Izotropic Featured in Announcement of Research and Markets' U.S. Breast Cancer Analysis and Forecast

Rhea-AI Summary

Izotropic has been featured in Research and Markets' analysis of the U.S. breast cancer screening and diagnostic market. The report projects market growth from $1.55 billion in 2024 to $2.34 billion by 2030, with a 7.05% CAGR.

The company's IzoView Breast CT system offers true 3D breast imaging without compression, completing scans in 10 seconds with radiation doses comparable to 2-view mammography. This technology addresses limitations in current screening methods, particularly for dense breast tissue patients who comprise 50% of U.S. women. The system can detect lesions as small as 2mm when used with contrast enhancement, potentially offering 1¼ years earlier detection compared to traditional mammography, which typically finds 11mm tumors.

Digital breast tomosynthesis (DBT) currently leads the market with a 49.93% share as of 2023, though it still faces challenges in detecting cancers in dense breast tissue.

Positive

• Market opportunity validated by projected growth to $2.34B by 2030
• IzoView technology offers superior detection capability (2mm lesions vs 11mm in traditional mammography)
• Addresses unmet need in dense breast tissue screening (50% of U.S. women)
• Faster scanning time (10 seconds) with no breast compression

Negative

• Product not yet FDA approved
• Entering market dominated by established DBT technology (49.93% market share)

- Company listed in Research and Markets' announcement and description of new research report on the U.S. Breast Cancer Screening and Diagnostic Market-

- "U.S. breast cancer screening and diagnostic [device] market was valued at $1.55 billion in 2024 and is anticipated to reach $2.34 billion by the end of 2030, at a CAGR of 7.05% during the forecast period 2024-2030¹"-

-Report supports Company's regulatory strategy for IzoView Breast CT, reinforces high demand for new breast imaging modalities, strengthens the potential for rapid market adoption and significant market share -

Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - January 17, 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 it has been featured in a press release from Research and Markets ("R&M"), "the world's largest market research store with clients all over the world, including 450+ of the Fortune 500 [companies]²".

The press release and report description featuring Izotropic highlight R&M's new report analyzing the U.S. breast cancer screening and diagnostic market, with forecasts extending through 2030. Their analysis suggests a robust and steady growth rate in the market sector from $1.55 billion to $2.34 billion in 2030 at a compound annual growth rate (CAGR) of 7.05%, underscoring the Company's appropriate timing to pursue regulatory authorization and the strategic positioning of its first medical imaging device, IzoView- a disruptive device offering ultra-high-resolution, true 3D, dedicated breast CT imaging, indicated for breast cancer screening adjunctive to digital breast tomosynthesis ("DBT", also known as 3D mammography) for patients with dense breast tissue.

R&M reports that "the U.S. breast cancer screening and diagnostic, image-based market was led by the digital breast tomosynthesis segment, which held a 49.93% share in 2023 [and that the] rising adoption of digital breast tomosynthesis reflects a strong demand for advanced breast cancer screening technologies. DBT is particularly effective in improving detection rates for women with dense breast tissue, making it a vital tool for early diagnosis³."

DBT, like traditional mammography, is a breast compression-based imaging device that uses software and 15-50-degree image acquisition (depending on the make and model of the machine) to generate slightly 3D images from a series of x-ray images acquired in 2D. It is due to the greater range and angles of image acquisition that studies have confirmed that DBT has a "higher sensitivity than digital mammography and at least as high specificity⁴". Unfortunately, compression-based breast imaging devices are less effective in patients with dense breast tissue, a patient characteristic present in 50% of the women in the U.S. Both dense breast tissue and suspicious lesions and tumors appear white on compression-based breast images, and the density of the tissue itself can overlap under compression creating imaging artifacts that can mimic the appearance of cancer and mask cancers within the dense tissue itself. Due to the limitations of compression-based imaging devices, studies have shown that DBT still produces false negative results and that women with extremely dense breast tissue are predisposed to missed cancers on DBT screening⁵.

Despite the increased detection capabilities and wide adoption of DBT noted in the report, the U.S. Food and Drug Administration has mandated reporting of a patient's breast density information on their breast cancer screening results⁶, and some states additionally require a statement recommending women discuss the option of supplemental screening with ultrasound or MRI due to dense breasts with their primary care clinicians. The unmet need for the dense-breasted patient population is so high that even the U.S. Preventative Services Task Force is "urgently calling for more research on whether and how additional screening might help women with dense breasts find cancers earlier⁷."

IzoView Breast CT provides a clear solution to fill the gaps in the breast imaging device market, and is seeking regulatory authorization at a time when the clinical and market forecast data dictates a high degree of market readiness, acceptance, and a high likelihood of rapid adoption, given how quickly DBT was adopted and its large market share captured by providing increased detection capabilities with slightly 3D compression-based breast imaging.

The IzoView Breast CT Imaging System produces true 3D breast images with 360-degree image acquisition in a 10-second scan without breast compression, and a radiation dose comparable to 2-view mammography. Approximately 500 images are acquired (depending on the length of the breast) and are reconstructed into a 3D model within 30 seconds that a radiologist can then view from any angle like a 3D model or slide through the 500 cross-sectional images individually to more accurately determine the size, shape and location of an abnormality, as well as its relation to other internal breast structures.

