Izotropic Corporation provided an update on its regulatory status with the U.S. Food and Drug Administration ("FDA") and operational activities. FDA Regulatory Update. Izotropic completed a pre-submission meeting with the FDA on October 25, 2023.

The purpose and objective of this meeting were to facilitate a productive dialogue, obtain valuable feedback, and confirm the next steps in the Company's regulatory strategy for market entry, which focuses on broadening IzoView's intended use as a CT tool with market clearance as a Class II device under the FDA's 510(k) pathway. Prior to the October meeting, the Company had held other pre-submission meetings with the FDA regarding a Class III diagnostic indication for use comparing IzoView to standard-of-care imaging modalities through a Pre-Market Approval regulatory pathway. The Class II 510(k) pre-submission was filed as a continuation of the pre-existing Class III PMA file at the FDA, and as such, the meeting took place with the FDA's Mammogram and Ultrasound team, and the FDA's CT team members were not present.

The discussions allowed the Company to clarify its revised regulatory strategy to the FDA, and an announcement followed disclosing that while further discussion with the agency regarding the details of this regulatory strategy will be required to ensure its viability, the FDA appeared open to the Company's new market clearance direction. As required by the FDA for purposes of concurrence, Izotropic promptly coordinated with its team members to draft and finalize meeting minutes, which were submitted to the FDA for review. Izotropic received a formal acknowledgment letter on November 8, 2023, from which the FDA had a 30-day period to review the meeting minutes and respond.

On December 7, 2023, Izotropic received the minutes back from the FDA, and the material information discussed in the meeting was consistent for both the FDA and Izotropic, and the meeting minutes were subsequently approved. Since the meeting, Izotropic has maintained an ongoing correspondence with the FDA via email regarding ongoing questions and responses to the pre-submission meeting content and has received confirmation that the pre-submission material has been provided to the FDA CT team; the FDA representatives that attended the October 2023 meeting have met with the CT team to discuss the pre-submission content; and the FDA has agreed to provide a response with more definitive guidance to the Company in January 2024. For clarity to Izotropic's shareholders, as of the date of this news announcement, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.

Izotropic will promptly report the outcomes of the FDA's response once it becomes available.