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Additional risks and uncertainties are not currently known to us, or that our management currently deems to be immaterial, also may adversely affect our business, financial condition, and/or operating results.
−Removed: 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.
−Removed: We may not be successful in obtaining FDA authorization and successful commercialization for DrugSorb-ATP in the U.S.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: or Canada, respectively
+Added: 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.
+Added: The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process.
+Added: In July, the Company participated in an appeal hearing with the FDA for supervisory review (administrative appeal) under 21 CFR 10.75.
+Added: The appeal hearing included FDA senior leadership, Company management and our external surgical experts.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
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.
+Added: 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.
+Added: Our future financial performance will depend, at least in part, upon the introduction, and customer and healthcare community acceptance of our products.
+Added: 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.
+Added: 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.
+Added: The degree of market acceptance will depend upon a number of factors, including:
+Added: ● the receipt of regulatory clearance of marketing claims for the uses that we are developing
+Added: ● the establishment, demonstration, and acceptance of the advantages, safety and efficacy of our polymer technology and products as evidenced by product adoption, sales, reimbursement, inclusion in treatment guidelines, etc;
+Added: ● pricing and reimbursement policies of government and third-party payers such as insurance companies, health maintenance organizations and other health plan administrators;
+Added: ● the development by our competitors of products or product candidates that are similar or identical to ours;
+Added: ● our ability to attract corporate partners, including medical device companies, to assist in commercializing our products;
+Added: ● our ability to effectively market our products
+Added: Physicians, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our products.
+Added: 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.
+Added: We may also need to conduct additional clinical studies to gather additional data for marketing purposes.
+Added: 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.
Unregistered Sales of Equity Securities and Use of Proceeds.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.