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CytoSorbents Corporation (NASDAQ: CTSO) is a prominent player in the field of critical care immunotherapy, with a strong focus on blood purification technologies. The company has made significant strides with its flagship product, CytoSorb®, which has received approval in the European Union and is distributed across 40 countries globally. CytoSorb® is an extracorporeal cytokine adsorber designed to mitigate the 'cytokine storm' or 'cytokine release syndrome' that can lead to severe inflammation, organ failure, and death in critical conditions such as sepsis, burn injuries, trauma, lung injuries, and pancreatitis. It is also employed in cancer immunotherapy and during cardiac surgeries to remove inflammatory mediators that may cause post-operative complications.
The core technology of CytoSorbents is based on biocompatible, highly porous polymer beads that efficiently purify the blood. Apart from CytoSorb®, the company offers other innovative products like ECOS-300CY, VetResQ, HemoDefend, and DrugSorb-ATR, which cater to different aspects of critical care and blood purification.
CytoSorbents operates through various segments, including Direct Sales, Distributors/Strategic Partners, and Government contracts. Its revenue is primarily driven by product sales, particularly in Germany, with additional income sourced from grants by agencies in the United States.
In Q3 2023, CytoSorbents reported a 20% growth in product sales, reaching $7.8 million, compared to $6.5 million in Q3 2022. The total revenue for the same quarter was approximately $8.8 million. The company is also advancing its pivotal STAR-T trial, with the database lock nearing completion and initial data analysis expected before the year's end.
For more detailed financial results and updates, investors can refer to the company’s official filings, such as the Form 10-K for the period ending December 31, 2023, and the Form 10-Q for the period ending March 31, 2024, available on the SEC website.
CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification for life-threatening conditions, announced its participation in two virtual investor conferences. CEO Dr. Phillip Chan will engage in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 10:00 a.m. ET, with a live webcast available. He will also participate at the Cowen 42nd Annual Health Care Conference on March 9, 2022, at 2:10 p.m. ET. Recordings of the conferences will be available on the company's website for 30 days.
CytoSorbents Corporation (NASDAQ: CTSO) announced the enrollment of the first patient in the PROCYSS trial, aimed at evaluating the efficacy of CytoSorb in treating refractory septic shock. Conducted in Germany, this multicenter, randomized controlled trial is designed to enroll up to 160 patients across 20 sites and is expected to be completed by the end of 2023. The trial will assess CytoSorb's ability to restore hemodynamic stability in patients suffering from this critical condition, potentially paving the way for improved treatment protocols in critical care.
On January 24, 2022, CytoSorbents Corporation (NASDAQ: CTSO) announced a new publication in Annals of Thoracic and Cardiovascular Surgery, reporting the efficacy of their hemoadsorption technology in reducing bleeding complications during urgent aortic dissection surgeries. A study involving 171 patients showed that among those treated with hemoadsorption, 30-day mortality was lower at 10% compared to 27.3% without treatment. The technology also resulted in fewer re-operations and a reduced ICU stay from 9 days to 4 days, highlighting its potential to improve patient outcomes.
CytoSorbents Corporation (NASDAQ: CTSO) released a stockholder letter and reported preliminary unaudited results for Q4 and full year 2021, showing total revenue of approximately $43.2 million, slightly up from $41.0 million in 2020. The total treatments delivered exceeded 162,000, marking a 34% increase. Q4 revenue was $10.8 million compared to $12.0 million in Q4 2020. The company has a strong cash balance of approximately $54 million and is set to renew a $15 million term loan. CytoSorb's core (non-COVID-19) product revenue rose by 13% in 2021.
On December 21, 2021, CytoSorbents Corporation (NASDAQ: CTSO) announced the appointment of Professor Daniel Wendt, MD, PhD, MHBA, FETCS, as Vice President of Medical Affairs Cardiovascular, effective January 1, 2022. Dr. Wendt is a seasoned cardiac surgeon with over 15 years of experience and a track record in complex cardiovascular care. He will oversee cardiovascular medical affairs and contribute to the company’s clinical trial strategies for CytoSorb, a device approved in the EU for removing harmful cytokines during cardiac procedures.
On December 20, 2021, CytoSorbents Corporation (NASDAQ: CTSO) announced the publication of results from its U.S. CytoSorb Therapy in COVID-19 retrospective registry in the Frontiers in Medicine. The study covered 52 critically ill COVID-19 patients on ECMO who received CytoSorb therapy, showing a 90-day ICU mortality rate of 26.9%, significantly lower than the typical rate of 50%. All participating centers reported that CytoSorb was well-integrated and well-tolerated. The results support the potential of CytoSorb to enhance recovery in severely ill patients while emphasizing timely intervention.
CytoSorbents Corporation (NASDAQ: CTSO) announces its participation in two major investor conferences. The Canaccord Genuity Virtual MedTech Forum will feature CEO Dr. Phillip Chan on November 18, 2021, at 11:00 a.m. ET. A second presentation is scheduled for the Jefferies London Healthcare Conference on the same day, available on-demand starting at 3:00 a.m. ET. An archive of both presentations will be available for 30 days on their website. CytoSorbents specializes in blood purification technologies to treat critical illnesses and is effective in over 70 countries.
CytoSorbents Corporation (NASDAQ: CTSO) reported Q3 2021 revenue of $9.8 million, a 7% decline compared to Q3 2020. Product sales fell 13% to $8.9 million, impacted by a 24% drop in Germany due to COVID-19 restrictions. However, core non-COVID-19 product sales rose 3% to $7.8 million. The company holds $61 million in cash with no debt and maintains its 2021 revenue guidance of at least $39.3 million. Recent trials and FDA designations signal potential future growth despite pandemic challenges.
CytoSorbents Corporation (NASDAQ: CTSO) provided insights following the presentation of the REMOVE study results at the EACTS annual meeting on October 16, 2021. The study aimed to evaluate the safety and efficacy of CytoSorb in cardiac surgery patients with infective endocarditis. Though the primary outcome was neutral, the study showed CytoSorb's potential to reduce cytokines without adverse effects. Future analyses will target identifying specific patient populations that may benefit from this therapy. The company remains focused on advancing its clinical programs based on these findings.
CytoSorbents Corporation (NASDAQ: CTSO) has announced the enrollment of the first patient in its STAR-T trial, a pivotal study aimed at obtaining FDA approval for the DrugSorb-ATR™ system. This double-blind, randomized, controlled trial will evaluate the system's efficacy in removing the antiplatelet drug ticagrelor during cardiothoracic surgery to mitigate bleeding risks. The STAR-T trial received full FDA IDE approval in July 2021 and aims to enroll 120 patients across 20 sites, expected to finish by 2022. The initiative addresses a critical medical need in cardiac surgery.
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