When used with contrast enhancement in research trials, breast CT may find lesions and tumors in the 2mm size range⁸. Compared to the average-sized 11mm tumor found on screening mammography⁹ and considering that the average growth rate of breast cancers results in their doubling in size every 6 months¹⁰, breast CT may offer approximately 1 ¼ (one and one quarter) years earlier detection of breast cancers.

The Company looks forward to being the subject of a research report in the future when IzoView Breast CT has been progressively adopted and Izotropic has become a leader in breast cancer screening and diagnostic imaging device sales.

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.

Contacts:

Robert Thast
Interim Chief Executive Officer
Telephone: 1-604-220-5031 or 1-800-IZOCORP ext. 3
Email: bthast@izocorp.com

General Inquiries
Telephone: 1-604-825-4778 or 1-800-IZOCORP ext. 1
Email: info@izocorp.com

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Sources:

¹ (2025, January 16). U.S. Breast Cancer Screening & Diagnostic Market Analysis and Forecast 2024-2030 - Multi-Modality Imaging Revolutionizes Breast Cancer Diagnostics, Boosting Detection Accuracy. Research and Markets. Retrieved January 16, 2025, from https://www.globenewswire.com/news-release/2025/01/16/3010562/0/en/U-S-Breast-Cancer-Screening-Diagnostic-Market-Analysis-and-Forecast-2024-2030-Multi-Modality-Imaging-Revolutionizes-Breast-Cancer-Diagnostics-Boosting-Detection-Accuracy.html

² (2025, January 16). Why We're Different We Make Intelligent Decisions Happen. Research and Markets. Retrieved January 16, 2025, from https://www.researchandmarkets.com/about-us

³ (2025, January 16). U.S. Breast Cancer Screening & Diagnostic Market Analysis and Forecast 2024-2030 - Multi-Modality Imaging Revolutionizes Breast Cancer Diagnostics, Boosting Detection Accuracy. Research and Markets. Retrieved January 16, 2025, from https://www.globenewswire.com/news-release/2025/01/16/3010562/0/en/U-S-Breast-Cancer-Screening-Diagnostic-Market-Analysis-and-Forecast-2024-2030-Multi-Modality-Imaging-Revolutionizes-Breast-Cancer-Diagnostics-Boosting-Detection-Accuracy.html

⁴ Rosenqvist, S., Brännmark, J. & Dustler, M. Digital breast tomosynthesis in breast cancer screening: an ethical perspective. Insights Imaging 15, 213 (2024). https://doi.org/10.1186/s13244-024-01790-w

⁵ (2023). 2023 ARRS Annual Meeting- Abstracts. ARRS. Retrieved December 2, 2024, from https://apps.arrs.org/AbstractsAM23Open/Main/Abstract/2618

⁶ (2023, March 9). FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight. U.S. Food and Drug Administration. Retrieved January 7, 2025, from https://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance

⁷ (n.d.). Breast Cancer: Screening, Frequently Asked Questions. U.S. Preventative Services Task Force. Retrieved January 2, 2025, from https://www.uspreventiveservicestaskforce.org/uspstf/faqs/final-faq-document/breast-cancer-screening

⁸ [Izotropic Corporation]. (2023, March 6). Micro-calcifications, Smaller Cancers, Biopsies & more with Breast CT! [Video]. Https://www.Youtube.com. https://youtu.be/_Ip7xErSWgA?si=b9GBAekib6wPokVn

⁹ Eldridge, L. E. M., MD, & Paul, D., MD (2024, September 19). How Fast Does Breast Cancer Start, Grow, and Spread?VeryWellHealth. Retrieved December 6, 2024, from https://www.verywellhealth.com/breast-cancer-growth-rate-4175666

¹⁰ Morgan, K. K., & Ratini, M., MS, DO (2024, March 7). How Fast Does Breast Cancer Grow? WebMD. Retrieved December 6, 2024, from https://www.webmd.com/breast-cancer/breast-cancer-how-fast-grows

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/237547

FAQ

What is the projected market size for breast cancer screening devices by 2030 affecting IZOZF?

The U.S. breast cancer screening market is projected to reach $2.34 billion by 2030, growing at a CAGR of 7.05% from $1.55 billion in 2024.

How does Izotropic's IzoView Breast CT scanning time compare to traditional methods?

IzoView Breast CT completes scans in 10 seconds, producing approximately 500 images that are reconstructed into a 3D model within 30 seconds.

What advantage does IZOZF's IzoView technology offer in tumor detection size?

When used with contrast enhancement, IzoView can detect lesions as small as 2mm, compared to traditional mammography's average detection size of 11mm tumors.

What percentage of the U.S. breast cancer screening market does DBT currently hold?

Digital Breast Tomosynthesis (DBT) held a 49.93% share of the U.S. breast cancer screening and diagnostic market in 2023.

How many U.S. women could benefit from IZOZF's dense breast tissue screening technology?

50% of women in the U.S. have dense breast tissue, representing the target market for IzoView's enhanced screening capabilities.