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CytoSorbents Corp.

Aferetica, CytoSorbents gain EU nod for organ perfusion system

October 14, 2020 By Nancy Crotti

CytoSorbents (NSDQ:CTSO) and Aferetica today announced the European Union approval of Aferetica’s PerLife integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Italian startup Aferetica designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and organ rejection. […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance, Transplants, Wall Street Beat Tagged With: Aferetica srl, CE Mark, CytoSorbents Corp.

CytoSorbents wins $1.1M DoD contract for universal plasma

October 9, 2020 By Sean Whooley

CytoSorbents (OTC:CTSO) announced today that the U.S. Army has awarded it a $1.1 million contract to develop its HemoDefend-BGA adsorber. HemoDefend-BGA can rapidly remove more than 99% of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity, according to […]

Filed Under: Blood Management, Business/Financial News, Clinical Trials, Featured, Funding Roundup Tagged With: CytoSorbents Corp., U.S. Army, U.S. Department of Defense

Cytosorbents announces $40m offering

July 21, 2020 By Sean Whooley

CytoSorbents (OTC:CTSO) announced that it commenced an underwritten public offering of shares of its common stock worth $40 million. Monmouth Junction, N.J.-based CytoSorbents intends to grant underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering as well, according to a […]

Filed Under: Business/Financial News, Cardiovascular, Funding Roundup Tagged With: CytoSorbents Corp.

FDA grants breakthrough designation to CytoSorb blood purification tech

April 21, 2020 By Sean Whooley

CytoSorbents (OTC:CTSO) announced that it received FDA breakthrough device designation for its CytoSorb blood purification technology for use during emergent and urgent cardiothoracic surgery. Monmouth Junction, N.J.-based CytoSorbents designed its CytoSorb technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients. The FDA breakthrough nod is for the use of CytoSorb for […]

Filed Under: Blood Management, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: CytoSorbents Corp., FDA

FDA grants EUA for CytoSorb blood purification technology

April 13, 2020 By Sean Whooley

CytoSorbents (OTC:CTSO) announced today that it received FDA emergency use authorization (EUA) for use of its CytoSorb blood purification technology in COVID-19 patients. With the authorization, Monmouth Junction, N.J.-based CytoSorbants is entitled to make CytoSorb commercially available to all U.S. hospitals for coronavirus patients aged 18 and older who are admitted to the intensive care unit […]

Filed Under: Blood Management, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, CytoSorbents Corp.

COVID-19 test development surges with pandemic

March 16, 2020 By Nancy Crotti

Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a  diagnostic test that certain U.S. laboratories […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Featured, Hospital Care, Patient Monitoring, Research & Development, Respiratory Tagged With: Advaite, becton dickinson, coronavirus, CytoSorbents Corp., EarlySense, Mayo Clinic, PreCheck Health Services, Rapid Dx for Life, Surgisphere, Thermo Fisher Scientific, Vikor Scientific

Safety board OKs continuation of CytoSorbents endocarditis trial

February 6, 2019 By Fink Densford

CytoSorbents (OTC:CTSO) said this week it the Data Safety Monitoring Board of its REMOVE trial gave the company the green light to continue the study after analyzing data from the first 50 patients. The German gov’t-funded randomized, controlled, multi-center 250-patient REMOVE trial, which was launched in late 2017, looked to explore the safety and efficacy of […]

Filed Under: Blood Management, Clinical Trials, Regulatory/Compliance Tagged With: CytoSorbents Corp.

Feds give CytoSorbents’ blood filter a shot at $3 million

August 22, 2018 By Nancy Crotti

CytoSorbents (NASDAQ: CTSO)  said it has won another round of funding from the U.S. government to commercialize its HemoDefend red blood cell (RBC) transfusion filter. The critical-care immunotherapy company, based in Monmouth Junction, N.J., specializes in blood purification. The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health, granted the three-year, Phase IIB […]

Filed Under: Blood Management Tagged With: and Blood Institute NHLBI, CytoSorbents Corp., National Institutes of Health (NIH)

Could this system make more kidneys, livers usable for transplant?

July 10, 2018 By Nancy Crotti

An Italian startup has teamed with critical-care immunotherapy company CytoSorbents Corporation (NASDAQ: CTSO) on an integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Aferetica srl (Mirandola, Italy) designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and […]

Filed Under: Transplants Tagged With: Aferetica srl, CytoSorbents Corp.

7 medtech stories we missed this week: June 15, 2018

June 15, 2018 By Danielle Kirsh

From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]

Filed Under: 510(k), Contract Manufacturing, Diagnostics, Digital Health, Food & Drug Administration (FDA), Hospital Care, Implants, Neuromodulation/Neurostimulation, Orthopedics, Regulatory/Compliance, Spine, Surgical Tagged With: Centinel Spine LLC, CytoSorbents Corp., dyansys, Globus Medical, MedTech, Optovue, Prescient Surgical, summitmedical

CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial

December 13, 2017 By Fink Densford

CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis. The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative […]

Filed Under: Blood Management, Business/Financial News, Cardiovascular, Clinical Trials Tagged With: CytoSorbents Corp.

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