Latest news with #IzoViewBreastCTImagingSystem
Toronto Star
2 days ago
- Business
- Toronto Star
BreastCT.com Debuts as Go-To Resource for Breast CT Technology & Izotropic's IzoView Device
VANCOUVER, British Columbia, and SACRAMENTO, Calif., Aug. 19, 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 launch of a new online platform supporting the Company's awareness initiatives. has been created as a central educational resource on dedicated breast CT technology and the Company's IzoView Breast CT Imaging System, with a focus on its potential to address persistent challenges in detecting breast cancer in the 50% of women with dense breast tissue. With IzoView's engineering complete, the site is designed to evolve alongside the Company through clinical study preparation, U.S. and global regulatory phases, and ongoing education and awareness initiatives leading to commercial launch.
Hamilton Spectator
29-07-2025
- Business
- Hamilton Spectator
Izotropic's IzoView Breast CT Device Stands Distinct vs Existing Breast Imaging Technologies
- IzoView positioned to disrupt high-growth breast imaging markets with target device price of USD $500K - IzoView to launch into projected fastest-growing imaging category with potential to displace well-established technologies - Differentiated from existing device types through upgradeability, pipeline, and platform business model VANCOUVER, British Columbia, and SACRAMENTO, Calif., July 29, 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 an educational overview of how its flagship device, the IzoView Breast CT Imaging System ('IzoView'), compares to existing breast imaging technologies. IzoView stands apart in terms of clinical performance, cost, and commercial positioning and holds tremendous potential to displace or complement standard-of-care modalities in a growing global market. Breast Imaging Devices in Use Today The breast imaging market is dominated by traditional mammography, digital breast tomosynthesis ('DBT', '3D mammography'), ultrasound, and MRI technologies, each of which has established clinical applications with well-known limitations. Mammography and DBT remain the primary 2D-based screening tools, yet their sensitivity decreases in approximately 50%+ of women with dense breast tissue1, where overlapping structures under breast compression can obscure lesions and tumours. Ultrasound is often used as a supplemental imaging tool for dense breasts, but it often returns high false-positive rates and can be dependent on operator skill. Automated breast ultrasound ('ABUS') has been designed to eliminate operator-dependency, but any abnormalities still need to be verified by handheld ultrasound, adding more steps to the workflow. Contrast-enhanced mammography ('CE-mammo') is a dedicated system, not simply the addition of injectable contrast to conventional mammography machines. CE-mammo intends to compensate for the limitations of its 2D, compression-based design with the addition of contrast, but cannot provide the same high-value clinical information that comes with true 3D imaging. Molecular breast imaging ('MBI') is an emerging modality that uses gamma radiation and injectable radioactive tracers. It is typically reserved for investigational diagnostic imaging and delivers a higher dose than x-ray-based systems like mammography, DBT, and breast CT. Breast MRI and its faster variant, abbreviated MRI, are highly sensitive but costly, time-consuming, and generally reserved for high-risk patients. MRI machines are not breast dedicated, and competition with other medical specialties persists, leading to long wait times. IzoView: Bridging the Gap Between DBT and MRI IzoView, developed with the global licensing rights to breast CT technology from The Regents of the University of California ('UC Davis'), is positioned as a new category in breast imaging that bridges the gap between DBT and MRI, offering true 3D imaging without breast compression. Unlike compression-based mammography and DBT, IzoView images the breast in its natural shape, delivering ultra-high-resolution, contrast-enhanced imaging that serves as a powerful alternative for breast cancer screening, including for high-risk patients. Compared to MRI, IzoView offers 100x greater spatial resolution. Breast CT technology, in academic research trials conducted at UC Davis, has been shown to have performance comparable to MRI2, and 'may offer more accurate margin analysis, improved lesion characterization, and superior visualization of microcalcifications3'. With a shorter scan time and a target sales price significantly below MRI, IzoView is designed for greater accessibility across imaging centers of various sizes and resource levels. IzoView vs the Rest: Comparing the Breast Imaging Technologies Breast cancer imaging methods vary widely in performance, cost, and availability, impacting how and where they are used across patient populations. Below are comparisons of breast cancer imaging modalities. Costs for devices and imaging exams are taken from public information available online. The Company acknowledges there may be outliers to these averages. Chart 1: Breast Imaging Modalities: Technical & Clinical Attributes Chart 2: Cost, Access & Adoption Factors Market Opportunity and Displacement Potential The global breast imaging device market is projected to grow from USD $5.4 billion in 2024 to $8.69 billion by 2030, representing a compound annual growth rate (CAGR) of 8.25%. With its initial Indication for Use as an adjunct to DBT with contrast-enhancement for breast cancer screening in asymptomatic patients with dense breast tissue, IzoView is positioned to launch into the market with the potential to displace ultrasound, CE-mammo, and breast MRI devices. This positioning allows IzoView to address both the performance gap in dense breast imaging and the economic burden of multi-modality diagnostic pathways, while capturing market share from incumbent technologies and helping define the high-growth segment of next-generation breast imaging. Economic Value and Diagnostic Efficiency From a health system perspective, IzoView addresses a major financial burden associated with current diagnostic imaging pathways. In the U.S. alone, approximately $8 billion is spent annually on follow-up imaging and diagnostic procedures post-initial mammography screening, driven by false positives and inconclusive findings that can require sequential imaging across multiple modalities and unnecessary biopsies5. IzoView's ability to offer high-value clinical information to detect, characterize, and evaluate breast lesions in a 10-second imaging session offers the potential to consolidate a fragmented pathway, reduce unnecessary procedures, and enable more accurate diagnosis and early treatment. A Platform for Expansion and Durable Competitive Advantage From a competitive standpoint, IzoView sets a new benchmark in dedicated breast CT imaging. Two other breast CT systems are currently on the market, both representing early commercial entries into the modality. Based on non-public sources provided to the Company, one is priced