Cytosorbents Corp
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
CTSO$4.80+4.3%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001410578-25-001268
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001410578-25-001612
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 5 previous paragraphs and 10 current paragraphs.
2 unchanged; 3 reworded; 4 added; 0 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 0 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
On June 26, 2025, Health Canada issued a Notice of Refusal of the Company’s Medical Device License application, identifying remaining deficiencies that must be addressed before the application may be granted and the device authorized for commercialization. As part of Health Canada’s prescribed reconsideration process, and following discussions with Health Cananda, the Company has filed a Level 1 “Request for Reconsideration” and with agreement from the Medical Devices Directorate Bureau Director will pursue the review following conclusion of the Company’s review with the FDA. If marketing authorization is not received as part of the reconsideration process, the Company can then file a formal Appeal with the Director General of the Medical Devices Directorate.
Current report
Acceptance of our medical devices in the marketplace is uncertain, and failure to achieve market acceptance will prevent or delay our ability to generate revenues.
Current report
Our future financial performance will depend, at least in part, upon the introduction, and customer and healthcare community acceptance of our products. Even with current or future regulatory or marketing approvals for our CytoSorb, ECOS-300CY, and PuriFi pump devices, other products like VetResQ, and product candidates such as DrugSorb-ATR, these products may not achieve market acceptance in the countries where they are sold. There is no guarantee that we will be able to achieve additional regulatory approvals, and even if we do, our products may not achieve market acceptance in the countries covered by such approvals. The degree of market acceptance will depend upon a number of factors, including:
Current report
Physicians, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our products. For example, the approval of our CytoSorb device as a cytokine adsorber as well as the data we have gathered in our clinical studies to support device usage in this indication may not be sufficient for market acceptance in the medical community. We may also need to conduct additional clinical studies to gather additional data for marketing purposes. If we are unable to obtain regulatory approval or commercialize and market our products when planned, we may not achieve any market acceptance or generate revenue.
Reworded paragraphs (3)
Previous wording
The following is a new [significant] risk factor that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.
Current wording
The following represent modification to risk factors that could materially harm our business, financial position, or operating results or could cause our actual results to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this report.
Previous wording
We may not be successful in obtaining FDA authorization and successful commercialization for DrugSorb-ATP in the U.S.
Current wording
We may not be successful in obtaining the FDA’s or Health Canada’s authorization and successful commercialization for DrugSorb-ATR in the U.S. or Canada, respectively
Previous wording
On April 25, 2025, the FDA issued us a denial letter (the “FDA Letter”) regarding the Company’s De Novo Request for DrugSorb-ATR, identifying deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through a formal appeals process that enables direct interaction and engagement with FDA senior leadership and our external experts. The Company intends to submit a formal appeal within 60 days of receipt of the FDA letter, or by June 25, 2025, that requests reconsideration of the denial and reversal of the final decision. We may be unsuccessful in our appeal which may significantly impact our ability to generate any significant revenues or ever achieve and maintain a substantial level of sales of our product candidates in the U.S.
Current wording
On April 25, 2025, the FDA issued a denial letter regarding the Company’s De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process. In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75. The appeal hearing included FDA senior leadership, Company management and our external surgical experts. The Company continues to believe that remaining deficiencies in its DeNovo application can be effectively resolved through this supervisory review process which is expected to be completed by the end of August 2025, and that a final regulatory decision can be achieved in 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
We may be unsuccessful in our appeal which may significantly impact our ability to generate any significant revenues or ever achieve and maintain a substantial level of sales of our product candidates in the U.S. and Canada.