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 (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 (NASDAQ: CTSO) has initiated its previously announced Rights Offering. Stockholders and certain Warrantholders of record as of December 16, 2024, will receive one non-transferable Subscription Right Warrant for each share owned. Each Subscription Right allows the purchase of one Unit at $1.00, comprising one common stock share and two transferable short-term Right Warrants for additional shares at discounted prices.
The offering expires at 5:00 PM EST on January 10, 2025. Stockholders can exercise all, some, or none of their rights. Those exercising all basic subscription rights can participate in oversubscription of unsubscribed rights. D.F. King & Co., Inc. serves as the information agent, while Moody Capital Solutions, Inc. acts as dealer manager.
CytoSorbents (NASDAQ: CTSO), a specialist in blood purification for critical care and cardiac surgery, has announced plans to conduct in-person investor meetings in San Francisco during the 43rd Annual J.P. Morgan Healthcare Conference from January 13-15, 2025. The meetings will be coordinated by ICR Healthcare, offering investors the opportunity to meet with CEO Dr. Phillip Chan and CFO Peter J. Mariani. Interested parties can schedule meetings by contacting ICR Healthcare at ir@cytosorbents.com.
CytoSorbents (NASDAQ: CTSO) has announced a Rights Offering where stockholders of record as of December 16, 2024, will receive one non-transferable Subscription Right Warrant for each share owned. Each Subscription Right allows purchase of a Unit at $1.00, consisting of one common stock share and two transferable Right Warrants.
The offering aims to raise funds for general corporate purposes and unlock $3.0-$5.0 million in restricted cash. A maximum of 6.25 million Units will be offered, with an additional 6.25 million shares reserved for warrant exercises. The Rights Offering expires on January 10, 2025, at 5:00 PM EST.
The Series A and B Right Warrants enable purchase of additional shares at 90% of the 5-day volume weighted average price, with specific price floors and ceilings, exercisable on February 24, 2025, and April 10, 2025, respectively.
CytoSorbents (NASDAQ: CTSO), a company specializing in blood purification for critical care and cardiac surgery, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The event will take place from December 3-5, 2024, in New York, NY. Dr. Phillip Chan, CEO, and Peter J. Mariani, CFO, will conduct one-on-one investor meetings on December 4, 2024. Interested parties can schedule meetings through Piper Sandler representatives or by contacting CytoSorbents' investor relations team.
CytoSorbents (NASDAQ: CTSO) and Converge Biotech have announced a strategic partnership to expand their market reach in India's sepsis and critical care markets. CytoSorbents' flagship product, CytoSorb, a blood purification technology that reduces cytokine storm and inflammatory toxins, will be distributed through Converge Biotech's extensive critical care sales network. CytoSorb, currently used in 76 countries with over 250,000 treatments administered, treats conditions like sepsis, septic shock, lung failure, acute liver disease, and trauma. The partnership aims to improve patient outcomes across Indian hospitals and ICUs by combining CytoSorbents' innovative technology with Converge's established critical care presence.
CytoSorbents reported Q3 2024 financial results with product revenue of $8.6 million, showing 11% growth vs Q3 2023. Total revenue reached $9.4 million, a 7% increase year-over-year. Product gross margins decreased to 61% from 72% due to planned production slowdown. The company reported a net loss of $2.3 million ($0.04 per share), improved from $9.2 million loss in Q3 2023. Cash position stood at $12.2 million. The company submitted DrugSorb-ATR De Novo application to FDA and Medical Device License application to Health Canada, targeting a potential North American market exceeding $300 million.
CytoSorbents has submitted its DrugSorb™-ATR Medical Device License application to Health Canada while receiving Medical Device Single Audit Program (MDSAP) certification. DrugSorb-ATR aims to enable safe and timely coronary artery bypass graft surgery in patients on ticagrelor blood thinner. The submission follows the U.S. FDA De Novo filing, with both regulatory decisions expected in 2025. The 140-patient STAR-T trial data supports these submissions. The device addresses a critical need in Canada, where ticagrelor is the preferred treatment for acute coronary syndrome patients, who currently face 3-5 day surgery delays for drug washout to prevent bleeding complications.
CytoSorbents (NASDAQ: CTSO) announced that the FDA has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. DrugSorb-ATR aims to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft (CABG) surgery. The device has received FDA Breakthrough Device Designation, making it eligible for priority review.
The company anticipates an FDA decision in 2025. The application is based on data from the 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial. CytoSorbents believes DrugSorb-ATR will allow patients to proceed with CABG surgery safely and timely, avoiding the current 3-5 day delay recommended for ticagrelor washout. The company also plans to submit DrugSorb-ATR for Health Canada Medical Device Licensure.
CytoSorbents (NASDAQ: CTSO), a leader in blood purification for treating life-threatening conditions in intensive care and cardiac surgery, has announced it will report its third quarter 2024 operating and financial results after market close on Thursday, November 7, 2024. The company's management will host a live conference call, presentation webcast, and Q&A session starting at 4:30 PM ET on the same day.
Interested parties can access the webcast through the provided link or join via phone using the toll-free dial-in number. Participants are advised to dial in about 10 minutes before the call starts. An archived recording of the conference call will be made available on the Investor Relations section of CytoSorbents' website.
CytoSorbents (NASDAQ: CTSO) has submitted a De Novo marketing application to the U.S. FDA for DrugSorb™-ATR, a device designed to reduce bleeding severity in heart bypass surgery patients on ticagrelor. The application, submitted on September 27, 2024, is eligible for FDA priority review due to its Breakthrough Device Designation. CytoSorbents is also preparing to submit a Medical Device License application to Health Canada, pending MDSAP certification.
The submission is based on data from the 140-patient North American STAR-T trial, which evaluated DrugSorb-ATR's safety and efficacy in removing ticagrelor and reducing perioperative bleeding complications in urgent CABG surgery patients. FDA and Health Canada decisions are expected in 2025. This milestone represents years of clinical, regulatory, and manufacturing efforts by CytoSorbents and its collaborators.
FAQ
What is the current stock price of Cytosorbents (CTSO)?
What is the market cap of Cytosorbents (CTSO)?
What is CytoSorbents Corporation's primary focus?
What is CytoSorb®?
In which regions is CytoSorb® approved?
What was CytoSorbents' product sales growth in Q3 2023?
What are some other products offered by CytoSorbents?
Where does CytoSorbents generate most of its revenue?
What are the main segments through which CytoSorbents operates?
What are the latest developments in CytoSorbents’ STAR-T trial?
Where can investors find detailed financial results for CytoSorbents?
Who should be contacted for investor relations at CytoSorbents?
