QT IMAGING HOLDINGS, INC.

The following discussion reflects the business of the Company. In this section, “we,” “us,” “our,” “the Company” or “QT Imaging” below generally refers to QT Imaging Holdings, Inc. and its subsidiaries.

Background of the Business Combination

On December 8, 2022, GigCapital5, Inc. (“GigCapital5”), our legal predecessor company and a special purpose acquisition company which was incorporated in Delaware in 2021, entered into the Business Combination Agreement with its wholly owned subsidiary, QTI Merger Sub, Inc. (“Merger Sub”), and QT Imaging, Inc. When the transactions contemplated by the Business Combination Agreement (the “Business Combination”) closed on March 4, 2024, Merger Sub merged with and into QT Imaging, Inc. with QT Imaging, Inc. the surviving company in such merger, and after giving effect to the Business Combination, QT Imaging, Inc. became a wholly owned subsidiary of GigCapital5, which was renamed as QT Imaging Holdings, Inc.

QT Imaging, Inc. was incorporated in Delaware on December 31, 2020 by converting from its predecessor, QT Ultrasound LLC (“QT Ultrasound”), which was a limited liability company formed in 2012 to focus on the research, development, and commercialization of innovative body imaging systems using low energy sound. On that date, QT Ultrasound changed its name from QT Ultrasound LLC to QT Imaging, Inc. and revoked the limited liability company election status by the incorporation.

QT Imaging is headquartered in Novato, California.

A Novel Body Imaging Technology

The Company—with the support of nearly $181 million in financial support from the U.S. National Institutes of Health—has developed a novel, comprehensive body imaging technology designed to produce high-resolution volumetric images of breast tissue using low-energy transmitted sound. The technology is based on ultra-low frequency transmitted and reflected sound waves and utilizes a proprietary sound back-scatter design together with inverse-scattering reconstruction algorithms to generate quantitative three-dimensional images of tissue properties.

The Company is a medical device company founded in 2012 and engaged in the research, development, and commercialization of innovative body imaging systems using low energy sound. We believe that medical imaging, and in particular 3D imaging, is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable and accessible. Our goal is to improve global health outcomes through the development and commercialization of imaging devices that address critical healthcare challenges with accuracy and precision.

The current standard of care for imaging in breast cancer screening, diagnosis, and treatment is far from satisfactory. Generally, the process starts with X-ray mammography, the primary screening tool for women. Mammography uses radiation, which in sufficient cumulative doses can increase the risk of cancer and requires breast compression, which can be uncomfortable or painful for patients. Callbacks for adjunct screening and diagnosis include ultrasound, magnetic resonance imaging (“MRI”), and may include biopsies. This process is expensive, time consuming, and can be stressful for women. In addition, the reliance on multiple imaging modalities reflects the limitations of any single modality in adequately screening for and diagnosing breast cancer.

The Company’s opportunity in breast imaging is to shorten the time to diagnosis for women with cancer and to provide reassurance for women who do not have the disease while delivering an improved patient experience and lower cost compared to the current standard of care.

The Company’s technology provides automated 3D imaging of the breast without ionizing radiation and without breast compression, enabling high-resolution volumetric imaging and quantitative analysis of breast tissue.

The current QT Breast Scanner, the Breast Acoustic CT™ scanner, developed by the Company is a Class II device subject to premarket notification and clearance under Section 510(k) of the Food, Drug, and Cosmetic Act (the “FDCA”). On August 23, 2016, QT Ultrasound submitted a Section 510(k) Summary of Safety and Effectiveness application for the QT

1 This is comprised of previous grants including grants to the University of Utah ($811 thousand) and the current five year grant 1RO1CA273700 from the U.S. National Institute of Health for $2.58 million (Quantitative Ultrasound Monitoring of Breast Cancer Therapies), which was awarded to 3 institutions: University of Illinois, University of Toronto (Sunnybrook) and QT Imaging, which received $1.08 million of the $2.58 million grant.

Breast Scanner in accordance with 21 CFR 807.92 under 510(k) Number K162372. As part of meeting the general requirements for basic safety and essential performance of the QT Breast Scanner (formerly, QT Ultrasound Breast Scanner) pursuant to AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical Electrical Equipment, testing was conducted by Intertek, an independent testing laboratory located in Menlo Park, CA. Intertek also conducted applicable testing pursuant to IEC 60601-1-6 Edition 3.1 2013-10—Medical Electrical Equipment Part 1-6 General Requirements for Safety—Collateral Standard: Usability. In addition, QT Ultrasound conducted, and Intertek witnessed, all applicable testing pertaining to the requirements for the safety of ultrasonic medical diagnostic and monitoring equipment and to demonstrate compliance with the Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. This test on acoustic output was pursuant to IEC 60601-2-37 Edition 2.0.2007—Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment. Finally, system verification testing was conducted to ensure that the QT Breast Scanner met all design and other requirements including but not limited to that no new issues of safety or effectiveness compared to the predicate device, the SoftVue System manufactured by Delphinus Medical Technologies, were raised.

