• Izotropic’s IzoView Breast CT Imaging System represents a breakthrough in dedicated breast imaging technology, addressing persistent limitations in conventional screening methods through proprietary hardware and software
• FDA regulatory pathway alignment clears the path for a pivotal U.S. clinical study, with the company completing a comprehensive 150-page strategic business plan and advanced financial modeling for commercialization
• Strategic awareness initiatives including dedicated breastct.com platform and podcast series position the company for market education as breast CT technology emerges as the next generation of cancer detection

The medical community stands at the threshold of what could become the most significant advancement in cancer detection since the introduction of mammography over half a century ago. While survival rates for many cancers have improved dramatically through better treatments, the fundamental challenge of early detection remains largely unchanged. Current screening technologies, despite decades of refinement, still miss cancers in their earliest, most treatable stages, while simultaneously generating false positives that lead to unnecessary anxiety and interventions.

This detection gap represents more than a technological limitation; it reflects a fundamental constraint in how we approach cancer screening. Traditional imaging methods were technologies designed for general diagnostic purposes and later adapted for cancer detection, creating inherent compromises in sensitivity, specificity, and patient experience. The result is a screening paradigm that, while valuable, leaves substantial room for improvement in the precise detection capabilities needed to identify cancers when they are most curable.

Recent advances in computational imaging, artificial intelligence, and dedicated diagnostic hardware have converged to create unprecedented opportunities for purpose-built cancer detection systems. Unlike incremental improvements to existing technologies, these innovations enable entirely new approaches to imaging that can detect abnormalities with greater precision while reducing both missed cancers and false positives.

The potential impact extends beyond improved detection rates to fundamentally changing the cancer care paradigm from treatment-focused to prevention-focused, where early identification enables intervention before cancers progress to advanced stages.

That transformation potential is exactly what Izotropic (CSE: IZO) (OTCQB: IZOZF) is pursuing through its development of dedicated breast imaging technology designed specifically for next generation cancer detection.

Purpose-Built Technology Addresses Fundamental Screening Limitations

Izotropic’s competitive advantage lies in its commitment to developing CT imaging technology, specifically engineered for breast applications while addressing limitations of general-purpose and legacy screening systems. Breast CT Imaging System represents a ground-up approach to breast imaging, incorporating proprietary hardware innovations and software elements, and is optimized for next-generation AI integrations specifically for breast cancer detection.

The dedicated breast CT approach offers several advantages over conventional mammography and even competing breast imaging technologies. By utilizing three-dimensional imaging capabilities specifically designed for breast tissue analysis, IzoView can potentially identify abnormalities that traditional two-dimensional mammography might miss due to tissue overlap or density masking.

Izotropic’s exclusive worldwide licensing agreement with the Regents of the University of California provides the foundation for this technological approach. The revised licensing agreement, requiring FDA approval or a foreign equivalent by specified timelines aligned with the Company’s commercialization plans, demonstrates the company’s commitment to bringing this technology through regulatory approval and into clinical practice.

Regulatory Pathway Validation Enables Clinical Advancement

Izotropic’s confirmation of regulatory alignment with the FDA represents a critical milestone that positions the company for clinical study initiation and eventual market authorization. The pre-submission meeting process and formal meetings on regulatory strategy and clinical study design provide the framework needed to advance IzoView through the approval process.

This regulatory clarity is particularly significant given the complexity of medical device approval pathways. FDA alignment on both regulatory strategy and clinical study design reduces uncertainty around the approval process while providing a clear roadmap for the clinical evidence needed to demonstrate safety and efficacy.

The company’s completion of a comprehensive 150-page strategic business plan and sophisticated financial modeling demonstrates the depth of preparation for commercialization beyond regulatory approval. These materials integrate multi-year projections, capital requirements, and scenario-based analysis across various clinical and commercial settings, providing the strategic framework needed for successful market entry.

“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,” according to the company’s recent corporate update.

Market Education Strategy Builds Foundation for Adoption

Izotropic’s strategic awareness initiatives recognize that successful commercialization of breakthrough medical technology requires comprehensive market education alongside regulatory approval. The company’s multi-platform approach addresses different stakeholder groups with targeted information designed to build understanding and support for dedicated CT technology.

The forthcoming launch of breastct.com as a dedicated educational platform will evolve with the company as it progresses toward commercialization, ultimately providing a centralized resource for patients, clinicians, and advocates seeking information about breast CT technology and its advantages over conventional imaging methods. This educational foundation is essential for market adoption, as healthcare providers and patients need to understand the benefits of new imaging approaches to drive utilization.

The accompanying podcast series offers another communication channel for delivering updates on corporate developments, clinical milestones, and regulatory progress while providing context around broader trends in breast imaging and medical technology. This consistent communication approach helps build stakeholder engagement throughout the development and commercialization process.

These awareness efforts complement the company’s investor outreach initiatives, which utilize tailored materials derived from the strategic business plan to engage sophisticated investors and institutional stakeholders interested in funding clinical studies and commercialization strategy.

Positioning for Transformational Impact

Izotropic’s development of purpose-built breast imaging technology positions the company at the forefront of what could become a fundamental shift in cancer detection capabilities. As the medical community increasingly recognizes the limitations of conventional screening approaches, dedicated imaging technologies designed specifically for cancer detection offer the potential for significantly improved outcomes.

The combination of proprietary technology development, regulatory pathway clarity, comprehensive commercialization planning, and strategic market education creates a foundation for successful advancement from clinical development through market adoption.

If successful, IzoView could represent more than an incremental improvement in breast imaging; it could exemplify the type of purpose-built imaging technology needed to make early-stage cancer detection significantly more effective, potentially transforming breast cancer from a treatment challenge to a prevention opportunity.

For more information, visit the company’s website at www.IzoCorp.com.

NOTE TO INVESTORS: The latest news and updates relating to IZOZF are available in the company’s newsroom at ibn.fm/IZOZF

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