What is IzoView Breast CT?
IzoView is a dedicated breast CT imaging system developed by Izotropic Corporation. It uses 360-degree x-ray imaging to create high-resolution, true 3D images of the breast without the need for compression. IzoView is designed to improve the accuracy of breast cancer detection, especially in women with dense breast tissue, to offer a more comfortable, efficient, and accessible experience than traditional breast imaging technologies.

How does IzoView Breast CT Work?
IzoView is a next-generation breast CT imaging system that delivers high-resolution, 360-degree images of the breast in its natural, uncompressed shape. The patient lies face-down on a padded tabletop, placing their breast through an opening into the imaging chamber. The system’s hardware rotates around the breast in a full circle and captures up to 500 ultra-high-resolution images in under 10 seconds, depending on breast length. The software then reconstructs a 3D volume in approximately 30 seconds—with no need for manual positioning or breast compression.

What clinical problem is IzoView designed to solve?
IzoView is designed to solve the long-standing limitations of current breast imaging technologies, especially for women with dense breast tissue. Mammography and digital breast tomosynthesis ("DBT") rely on breast compression, which can distort anatomy and obscure cancers. MRI is expensive, time-consuming, and inaccessible to many patients. IzoView eliminates compression and delivers true 3D breast imaging that may enhance visibility, accuracy, and diagnostic confidence while reducing patient discomfort.

Why is breast density a challenge in breast cancer screening?
Approximately 50% of women have dense breast tissue, which appears white on mammograms—just like tumors. Furthermore, breast compression causes structures to overlap, often hiding tumors and making it harder to detect cancer using traditional 2D imaging. Dense tissue increases the risk of both developing breast cancer and of missing it during screening. Interval cancers are also more aggressive and more common in women with dense breasts. U.S. guidelines now require breast density reporting, reinforcing the need for more effective imaging with new technologies. 

Why is IzoView important for women with dense breast tissue?
With approximately 50% of women having dense breast tissue tumors can be masked on standard mammograms. Studies show that up to 20% of cancers are missed on mammography. IzoView offers a breakthrough by imaging the entire breast volume in high detail without compression and designed for easier characterization of tumors in dense tissue. This positions IzoView as a crucial tool for improving outcomes in one of the most underserved populations in breast screening. 

Why is IzoView considered a breakthrough in breast imaging?
IzoView is considered a breakthrough because it directly addresses many of the limitations associated with mammography, DBT, ultrasound, and MRI. It offers high spatial resolution 100x greater than MRI, the current gold standard for 3D breast imaging. IzoView’s ability to provide fast, patient-friendly, and diagnostically rich imaging in a single 10-second scan positions it as a transformational technology in breast cancer imaging. 

Which press releases have more information on IzoView Breast CT?
1. Izotropic’s IzoView Breast CT Device Stands Distinct vs Existing Breast Imaging Technologies
2. Izotropic’s IzoView Positioned to Capitalize on Key Global Breast Imaging Market Drivers
3. Izotropic’s AI Breakthrough Positions IzoView to Redefine Breast CT Imaging Standards

What is the difference between Breast CT technology and IzoView Breast CT?
Izotropic Corporation holds the exclusive global licensing rights to breast CT technology from the Regents of the University of California. This technology was originally developed at the University of California, Davis, under the Breast Tomography Project led by Company Director Dr. John Boone and his clinical collaborators. Four successive breast CT research devices were developed and evaluated at UC Davis. The clinical data and images referenced by the Company were generated using these research prototypes. IzoView, the commercial breast CT system developed by Izotropic Corporation, is a distinct and separate device designed for commercial use and was not used to generate this data or these images.

Accordingly, any clinical performance data or images referenced by the Company should not be interpreted as evidence of IzoView’s abilities, safety or effectiveness. IzoView remains an investigational device and has not been evaluated in clinical trials or studies to support claims of diagnostic performance. No assurances are made that results achieved with earlier breast CT systems will be replicated with IzoView. The Company makes no claims or guarantees regarding the diagnostic capabilities, clinical benefits, or regulatory approval of IzoView at this time.

IzoView has not been approved or cleared by any regulatory authority and is not yet available for commercial sale. Any statements regarding potential clinical utility are for informational purposes only. 

