What Izotropic does

Izotropic Corporation is a publicly traded medical device company (CSE: IZO, OTCQB: IZOZF, FSE: 1R3), founded in 2015 and headquartered in Surrey, British Columbia, with engineering operations in Sacramento, California. The company is commercializing the IzoView Breast CT Imaging System, a dedicated breast CT platform that produces true 3D volumetric images (approximately 500 high-resolution images per scan in 10 seconds, with reconstruction in 30 seconds) without breast compression. The underlying technology was developed at UC Davis Medical Center over approximately 20 years of clinical research, and Izotropic holds exclusive global licensing rights. The system is designed primarily for the approximately 50% of women with dense breast tissue (BI-RADS density categories C and D), where standard-of-care mammography and digital breast tomosynthesis have reduced sensitivity, and targets a U.S. eligible population of roughly 35.45 million women annually.

The platform's differentiating components include a proprietary self-supervised deep-learning reconstruction algorithm co-developed with Johns Hopkins University School of Medicine and protected as a trade secret, a patent-pending optical pre-scan system for personalized radiation dose, the only U.S. patent for computer-aided diagnosis with breast CT (planned as a post-market software upgrade), and a modular, self-shielded design that allows installation in standard rooms without leaded walls. Reported technical performance includes detection of lesions as small as 2 mm (vs. ~11 mm average on screening mammography) and spatial resolution 100x greater than MRI, at a target unit price of $500,000 — well below competing breast CT systems ($1.2M–$1.5M) and MRI systems ($1M–$3M+). The device has not yet received U.S. FDA approval or CE Mark; Izotropic is pursuing a Pre-Market Approval pathway and has achieved FDA alignment on its clinical study design following a pre-submission meeting in March 2025, with a pivotal clinical study of approximately 2.5 years and $3.5M planned.

Izotropic's business model is pre-commercial and depends on hardware sales as the primary future revenue stream, supplemented by post-market software upgrades tied to 14 identified future Indications for Use and by sublicensing/distribution economics through the Izotropic Africa joint venture (40% interest, covering 38 African countries and 6 GCC nations). The company plans an EU-first commercial launch, followed by the United States, with go-to-market centered on direct enterprise sales to hospitals, breast centers, and imaging clinics, and an initial wave of clinical-study-site sales at discounted rates. To date, operating capital has been raised through a CAD $2M unsecured loan (April 2022, balance of CAD $2.675M as of March 2025) and a series of small non-brokered private placements totaling roughly CAD $1.13M between February 2025 and February 2026; no commercial revenue has been recorded.

Name

Izotropic

Legal name

Izotropic Corporation

Website

https://izocorp.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

Izotropic Corporation is a publicly traded medical device company developing the IzoView Breast CT Imaging System, a dedicated 3D breast CT platform targeting the ~50% of women with dense breast tissue where mammography underperforms. The device is pre-commercial, pending FDA Pre-Market Approval.

Ownership category

akta.pro rank

Product category

Breast Imaging Diagnostic Equipment

NAICS

Surgical and Medical Instrument Manufacturing (339112), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

X-Ray Apparatus & Tubes & Related Irradiation Apparatus (3844), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Mammography & Breast Imaging Systems (HLAHABAF)

akta.pro secondary industry

Medical Imaging AI (HDAAAEAH)

Keywords

• Breast CT imaging
• Medical imaging devices
• Computed tomography systems
• Cancer screening equipment
• Diagnostic imaging hardware

Headquarters

HQ city

Sacramento

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. IzoView Breast CT Device Sales: Sale of IzoView Breast CT Imaging System as the primary revenue stream. Target sales price of USD $500,000 per unit, significantly below competing breast CT systems ($1.2M-$1.5M) and MRI systems ($1M-$3M+). Initial sales will focus on clinical study sites at discounted rates, expanding to hospitals, medical facilities, and imaging clinics globally.
2. Software Upgrades and Expanded Indications: Post-approval software upgrades enabling additional Indications for Use (14 identified across screening, diagnosis, monitoring, planning, and personalized medicine). Early adopters can increase clinical utility without replacing core system, creating recurring revenue model and upgrade incentives.
3. Sublicensing and Distribution Fees (Izotropic Africa): Under the Letter Agreement, Izotropic holds 40% fully diluted interest in Izotropic Africa joint venture. Sub-licensing rights enable commercialization in global business sectors in exchange for sales revenues, distribution fees, and/or pay-per-use fees on licensed products across Africa and GCC countries.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels9 records

