Item 1A. Risk Factors
Item 1A. Risk Factors.
There have been no material changes to our critical accounting estimates since our Annual Report on Form 10-K for the year ended December 31, 2024. For a discussion of risks that affect the Company’s business, please refer to Part I, Item IA, “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. In addition to the other information set forth in this Quarterly Report on Form 10-Q, please carefully consider the factors described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. The risks described are not the only risks facing us. 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.
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.
We may not be successful in obtaining FDA authorization and successful commercialization for DrugSorb-ATP in the U.S.
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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
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