How does IzoView Breast CT differ from mammography?
Mammography is a 2D imaging method that compresses the breast to capture X-ray images. This approach has limitations, particularly in women with dense breast tissue, where overlapping structures can hide tumors. IzoView eliminates compression and provides true 3D imaging using a 360-degree rotation around the breast, capturing fine anatomical detail that mammography can miss.

Is IzoView Breast CT the same as digital breast tomosynthesis ("DBT")?
No, digital breast tomosynthesis ("DBT"), also known as 3D mammography, is a limited-angle imaging technique. It uses a short arc of x-ray projections (15° to 50°), still with compression. IzoView performs a full 360° scan, generating real 3D volumetric images without compression, for more clarity, especially in dense breasts.

How does IzoView Breast CT compare to breast ultrasound?
Breast ultrasound is a widely used supplemental imaging tool, especially in dense breast tissue. Ultrasound uses sound waves to create images, unlike IzoView Breast CT that uses low-dose X-rays. Ultrasound can be highly dependent on operator skill levels and can produce variable results. It is typically used to evaluate areas already identified as suspicious. IzoView provides high-resolution, true 3D imaging of the entire breast in a single, fast scan—without compression and eliminates operator variability. IzoView delivers consistent, full-volume imaging data that may improve diagnostic confidence and streamline workflows.

How does IzoView Breast CT differ from automated breast ultrasound ("ABUS")?
Like traditional handheld ultrasound, automated breast ultrasound has been developed to standardize breast ultrasound imaging and mitigate operator skill level variability. Automated breast ultrasound has been implemented as a supplementary imaging tool, however, any abnormalities found on an ABUS exam must be verified by a handheld ultrasound exam, increasing imaging exams and workflows. IzoView provides high-resolution, X-ray based, true 3D imaging of the entire breast in a single, fast scan—without compression and eliminates operator variability. It delivers consistent, full-volume imaging data that may improve diagnostic confidence and streamline workflows.

What is the difference between IzoView Breast CT and contrast-enhanced mammography ("CE-mammo")?
Contrast-enhanced mammography is a separate device from traditional mammography that utilizes the same 2D, compression-based process with the addition of injectable contrast, to attempt to compensate for the limitations of 2D, compression-based imaging. IzoView, with its initial Indication for Use also uses contrast-enhancement, but images the breast without compression, in its natural shape to produce true 3D images. 

What is the difference between IzoView Breast CT and molecular breast imaging ("MBI")?
Molecular breast imaging uses gamma radiation and an injected radioactive tracer to detect metabolic activity in breast tissue. It is typically used as a problem-solving tool rather than a screening method due to higher radiation exposure and limited availability. IzoView uses low-dose X-rays with standard iodine-based contrast to produce high-resolution, true 3D anatomical images without the need for radioactive tracers.

How does IzoView compare to breast MRI?
Breast MRI is highly sensitive but expensive, time-consuming, delivers high false-positive rates, and is often inaccessible. It is generally reserved for high-risk patients. Breast CT delivers comparable images, faster scan times, and lower cost. Unlike MRI, IzoView is designed specifically for dedicated breast imaging and can be deployed in a wider variety of clinical environments due to its smaller footprint and lower infrastructure requirements.

What are the limitations of current breast imaging technologies?
Current breast imaging tools—including mammography, DBT, ultrasound, contrast-enhanced mammography, and MRI—all have known limitations. Mammography and DBT are less sensitive in dense tissue. Ultrasound is highly operator-dependent and has high false-positive rates. Contrast-enhanced mammography improves detection but lacks 3D data. MRI is costly, time-intensive, has high false-positive rates, can’t detect cancer indicating microcalcifications, is not breast-dedicated, and a high percentage of women can’t take an MRI exam as they are claustrophobic. IzoView is designed to address each of these gaps with true 3D imaging, high resolution, speed, and accessibility.

What imaging modalities does IzoView compete with?
IzoView initial planned Indication for Use competes with and may replace supplemental screening technologies such as handheld ultrasound, automated breast ultrasound ("ABUS"), contrast-enhanced mammography, and breast MRI. It offers benefits in speed, comfort, resolution, and cost that make it a strong contender.

How does IzoView compare in terms of cost?
IzoView has a target device sales price of USD $500K. IzoView's target pricing is positioned in between DBT (USD $150K- $300K) and MRI (USD $1M- $3M+). More pricing information can be found here. 

