Izotropic’s IzoView Positioned to Capitalize on Key Global Breast Imaging Market Drivers

- Global breast imaging market projected to reach $8.69 billion by 2030, with IzoView addressing key clinical and commercial trends driving demand

- Company positioned to lead in dense breast imaging, where rising incidence and new screening mandates are expanding access to advanced technologies

- IzoView optimized for AI-readiness, addressing a critical need as imaging centers adopt smart workflows and algorithmic support tools

VANCOUVER, British Columbia, and SACRAMENTO, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- via IBN -  Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) (“Izotropic”, or the “Company”), a medical device company commercializing innovative, emerging technologies and imaging-based products for the more accurate screening, diagnoses, and treatment of breast cancers, provides insight into the global market forces shaping breast cancer imaging and the unique advantages of its flagship device, the IzoView Breast CT Imaging System, (“IzoView”).

Breast cancer remains the most commonly diagnosed cancer among women globally, with more than 2.3 million new cases reported each year(1). In the U.S. alone, breast cancer is expected to be diagnosed in over 315,000 cases in 2025(2), representing nearly one in three new cancer diagnoses in women. As more women enter the screening-eligible age range and the population continues to age, the burden on healthcare systems and screening infrastructure is intensifying. This rising disease burden corresponds with strong market growth projections for breast imaging technologies. The total global market is expected to grow from USD $5.4B in 2024 to $8.69B in 2030(3) (CAGR 8.25%), with the U.S. market expanding from $1.0B to $1.55B(4) in the same period (CAGR 7.57%).

This growth is fueled by advances in technology, regulatory shifts, and a rising need for more personalized and effective screening in populations with dense breast tissue, a group representing approximately 50% of women(5).

The future of breast cancer imaging is focused on enhanced accuracy, efficiency, and accessibility. With continued advancements in AI, 3D imaging, contrast-enhanced techniques, and personalized screening strategies, the industry is moving toward earlier and more precise detection, to enable better patient outcomes and higher survival rates. As awareness grows around breast density as a risk factor that can reduce the effectiveness of certain imaging modalities, patients and providers alike are increasingly seeking alternatives to conventional 2D mammography. This trend is contributing to broader clinical acceptance of modalities such as digital breast tomosynthesis (“DBT”, a pseudo-3D version of mammography), ultrasound, contrast-enhanced mammography, and MRI, all of which have demonstrated improved effectiveness in dense breast tissue over traditional mammography.

Patient experience is also playing a growing role in technology adoption, with demand rising for non-compressive, faster, and more comfortable imaging procedures that increase screening compliance and streamline workflows. These expectations are reshaping purchasing decisions in imaging centers and hospitals, as radiology departments prioritize systems that align with both clinical performance and operational efficiency, while also fitting within diverse budget constraints and resource environments; imaging technologies must deliver value not only through accuracy and high-value clinical data, but also through affordability, scalability, and adaptability across settings ranging from high-volume academic centers to under-resourced community clinics.

The following chart shows global growth projections by breast imaging modality. Figures are in millions of U.S. dollars (USD).

(1), (2), (3) (2025). Breast Imaging Market Global Forecast 2025-2030. 360i Research.

The shift toward risk-adapted, personalized screening strategies is further accelerating the demand for advanced imaging technologies. Uniform screening guidelines are shifting toward stratified protocols that consider breast density, family history, and genetic risk. This has led to an increase in supplemental imaging, particularly with ultrasound and contrast-enhanced modalities, for women whose cancers are more likely to be missed by mammography alone, which fails to detect approximately 20% of breast cancers present at the time of screening(6). In response, governments and payers are adjusting policy frameworks to support early detection initiatives. In the U.S., Food and Drug Administration (“FDA”)-mandated regulations now require providers to inform patients of their breast density, and 38 states have mandated insurance coverage for supplemental screening(7). Similar policy developments are occurring globally. These regulatory shifts are removing financial and administrative barriers to adoption, opening new reimbursement channels, and creating an environment more favorable to the commercialization of advanced technologies.