On June 6, 2017, the FDA, in response to the Company’s Section 510(k) Summary of Safety and Effectiveness premarket notification, determined that the QT Breast Scanner is substantially equivalent to the predicate device under 510(k) Number K162372.

On August 31, 2022, the FDA granted a further 510(k) clearance (K220933) for the Company’s QT Scanner 2000 Model A, which enables the system to calculate quantitative measurements of breast fibroglandular tissue volume and the ratio of fibroglandular tissue volume to total breast volume based on reflection-mode and transmission-mode ultrasound images. These measurements may assist clinicians in assessing breast density and monitoring changes in breast tissue over time.

On March 10, 2026, the FDA granted an additional 510(k) clearance for an enhanced configuration of the Company’s Breast Acoustic CT scanner designed to improve imaging coverage of posterior breast tissue. The updated configuration incorporates a tilted transmitter geometry, which enhances tomographic visualization of breast tissue located near the chest wall—an area that can be challenging to image with conventional breast imaging approaches. This enhancement expands the scanner’s imaging coverage and supports more complete visualization of posterior breast anatomy while continuing to generate volumetric tomographic images using reflection-mode and transmission-mode ultrasound data.

The Company's Cloud software-as-a-service (“SaaS”) platform will serve as the unified delivery framework for upcoming artificial intelligence and machine learning algorithms developed by the Company. Leveraging DICOM-compatible architecture, the Company will integrate these modules through the cloud for quantitative feature extraction and diagnostic decision support. Built on advanced acoustic signal analysis and volumetric data fusion, the algorithms will be deployed through the cloud infrastructure to enable real-time or near-real-time analysis of imaging data.

This approach will enable future artificial intelligence-driven capabilities, including automated lesion segmentation, volumetric tissue characterization, and computer-aided diagnostic support, to be securely delivered to connected QT Breast Scanners without requiring on-premise software updates. As quantitative biomarkers allow imaging to move beyond detection toward diagnostic and prognostic precision through quantitative imaging, the Company’s goal is to build a biomarker-driven Cloud SaaS platform that evolves the business from a hardware manufacturer into a precision imaging platform combining hardware, software, and cloud-based artificial intelligence modules.

The Purpose of the Company

Most conventional imaging technologies—including X-ray computed tomography (“CT”), MRI, and positron-emission tomography (“PET”)—typically require complex infrastructure, specialized facilities, and highly trained personnel. These systems often involve ionizing radiation or contrast agents and require shielding and specialized clinical environments. As a result, imaging procedures using these technologies can be time-consuming and expensive and are generally limited to hospital or tertiary care settings.

These limitations restrict access to advanced imaging technologies and make deployment in decentralized or lower-resource environments challenging.

The Company believes its imaging technology platform, which uses low-energy transmitted sound to generate high-resolution three-dimensional images, can address several of these limitations. By avoiding ionizing radiation and eliminating breast compression, the Company’s systems are designed to provide a more comfortable patient experience while enabling volumetric imaging and quantitative tissue characterization.

The Company is also developing a cloud-based imaging platform designed to deliver quantitative imaging biomarkers and advanced analytics. Through collaborations with industry partners, the Company is integrating advanced visualization, quantitative analytics, and AI-ready imaging technologies into its Cloud SaaS infrastructure to support clinical interpretation, research workflows, and quantitative imaging analysis. This platform is designed to enable secure cloud-based delivery of Breast Acoustic CT studies with high-performance visualization and multimodality integration across breast imaging workflows.

The Clinical Problem

The current medical imaging technologies—CT, MRI and PET—are commonly used in advanced health care facilities in North America, Europe, Japan and South Korea, with more limited deployment in selected tertiary care facilities in other countries—usually large urban areas. These current technologies are based on advanced engineering solutions that use high energy (X-rays, positrons or nuclear magnetic resonance signals) to see inside of the human body. These technologies require large capital investments, are limited to specialized facilities and require advanced certifications for the machines and their operators to insure safe operation. These machines are also expensive to purchase and maintain. All these factors combine to restrict their deployment to advanced clinical centers and tertiary care institutions.