Are there other companies with breast CT devices?
Yes. 2 other companies have breast CT devices currently on the market: Koning Corporation based in the United States with the device "Vera" , and AB-CT based in Germany with the device "nu:view". 

How is Izotropic's IzoView Breast CT different from Koning Vera or AB-CT nu:view?

IzoView differs from Koning Vera and AB-CT nu:view in several key areas, offering a more accessible, scalable, and advanced solution for breast cancer imaging. All three systems perform true 3D imaging using full 360° CT scans, but IzoView is designed to improve on both clinical utility and operational flexibility. One of the most significant differences is price. IzoView has a target sales price of USD $500,000, while Koning Vera and AB-CT nu:view have been known to sell for up to USD $1.5 million. This positions IzoView as a more attainable solution for a broader range of imaging environments, from outpatient centers to regional hospitals.

In addition to a major price advantage, IzoView Breast CT has multiple patented and patent-pending engineering features and innovations that differentiate it from other breast CT devices including full radiation self-shielding, allowing it to be operated in standard clinical rooms without the need for lead-lined walls or radiation-safe construction; modular sub-system engineering for easy shipping, installation, service, and maintenance; and the integration of an AI-based deep- learning reconstruction algorithm, developed specifically for breast CT using 15 years of clinical imaging data. Unlike traditional noise-reduction methods, this algorithm works directly on raw scan data to reduce image noise without increasing radiation dose or scan time. The result is consistently high-quality imaging at low radiation doses, optimized for both clinical performance and safety.

Future press releases and updates will highlight additional features that further distinguish IzoView.

Izotropic also holds the only U.S. patents for measuring breast density with Breast CT, performing biopsy with Breast CT, and computer-aided diagnosis with Breast CT. Other breast CT devices performing these functions with Breast CT are likely in infringement. 

Together, these differences position IzoView as a distinct and forward-looking solution in the breast CT landscape, engineered to meet the clinical, economic, and operational demands of modern breast imaging.

What type of radiation does IzoView use?
IzoView uses low-dose X-ray radiation, at a dose comparable to what is used in standard 2-view mammography.

What is the spatial resolution of IzoView?
IzoView provides ultra-high-resolution imaging with spatial resolution 100 times greater than MRI. This may enable radiologists to detect and characterize very small lesions and microcalcifications with greater confidence. This resolution also makes the images ideal for advanced diagnostic support and future AI integrations.

How long does an IzoView scan take?
An IzoView scan takes approximately 10 seconds to complete, with a true 3D data set reconstructed in approximately 30 seconds. 

What clinical trials/ studies support breast CT imaging?
Breast CT technology has been validated in over 20 years of clinical research, including NIH-funded trials / studies and four generations of prototype scanners developed at UC Davis Medical Center ("UC Davis"). These trials / studies have shown that breast CT is practical, cost-effective, and may improve lesion visibility, including in small invasive tumors and benign calcifications. More than 50 peer-reviewed publications support its use in breast imaging. More information on breast CT technology, including links to publications can be viewed here. 

Has breast CT technology been clinically validated?
Breast CT technology has been studied for over 20 years, with more than $20 million in development funding. UC Davis-led clinical studies using prototype systems have imaged hundreds of patients and published more than 50 papers. Clinical evidence shows that malignant lesions are better visualized on contrast-enhanced breast CT than on digital mammography or DBT, and that benign and malignant calcifications can be more easily characterized using breast CT. IzoView is the commercial breast CT model developed by Izotropic Corporation with the exclusive global licensing rights to breast CT technology from The Regenets of the University of California. IzoView is a distinct and separate device designed for commercial use and was not used to generate this data, and has yet to be approved or cleared by any regulatory authority. 

What do clinical studies say about breast CT technology?
Clinical trials for academic research purposes at UC Davis Medical Center have shown that contrast-enhanced breast CT enables better visualization of malignant tumors compared to digital mammography or DBT. Malignant micro-calcifications are visible on mammography and DBT, but MRI can’t see cancer indicating microcalcifications. Breast CT also improves the visualization of benign calcifications and overall, studies suggest that breast CT is more practical and cost-effective than MRI in breast imaging clinics.

