Every 8-K that Cytosorbents Corp. (CTSO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CTSO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CTSO filings page.
CytoSorbents Corporation (CTSO) implemented a 1-for-20 reverse stock split of its common stock, effective at 12:01 a.m. E.T. on September 8, 2026. As of September 3, 2026, there were 63,022,020 shares of common stock outstanding that became subject to this reclassification.
Every twenty previously issued and outstanding shares of common stock were automatically reclassified into one share, with no change to the $0.001 par value and no change to the total number of authorized shares. Fractional entitlements were rounded up to the nearest whole share, and outstanding options and warrants were proportionately adjusted in both share amount and exercise price. Trading continues on Nasdaq on a split-adjusted basis under CTSO, with a new CUSIP of 23283X305.
CytoSorbents Corporation held its 2026 Annual Meeting of Stockholders on August 13, 2026. Stockholders representing 42,487,327 of 62,842,748 outstanding common shares were present in person or by proxy, constituting a quorum. Five directors, including Dr. Phillip P. Chan, were elected with support levels generally above 23.6 million votes in favor for each nominee, with substantial broker non-votes recorded.
On a non-binding, advisory basis, compensation of named executive officers received 21,831,424 votes for, 2,988,267 against, and 2,642,933 abstentions. Stockholders ratified WithumSmith+Brown, PC as independent registered public accounting firm for 2026 with 41,517,193 votes for. They also approved a charter amendment authorizing a reverse stock split at a ratio between 1-for-5 and 1-for-20, to be implemented at the Board’s discretion within one year of the meeting, and approved a potential adjournment proposal, though no adjournment was needed.
CytoSorbents Corporation furnished an investor presentation outlining Q2 2026 performance and strategic priorities. Product revenue was $9.6 million, flat year over year, with growth from distributors and strategic partners and direct international sales offset by lower German revenue following a salesforce restructuring. Gross margin improved to 73%, total operating expenses declined to $9.7 million from $10.4 million, and operating loss narrowed to ($2.6 million). Reported net income was $1.9 million, or $0.03 per share, compared with a $4.4 million loss a year earlier, while adjusted net loss was ($2.9 million) and adjusted EBITDA loss ($1.6 million). Cash, cash equivalents and restricted cash totaled $5.9 million with net operating cash burn of about $0.4 million in Q2, including $0.2 million of restructuring payments; management continues to target operating cash flow breakeven in the second half of 2026.
Management highlights four value drivers: achieving operating cash flow breakeven, returning core CytoSorb sales to growth, opening the U.S. market with DrugSorb-ATR, and unlocking the value of HemoDefend-BGA. Trailing twelve-month core product sales reached $37.3 million as of June 30, 2026, with more than 300,000 CytoSorb treatments performed in over 70 countries. For DrugSorb-ATR, the pivotal STAR-T trial showed a 58% risk reduction and 16.3% absolute reduction in major bleeding (NNT=6) despite missing its primary endpoint, leading to an FDA De Novo denial. On appeal, FDA raised no major safety concerns, indicated a new large trial is not required, and invited a focused new De Novo submission supported by additional mechanistic data and real-world evidence from European use. The company is also exploring a parallel De Novo pathway for direct oral anticoagulant removal. HemoDefend-BGA, a gravity-driven filter to create universal plasma and blood products, has been developed with more than $16 million in non-dilutive government funding; the company recently received constructive FDA feedback on a planned clinical pathway and is preparing for clinical trials while positioning the asset for potential partnerships, licensing, or other strategic options.
CytoSorbents Corporation reported second quarter 2026 net revenue of $9,633k, compared with $9,617k a year earlier, with product gross margin rising to 73%. Operating expenses were $9,687k, yielding a loss from operations of $2,638k and a net loss of $4,417k versus net income of $1,947k in the prior-year quarter. Adjusted EBITDA improved to a loss of $1,649k from a $2,640k loss, and operating cash burn fell to about $200k excluding restructuring payments. Since September 2025 the workforce has been reduced by approximately 23% to create a leaner organization.
As of June 30, 2026, cash and cash equivalents totaled $4,413k, restricted cash $1,522k, total assets $37,960k, and stockholders’ equity was a deficit of $751k driven by an accumulated deficit of $321,754k. Management highlighted four value drivers over the next 6–18 months: achieving sustainable operating cash flow breakeven, returning the CytoSorb franchise to profitable growth, pursuing FDA De Novo submissions and potential marketing authorization for DrugSorb-ATR in a U.S. and Canada market estimated at $500 million to $1 billion, and realizing the strategic value of HemoDefend-BGA, developed with roughly $16 million of prior non-dilutive U.S. government funding.
CytoSorbents Corporation reported that it received a notice from Nasdaq stating it is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires a minimum Market Value of Listed Securities of $35 million for the Nasdaq Capital Market.
The company has 180 calendar days, until December 28, 2026, to regain compliance by having its market value meet or exceed $35 million for at least 10 consecutive business days, subject to potential Nasdaq discretion. The notice does not immediately delist the stock, but failure to regain compliance could lead to a delisting determination, which the company could then appeal.
CytoSorbents is evaluating potential actions to regain compliance, including actively monitoring its market value and potentially increasing stockholders’ equity to at least $2.5 million as another route to satisfy Nasdaq’s continued listing standards. The filing notes there is no assurance the company will succeed in maintaining its Nasdaq Capital Market listing.