A Breast Cancer Solution to Increasing the Quality of Health Care and Lowering Costs

Breast cancer screening today relies primarily on mammography as the front-line modality within the standard breast care pathway 2,3. While mammography has played an essential role in improving early detection, it is an imaging approach that uses ionizing radiation and, in certain diagnostic contexts such as contrast-enhanced mammography, may require the administration of iodinated contrast 2. The modality also requires specialized facilities and trained personnel to operate, which can limit access and increase operational costs 2.

In addition, mammography can be less effective for women with dense breast tissue, where image interpretation is often more challenging and results may be inconclusive 3,4. This frequently leads to additional supplemental imaging—such as ultrasound or MRI—to clarify findings 3,5. As a result, many patients experience a multi-step diagnostic process that can involve repeated appointments, multiple imaging modalities, and increased out-of-pocket costs. These factors can contribute to patient anxiety, higher recall rates, and in some cases attrition from recommended screening programs 5.

These challenges are particularly relevant for women who require regular monitoring but may be hesitant to undergo repeated imaging involving radiation or compression. Concerns regarding cumulative lifetime radiation exposure, procedural discomfort, scheduling complexity, and cost can all impact adherence to recommended screening regimens 5.

The Company intends to address this gap by establishing its imaging modality as a preferred screening solution for all intermediate-risk women and high-risk younger women (under 40) identified through established risk stratification frameworks such as the Tyrer-Cuzick model 5,6. Together, these patient segments represent approximately 70% of the screening population, when considering intermediate-risk populations and the large proportion of women with dense breast tissue requiring enhanced screening pathways 3,6, creating a large opportunity to improve both access and outcomes in breast imaging.

The Company’s technology is designed to optimize imaging performance in dense breast tissue while offering an approach that more closely resembles MRI-style physiologic imaging, enabling the capture of multiple physiologic biomarkers in a single examination. These physiologic biomarkers reflect functional characteristics of breast tissue—such as vascular, structural, and mechanical properties—derived directly from imaging data, distinguishing them from molecular biomarkers, which are typically obtained through laboratory or tissue-based testing 7. This “one scan, multiple physiologic biomarkers” approach can provide clinicians with richer functional insight into breast tissue while reducing the need for multiple follow-on tests.

Beyond the imaging hardware, the Company intends to build and deploy a SaaS precision diagnostics ecosystem around the scanner platform. This ecosystem is designed to generate elevated clinical insights for providers by analyzing physiologic biomarkers derived from the scan data. Specifically, the platform will leverage the geometric, elastic, and spectral properties of breast tissue captured during the scan to produce advanced quantitative assessments that support diagnostic interpretation, longitudinal monitoring, and clinical decision-making 7. By integrating these capabilities into a

2 American College of Radiology (ACR). ACR Appropriateness Criteria®: Breast Cancer Screening.

3 Mann RM et al. “Breast cancer screening in women with extremely dense breasts.” European Society of Breast Imaging (EUSOBI) Recommendations. European Radiology.

4 Boyd NF et al. “Mammographic density and the risk and detection of breast cancer.” New England Journal of Medicine.

5 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis.

6 Pashayan N et al. “Risk-stratified screening for breast cancer.” Nature Reviews Clinical Oncology.

7 Gillies RJ, Kinahan PE, Hricak H. “Radiomics: Images are more than pictures.” Radiology.

scalable software environment, the Company aims to deliver precision diagnostics that enhance clinical insight while continuously increasing the value of each scanner installed.

Beyond clinical performance, the platform is designed to improve reproducibility through an operator-independent imaging workflow. By minimizing operator variability, the system aims to produce more consistent and reliable imaging results across sites and patient populations.

From an economic perspective, the technology is intended to reduce the overall cost of imaging by lowering capital equipment requirements, simplifying operations, and reducing the need for highly specialized personnel. At the same time, the platform is designed to support revenue growth to providers through access to existing reimbursement pathways for baseline scans, with the potential for additional reimbursement tied to physiologic biomarker–driven precision diagnostic insights delivered through the Company’s software platform.

Equally important, the system is designed with patient experience in mind. By eliminating breast compression, ionizing radiation, and contrast injections, the scanning process is intended to be significantly more comfortable and less intimidating for patients. This patient-centric approach may improve adherence to recommended screening programs, reduce anxiety associated with repeat imaging, and support more consistent longitudinal monitoring.