What is the clinical value of IzoView?
Research from UC Davis Medical Center has shown that contrast-enhanced breast CT, the technology behind IzoView, offers diagnostic performance comparable to MRI, and that the technology may have improved lesion characterization and margin analysis, in addition to breast CT’s ability to visualize microcalcifications, which may make it a powerful imaging tool.  IzoView is the commercial breast CT model developed by Izotropic Corporation with the exclusive global licensing rights to breast CT technology from The Regents of the University of California ("UC Davis"). IzoView is a distinct and separate device designed for commercial use and was not used to generate this data, and has yet to be approved or cleared by any regulatory authority. 

Will IzoView reduce unnecessary follow-up imaging?
IzoView has the potential to reduce the need for follow-up imaging and biopsies. Its ability to capture high-resolution 3D images in a single scan may allow for clearer results, reducing the reliance on multi-modality workflows that drive up cost and delay diagnosis.

How will IzoView help improve health system efficiency?
In the U.S., approximately $8 billion is spent annually on follow-up imaging and procedures after initial screening mammography. IzoView’s fast and accurate imaging could reduce false positive results, reduce imaging exams and hospital visits, and streamline diagnostic pathways, potentially reducing this financial burden.

Can IzoView replace existing imaging systems?
IzoView is not initially intended to replace all breast imaging systems. IzoView's initial planned Indication for Use is with contrast-enhancement adjunctive to DBT for breast cancer screening in asymtomatic patients with dense breast tissue. Izotropic anticipates that IzoView will displace other modalities that are also indicated for adjunctive breast cancer imaging. IzoView's speed, accuracy, and affordability may make it a preferred option over ultrasound, CE-mammo, and even MRI in certain clinical pathways.

What new AI breakthrough has Izotropic achieved for IzoView?
Izotropic has developed and integrated a proprietary machine-learning reconstruction algorithm into its IzoView Breast CT Imaging System. This AI-driven innovation significantly enhances image quality by reducing noise in CT images without increasing radiation dose. The algorithm is self-supervised, modality-specific, and trained on 15 years of specialized breast CT data, giving Izotropic a strong technological advantage over general-purpose AI models used in other imaging devices.

What is image noise in CT imaging?
Noise in CT imaging appears as grainy or speckled texture that can obscure fine details in the image. It typically increases at lower radiation doses and has the potential to reduce diagnostic clarity if not properly managed.

How does artificial intelligence improve IzoView image quality?
The proprietary AI algorithm developed for IzoView improves image quality by reducing a grainy texture on the final image known as image noise, which is a common output in all CT imaging. Traditional methods either require higher radiation exposure or extensive post-processing that can blur or overly smooth clinical details. IzoView’s AI works directly on raw X-ray data before reconstruction, preserving details while enabling superior noise reduction at consistent, low radiation doses.

What makes IzoView’s AI approach different from existing denoising methods?
IzoView’s AI solution stands apart from model-based iterative reconstruction (MBIR) and standard deep machine-learning reconstruction (DMLR) methods. MBIR is too slow and computationally intensive for real-world clinical use, often requiring minutes per image and producing unnaturally smooth outputs. DMLR typically requires paired high-dose and low-dose datasets, which is not feasible in breast CT. IzoView’s self-supervised algorithm eliminates limitations and optimizes image without adding more radiation or extended processing times.

How does this AI advancement support IzoView’s regulatory strategy?
The integration of the AI algorithm strengthens IzoView’s position for regulatory submissions and global market readiness by supporting the case for high-resoltion optimized images and low-dose protocols. The ability to consistently generate high-quality images at lower doses may also align with emerging regulatory expectations for safer, more efficient medical imaging devices.

What is the competitive advantage of IzoView’s AI?
IzoView’s AI is trained on 15 years of dedicated breast CT data and is protected as a trade secret. This modality-specific approach is not only highly specialized but also difficult to replicate, creating a durable competitive edge. Unlike general-purpose AI models that underperform in breast CT due to noise correlation and anatomical complexity, IzoView’s algorithm was purpose-built for this application. 

How will IzoView’s AI algorithm impact radiologists?
Radiologists will benefit from cleaner, more optimized images that are generated quickly and consistently. IzoView’s AI-driven reconstruction may help radiologists make more confident and accurate interpretations. These images are also more suitable for future use with computer-aided diagnostics and predictive analytics tools.

