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.
CytoSorbents Corporation (NASDAQ: CTSO) commemorated World Sepsis Day and Sepsis Awareness Month with several key initiatives, including sponsorships and studies related to its blood purification technology, CytoSorb. This product aims to combat severe inflammation caused by sepsis, a critical health issue linked to one in five deaths globally. The company announced the upcoming PROCYSS trial in Germany to evaluate CytoSorb's effectiveness in treating refractory septic shock, highlighting its potential in saving lives in high-risk patients.
CytoSorbents Corporation (NASDAQ: CTSO) has filed an Investigational Device Exemption (IDE) application with the FDA for the STAR-D clinical study, targeting the removal of direct oral anticoagulants apixaban and rivaroxaban during urgent cardiothoracic surgery. This follows the FDA's Breakthrough Device Designation granted in August 2021, acknowledging the unmet medical need to reduce severe bleeding risks in patients on these medications. CytoSorbents aims to address a U.S. market potential of one billion dollars for this application.
CytoSorbents Corporation (NASDAQ: CTSO) will host a webinar on September 13, 2021, at 5:00 p.m. EDT to discuss the topline results from its U.S. CTC Multicenter Registry. The registry studied 52 critically ill COVID-19 patients with ARDS on ECMO using CytoSorb, highlighting survival rates. Dr. Phillip Chan, CEO, will lead the session, which includes a review of the results by Dr. J. W. Awori Hayanga. Registration is available online, and the session will be accessible for later viewing.
CytoSorbents Corporation (NASDAQ: CTSO) announced promising results from its CytoSorb Therapy in COVID-19 (CTC) registry presented at the ISICEM 2021 symposium. The study included 52 critically ill COVID-19 patients and reported a 90-day ICU mortality rate of 27%, significantly lower than the 50% mortality observed in similar patients in the ELSO Registry. All participating centers noted the CytoSorb device was easily integrated with ECMO and had no unanticipated adverse events, indicating its potential as a life-saving therapy.
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.