breakthrough […]

CytoSorbents Awarded $1.5 Million Sequential Phase II SBIR Contract to Advance the Treatment of Severe Hyperkalemia in Traumatic Injury

MONMOUTH JUNCTION, N.J., May 11, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader commercializing its CytoSorb® and other blood purification technologies to treat deadly conditions in critically-ill and cardiac surgery patients around the world, announced the U.S Army Medical Research and Development Command has awarded CytoSorbents a Defense Health Agency (DHA) Sequential Phase […]

U.S. FDA Approves CytoSorbents to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., April 19, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for […]

CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for U.S. Trial on Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., March 16, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, “Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T),” in the United States to support an initial FDA regulatory approval.  This is being done under the previously announced FDA Breakthrough Designation granted for the removal of […]

CytoSorbents Announces 2020 Financial and Operational Results

2020 Total Revenue was $41.0 million, with 2020 Product Sales of $39.5 million, up 73% over 2019. Achieved record Product Gross Margins of 82% for Q4 2020 MONMOUTH JUNCTION, N.J., March 9, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill […]

CytoSorbents Appoints David D. Cox, PhD, MBA as Vice President – Global Regulatory Affairs

David D. Cox, PhD, MBA, seasoned regulatory professional, tapped to lead CytoSorbents global regulatory initiatives and U.S. FDA approval of CytoSorb MONMOUTH JUNCTION, N.J., Jan. 21, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the […]

CytoSorbents Pays Off $15M Term Loans and Establishes New Undrawn $15M Loan Commitment with Bridge Bank

Eliminates long-term debt with flexibility of a new term loan commitment to fund future expansion, if needed MONMOUTH JUNCTION, N.J., Dec. 10, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces it has […]