Can IzoView’s AI be used in real-time clinical workflows?
Yes, the algorithm was specifically developed for use in real-world clinical environments such as breast cancer screening. Unlike slower reconstruction techniques, IzoView’s AI enables fast image generation, supporting high-throughput workflows without increases in computational burden that can drain IT infrastructures. This allows IzoView to deliver both speed and optimized images, which are essential in modern breast imaging practices.

How does IzoView support the future of AI in radiology?
IzoView is designed to be an AI-native imaging platform. Its high-resolution, low-noise images are ideal for training and deploying advanced diagnostic AI models. As radiology increasingly incorporates AI-driven triage, decision support, and risk stratification tools, IzoView is positioned to be a foundational data source that can enable the next generation of intelligent imaging systems.

What has Izotropic announced regarding CADx for breast CT?
Izotropic has secured exclusive rights to the only U.S. patent that covers computer-aided diagnosis ("CADx") for breast CT. This patent falls under its global license agreement with the Regents of the University of California. It represents a major milestone for Izotropic and establishes the company as the sole entity authorized to commercialize CADx functionality specifically designed for use with dedicated breast CT imaging.

What is computer-aided diagnosis ("CADx") in breast imaging?
Computer-aided diagnosis, or CADx, refers to AI software tools used in radiology to assist physicians in interpreting medical images. These tools analyze imaging data to estimate the likelihood of malignancy and highlight regions that may require further clinical attention. In breast imaging, CADx aims to reduce diagnostic uncertainty, improve consistency, and support radiologists in identifying cancers that might be missed by the human eye due to breast density, overlapping tissue, or reader variability.

How can CADx improve breast cancer detection?
CADx can improve breast cancer detection by analyzing images to identify suspicious features such as asymmetries, masses, or calcifications that could indicate malignancy. In modalities like mammography, DBT, ultrasound, and MRI, CADx helps flag subtle findings that may be overlooked during initial reviews. For high-volume or complex modalities like breast CT and MRI, CADx can also reduce interpretation time by triaging scans and highlighting abnormalities for radiologist review.

Is the CADx feature available in IzoView?
No, IzoView will not initially launch with CADx functionality. The CADx system is planned as a post-market feature to be integrated into IzoView after additional regulatory approvals are obtained. Izotropic is strategically positioning CADx as a software upgrade that may be offered to early adopters of IzoView as an added clinical and commercial incentive.

How does this patent give Izotropic a competitive advantage?
The issued U.S. patent gives Izotropic exclusive rights to commercialize CADx technology for use with breast CT. This exclusivity limits other competitors from offering CADx-integrated breast CT systems in the U.S. market. Combined with the company’s existing rights to the underlying breast CT imaging technology, this positions Izotropic as the sole provider of a full-stack solution that combines true 3D imaging and machine-learning with AI-assisted diagnostic support.

Will CADx be offered as a separate product or part of IzoView?
CADx is expected to be offered as a software upgrade to IzoView, the company’s flagship breast CT imaging platform. This approach allows Izotropic to extend IzoView’s clinical capabilities without requiring customers to purchase new hardware. Offering CADx as a modular upgrade creates a recurring revenue opportunity and provides ongoing value to early adopters through new features over time.

What is the current status of IzoView’s development?
IzoView is fully engineered and entering the final stages of pre-clinical preparation for a U.S.-based, multi-site clinical study. The Company has completed the mechanical build of the first IzoView unit and will finalize the software user interface. It will then undergo calibration and characterization using imaging phantoms, radiation safety certification, and regulatory testing before being deployed to the first clinical site, pending financing.

Where is IzoView in its development timeline?
IzoView is a fully engineered, pre-commercial medical imaging device entering regulatory stages. The company is preparing for its pivotal U.S. clinical study and is actively raising funds to support the study, operations, product launch, and commercialization. 

What are the seven phases of the IzoView product launch?
The IzoView launch is structured around seven distinct phases: Prepare IzoView, Site Setup, Clinical Study, Reader Study, Modular Submissions, PMA Application, and Approval and Sales. Each phase contains specific milestones designed to generate value, inform investors, and advance the company toward FDA approval and market commercialization.