The non-invasive nature of the modality also makes it particularly well suited for therapy monitoring. Because the technology does not rely on ionizing radiation—unlike modalities such as mammography or digital breast tomosynthesis—and does not require contrast agents as in MRI, there are fewer practical or clinical restrictions on how frequently patients can be scanned. This allows clinicians to monitor treatment response more frequently and with greater patient comfort, potentially enabling earlier insights into therapeutic effectiveness.

Through this strategy, the Company aims to complement the existing breast imaging ecosystem while expanding safe, accessible screening and monitoring options for a large segment of the population that remains underserved by current imaging pathways.

Our Competitive Strengths

We believe that our competitive strengths include the following:

•the world-wide market for medical imaging is large and it has a potential to expand in the areas where the Company has differentiation;

•a non-ionizing, non-contrast dye injection imaging modality;

•an imaging modality with superior performance as compared to traditional mammogram with respect to specificity (false positive), thus less unnecessary emotional trauma for patients, reduced numbers of invasive follow-up procedures and a reduction of costs for both patient and broader society;

•an imaging modality with the potential to offer superior specificity compared to screening breast MRI for younger women (under 40 years of age) at above-average risk. By reducing false positives, it holds the potential of sparing patients from undue emotional distress, limiting unnecessary biopsies and follow-up procedures, and ultimately decreasing healthcare costs for both individuals and society;

•a lower price point than conventional high-energy imaging equipment;

•the Company’s technology can be deployed to low resources environments (“LREs”) because of its automation, small footprint, no shielding, no contrast-dye injection;

•the Company’s technology is portable and can be used in point-of-care settings such as LREs;

•the Company’s technology is deployable in outdoor settings such as sports, military, and naval settings;

•the Company’s technology reduces the barriers to testing and follow up-care for women, as there is no need for specialized training and the technology is well-suited for lowering health care costs by being affordable and easily accessed;

•the Company’s technology provides optimized patient experience, as no radiation is involved, with the patient being able to be followed with no limitation to imaging frequency;

•the Company’s technology is well-suited for traditional tertiary care hospitals and additionally for direct-to-consumer (“DTC”) and direct-to-practitioner (“DTP”) applications, that are outside these institutions;

•the Company’s technology is uniquely proprietary, disruptive and a one-of-a kind product that can address a variety of unmet medical needs in the medical marketplace;

•the Company’s scanner features a uniquely simple design with a small number of components, which in turn significantly reduces the cost of the bill of materials, cost of goods sold, and the total-cost-of-ownership, and enables a lower average selling price compared to other available systems, thus making it much more affordable to large mass deployments; and

•the Company’s products have potential strong revenue growth, with capital purchase supporting substantial long-term gross margin.

Our Strategies

We believe that our strategies include the following:

•create disruptive technological innovation (software, artificial intelligence, and smart physics) to improve medical imaging and thus health care quality and access.

•continue to improve our high quality, high resolution, native 3D, reproducible image quality regardless of operator or breast size/tissue type breast imaging technology, as well as the techniques for quantifiable analysis, comparison, and training.

•build a biomarker-driven Cloud SaaS platform to shift from a hardware company to a precision imaging artificial intelligence platform combining hardware, software and cloud-based artificial intelligence modules. Biomarkers allow us to move beyond detection toward diagnostic and prognostic precision through quantitative imaging.

•partner with strategic business and distribution channels to address the U.S. market for breast imaging immediately and, other regions in the future, to place the QT Breast Scanner in hospitals, radiology centers, etc. and generate awareness of the benefits of the Company’s technology.

•perform small scale manufacturing internally to the Company and partner strategically for large scale manufacturing.

•expand the market by supporting additional DTC and DTP approaches to enable the ability to lower health care costs and increase access via personal medical imaging.

•provide a new social and economic opportunity for consumers to take control of some aspects of their own health care—such as imaging for minor injuries or medical conditions without needing a healthcare “gate-keeper.”

•focus our intellectual capabilities and ethical framework to become unified in our mission to improve the quality and lower the cost of health care world-wide... “It’s about time.”

•leverage on the intellectual property and know-how of the company as is demonstrated through the first family of QT Breast Scanner commercialization, to develop other scanning medical imaging products, such as infant scanners, full-body scanner and/or other products.

