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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.
−Removed: The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process.
+Added: The Company filed an appeal of the decision through the formal appeal process with the FDA.
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.
−Removed: 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 August 14, 2025, the Company received an FDA appeal decision following its July 2025 in-person supervisory administrative review (appeal) meeting with the FDA under 21 CFR 10.75.
+Added: In the appeal decision, the FDA found no issues with device safety but upheld its prior De Novo denial decision citing the need for additional information to support the Company’s desired label indication.
+Added: Additionally, the FDA proactively proposed a potential expedited path forward for market authorization but noted the Company could also appeal to a final higher level within the FDA with the Director of the FDA’s Center for Devices and Radiologic Health (CDRH).
+Added: On September 16, 2025, the Company announced that it decided to not file a final appeal with the CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the Company’s original desired label indication.
+Added: The Company expects to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication in early 2026.
+Added: As part of the resubmission process, the Company filed a pre-submission meeting request with supporting documentation to the FDA on November 7, 2025.
+Added: A formal meeting with the FDA is anticipated in either late fourth quarter of 2025, or early 2026 to confirm the requirements for the new De Novo submission.
+Added: A regulatory decision is expected in mid-2026 following a typical 150-day review process.
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.
−Removed: 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.
−Removed: 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.
+Added: On September 16, 2025 the Company announced that it had timely filed a Level 1 “Request For Reconsideration” with Health Canada.
+Added: However, following interactive discussions with the Medical Devices Directorate Bureau Director and the Company’s Canadian regulatory counsel, it was recommended that any subsequent review of DrugSorb-ATR in Canada be delayed until better clarity was received from the FDA.
+Added: As such, the Company withdrew the Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.
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.
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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.
+Added: If we are not in compliance with the continued listing standards of the Nasdaq Stock Market LLC (“Nasdaq”), our common stock may be delisted, which could have a material adverse effect on the liquidity of our common stock.
+Added: Our common stock is listed on the Nasdaq Stock Market LLC (“Nasdaq”).
+Added: On October 2, 2025, we were notified that we were not in compliance with the Nasdaq’s continued listing requirements relating to the minimum average closing price per share of our common stock, because the average closing price of our common stock over a consecutive 30 trading-day period was below $1.00 per share (the “Minimum Bid Price Requirement”).
+Added: We have timely notified the Nasdaq of our intent to regain compliance with the minimum price condition within a 180-day cure period provided by Nasdaq rules, or until March 31, 2026 (the “Compliance Date”).
+Added: We can regain compliance at any time within the cure period if, the closing bid price of the Company’s common stock meets or exceeds $1.00 per common share for a minimum of 10 consecutive business days prior to the Compliance Date, unless the Nasdaq staff exercises its discretion to require the Company to meet the Minimum Bid Price Requirement for a longer period pursuant to applicable Nasdaq rules.
+Added: If we fail to regain compliance with the Nasdaq’s minimum price condition by the end of the cure period, the Company would be eligible for an additional compliance period of 180 days provided it presents an acceptable plan to Nasdaq to regain compliance.
+Added: The Company intends to actively monitor the closing bid price of its common stock and will consider its options to regain compliance with the Minimum Bid Price Requirement.
+Added: There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq listing standards.
+Added: If the Company is unable to regain compliance with the Minimum Bid Price Requirement, our common stock will be subject to the Nasdaq’s suspension and delisting procedures.
+Added: During this time, our common stock will continue to be listed on the Nasdaq, subject to our compliance with other Nasdaq continued listing requirements.
+Added: However, there can be no assurance about our ability to regain compliance with the Nasdaq’s minimum price condition within the applicable cure periods.
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.