Core offering

Izotropic develops and intends to commercialize the IzoView Breast CT Imaging System, a dedicated breast computed tomography platform engineered for breast cancer screening in women with dense breast tissue. The device delivers true 3D, 360-degree volumetric breast imaging without compression, supported by a proprietary AI-based machine-learning reconstruction algorithm developed with Johns Hopkins University. The system is being positioned for adjunctive screening to digital breast tomosynthesis (DBT) at a target sales price of $500,000 per unit, with planned software-enabled expansion across 14 potential indications for use.

Product overview

Izotropic Corporation offers the IzoView Breast CT Imaging System as its flagship medical device product, a dedicated breast CT platform purpose-built for the 50% of women with dense breast tissue where traditional mammography and tomosynthesis often fail to detect cancers. IzoView combines true 3D imaging without breast compression, proprietary AI-powered image reconstruction, and a modular engineering design at a target price of $500,000—significantly below competing breast CT systems ($1.2M-$1.5M). The platform is designed to bridge the gap between digital breast tomosynthesis and MRI, with planned expansion to 14 indications for use and computer-aided diagnosis (CADx) software capabilities. The company is pursuing U.S. FDA Pre-Market Approval (PMA) and European CE Mark regulatory pathways, with the device not yet approved for commercial sale.

Differentiator

Problem solved

Functional benefit

Brands

• Izotropic Africa: Regional operations hub based in Casablanca, Morocco, operating across 38 African countries and all six GCC nations for licensing, marketing, distribution, and evaluation of manufacturing of IzoView Breast CT products

Products and services

• IzoView Breast CT Imaging System A dedicated breast CT imaging system designed for breast cancer screening adjunctive to digital breast tomosynthesis (DBT) in women with dense breast tissue. Provides true 3D volumetric imaging without breast compression, 100x greater spatial resolution than MRI, a proprietary AI reconstruction algorithm, and a patent-pending personalized radiation dose system. Target sales price of $500,000 per unit with 14 potential future indications for use deliverable through software upgrades. Currently pursuing FDA PMA and CE Mark.

Quantifiable outcome

• Detection of 2mm lesions vs 11mm average mammography detection, enabling approximately 1.25 years earlier cancer detection
• +6 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature6 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Mohammed VI Foundation for Science & Health (FM6SS)coreStrategic or Co-development Partner · 25 February 2026Partnership discussions focused on clinical research, regulatory advancement, and localized manufacturing of IzoView Breast CT Imaging System in Morocco. Under discussions, IzoView device valued at USD $500,000 would be placed at leading Moroccan hospital at no cost for clinical evaluation. Parties aim to finalize formal agreement by April 30, 2026 (extended to June 30, 2026). FM6SS is public utility institution under patronage of King Mohammed VI.
• Business Group (Izotropic Africa Joint Venture Partner)coreStrategic or Co-development Partner · 18 February 2026Letter Agreement signed February 2026 to establish Izotropic Africa joint venture entity based in Casablanca, Morocco. Business group holds 60% fully diluted interest; Izotropic retains 40%. Entity will license, market, distribute, and evaluate manufacturing of IzoView Breast CT products across Africa and GCC. Izotropic's 40% share of first-year startup budget is approximately USD $120,000. Distribution planned across 38 African countries and 6 GCC nations.
• Evolux Capital (1822053 Alberta Ltd.)minorGTM or Marketing Partner · 19 September 2025Arm's-length marketing firm engaged for 12-month term (ending September 2026) at CAD $60,000. Provides investor awareness and digital marketing services including social media advertising, communications strategies, brand development, and coordination with advertising partners.
• Departures Capital Inc.minorGTM or Marketing Partner · 19 September 2025Service agreement for strategic consulting, investor communications, digital media production, and related services. One-year term expiring September 2026 at CAD $25,000. Arm's-length party with no equity interest in the company.
• University of California, Davis (UC Davis)coreOEM/ Whitelabel/ Licensing PartnerExclusive global licensing agreement to breast CT technology developed at UC Davis Medical Center. Covers all patents, patent applications, and technology for screening, diagnostic, and therapeutic use in humans. Includes sublicensing rights for global commercialization. Amended June 2025 with alignment on regulatory milestones. Diligence obligation fee of USD $85K due November 2025.
• Johns Hopkins University School of MedicinecoreTechnology or IntegrationCollaboration with Johns Hopkins University School of Medicine to develop proprietary AI-based machine-learning reconstruction algorithm. Algorithm trained on 15 years of specialized breast CT data and protected as trade secret by Izotropic.
• JG Global Communications (James Gagnon)minorGTM or Marketing PartnerInternational Communications Consultant engaged for 6-month term at $6,000/month. James Gagnon brings 20+ years experience in international finance and investor relations with multilingual capabilities. Leads proactive outbound investor communications and global outreach focusing on Asia and Europe markets.