Sales and Marketing

The breast imaging market represents a substantial and growing opportunity, with the current total addressable market (TAM) valued at approximately $6 billion 8,9. This market includes established modalities such as mammography, ultrasound, and MRI, which together form the backbone of breast cancer screening and diagnostics globally 10,11. Within this, the accessible reimbursed markets (SAM)—covering key regions such as the United States, Organization for Economic Co-operation and Development countries, Korea, and Japan—are projected to grow from approximately $1.7 billion in 2025 to $2.6 billion by 2030, reflecting a compound annual growth rate (“CAGR”) of roughly 8–9%.

The Company aims to capture meaningful share within this accessible market, targeting approximately 10% SAM penetration by 2030. This represents significant growth potential as the Company’s innovative technology advances the breast imaging paradigm.

Moreover, the Company is positioned to participate in a newly emerging market segment valued at around $1 billion, focused on SaaS-enabled precision diagnostics and imaging analytics using physiologic biomarkers 12,13. This emerging category reflects a broader shift toward AI-enabled quantitative imaging and precision medicine platforms, which enable more personalized treatment approaches with improved therapy guidance and monitoring capabilities 12,13.

To support this initiative, the Company has entered into strategic partnerships with Intelerad Medical Systems Incorporated (“Intelerad”) and Olea Medical S.A.S (“Olea Medical”) to provide the imaging informatics and advanced post-processing infrastructure necessary for physiologic biomarker discovery and clinical deployment. Through its combined hardware and software platform, the Company is uniquely positioned to capitalize on both the expanding traditional imaging market and the emerging precision diagnostics opportunity, driving transformation across breast health care.

Leverage Current Clearances to Build Presence and Awareness in the Medical Community

The current QT Breast Scanner is a Class II device subject to premarket notification and clearance under Section 510(k) of the FDCA. The QT Breast Scanner is currently cleared by the FDA under Section 510(k) (which clearance was granted in June 2017) for breast imaging but not as a replacement for screening mammography – currently, the device has FDA approval and can be reimbursed in cases where additional breast imaging is necessary. This includes women who need adjunctive screening, such as: women with dense breasts or where there is a finding; high risk women below the recommended age for mammography; and women who would benefit from more frequent breast imaging, such as women undergoing treatment or women on prophylactic medication to prevent breast cancer.

Many patients may find the QT Imaging modality preferable for dense breasts, implants, post therapy screening where breasts can be very sensitive to compression and where patients have concerns about the radiation dose.

A particular opportunity for the Company under its current clearance is to provide a backup option for women who are recommended for a breast MRI but are unwilling or unable to have it for cost or accessibility reasons. With additional clinical data comparing the clinical efficacy of the QT Breast Scanner to MRIs, the QT Breast Scanner may become a less expensive, more patient-friendly alternative to MRIs (no contrast-dye, no claustrophobia, no noise). QT Scanners will free MRI scanners for other non-breast imaging studies.

Achieving clinical adoption requires building awareness and acceptance in the medical community. The first step will be to place machines with early adopters who see the benefits of the Company’s technology, are interested in using the device in their practice, are willing to collect data on its use, and will publish results or speak to their peers about its clinical value.

An example of this strategy in practice is the National Cancer Institute grant received in 2022 in partnership with the University of Illinois – Urbana-Champaign whereby the Company will place a QT Breast Scanner at St. Margaret’s Hospital in Toronto, Canada. The objective is to evaluate and measure the effectiveness of the QTscan in evaluation and monitoring cancer treatment in comparison to breast MRI which is currently the standard-of-care in quantitative monitoring

8 Markets and Markets. Breast Imaging Market – Global Forecast to 2030. Industry analysis estimating global breast imaging market size and growth trends.

9 Grand View Research. Breast Imaging Market Size, Share & Trends Analysis Report. Global and regional market projections including CAGR estimates for imaging modalities.

10 American College of Radiology (ACR). ACR Appropriateness Criteria®: Breast Cancer Screening. Guidelines describing mammography, ultrasound, and MRI as core breast imaging modalities.

11 Mann RM et al. European Society of Breast Imaging (EUSOBI) recommendations for breast cancer screening. European Radiology.

12 McKinsey & Company. The Future of AI-Enabled Diagnostics in Healthcare. Discussion of imaging analytics, radiomics, and SaaS-based precision diagnostics platforms.

13 Gillies RJ, Kinahan PE, Hricak H. “Radiomics: Images Are More Than Pictures.” Radiology.

of response to therapy. The results of the study will be published and would represent an independent validation of the clinical value of the QTscan with the imprimatur of a respected university, hospital, and the National Cancer Institute. The Company intends to establish similar peer-review partnerships with respected medical organizations, practices, and practitioners in the future.