What happens during the “Prepare IzoView” phase?
During this phase, Izotropic finalizes the user interface software, calibrates the device using imaging phantoms, completes a third-party radiation safety survey, and performs standard regulatory and quality control testing. Once these steps are complete, the first of 3 IzoView units will be shipped from Izotropic’s engineering facility in Sacramento, California to the first clinical study site, pending financing. This phase is expected to take six months, with the second and third units being completed in back-to-back six-week intervals.

How will IzoView units be installed at clinical study sites?
IzoView system is designed with modular engineering so it can be disassembled into subsystems that fit through standard elevators and doorways. This avoids the need for costly building modifications, cranes, or road closures that are often required for installing large imaging equipment. The installation process includes system testing and training of clinical site staff to ensure readiness for patient imaging.

What is the timeline for the "Site Setup" phase?
Setup is expected to take six months for the first site, with overlapping setup processes for the second and third sites. During this phase, Izotropic will contract with clinical partners, engage a clinical research organization (“CRO”), and hire on-site coordinators. Once each site receives and installs its unit, testing and staff training will be conducted before patient imaging begins.

What is the purpose of the clinical study?
The clinical study is planned to be conducted to collect the data necessary for FDA approval of IzoView. It involves recruiting patients, imaging them using the IzoView system, and tracking outcomes. The imaging phase of the clinical study is expected to last 9 to 18 months, pending recruitment rates, followed by a 12-month negative case validation period to confirm that women who were not diagnosed with cancer remain cancer-free after one year.

How will participants be recruited for the clinical study?
Patients will be recruited through each participating clinical study site. Recruitment efforts will be supported by the CRO, advertising campaigns, and on-site coordinators. Participants will be compensated for their involvement in the study, which is standard industry practice. Izotropic anticipates strong recruitment based on growing awareness of the limitations of current breast imaging methods in women with dense tissue.

What is the "Reader Study" phase?
The Reader Study phase involves a multi-reader, multi-case evaluation of the images collected during the clinical study. Trained radiologists will review and score images based on lesion detection and diagnostic confidence. The study includes a truthing phase, where known lesion locations are marked, and a reading phase, where radiologists independently evaluate the scans.

What are modular submissions in the FDA PMA process?
Izotropic will submit its FDA Pre-Market Approval (PMA) application in four separate modules: Verification, Non-Clinical Validation, Manufacturing, and Clinical Data. This modular approach allows the company to begin submitting parts of the application while the clinical study is still ongoing, potentially reducing total review time by six months and accelerating time to market.

When will Izotropic submit the final PMA application?
The final PMA application will be submitted after the Reader Study is complete and all clinical data is analyzed. The Clinical Data module will be the last of the four modules submitted.

What happens once IzoView is approved by the FDA?
Upon receiving FDA approval, Izotropic will begin commercial sales of IzoView, starting with discounted sales to the clinical study sites that participated in the study. These early adopters will be the first to advertise and offer IzoView commercially to their patients. The Company will also activate its sales and marketing infrastructure to begin broader distribution.

What is the plan for marketing IzoView after approval?
Following FDA approval, Izotropic plans to launch a nationwide marketing campaign targeting breast imaging providers, cancer centers, and diagnostic clinics. The campaign will leverage both traditional outreach and the advocacy of the company’s scientific and advisory team. Izotropic has also built a database of prospective buyers that will be re-engaged for early commercial orders.

Will IzoView be available outside the United States?
Yes, Izotropic plans to submit an application for CE Mark certification in Europe using the clinical data from the first 100 patients during the U.S. study. The company will engage a notified body authorized to assess medical device conformity under EU regulations. The specific timeline for CE Mark submission will be announced separately.

How does IzoView’s design support faster commercialization?
IzoView’s modular sub-system engineering allows for easier manufacturing, shipping, installation, and servicing. Its self-shielded radiation design also means it can be used in standard clinical rooms without requiring lead-lined walls. These features make it easier for healthcare providers to adopt the system quickly after approval.

How does Izotropic plan to scale manufacturing after approval?
Once FDA approval is received, Izotropic will begin manufacturing of IzoView units. The company’s engineering facility in Sacramento has been configured for early production and more traditional production will be established through a medical equipment grade manufacturer ahead of the expected FDA approval date. 

