Welcome to our dedicated page for Cytosorbents news (Ticker: CTSO), a resource for investors and traders seeking the latest updates and insights on Cytosorbents stock.
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.
On August 12, 2021, CytoSorbents Corporation (NASDAQ: CTSO) announced that the FDA granted a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System. This designation covers the removal of Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during urgent cardiothoracic surgeries, aiming to reduce life-threatening bleeding risks. This milestone supports the company's U.S. strategy and highlights a potential market exceeding $500 million. The system addresses a significant unmet medical need, especially as the population using these anticoagulants grows.
CytoSorbents Corporation (NASDAQ: CTSO) announced its Q2 2021 results, reporting total revenue of $12.0 million, a 23% increase from $9.8 million in Q2 2020. Core non-COVID-19 product sales surged 38% to a record $9.7 million. Gross profit reached $9.3 million with margins at 82%. The company has FDA approval for the STAR-T trial aimed at gaining marketing approval for its DrugSorb-ATR system. CytoSorbents expects at least 30% year-over-year growth in core product sales for the remainder of 2021, with limited COVID-19-related sales anticipated.
CytoSorbents Corporation (NASDAQ: CTSO) has successfully completed its MISSION 100,000 fundraising campaign, raising $100,000 for the humanitarian organization CARE to combat COVID-19. This initiative coincides with the milestone of shipping over 131,000 CytoSorb® blood purification cartridges, used in treating severe COVID-19 cases. The funds will aid CARE's Crisis Response Campaign, providing vaccination and sanitation efforts globally. CEO Phillip Chan expressed gratitude for support, emphasizing the importance of corporate partnerships in the fight against the pandemic.
CytoSorbents Corporation (NASDAQ: CTSO) will release its second quarter 2021 operating and financial results on August 3, 2021, after market close. The company specializes in blood purification technology to treat critical conditions in intensive care and during cardiac surgery. Following the results announcement, a conference call will occur at 4:30 p.m. ET on the same day. CytoSorbents' flagship product, CytoSorb®, is approved in the EU and has been used in over 131,000 treatments globally.
CytoSorbents Corporation (NASDAQ: CTSO) has received full FDA approval for its Investigational Device Exemption (IDE) to initiate the pivotal STAR-T trial. This double-blind, randomized trial will evaluate the use of DrugSorb-ATR in removing ticagrelor during cardiothoracic surgery, targeting up to 120 patients at 20 sites across the U.S. The study aims to reduce peri-operative bleeding risks associated with ticagrelor, a medication used in cardiovascular patients. Participant enrollment is expected to commence this summer, with completion anticipated in 2022.
CytoSorbents Corporation (NASDAQ: CTSO) has appointed Terri Anne Powers as Vice President of Investor Relations and Corporate Communications, effective immediately. Powers brings over 15 years of healthcare industry experience, including her recent role at Diplomat Pharmacy and over nine years with Veolia Environnement. In her new position, she aims to enhance the company's visibility and foster dialogue with investors. CytoSorbents, known for its CytoSorb® blood purification technology, seeks to leverage her expertise to communicate its growth story and potential FDA approvals.
CytoSorbents Corporation (NASDAQ: CTSO) announced its presentation at the Jefferies Virtual Healthcare Conference on June 3, 2021. The company will detail its progress in the field of blood purification technology, specifically its flagship product, CytoSorb®, used to treat critical conditions in patients. Management will also engage in one-on-one meetings with investors throughout the day. A live webcast of the presentation will be available, with an archived replay accessible for 30 days post-event.
CytoSorbents Corporation (NASDAQ: CTSO) announced that its CytoSorb® blood purification technology is now registered and commercially available in Singapore. This approval includes treatments for reducing cytokine storms, bilirubin in liver disease, and myoglobin in trauma cases, following European Union indications. The company expects increased demand due to Singapore's high prevalence of sepsis and cardiovascular diseases. The partnership with distributor Humedical aims to enhance patient care in the region. CytoSorb has been utilized in over 131,000 treatments globally.
CytoSorbents Corporation (NASDAQ: CTSO) has announced its participation in the UBS Global Healthcare Virtual Conference and the Oppenheimer MedTech, Tools, and Diagnostic Summit on May 26, 2021. The company will present an overview of its progress and outlook, along with conducting one-on-one meetings with investors. CytoSorbents specializes in blood purification technology, particularly its CytoSorb® product, which is approved in the EU and utilized in over 131,000 treatments globally.
CytoSorbents Corporation (NASDAQ: CTSO) secured a Defense Health Agency (DHA) Sequential Phase II Small Business Innovation Research (SBIR) contract worth $1.5 million to enhance its K+ontrol™ platform for treating severe hyperkalemia resulting from traumatic injuries. This follows prior Phase I and II successes, accumulating $1.15 million in funding. The technology aims to address life-threatening hyperkalemia in environments lacking modern medical facilities, providing critical treatment in emergencies, particularly for military and mass casualty scenarios.