at approximately USD $1.5 million, and the other at €1.2 million (approximately USD $825K). In comparison, IzoView's target sales price of USD $500K is between 40% and 67% lower. The Company believes IzoView's differentiators, including its modular engineering, radiation self-shielding, patient-centered design, advanced imaging performance, and significantly lower target cost structure, align strongly with key clinical needs and prevailing industry trends. These advantages position IzoView for rapid adoption in imaging environments where other breast CT systems may face financial and integration barriers. IzoView, in its current form, is uniquely suited to support advanced functions beyond adjunctive breast cancer screening with 14 identified potential future Indications for Use across five key areas of breast health: screening, diagnosis, monitoring, planning, and personalized medicine, with additional devices planned that expand upon IzoView's core imaging platform. Many of these additional Indications for Use can be delivered after new clinical studies through software upgrades, creating strong incentives for early adopters as IzoView's clinical utility increases without replacing the core system, creating a scalable upgrade path and recurring revenue model. Intellectual Property Designed to Enable Long-Term Product Leadership Izotropic continues to develop a strategically layered patent portfolio, designed to protect the most commercially and clinically significant aspects of the IzoView as a platform. Rather than focusing solely on imaging hardware, the portfolio focuses on a broad range of integrated capabilities, including image acquisition, data presentation, radiation safety, system usability, and workflow integration, reflecting how it can function as a complete solution for breast health in real-world healthcare environments. This approach makes it difficult for competitors to replicate IzoView's full potential feature set and positions the Company for a durable competitive advantage across clinical settings. The Company's portfolio includes a mix of foundational patents and newer filings, with commercially relevant protections extending into the 2040s. In addition to patent claims, Izotropic has secured key innovations as trade secrets, such as its deep machine learning image reconstruction algorithm. IzoView Is the Imaging Platform the Future of Breast Cancer Care Demands IzoView is not simply an incremental improvement; it is a fundamental reimagining of what breast cancer imaging can and should be. It meets a well-defined and increasingly urgent clinical need, has the potential to deliver measurable improvements over the standard-of-care, can integrate into a broad range of healthcare environments, and offers a clear path to revenue growth and long-term expansion. As health systems evolve toward more personalized, risk-adapted, and patient-centric models of care, IzoView is uniquely positioned to become the cornerstone of next-generation breast imaging. Source: About Izotropic: More information about Izotropic Corporation can be found on its website at and by reviewing its profile on SEDAR at . 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@ James Gagnon, International Communications Telephone: 1-604-780-7576 or 1-833-IZOCORP ext. 2 General and Corporate Inquiries Telephone: 1-604-825-4778 or 1-833-IZOCORP ext. 3 Email: info@ Wire Service Contact: IBN Austin, Texas 512.354.7000 Office Editor@
Yahoo
17-05-2025
- Business
- Yahoo
Izotropic's U.S. FDA Regulatory Pathway Greenlit, Company Provides Corporate Update
- Regulatory alignment with FDA confirmed, clearing path to pivotal U.S. clinical trial - - 150-page strategic business plan and advanced financial models completed - - Investor outreach launched to fund clinical execution and market entry - Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - May 16, 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 further to its March 25th press release, it has confirmed alignment with the U.S. Food and Drug Administration ("FDA") on its regulatory strategy for the IzoView Breast CT Imaging System, ("IzoView"), finalized an updated business plan and financial model, and is now actively engaged in financing meetings to support its planned U.S.-based clinical study for market authorization. In March 2025, the Company held a pre-submission meeting with the FDA to review its proposed regulatory pathway for IzoView. Following the meeting, the Company submitted formal meeting minutes, which were reviewed, amended, and finalized by the FDA, confirming alignment on both the regulatory strategy and overall clinical study design. With this alignment in place, and subject to financing, the Company will finalize the full clinical study protocol (building on the synopsis previously submitted) and initiate its U.S. clinical study for market authorization. Preparations will run in parallel with the manufacturing and deployment of IzoView units for the clinical study. Izotropic has completed a 150-page strategic business plan that articulates a data-driven roadmap for the commercialization of IzoView and outlines the Company's broader growth trajectory as a global medical imaging innovator. 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. It also includes a forward-looking new product development roadmap, identifying key opportunities for IzoView platform expansions, future applications, and new imaging-based products. Complementing the business plan, Izotropic has finalized sophisticated financial modeling that integrates multi-year projections, capital requirements, and scenario-based sensitivity analysis across various clinical and commercial settings. Together, these materials align Izotropic's clinical, regulatory, and commercial priorities under a cohesive strategic framework, enabling focused execution, informed capital deployment, and a structured transition into clinical operations and commercial readiness. To support its current financing initiatives, the Company has developed a suite of targeted investor materials, including tailored pitch decks, fact sheets, and translated versions to facilitate engagement across international markets. These materials, derived from the strategic content of the business plan, are designed to address the priorities of sophisticated investors and institutional stakeholders. Izotropic has begun a focused series of presentations and discussions with high-net-worth individuals and qualified investment groups evaluating the opportunity to fund the full scope of its planned U.S. clinical study and commercialization strategy. About Izotropic:More information about Izotropic Corporation can be found on its website at and by reviewing its profile on SEDAR at 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 OfficerTelephone: 1-604-220-5031 or 1-833-IZOCORP ext. 1Email: bthast@ James Gagnon, International CommunicationsTelephone: 1-604-780-7576 or 1-833-IZOCORP ext. 2 General and Corporate InquiriesTelephone: 1-604-825-4778 or 1-833-IZOCORP ext. 3Email: info@ To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