Sales and Marketing Strategy

Building on its clinical and technology strategy, the Company intends to drive continued growth through a focused commercial expansion plan. In the United States, the Company plans to strengthen its market presence through a hybrid commercialization model that combines strategic collaborations with targeted direct initiatives. A key component of this approach is leveraging its collaboration with NXC Imaging, Inc. (“NXC”), a wholly owned subsidiary of Canon Medical USA, Inc. (“CMSU”), and CMSU’s parent, Canon Medical Systems Corporation (“CMSC”, and collectively referred to with CMSU as “Canon”), which provides access to established sales infrastructure, market relationships, and distribution capabilities. This collaboration will be complemented by the Company’s own direct commercial initiatives aimed at expanding clinical partnerships, supporting early adopter sites, and building deeper engagement within the breast imaging community.

As part of its U.S. market development strategy, the Company also intends to undertake a multigenerational outreach and advocacy campaign focused on increasing awareness around breast health and early screening. This initiative will emphasize the theme “Women’s Health = Women’s Empowerment,” positioning proactive health management as a core component of personal and societal empowerment. The campaign is expected to leverage celebrity endorsements and thought leaders to generate earned media exposure and foster broad engagement across multiple generations of women. By combining advocacy, education, and public awareness, the Company aims to encourage earlier and more consistent participation in breast health screening while increasing visibility for new, patient-friendly imaging technologies.

In parallel with its U.S. growth strategy, the Company intends to expand into international markets, beginning with the Gulf Cooperation Council (GCC) region. The Company has established strategic distribution relationships with Gulf Medical Co. (“GMC”) for the Kingdom of Saudi Arabia and Al Naghi Medical Co. (“Al Naghi”) for the United Arab Emirates (the “UAE”). These partnerships are expected to provide strong regional market access through organizations with deep experience in medical technology distribution and established relationships with leading healthcare institutions.

Regulatory processes for both the Kingdom of Saudi Arabia and the United Arab Emirates are already underway, and the Company expects the required certifications to be in place in the near term, enabling commercial deployment in these markets.

Beyond these initial GCC markets, the Company is actively engaged in discussions to establish additional strategic distribution partnerships across the broader GCC region, including Kuwait, Qatar, Oman, and Bahrain. These markets represent attractive opportunities due to their growing healthcare infrastructure, increasing focus on early cancer detection, and openness to innovative medical technologies.

Looking further ahead, the Company intends to explore expansion into European and other international markets such as Australia and New Zealand (ANZ), South Korea, South Asia, and the Association of Southeast Asian Nations (ASEAN) through carefully selected distribution partnerships. This expansion will be supported by well-orchestrated market creation strategies, including collaborations with leading clinical institutions and research organizations to generate clinical evidence, build physician awareness, and support regulatory and reimbursement pathways in each geography. The Company is also working closely with Canon’s Japan operations (where Canon is headquartered) and a prominent luminary in Japan to explore opportunities within the Japanese market. Registration activities for Europe are planned to commence later this year, with other geographies that accept EU registration to be pursued subsequently.

Through this coordinated approach—combining technology innovation, precision diagnostic software capabilities, strong commercial partnerships, and strategic geographic expansion—the Company aims to build a scalable global platform for next-generation breast imaging and diagnostics.

Use an Installed Base as a Platform to Expand Awareness and Produce Additional Data for Clinical Acceptance, Reimbursement, and Additional FDA Clearances

Part of the challenge of achieving clinical acceptance and adoption of the Company’s technology is data that proves the efficacy of the QTscan relative to the current standard of care for breast imaging in screening, diagnosis and treatment. The rollout of QT Breast Scanners as described in the previous section will provide multiple means of collecting this data for clinicians, which can also be used to support reimbursement and expanded FDA clearances of the QT Breast Scanner as an alternative to screening breast MRI in younger women (under 40 years of age) with above average risk of breast cancer.

Data collection and analysis, support reimbursement and expanding FDA clearances are time-consuming, but with the help of the installations that will be accelerated through the placement programs detailed above, the Company believes that it can achieve these objectives with maximum efficiency.

Market Segments

As the installed base for QT Breast Scanners expands, and as discussed above, the Company intends to tailor its marketing efforts towards three segments as it builds awareness and acceptance for its imaging technology. All are important for success, and each requires its own strategy and messaging.

•Patients. This is the end-user/consumer – the women who are dissatisfied with the current scanning model. The Company intends to approach patients through multiple channels, beginning with outreach efforts to recruit key influencers and opinion leaders. These individuals would be recruited through networking and education via targeted interest groups and would become advocates of the benefits of the Company’s technology to their respective groups.

