Mr. Robert Thast reports

IZOTROPIC'S U.S. FDA REGULATORY PATHWAY GREENLIT, COMPANY PROVIDES CORPORATE UPDATE

Further to the March 25 press release, Izotropic Corp. has confirmed alignment with the U.S. Food and Drug Administration on its regulatory strategy for the IzoView breast CT imaging system, has finalized an updated business plan and financial model, and is now actively engaged in financing meetings to support its planned United States-based clinical study for market authorization.

In March, 2025, the company held a presubmission 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 road map 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 health care markets. It also includes a forward-looking new product development road map, identifying key opportunities for IzoView platform expansions, future applications and new imaging-based products. Complementing the business plan, Izotropic has finalized sophisticated financial modelling that integrates multiyear 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 finance the full scope of its planned U.S. clinical study and commercialization strategy.

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