Izotropic's U.S. FDA Regulatory Pathway Greenlit, Company Provides Corporate Update

- Regulatory alignment with FDA confirmed, clearing path to pivotal U.S. clinical trial -

- 150-page strategic business plan and advanced financial models completed -

- Investor outreach launched to fund clinical execution and market entry -

Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - May 16, 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 further to its March 25^th press release, it has confirmed alignment with the U.S. Food and Drug Administration ("FDA") on its regulatory strategy for the IzoView Breast CT Imaging System, ("IzoView"), finalized an updated business plan and financial model, and is now actively engaged in financing meetings to support its planned U.S.-based clinical study for market authorization.

In March 2025, the Company held a pre-submission meeting with the FDA to review its proposed regulatory pathway for IzoView. Following the meeting, the Company submitted formal meeting minutes, which were reviewed, amended, and finalized by the FDA, confirming alignment on both the regulatory strategy and overall clinical study design. With this alignment in place, and subject to financing, the Company will finalize the full clinical study protocol (building on the synopsis previously submitted) and initiate its U.S. clinical study for market authorization. Preparations will run in parallel with the manufacturing and deployment of IzoView units for the clinical study.

Izotropic has completed a 150-page strategic business plan that articulates a data-driven roadmap for the commercialization of IzoView and outlines the Company's broader growth trajectory as a global medical imaging innovator. The plan provides detailed market intelligence, competitive positioning, clinical and regulatory execution frameworks, and tailored go-to-market strategies across priority U.S. and international healthcare markets. It also includes a forward-looking new product development roadmap, identifying key opportunities for IzoView platform expansions, future applications, and new imaging-based products. Complementing the business plan, Izotropic has finalized sophisticated financial modeling that integrates multi-year projections, capital requirements, and scenario-based sensitivity analysis across various clinical and commercial settings. Together, these materials align Izotropic's clinical, regulatory, and commercial priorities under a cohesive strategic framework, enabling focused execution, informed capital deployment, and a structured transition into clinical operations and commercial readiness.

To support its current financing initiatives, the Company has developed a suite of targeted investor materials, including tailored pitch decks, fact sheets, and translated versions to facilitate engagement across international markets. These materials, derived from the strategic content of the business plan, are designed to address the priorities of sophisticated investors and institutional stakeholders. Izotropic has begun a focused series of presentations and discussions with high-net-worth individuals and qualified investment groups evaluating the opportunity to fund the full scope of its planned U.S. clinical study and commercialization strategy.

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/252517