•Medical Professionals/Radiologists. In addition to marketing to women, the Company launched an intensive campaign aimed at the medical community. This is a more difficult effort than that aimed at women – from the provider perspective, the need for multiple scans and callbacks that are a negative for patients are actually seen as an economic positive as additional patient visits generate a significant amount of revenue. This is true for both institutions and radiologists, and neither have a great incentive to deviate from the current status quo.

NXC Distribution Agreement

The Company is supported by a strong distribution and business partnership with NXC. On May 13, 2023, QT Imaging entered into the “NXC Sales Agent Agreement” with NXC, pursuant to which QT Imaging appointed NXC as the non-exclusive agent for the sale of the QT Breast Scanner and related services in non-exclusive territories: the U.S., U.S. territories, and U.S. Department of Defense installations. Additionally, NXC was appointed as the exclusive servicer of the QT Breast Scanners sold by NXC under the terms of the NXC Sales Agent Agreement. Under the NXC Sales Agent Agreement, QT Imaging had the right to set the price for its products and agreed to pay NXC a commission based on the purchase order price charged to a customer. Pursuant to the NXC Sales Agent Agreement, NXC was responsible for promotion and sale of the QT Breast Scanner and related services within the designated territory, as well as servicing the QT Breast Scanners sold by NXC. The initial term of the NXC Sales Agent Agreement was for three years.

Subsequently, effective June 10, 2024, the Company and NXC replaced the NXC Sales Agent Agreement with the “NXC Distribution Agreement”. Under the NXC Distribution Agreement, NXC is appointed as the exclusive reseller to market, advertise, and resell QT Breast Scanners in the U.S. and U.S. territories. NXC will purchase for the purpose of reselling, leasing or renting QT Breast Scanners directly to its customers, but is not obligated to purchase any particular quantity of QT Breast Scanners from the Company. The Company has reserved the right to sell directly to customers as an exception. Furthermore, the Company may, in its sole discretion, sell the QT Breast Scanners to any other person or entity anywhere in the world without notice to NXC or NXC’s prior consent. NXC is also allowed to assign sales agents for the purpose of QT Breast Scanner sales. NXC’s purchases will be in accordance with an agreed upon product pricing schedule (subject to change upon 60 days’ prior written notice by the Company), provided that neither NXC nor its assigned sales agents may mark-up the cost of the QT Breast Scanners more than twenty percent (20%) unless otherwise mutually agreed to between NXC and the Company. Each order will include information reasonably requested by the Company and is subject to the Company’s acceptance, after which it becomes an approved order. Any such approved orders are non-cancellable and not subject to rescheduling after acceptance by the Company. Any orders not accepted by the Company in writing are deemed rejected.

On October 29, 2024, the Company and NXC entered into Amendment No. 1 to the Distribution Agreement (the “First Amendment”) to expand Section 20 of the NXC Distribution Agreement to provide that NXC shall be obligated to inform its customers who purchase the QT Breast Scanner (the “Equipment”) that such customers shall not (i) use, copy, distribute, display, perform, or prepare derivative works of any materials accompanying or embodied in the Equipment (except to the extent expressly permitted by such customer’s license to such Equipment and its documentation) or (ii) use any Seller Marks (as defined in the NXC Distribution Agreement), in each case without the Company’s prior written consent. Further, the First Amendment provides that upon any unauthorized use of the Seller Marks or materials accompanying the Equipment by any customer, NXC shall promptly inform the Company and provide all reasonably requested assistance in termination such unauthorized use.

On December 11, 2024, the Company and NXC entered into the Amended and Restated Distribution Agreement (the “Amended NXC Distribution Agreement”), which amends and restates the NXC Distribution Agreement in its entirety. The Amended NXC Distribution Agreement provides for the following modifications to the NXC Distribution Agreement, with the balance of terms (including those added by the First Amendment) remaining materially unchanged:

Sale of Equipment

Under terms of the Amended NXC Distribution Agreement, in the event that CMSC enters into an OEM manufacturing agreement, then fulfillment by the parties to such manufacturing agreement of their respective obligations under such manufacturing agreement shall be a condition to NXC being the exclusive reseller to market, advertise, and resell the Equipment in the U.S. and U.S. territories.