CytoSorbents Corporation furnished an investor presentation describing its blood purification business and regulatory plans for its DrugSorb-ATR device. The company has scheduled two FDA pre-submission meetings in August 2026 to discuss ticagrelor removal in cardiac surgery and a potential expanded indication for DOAC removal.
The presentation highlights 2025 sales of $37 with 71% gross margins and a high-margin "razorblade" consumables model across more than 70 countries and 300,000+ CytoSorb treatments. In Q1 2026, sales were $8, up 2% year over year, with product gross margins of 69% as the company deliberately slowed production to reduce inventory.
Management reports negative free cash flow improving, ending Q1 2026 with $6.4 million in cash, cash equivalents and restricted cash and a cash burn of $1.1 million in the quarter. The company aims for operating cash flow breakeven in the second half of 2026 and targets profitability in 2027 while pursuing De Novo submissions for DrugSorb-ATR in North America.
CytoSorbents Corporation reported first quarter 2026 revenue of $8.9 million, roughly flat year over year, with 13% growth in direct markets outside Germany and slightly lower sales in Germany on a leaner sales team. Distributor sales were unchanged as delayed orders of about $0.5 million in parts of the Middle East offset progress elsewhere.
Gross margin was 69%, down slightly as the company deliberately reduced production to lower inventory and improve working capital. A late-2025 cost reduction that cut headcount by about 10% helped trim operating expenses, though net loss widened to $5.1 million, or $0.08 per share, versus a $1.5 million loss a year earlier. Adjusted EBITDA improved modestly to a loss of $2.2 million.
The company outlined its U.S. regulatory strategy for the DrugSorb-ATR device. After an FDA appeal maintained a prior denial but raised no safety concerns, CytoSorbents plans a new De Novo application for use with Brilinta, targeting submission in late 2026 or early 2027, and is preparing a separate pre-submission for a potential DOAC indication. Management reiterated its goal of reaching operating cash flow breakeven in the second half of 2026 while navigating temporary geopolitical headwinds and expanding its commercial footprint.
CytoSorbents Corporation received a 180-day extension from Nasdaq, until September 28, 2026, to regain compliance with the $1.00 minimum bid price requirement for its common stock. The company will regain compliance if its share price closes at or above $1.00 for at least 10 consecutive trading days before that date.
The notice has no immediate effect on the Nasdaq listing or SEC reporting, but the company warns there is no assurance it will regain compliance and its stock could be delisted. CytoSorbents is monitoring its share price and is considering options to address the deficiency, including a possible reverse stock split.
CytoSorbents Corporation reported modest revenue growth and a sharply reduced loss for 2025. Full-year revenue rose 4% to $37.1 million, with Q4 revenue of $9.2 million. Gross profit increased to $26.5 million, driven by higher sales outside Germany and distributor growth.
The net loss narrowed to $8.2 million from $20.7 million in 2024, helped by lower research and development spending and a favorable foreign currency impact. The company ended 2025 with $6.2 million in cash and cash equivalents and total stockholders’ equity of $5.9 million, while long-term debt rose to $16.7 million. Management implemented a 10% headcount reduction and other cost measures and now anticipates achieving cash flow breakeven in the second half of 2026, while continuing to pursue FDA De Novo authorization for DrugSorb-ATR.
CytoSorbents Corporation announced that it issued a press release with financial results for the quarter ended September 30, 2025. The press release is furnished as Exhibit 99.1 under Item 2.02.
The company states this information is furnished, not filed, and is not subject to Section 18 of the Exchange Act, nor incorporated by reference into other filings except as specifically stated.
CytoSorbents Corporation furnished a current report stating that it issued a press release providing a regulatory update on its -ATR program. The press release is attached as Exhibit 99.1 and is treated as furnished, not filed, under securities law.
CytoSorbents Corporation filed a current report describing a regulatory update for its DrugSorbTM-ATR device. The company states that it issued a press release announcing the outcome of its appeal to the U.S. Food and Drug Administration regarding the FDA’s earlier denial of its De Novo Market Authorization request for DrugSorb-ATR.
The press release with details of the appeal outcome is furnished as Exhibit 99.1 to the report, rather than being summarized in the body of the filing. This filing mainly serves to formally notify investors that the FDA appeal outcome and related information are now available through that exhibit.
CytoSorbents Corporation (Nasdaq: CTSO) filed a Form 8-K on June 24, 2025 to disclose a material regulatory development. Under Item 8.01 – Other Events, the company reported that it has decided to appeal the U.S. Food & Drug Administration’s (FDA) denial letter related to its De Novo request for DrugSorb-ATR, a blood purification device designed to remove antithrombotic agents during cardiothoracic surgery. The filing furnishes a press release (Exhibit 99.1) as additional detail; however, that release is not included in the body of the 8-K.
The appeal process indicates that management believes there are sufficient grounds to contest the FDA’s decision, but the 8-K offers no timetable, data, or probability of success. No sales, earnings, or forecast information is provided, and no other corporate actions (financing, partnerships, leadership changes) are mentioned. Investors should note that DrugSorb-ATR represents an important U.S. commercial opportunity for CTSO, but the denial—now under appeal—introduces regulatory uncertainty and potential delays to market entry.