As these patient and policy-driven changes continue to unfold, the adoption of AI is playing a pivotal role in enabling scalable and efficient delivery of advanced breast imaging. AI is increasingly integrated across imaging workflows to enhance interpretation, reduce reading time, and standardize reporting, particularly in settings where radiologist access is limited or current imaging tools lack sensitivity and specificity. These enhancements are also helping to compensate for known limitations in current technologies, offering a layer of analytical assistance to help streamline the diagnostic process. Since the beginning of 2025 alone, the FDA has approved over 100 AI algorithms in radiology(8), underscoring the pace of validation and integration of these technologies into clinical practice. AI-powered systems further facilitate predictive analytics, allowing providers to assess individualized cancer risk by integrating genetic data, imaging findings, and clinical history. However, the effectiveness of these algorithms relies heavily on the quality of the imaging data used for training and application, reinforcing the critical need for high-resolution, three-dimensional modalities capable of capturing the anatomical detail required for robust AI analysis. As imaging centers modernize, AI is becoming an essential component of new breast imaging systems, elevating performance while optimizing resources.

The projected growth across imaging modalities clearly reflects the impact of these converging trends. DBT is forecasted to grow from USD ~$950 million in 2024 to USD  ~$1.71 billion in 2030 (CAGR 10.28%), driven by its improved detection capabilities over traditional mammography and compatibility with current workflows. Similarly, breast ultrasound, including automated and handheld systems, is projected to reach USD ~$1.98 billion (CAGR 8.85%), supporting its continued role as a cost-effective adjunctive imaging tool. Molecular breast imaging, while still more niche using gamma radiation for functional imaging, is projected to grow at a CAGR of 9.34%  as it finds targeted use in problem-solving diagnostics versus screening for breast cancers. Demand for contrast-enhanced mammography (CAGR 8.79%), which is not simply the addition of contrast to existing mammography systems, but a dedicated device category, is rising along with breast MRI (CAGR 9.11%), aligning with the shift toward personalized, high-sensitivity imaging. Collectively, these growth rates across the 2024-2030 period reflect increasing reliance on modalities that enable greater diagnostic accuracy and improved patient experience. As healthcare systems push toward more precise and patient-centered care, these technologies are projected to capture growing clinical and commercial demand.

Notably, the “Other” category, which includes new technologies such as dedicated breast CT systems like IzoView, is projected to grow faster than any other segment at CAGR 11.15%. This signals a clear appetite for next-generation solutions that deliver the strengths of existing modalities while overcoming their limitations. Two other breast CT systems are currently on the market, both representing early commercial entries into the modality. Correcting figures initially released, based on non-public sources provided to the Company, these devices are priced at up to USD $1.2 million and USD $1.5 million. In comparison, these devices are 140-200% more expensive than IzoView’s target sales price of USD $500K(9).

IzoView is directly aligned with the industry trends driving demand. Designed as a dedicated platform, IzoView addresses the specific needs of patients, providers, and payers in a market undergoing structural transformation.

Its initial planned Indication for Use, as a contrast-enhanced screening adjunctive to DBT in asymptomatic women with dense breast tissue, targets one of the most underserved and fastest-growing segments in breast imaging. IzoView delivers true 3D imaging of the breast in its natural, uncompressed state, eliminating the tissue overlap and distortion that can limit the sensitivity of mammography and DBT in dense tissue.

In clinical scenarios such as high-risk screening, where MRI is currently the preferred modality, IzoView offers potential advantages, including spatial image resolution approximately 100x greater than MRI. Clinical trials conducted at UC Davis Medical Center, where the foundational breast CT technology was developed and for which Izotropic holds the exclusive global rights, have demonstrated that the diagnostic performance of contrast-enhanced breast CT is comparable to MRI, and have suggested that contrast-enhanced breast CT may enable more accurate margin analysis, improved lesion characterization, and superior visualization of microcalcifications(10).

IzoView is engineered to align with the shift toward personalized imaging and individualized screening protocols. Izotropic’s patent portfolio includes the only U.S. patents for measuring breast density using breast CT technology, an assessment currently limited to mammography, as well as the only U.S. patent for performing biopsy using breast CT technology. Breast CT-based density measurements may enable more personalized screening pathways, contributing to tailored care decisions based on individual risk profiles.

As expectations rise for imaging systems to deliver more than one-size-fits-all solutions, IzoView’s patented and patent-pending features position it as a forward-looking platform built for the evolving standard of care, with more advancements to be announced. Izotropic’s intellectual property portfolio is strategically layered, securing the platform across its most commercially and clinically significant dimensions. IP extends beyond imaging hardware to include integrated capabilities such as image acquisition, data presentation, system usability, radiation safety, and workflow integration, reflecting IzoView’s potential as a complete breast health solution.

