Izotropic Marks Breast Cancer Awareness Month by Highlighting Gaps in Care and the Need for IzoView Breast CT

Rhea-AI Summary

Izotropic (OTCQB: IZOZF) highlighted gaps in current breast imaging during Breast Cancer Awareness Month and positioned its IzoView Breast CT as a dedicated, true 3D adjunct for screening asymptomatic women with dense breasts. The company cited screening limits: ~20% cancers missed at mammography, 10–12% false negatives, and up to 50–60% of women experiencing a false positive within 10 years. Izotropic described IzoView as acquiring ~500 high-resolution images in ~10 seconds, reconstructing a true 3D volume, and targeting a device sales price of USD $500,000. The firm referenced market growth from USD $5.4B (2024) to $8.69B (2030, CAGR 8.25%) and research claims of breast CT offering markedly higher spatial resolution than MRI.

Positive

• Target device price of USD $500,000
• Acquires ~500 images per exam in ~10 seconds
• Initial screening indication adjunctive for dense-breast patients
• Market projected from $5.4B (2024) to $8.69B (2030) (CAGR 8.25%)
• Research-reported spatial resolution ~100x greater than MRI

Negative

• Initial Indication limited to asymptomatic women with dense breasts
• No FDA clearance date or commercial launch timeline disclosed
• Target device price of USD $500,000 may constrain some buyers

VANCOUVER, British Columbia, and SACRAMENTO, Calif., Oct. 08, 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, marks Breast Cancer Awareness Month by underscoring the persistent limitations in current breast cancer imaging tools and the significant commercial and clinical opportunity for the Company’s flagship device, the IzoView Breast CT Imaging System.

The Problem & Unmet Need

Breast cancer remains the most commonly diagnosed cancer among women globally, with more than 2.3 million new cases reported each year. In the U.S. alone, breast cancer is expected to be diagnosed in over 315,000 cases in 2025, 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 (CAGR 8.25%).

There is a clear unmet need for high-resolution, true 3D imaging modalities, especially for women with dense breast tissue, a patient characteristic affecting approximately 50% of women that reduces the effectiveness of compression-based screening. Studies indicate that approximately 20% of breast cancers present at the time of screening mammography are missed, 10–12% of screenings return false negatives, and 50–60% of women can expect at least one false positive after 10 years of annual screening, contributing to unnecessary anxiety and an estimated USD $8 billion in follow-up imaging and diagnostic procedure costs after initial mammography annually in the U.S.

In 2024, the FDA enforced a new mandate that all U.S. screening facilities inform women about their breast density with their mammography results. Some states additionally require a statement recommending that women discuss the option of supplemental screening with ultrasound or MRI due to dense breasts with their primary care clinicians.

The U.S. Preventive Services Task Force has also issued an urgent call for more research on whether and how additional screening might help women with dense breasts find cancers earlier.

Limitations of Current Modalities

Compression-based mammography and DBT remain the primary screening tools, but their sensitivity decreases in women with dense breast tissue, where overlapping structures under compression can obscure lesions. While studies show DBT has higher sensitivity than digital mammography, it still produces false negatives, and women with extremely dense breasts are predisposed to missed cancers.

Ultrasound is often used as a supplemental tool in dense breasts, but it can yield high false-positive rates and is operator-dependent. Automated ultrasound devices aim to reduce operator-dependency; however, abnormalities still require verification by handheld ultrasound, adding steps to the workflow. Contrast-enhanced mammography is a dedicated system intended to compensate for 2D, compression-based limitations with contrast, but it cannot provide the same high-value clinical information as true 3D imaging.

Breast MRI is highly sensitive as the current gold standard for 3D breast imaging, but it is costly and time-consuming, and because it returns high false positive rates, it is generally reserved for high-risk patients.

The IzoView Breast CT Solution

IzoView is a dedicated Breast CT imaging system, intended to launch with an initial Indication for Use for breast cancer screening adjunctive to digital breast tomosynthesis in asymptomatic women with dense breast tissue. Exams are performed with the patient lying face down without breast compression. The system acquires approximately 500 high-resolution images in about 10 seconds (depending on breast length) and reconstructs a true 3D breast volume that radiologists can review from any angle or by scrolling cross-sectional slices. In research trials breast CT technology founded at UC Davis and exclusively licensed to Izotropic, malignant masses have been shown to be more conspicuous on contrast-enhanced breast CT than mammography and DBT, while offering spatial resolution approximately 100x greater than MRI. Positioned to bridge the gap between DBT and MRI, and with a target device sales price of USD $500K, IzoView can address the unmet need  for advanced breast cancer imaging tools at a price point intended to support adoption across a broad range of imaging environments with varying resource capabilities.

Breast Cancer Awareness Month underscores that today’s screening tools still leave important gaps, particularly for women with dense breast tissue. Regulators and guideline bodies are directing attention to these challenges, and the growing burden on screening infrastructure highlights the need for new imaging approaches that deliver true 3D information without breast compression. Izotropic sees a clear role for dedicated breast CT as part of a more effective screening pathway. 

This month, Izotropic acknowledges the patients, families, and clinicians affected by breast cancer and reiterate our commitment to developing tools intended to enable earlier detection and better care. 

About Izotropic:

More information about Izotropic Corporation can be found on its corporate website at izocorp.com, its educational website at breastct.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 1-833-IZOCORP ext. 1
Email:  bthast@izocorp.com

James Gagnon, International Communications
Telephone: 1-604-780-7576 or 1-833-IZOCORP ext. 2
Email: jgagnon@izocorp.com

General and Corporate Inquiries
Telephone: 1-604-825-4778 or 1-833-IZOCORP ext. 3
Email: info@izocorp.com

Corporate Communications
IBN
Austin, Texas
www.InvestorBrandNetwork.com
512.354.7000 Office
Editor@InvestorBrandNetwork.com

FAQ

What indication will Izotropic's IzoView breast CT target at launch (IZOZF)?

IzoView targets an initial indication as an adjunctive screening tool to DBT for asymptomatic women with dense breasts.

How fast is an IzoView exam and how many images does it capture?

The system acquires approximately 500 high-resolution images and reconstructs a 3D breast volume in about 10 seconds (depending on breast length).

What is Izotropic's target device sales price for IzoView (IZOZF)?

Izotropic cited a target device sales price of USD $500,000 intended to support broader adoption.

How does Izotropic describe IzoView's image resolution versus MRI?

The company cited research reporting breast CT spatial resolution approximately 100x greater than MRI for malignant mass conspicuity.

What market growth does Izotropic cite for breast imaging?

The company referenced a projected market increase from $5.4B in 2024 to $8.69B in 2030 (CAGR 8.25%).

Does Izotropic provide a commercial launch date or regulatory approval timeline for IzoView?

No specific FDA clearance date or commercial launch timeline was disclosed in the announcement.