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) received a denial letter from the FDA on April 25, 2025, regarding its De Novo Request for DrugSorb-ATR, a breakthrough device designed to reduce bleeding severity in coronary artery bypass grafting (CABG) patients who recently stopped taking Brilinta®. The FDA identified remaining deficiencies that need to be addressed before authorization.
The company has met with the FDA and will continue discussions to resolve the issues. If no resolution is reached, CytoSorbents plans to file a formal appeal within 60 days. Despite this setback, the company remains confident in obtaining a final regulatory decision in 2025 for this device, which addresses an unmet medical need affecting tens of thousands of U.S. patients annually.
CytoSorbents Corporation (NASDAQ: CTSO), a pioneer in blood purification technology for treating critical conditions in intensive care and cardiac surgery, has scheduled its Q1 2025 financial results announcement for May 14, 2025, after market close.
The company will host a live conference call and webcast at 4:30 PM ET on the same day, featuring:
- Financial results presentation
- Recent business highlights
- Interactive Q&A session
Participants can join via:
- North American toll-free: 1-800-836-8184
- International toll: 1-646-357-8785
- Live webcast: Available through dedicated link
Attendees are advised to dial in 10 minutes before the call. A recording will be accessible later through CytoSorbents' investor relations website.
CytoSorbents (NASDAQ: CTSO) has received $1.7 million in cash proceeds from selling its 2023 and amended 2022 Net Operating Loss (NOL) and R&D tax credits through the New Jersey Technology Business Tax Certificate Transfer Program. The non-dilutive funding, sponsored by the New Jersey Economic Development Authority (NJEDA), will support:
- Preparations for DrugSorb™-ATR launch in the U.S. and Canada
- Manufacturing scale-up at the new Princeton facility
- Other strategic initiatives
The program enables approved Technology and Biotechnology Businesses to sell their unused NOL and R&D Tax Credits for at least 80% of the value to profitable NJ corporate taxpayers. Due to New Jersey's tax reform legislation A.B. 5323 enacted on July 3, 2023, CytoSorbents amended its 2022 return, increasing the NOL amount available for sale.
CytoSorbents (NASDAQ: CTSO) has appointed Melanie Grossman, CPA as Vice President and Corporate Controller. Grossman brings over 25 years of finance and accounting experience from global, publicly-traded companies, including previous roles at Staffing 360, Vaxxinity, Byram Healthcare, and Stryker Orthopedic.
As part of her appointment, Grossman received several inducement awards under Nasdaq Listing Rule 5635(c)(4), including:
- 25,000 Non-Qualified Stock Options with a $0.99 exercise price, vesting over three years
- 35,000 Signing Restricted Stock Units with four-year cliff vesting
- 35,000 Change-of-Control Restricted Stock Units vesting upon change-in-control
CytoSorbents (NASDAQ: CTSO) has appointed Thomas Shannon as Vice President of Marketing for North America. Shannon will lead the marketing strategy for DrugSorb-ATR in the U.S. and Canada, pending regulatory approval.
Shannon brings over 25 years of experience in commercializing cardiovascular and critical care technologies. His background includes executive roles at Genesee Biomedical, Fresenius Medical Care, Getinge, and Medtronic, where he managed a $450 million cardiac portfolio and achieved consistent double-digit growth. He also has 17 years of healthcare practitioner experience, including 12 years as a cardiovascular perfusionist.
DrugSorb-ATR, an FDA Breakthrough device, aims to reduce perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on blood thinners like Brilinta®. The product is currently under review by U.S. FDA and Health Canada, with regulatory decisions expected in 2025.
CytoSorbents (NASDAQ: CTSO) has announced an extension to the expiration date of its Series B Right Warrants from April 10, 2025, to June 10, 2025. These warrants, initially issued during the Company's Rights Offering in January 2025, are exercisable at 90% of the 5-day volume weighted average stock price prior to the June 10 expiration, with a price floor of $2.00 and ceiling of $4.00.
Approximately 4.8 million shares of common stock remain reserved for warrant exercise. Warrant holders must provide the maximum price of $4.00 to exercise, with refunds issued based on the final exercise price. Unexercised warrants will expire worthless after the new deadline.
CytoSorbents (NASDAQ: CTSO) reported strong Q4 2024 results with product revenue of $9.2M, up 25% from Q4 2023. Full-year 2024 product revenue reached $35.6M, a 15% increase year-over-year, with 71% product gross margins.
Q4 operating loss improved 61% to $3.7M, while net loss was $7.6M ($0.14/share). The company strengthened its balance sheet through a successful Rights Offering, raising $7.3M in net proceeds.
Key developments include FDA's acceptance of DrugSorb-ATR De Novo application and submission to Health Canada, with regulatory decisions expected in 2025. The company reported strong international growth with 28% increase in direct sales outside Germany and 22% growth in Distributor/Partner sales, though German sales remained flat.
Management expects Q1 2025 product sales to decline modestly due to German sales team restructuring, but anticipates improved results in H2 2025 as they work toward breakeven in core business.
CytoSorbents (NASDAQ: CTSO) has rescheduled its Q4 and full year 2024 earnings release to March 31, 2025, to complete the annual financial audit. The company reaffirms its preliminary financial results, projecting:
- Q4 2024 product revenue of $9.0-9.2 million (22-25% growth vs Q4 2023)
- Full-year 2024 product revenue of $35.4-35.6 million (14% growth vs 2023)
- Q4 2024 product gross margin of ~70%
The company raised $7.85 million in Q1 2025 through a Rights Offering and warrant exercises, with net proceeds of $7.3 million. The pro-forma cash balance as of December 31, 2024, would have been approximately $17.0 million, including unrestricted cash of $15.5 million. Q4 2024 cash burn was approximately $2.5 million. Regulatory decisions for DrugSorb-ATR marketing applications from FDA and Health Canada are expected in 2025.