What does IzoView cost?
IzoView has a target device sales price of $500K USD.

How much does an IzoView exam cost?
The target exam cost for IzoView is between USD $250- $500, aligning with the cost of contrast-enhanced mammography and significantly undercutting MRI exams, which can range from $400 to over $6,000+. This lower cost of use positions IzoView as a cost-effective solution for routine supplemental screening in patients with dense breasts.

What is IzoView’s revenue model?
Izotropic is commercializing IzoView with a platform-based model that supports recurring revenue. In addition to equipment sales, future revenue will be generated through software upgrades over-the-air, feature unlocks, clinical use expansion, and companion product add-ons. The business model includes flexible financing options, such as leasing and revenue-sharing, to support broader market access and early adoption .

What types of facilities can use IzoView?
Because IzoView is self-shielded and does not require lead-lined rooms, beside major hospitals, it can be installed in a broad range of environments, including outpatient imaging centers, diagnostic clinics, mobile units and community hospitals. Its modular engineering supports ease of transportation, installation, and maintenance, making it viable for facilities that may not have been able to accommodate large-scale imaging systems like MRI.

Where will IzoView be used?
IzoView is designed for rapid adoption across major outpatient imaging centers, national cancer screening programs and underserved global regions. Its modular, compact, and self-shielded design also allows for installation in locations that lack specialized infrastructure. It can be deployed in clinics, mobile units, and mid-sized hospitals without requiring facility modifications like lead-lined rooms or reinforced floors.

How does Izotropic plan to commercialize IzoView?
Izotropic plans to commercialize IzoView through a mix of direct sales and distributor-led partnerships. The company is targeting early adoption through clinical validation sites and early adopter hospitals. There are a growing number of pre-sale discussions and letters of intent are being pursued to build an installation pipeline ahead of regulatory approvals.

What is the global market opportunity for IzoView?
The global breast imaging device market is projected to grow from USD $5.4 billion in 2024 to $8.7 billion by 2030. In the U.S., the market is expected to grow from $1.01 billion to $1.55 billion in the same timeframe. With rising screening mandates, insurance coverage expansion, and increased awareness about breast density, IzoView is well-positioned to address both clinical and commercial demand in this high-growth market .

Why is now the right time for IzoView?
Breast cancer imaging is undergoing regulatory and reimbursement transformation. FDA mandates now require breast density disclosures, driving demand for more accurate imaging. As awareness grows, and as insurers expand coverage for supplemental screening, providers are actively seeking new technologies that improve clinical outcomes and workflow efficiency. IzoView’s platform, pricing, and performance make it uniquely suited to lead in this moment of inflection for global breast cancer detection .

What makes IzoView a scalable platform?
IzoView is built with modular engineering, allowing future upgrades and new Indications for Use. This makes it a platform rather than a one-time device, enabling a scalable path across all areas of breast health including diagnosis, monitoring, and even treatment planning. 

Will IzoView support future applications beyond screening?
Yes, Izotropic has identified 14 potential future Indications for Use across screening, diagnosis, biopsy, monitoring, planning, and personalized medicine. Many of these can be enabled through future software updates, adding clinical utility without requiring new hardware.

Disclaimer: IzoView & Breast CT Technology

Izotropic Corporation holds the exclusive global licensing rights to breast CT technology from the Regents of the University of California. This technology was originally developed at the University of California, Davis, under the Breast Tomography Project led by Company Director Dr. John Boone and his clinical collaborators. Four successive breast CT research devices were developed and evaluated at UC Davis. The clinical data and images referenced by the Company were generated using these research prototypes. IzoView, the commercial breast CT system developed by Izotropic Corporation, is a distinct and separate device designed for commercial use and was not used to generate this data or these images.

Accordingly, any clinical performance data or images referenced by the Company should not be interpreted as evidence of IzoView’s abilities, safety or effectiveness. IzoView remains an investigational device and has not been evaluated in clinical trials or studies to support claims of diagnostic performance. No assurances are made that results achieved with earlier breast CT systems will be replicated with IzoView. The Company makes no claims or guarantees regarding the diagnostic capabilities, clinical benefits, or regulatory approval of IzoView at this time.

IzoView has not been approved or cleared by any regulatory authority and is not yet available for commercial sale. Any statements regarding potential clinical utility are for informational purposes only.