Scale indicators13 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Hologic: Hologic is the dominant incumbent in breast imaging via its 3D mammography / Genius DBT platform (Selenia Dimensions, 3Dimensions) and serves the same hospital and breast-center customers IzoView targets. Comparable as the entrenched workflow IzoView must displace or supplement.
• Fujifilm Healthcare: Fujifilm offers digital mammography systems and broader imaging/PACS infrastructure to hospitals and imaging centers. Comparable as a multi-modality incumbent competing for breast imaging capital budgets and downstream IT integration.
• Canon Medical Systems: Canon Medical supplies digital mammography systems and a broader imaging portfolio to the same hospital and outpatient imaging customers. Comparable as a multi-modality incumbent in breast imaging capital equipment.
• Siemens Healthineers: Siemens provides mammography (MAMMOMAT), MRI, and AI imaging solutions for the same radiology departments and breast centers IzoView targets. Comparable as an established, multi-modality competitor with strong European footprint aligned to Izotropic's planned EU-first launch.
• Philips Healthcare: Philips offers mammography, ultrasound, MRI, and AI-enabled diagnostic imaging for similar hospital and breast-center buyers. Comparable as a broad incumbent competing for the same capital equipment budget and radiology workflow share.
• GE HealthCare: GE offers mammography (Senographe Pristina), MRI, and contrast-enhanced imaging across the same hospital buyers as Izotropic. It is a broad incumbent whose installed base and service network set the competitive benchmark for breast imaging procurement.

Emerging players

• Lunit: Lunit develops AI software (Lunit INSIGHT) for mammography and DBT breast cancer detection, with FDA-cleared products. Comparable as a software-AI peer in breast imaging whose AI-vs-AI narrative parallels Izotropic's AI reconstruction and planned CADx positioning.
• Volpara Health: Volpara provides breast density assessment and AI-based imaging analytics software integrated with mammography workflows. Comparable as an emerging software peer addressing the dense-breast population that IzoView's primary indication targets, although Volpara is software-only rather than capital equipment.
• iCAD: iCAD provides AI-based computer-aided detection (ProFound AI) for breast cancer screening on mammography and DBT. Comparable because it overlaps with Izotropic's planned CADx module and targets the same radiologist end-user with AI decision support. Izotropic's former regulatory consultant John DeLucia was previously VP at iCAD.

Direct peers

• Koning Health: Koning is the most directly comparable peer — a commercial-stage developer of dedicated cone-beam breast CT systems (Koning KBCT) that compete head-to-head with IzoView in the dedicated breast CT category. Both target the dense-breast screening indication and the same hospital/imaging-center buyer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@izotropic/playlists
• Xx.com/izotropic
• Facebookfacebook.com/izotropic

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds12 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Izotropic