IZOTROPIC CORP - IZOZF STOCK NEWS

Izotropic (CSE: IZO) (OTCQB: IZOZF) announces plans to launch IzoView, a breast CT imaging system, as a diagnostic device for patients with dense breast tissue in the U.S. and EU. The company is pursuing a Pre-Market Authorization (PMA) clinical study in the U.S., estimated to cost $3.5M USD and involve 400 patients. The study aims to prove the superiority of Digital Breast Tomosynthesis (DBT) combined with Contrast-Enhanced Breast CT over DBT alone for breast cancer detection in women with dense breasts.

Izotropic is also seeking CE Mark approval in the EU, which may result in earlier commercialization. The company's strategy focuses on patients with BI-RADS C and D breast density classifications, addressing a significant market as nearly half of U.S. women aged 40+ have dense breasts, which increases breast cancer risk.

Izotropic Corporation, a medical device company, announces that it has received a response from the U.S. FDA regarding its pre-submission seeking guidance on a Class II 510(k) pathway for its CT imaging system. The FDA's mammogram and ultrasound team has responded with additional questions, and Izotropic's management, regulatory, and engineering teams will promptly respond and report the outcomes. As of the announcement date, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.

Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) provides an update on its regulatory status with the U.S. Food and Drug Administration and operational activities, including FDA pre-submission meeting, ongoing correspondence, and business development discussions.

Izotropic Corporation, a medical device company, completed a pre-submission meeting with the U.S. FDA to discuss its application for market authorization. The meeting allowed Izotropic to clarify its regulatory strategy and the FDA appeared open to the company's new market clearance direction.

Izotropic Corporation confirms pre-submission meeting with FDA for its CT imaging system, IzoView, on October 25, 2023.

Izotropic Corporation completes pre-submission application to FDA for market clearance of IzoView CT Imaging System as a Class II device. Plans to use pre-existing data for 510(k)-submission and aims for market clearance in the second half of 2024. Intends to secure collaborations with hospitals for generating clinical data. Switching to Class II pathway due to lower costs and shorter timeline. Selects CurveBeam HiRise and NeuroLogica OmniTom as predicate devices. Proceeding confidently with Class II 510(k) pathway.

Izotropic Corporation modifies its FDA market approval pathway for IzoView, a breast imaging system, by deferring Class III device classification and pursuing Class II regulatory clearance. The modified strategy is expected to shorten the approval timeline, save $10+ million in investment, and provide broader intended use for clinicians.