Izotropic Completes Pre-Submission Meeting with FDA for Breast Cancer Screening Indication

Rhea-AI Summary

Izotropic (OTCQB: IZOZF) has completed its pre-submission meeting with the FDA on March 20, 2025, regarding its IzoView Breast CT Imaging System. The meeting focused on advancing the regulatory strategy for breast cancer screening indication.

The discussion involved key stakeholders including Izotropic's executive leadership, technical teams, medical advisors, and FDA representatives. Critical topics addressed included clinical protocol synopsis, radiation dose considerations, and the management of breast cancers detected by IzoView but not visible through digital breast tomosynthesis.

According to FDA Consultant Dr. Kyle Myers, the discussion was positive, with most of Izotropic's clinical data collection and study design approaches aligning with FDA expectations. Research indicates the technology's benefit in detecting additional cancers is approximately 10 times the relative risk from radiation exposure to patients.

Positive

• Technology shows 10x benefit-to-risk ratio in cancer detection
• Strong alignment between company's clinical approach and FDA expectations
• System capable of detecting tumors not visible through current technology

Negative

• Additional radiation exposure and contrast agent risks require careful consideration
• Complex workflow considerations for contrast-enhanced imaging of both breasts

- FDA meeting facilitated positive collaborative exchange -

- Key topics included the clinical study protocol synopsis, the benefits versus risks of contrast-enhancement, and the management of breast cancers found on IzoView Breast CT that are not visible on digital breast tomosynthesis -

- Izotropic to submit meeting minutes to the FDA prior to more detailed disclosure -

Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - March 25, 2025) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing imaging-based products utilizing innovative and emerging technologies for the more accurate screening, diagnoses, and treatment of breast cancers, is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025.

The purpose of the meeting was to discuss Izotropic's recent pre-submission filing and advance the regulatory strategy for its IzoView Breast CT Imaging System. Participants included Izotropic's executive leadership, technical and engineering teams, medical advisors, FDA and statistical consultants, and legal counsel, alongside FDA representatives. The meeting discussion facilitated a collaborative exchange with the FDA, allowing the Company to address the agency's questions and considerations while aligning on expectations for the indication for use and overall clinical study.

Key topics included the overall protocol synopsis, cumulative radiation dose, study patient populations, the number and types of participating clinical study sites, and detailed discussions surrounding contrast agent usage. Specific focus was given to the benefits of contrast-enhanced breast CT in improving breast cancer detection rates in patients with dense breast tissue balanced against the associated risks of additional radiation and iodinated contrast agents. The Company and the FDA further reviewed the expected scan times and workflow for contrast-enhanced imaging when both breasts are scanned in a screening environment. Discussions also covered the proposed protocol and management of lesions and tumors visible only on IzoView Breast CT and not on digital breast tomosynthesis, and how the reference standard or "truth" for these cases would be determined to support evaluation of radiologist performance.

Izotropic's FDA Consultant, Dr. Kyle Myers reflects on the discussion:

"I thought the Izotropic-FDA pre-submission discussion was very positive. Given the large number of points for which Izotropic's approach to the clinical data collection and study design are in alignment with the FDA's expectations, we were able to focus on a small number of remaining questions from the Agency. Having Dr. Martin Yaffe and Dr. John Boone lay out their consistent finding that the estimated benefit of this technology, in terms of the additional cancers found, is around 10 times the relative risk due to the radiation to the patients was a great place to close out the meeting."

For congruence and per the FDA's procedures, the Company will submit meeting minutes to the FDA for their review prior to additional disclosure.

About Izotropic:
More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR+ at sedarplus.ca.

Forward-Looking Statements:
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.

These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView has not yet been approved or cleared for sale.

Contacts:

Izotropic Corporation
Robert Thast
Interim Chief Executive Officer
Telephone: 1-604-220-5031 or 1-800-IZOCORP ext. 3
Email: bthast@izocorp.com

General Inquiries
Telephone: 1-604-825-4778 or 1-800-IZOCORP ext. 1
Email: info@izocorp.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/245948

FAQ

What was the outcome of IZOZF's FDA pre-submission meeting on March 20, 2025?

The meeting was successful with positive collaborative exchange, showing alignment between Izotropic's approach and FDA expectations for clinical data collection and study design.

What are the key benefits vs risks of IzoView Breast CT discussed with FDA?

Research shows the benefit of detecting additional cancers is approximately 10 times greater than the relative risk from radiation exposure to patients.

How does IZOZF's IzoView technology handle breast cancer detection in dense tissue?

IzoView uses contrast-enhanced breast CT imaging to improve cancer detection rates in dense breast tissue, balancing benefits against radiation and contrast agent risks.

What unique detection capabilities does IZOZF's IzoView Breast CT offer?

IzoView can detect certain lesions and tumors that are not visible on digital breast tomosynthesis, offering potentially enhanced detection capabilities.