Izotropic’s IzoView Breast CT the First in Category to Offer Patent-Pending Personalized Radiation Dose

Rhea-AI Summary

Izotropic (OTCQB: IZOZF) has announced a groundbreaking advancement for its IzoView Breast CT Imaging System, introducing the first-ever patent-pending radiation dose personalization feature in breast CT systems. The system utilizes a radiation-free optical pre-scan technology to customize radiation doses based on individual breast size and composition.

The innovation comes as the global breast imaging market is projected to grow from $5.4 billion in 2024 to $8.69 billion by 2030. IzoView is advancing through the FDA's Pre-Market Approval process and plans a dual-path strategy for both U.S. and European market entry, leveraging data from its upcoming U.S. clinical study for CE Mark submission.

Positive

• First-to-market with patent-pending personalized radiation dose technology for breast CT
• Technology eliminates manual dose selection, improving operational efficiency
• Dual regulatory strategy targeting both U.S. FDA approval and European CE Mark
• Exclusive global rights to breast CT technology developed through decades of research at UC Davis
• Aligned with growing breast imaging market projected to reach $8.69B by 2030

Negative

• FDA approval still pending and contingent on financing for clinical trials
• Commercial launch timeline dependent on successful completion of regulatory processes

- Patent-pending pre-scan technology enables custom radiation dose tailored to patient’s unique breast size and composition -

- Feature aligns with personalized medicine trends driving the global breast imaging device market size to USD $8.69 billion by 2030 -

- Integrated into the IzoView commercial model alongside modular engineering, compression-free imaging, and AI-driven image optimization -

VANCOUVER, British Columbia, and SACRAMENTO, Calif., Sept. 23, 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, announces the integration of a new patent-pending radiation dose personalization feature into its flagship device, the IzoView Breast CT Imaging System. This proprietary capability positions IzoView as the first breast CT system to offer real-time customized radiation dosing, using an integrated radiation-free optical pre-scan feature and proprietary software.

 Radiation Dose Personalization Engineered into IzoView Using Optical Pre-Scan

The optical pre-scan system captures a radiation-free image of the breast and uses it to calculate a personalized radiation dose, custom to each patient’s breast size. The system uses this pre-scan data and dose reference models developed at UC Davis Medical Center (“UC Davis”), where breast CT technology was founded and advanced through over two decades of academic research and clinical trials involving hundreds of patients. Izotropic holds the exclusive global rights to breast CT technology, and IzoView has been engineered as the commercial device model.

By eliminating the need for manual dose selection by a technician, the optical pre-scan system streamlines exam setup and contributes to operational efficiency. Combined with IzoView’s compression-free, contact-free design, the system is intended to enhance patient comfort and support compliance in both screening and diagnostic environments.

Market Trends Support Adoption of Personalized Breast Imaging Solutions

The introduction of patient-specific radiation dosing into IzoView supports a broader market shift toward personalized medicine, where screening protocols are increasingly adapted to reflect individual risk factors, including breast density, family history, and genetic predisposition. These trends are contributing to a global expansion of the breast imaging market, which is projected to grow from USD $5.4 billion in 2024 to USD $8.69 billion by 2030. This growth is being driven by rising breast cancer incidence, expanded reimbursement for supplemental screening in women with dense breast tissue, and the adoption of technologies that support individualized imaging protocols and intelligent automation. IzoView is ready to meet these demands following market authorization by delivering a device that now combines personalized radiation dosing with a proprietary deep-learning image reconstruction algorithm for image optimization without increasing radiation doses unlike other AI-based methods.

IzoView’s Regulatory Timeline Positioned to Support Global Commercial Entry

IzoView is advancing through a defined regulatory pathway under the U.S. FDA’s Pre-Market Approval process and has achieved alignment with the agency on a clinical study design through a pre-submission earlier this year. The Company is preparing to initiate its pivotal U.S.-based clinical study upon financing and will leverage data from the first 100 patients imaged in the U.S. for a European CE Mark submission. This dual-path strategy is designed to accelerate time to market while establishing IzoView’s presence in high-value healthcare regions, positioning the system as a next-generation platform that reflects the future of breast imaging through personalized care, workflow automation, and intelligent design.

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
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Editor@InvestorBrandNetwork.com

FAQ

What is unique about Izotropic's (IZOZF) new IzoView Breast CT technology?

IzoView is the first breast CT system to offer real-time customized radiation dosing using a radiation-free optical pre-scan feature and proprietary software that personalizes dose based on breast size and composition.

How does IzoView's radiation dose personalization system work?

The system uses an optical pre-scan to capture a radiation-free image of the breast, then calculates a personalized radiation dose based on the patient's breast size using dose reference models developed at UC Davis Medical Center.

What is the market potential for Izotropic's (IZOZF) breast imaging technology?

The global breast imaging market is projected to grow from $5.4 billion in 2024 to $8.69 billion by 2030, driven by rising breast cancer incidence and expanded reimbursement for supplemental screening.

What is the regulatory status of Izotropic's (IZOZF) IzoView system?

IzoView is currently advancing through the FDA's Pre-Market Approval process and plans to initiate a pivotal U.S. clinical study, while also pursuing European CE Mark approval using data from the first 100 U.S. patients.

What are the key benefits of IzoView's breast CT system?

IzoView offers compression-free imaging, personalized radiation dosing, AI-driven image optimization, and improved operational efficiency through automated dose selection.