The portfolio includes foundational patents and new filings, with protections extending into the 2040s, as well as key innovations like Izotropic’s proprietary deep machine-learning reconstruction algorithm, held as a trade secret. IzoView is uniquely positioned to support 14 potential future Indications for Use in its current form, across five key areas of breast health: screening, diagnosis, monitoring, planning, and personalized medicine. Many of these expanded indications can be enabled with new clinical studies and delivered through software upgrades, allowing early adopters to increase IzoView’s clinical utility without replacing the core system, supporting long-term expansion, platform extensibility, and a recurring revenue model.

IzoView is also uniquely equipped to support the integration of artificial intelligence into breast imaging workflows- a market driver accelerating clinical adoption across the radiology landscape. IzoView’s high-resolution volumetric outputs are precisely the type of inputs required to supercharge advanced image analysis tools. Unlike modalities constrained by compression-induced distortion or variable operator skill levels, IzoView’s true 3D data acquisition can provide the consistency and anatomical detail necessary to unlock the full potential of AI applications. This positions IzoView as a data-rich platform aligned with the evolving direction of radiology: toward predictive analytics, clinical decision support, and workflow automation to reduce diagnostic error, elevate throughput, and enable more personalized care. As imaging centers modernize and new reimbursement pathways support the deployment of AI-driven tools, IzoView’s compatibility with machine learning ecosystems strengthens its commercial relevance in a market defined by the convergence of imaging hardware and intelligent software.

The IzoView experience itself is designed to meet growing expectations around comfort and convenience. IzoView eliminates breast compression and enables a fast, 10-second, contact-free exam, which could improve patient compliance while increasing screening throughput. These advantages are becoming gradually more important as patient satisfaction metrics influence institutional purchasing decisions.

IzoView’s inclusion in the highest-growth modality category is not incidental. It reflects the system’s alignment with what modern imaging stakeholders need. By integrating high-resolution 3D imaging, the groundwork for personalized scanning, AI-readiness, and operational scalability into a single platform, IzoView is engineered for today’s challenges and tomorrow’s care models.

It is not simply entering the market. IzoView is positioned to define a new standard in breast imaging.

Sources:

1. (2024, March 13). Breast cancer. World Health Organization. Retrieved February 1, 2025, from https://www.who.int/news-room/fact-sheets/detail/breast-cancer
2. (2025, May 5). Key Statistics for Breast Cancer. American Cancer Society. https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html

3. (2025). Breast Imaging Market Global Forecast 2025-2030. 360i Research.

4. (2025). Breast Imaging Market Global Forecast 2025-2030. 360i Research.

5. (2024, December 9). Dense Breasts: Answers to Commonly Asked Questions. National Cancer Institute. Retrieved July 24, 2025, from https://www.cancer.gov/types/breast/breast-changes/dense-breasts

6. (2023, February 21). Mammograms. National Cancer Institute. Retrieved July 16, 2025, from https://www.cancer.gov/types/breast/mammograms-fact-sheet

7. (2025, June 4). Expanded Breast Imaging Insurance Coverage by State. DenseBreast-Info.org. Retrieved July 30, 2025, from https://densebreast-info.org/wp-content/uploads/2025/06/DBI-INSURANCE-TABLE060425.pdf

8. Murphy, H. (2025, July 10). Over 100 AI-enabled radiology algorithms added to FDA's list of approvals. HealthImaging. Retrieved July 15, 2025, from https://healthimaging.com/topics/healthcare-management/healthcare-policy/over-100-ai-enabled-radiology-algorithms-added-fdas-list-approvals?utm_source=newsletter&utm_medium=hi_news_alert

9. Correction: Izotropic Corporation (July 29, 2025). Izotropic's IzoView Breast CT Device Stands Distinct vs Existing Breast Imaging Technologies. [Press Release]. https://www.investorwire.com/newsarticle/?qmstory=5535744170701878

10. Aminololama-Shakeri S, et al. Dedicated Breast CT: Getting Ready for Prime Time. J Breast Imaging. 2024. https://doi.org/10.1093/jbi/wbad099

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.

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Telephone: 1-604-220-5031 or 1-833-IZOCORP ext. 1
Email:  bthast@izocorp.com

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