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Cytosorbents Corporation develops blood purification technologies for life-threatening conditions in intensive care and cardiac surgery. Its lead product, CytoSorb®, is approved in the European Union, distributed internationally, and used for cytokine adsorption and CE-marked applications that include bilirubin, myoglobin, ticagrelor, and rivaroxaban removal; in the United States it has FDA Emergency Use Authorization for adult critically ill COVID-19 patients with respiratory failure and is not otherwise approved or cleared.
Company updates commonly address quarterly and annual results, gross margin and balance-sheet actions, product launches such as HotSwap™, distribution partnerships, clinical evidence for CytoSorb therapy, and regulatory work around the investigational DrugSorb®-ATR antithrombotic removal system. The product portfolio also includes ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, ContrastSorb, PuriFi®, and related blood purification technologies.
CytoSorbents Corporation (NASDAQ: CTSO) has achieved a significant milestone, delivering over 100,000 CytoSorb cartridges globally to treat critical conditions such as sepsis and inflammation. The technology is now utilized in 65 countries and has successfully treated tens of thousands of patients. CytoSorb is recognized for its ability to mitigate cytokine storms, a severe immune response, and has received FDA Emergency Use Authorization for COVID-19 patients. The company highlights its commitment to innovation and collaboration in critical care medicine.
CytoSorbents Corporation (NASDAQ: CTSO) received a three-year contract worth up to $4.42 million from the U.S. Department of Defense to advance the HemoDefend™-BGA plasma and whole blood adsorber. The aim is to develop 'universal plasma' for transfusions, enhancing safety by removing anti-A and anti-B antibodies. This award supports prior funding of $2.9 million for preclinical development and aims for FDA investigational device exemption approval. The technology could significantly improve blood product availability, benefiting both military and civilian patients.
CytoSorbents Corporation (NASDAQ: CTSO) announced a positive outcome from the Data Monitoring Committee (DMC) of the REFRESH 2-AKI trial, recommending the resumption of the study following a favorable safety data review. The trial had been paused due to a previous DMC request for additional clinical data. With safety analysis of 153 patients considered unremarkable, the company is set to continue the trial with minor modifications. The success in collaboration with a new contract research organization amid COVID-19 challenges highlights potential growth in cardiac surgery applications for its CytoSorb technology.
CytoSorbents Corporation (CTSO) will release its Q2 2020 financial results on August 4, 2020, after market close. Management will host a live conference call for operational and financial updates on the same day at 4:45 PM Eastern. CytoSorb® technology, designed for treating deadly inflammation in critically ill patients, is approved in the EU and has been utilized in over 98,000 treatments globally. The company has received substantial funding exceeding $37 million from various U.S. governmental agencies to support its innovative blood purification technologies.
CytoSorbents Corporation (Nasdaq: CTSO) announced the pricing of a public offering of 5,263,158 shares at $9.50 per share, generating gross proceeds of approximately $50 million. The offering's closure is expected on July 24, 2020, pending customary conditions. The funds will be used for general corporate purposes, including expansion in manufacturing, research and development, and clinical studies. The underwriters also have a 30-day option to purchase an additional 789,473 shares. Cowen and SVB Leerink are the joint book-running managers for this offering.
CytoSorbents Corporation (NASDAQ: CTSO) reported preliminary financial results for Q2 2020 with a total revenue of approximately $9.8 million, marking a 58% increase from $6.2 million in Q2 2019. Product revenues reached $9.5 million, up 61% year-over-year and 16% sequentially. The company generated about $667,000 in U.S. hospital sales for COVID-19 patients. Cash balance stood at $35.1 million. CytoSorb has now been used in over 98,000 treatments worldwide.
CytoSorbents Corporation (Nasdaq: CTSO) has announced a proposed public offering of $40 million in common stock. The offering may include a 30-day option for underwriters to purchase an additional 15% of the shares sold. Proceeds will be allocated for general corporate purposes, including expanding manufacturing, R&D, and clinical studies, as well as supporting sales and marketing efforts. The offering is subject to market conditions, and the company cautions that actual completion and size may differ.
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CytoSorbents Corporation (NASDAQ:CTSO) announced a Key Opinion Leader call scheduled for July 13, 2020, at 11:00 AM EDT, focusing on the use of CytoSorb technology to safely remove antithrombotic medications from patients at risk of bleeding during surgery. Notable speakers include Dr. Michael Gibson from Harvard University, Dr. Robert Storey from the University of Sheffield, and Prof. Michael Schmoeckel from Hamburg, Germany. The discussion will address the importance of managing patients on blood thinners to prevent life-threatening perioperative bleeding.
CytoSorbents Corporation (NASDAQ: CTSO) has announced the commercial launch of its CytoSorb blood purification technology in nine Latin American countries, including Colombia, Argentina, and Peru, amidst rising COVID-19 cases. The product helps treat dangerous inflammation in critically-ill patients and is now available in 65 countries globally. The launch is timely; Latin America reports over 2.1 million COVID-19 cases and a mortality rate of 4.6%. With the ongoing pandemic, CytoSorb is expected to play a crucial role in addressing cytokine storm complications in COVID-19 patients.