FDA Sets Meeting Date with Izotropic

Rhea-AI Summary

Izotropic (OTCQB: IZOZF) announces that the FDA has scheduled a pre-submission meeting for March 20, 2025, regarding the clinical study design for its IzoView Breast CT Imaging System. The company plans to launch IzoView with contrast-enhancement as an adjunctive screening tool to 3D mammography, specifically targeting patients with dense breast tissue.

Dense breast tissue, affecting approximately 50% of U.S. women, is both a risk factor for breast cancer and makes standard screening methods less effective. The technology, developed at UC Davis Medical Center, has demonstrated promising results through four successive breast CT systems tested in clinical trials. Izotropic holds exclusive global licensing rights to this technology, which has been supported by peer-reviewed scientific research.

Positive

• FDA pre-submission meeting date confirmed for March 20, 2025
• Technology targets large market with ~50% of U.S. women having dense breast tissue
• Exclusive global licensing rights secured from UC Davis
• Technology de-risked through four successive clinical trials
• Substantial peer-reviewed research supporting technology capabilities

Negative

• Product still pending FDA approval
• Timeline to market launch remains uncertain

Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - February 19, 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, announces that the U.S. Food and Drug Administration ("FDA") has set the Company's pre-submission meeting date, further to its January pre-submission filing.

The Company filed a pre-submission with the FDA on the subject of its clinical study design for the approval of its first medical imaging device, the IzoView Breast CT Imaging System ("IzoView"). The FDA has scheduled the pre-submission meeting for March 20, 2025.

Izotropic intends to launch IzoView with contrast-enhancement for breast cancer screening adjunctive to digital breast tomosynthesis, commonly referred to as 3D mammography, for patients with dense breast tissue. Dense breast tissue is both a risk factor for developing breast cancer and a patient characteristic that affects ~50% of the women in the U.S. Dense breast tissue makes the current standard-of-care breast cancer screening modalities less effective at detecting cancers. Contrast-enhanced breast CT has proven more than promising in research studies at UC Davis Medical Center ("UC Davis") in Sacramento, California, where the technology was founded and from which Izotropic has the exclusive global licensing rights. Four successive breast CT systems have been built and tested in clinical trials for research purposes at UC Davis, funded primarily by U.S. government grants, resulting in a fully de-risked technology with a large volume of published, peer-reviewed scientific research supporting its capabilities and potential.

Izotropic is committed to its mission to bring new devices and technologies to the market and will continue to seek out opportunities to increase efficiency and expedite patient access to its products to achieve better outcomes for patients and save lives from breast cancer.

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:
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/241425

FAQ

When is Izotropic's (IZOZF) FDA pre-submission meeting for IzoView scheduled?

The FDA pre-submission meeting for IzoView is scheduled for March 20, 2025.

What percentage of U.S. women could benefit from Izotropic's (IZOZF) IzoView system?

Approximately 50% of U.S. women have dense breast tissue and could potentially benefit from the IzoView system.

What is the primary target market for Izotropic's (IZOZF) IzoView system?

IzoView targets patients with dense breast tissue as an adjunctive screening tool to 3D mammography.

How many clinical trials has Izotropic's (IZOZF) breast CT technology undergone at UC Davis?

The technology has been tested through four successive breast CT systems in clinical trials at UC Davis Medical Center.

What type of licensing rights does Izotropic (IZOZF) hold for the breast CT technology?

Izotropic holds exclusive global licensing rights to the breast CT technology developed at UC Davis Medical Center.