Minimum Order Quantities and Pricing

The Amended NXC Distribution Agreement provides that no later than five days prior to the end of each calendar quarter, NXC shall provide to us a forecast of the anticipated purchases of Equipment during the subsequent twelve-month period. The Amended NXC Distribution Agreement further provides that the forecast for 2025 and 2026 shall be no less than the minimum order quantities (“MOQs”) set forth in an exhibit to the Amended NXC Distribution Agreement, by quarter and by year. Furthermore, all purchase orders from NXC shall be for no less than the MOQs, which NXC must order on the quarterly and annual basis as set forth in an exhibit to the Amended NXC Distribution Agreement. However, in the event that the Company and CMSC do not enter into an OEM manufacturing agreement, then the MOQs shall be non-binding only in the event that the Company cannot fulfill the manufacture and delivery volumes required for NXC to meet the MOQs.

Should NXC fail to submit a purchase order for no less than the MOQs in any quarterly or annual period, then the Company may invoice NXC and NXC shall pay the Company for the difference between the Equipment purchased and the MOQs for such period.

NXC’s purchases will be in accordance with a product pricing schedule attached to the NXC Distribution Agreement as an exhibit (subject to change upon 60 days’ prior written notice by the Company). The Amended NXC Distribution Agreement removed the cap on markup by NXC on its resale of the cost of the Equipment that was provided for by the NXC Distribution Agreement, such that NXC may set the resale price for customers at its sole discretion.

Payment Terms

Except as otherwise set forth in an applicable Approved Order, the Amended NXC Distribution Agreement provides that we will invoice NXC upon shipment of the Equipment and NXC shall pay the invoice by net thirty days from shipment of the Equipment.

After Sale Service

The Amended NXC Distribution Agreement obligates us to continue to provide technical support, spare parts, and necessary know-how in order for NXC to continue to service and support Equipment for at least five years after installation of the Equipment at a customer site. The Amended NXC Distribution Agreement also deleted a provision in the NXC Distribution Agreement that required NXC to request each of its customers to have a qualified or trained breast radiologist.

Limited Warranty

The Amended NXC Distribution Agreement contains limited warranties with respect to the Equipment and relevant spare parts, to remain in effect (a) for Equipment for the shorter of fifteen months from the shipment of the Equipment or twelve months from the date of customer acceptance of installed Equipment, and (b) the relevant spare parts for the shorter of twelve months from the date of their shipment and six months from the date that their completion is installed.

Non-Solicitation

The Amended NXC Distribution Agreement contains a non-solicitation provision stating that we agree, during the term thereof and for a period of three years after, we shall not, directly or indirectly: (a) interfere with or attempt to interfere with any relationship between NXC and any of its distributors, agents, employees, consultants, independent contractors, agents or representatives, (b) solicit the business or accounts of NXC, or (c) divert or attempt to direct from NXC any business or interfere with any relationship between the NXC or any of its clients, suppliers, customers or other business relations; provided, however, that we may engage with the end customers that have acquired the Equipment to the extent necessary to enable such end customers to utilize the Equipment. Furthermore, to the extent not otherwise prohibited by law, each party agrees that, during the term of the Amended NXC Distribution Agreement and for a period of three years after, each party shall not, directly or indirectly solicit for employment the employees of the other except to the extent that such solicitation is done through a general advertisement or solicitation that is not specifically targeting the employees of the other.

Term

The Amended NXC Distribution Agreement extends the term from December 31, 2025 until December 31, 2026, unless earlier terminated or extended by mutual written agreement.

On March 28, 2025, the Company entered into the First Amendment to Amended and Restated Distribution Agreement (the “First Amendment to A&R Distribution Agreement”). The First Amendment to A&R Distribution Agreement amends certain provisions of the Amended NXC Distribution Agreement. It provides, among other things, that the Company reserve the right to sell the Equipment directly to a third party as an exception, and any such direct sale by the Company shall occur after a prior written notification to NXC and shall count towards the MOQs, provided that if a third party is a competitor of NXC as defined in the First Amendment to A&R Distribution Agreement or an existing customer of NXC or NXC’s reseller or sales agent at the time when the Company seek to sell the Equipment directly to the third party, the Company may not sell the Equipment to such third party. It also provides that NXC shall provide the Company with the forecast of the anticipated purchases of Equipment during the subsequent twelve-month period no later than forty-five days prior to the end of each calendar quarter, rather than five days prior to the end of each calendar quarter. No changes are made to the amount of the MOQs by the First Amendment to A&R Distribution Agreement, but the MOQs shall not be binding if at any time (a) the Company cannot fulfill the manufacturing and delivery volumes required for NXC to meet the quarterly MOQs, including due to (i) failures or other circumstances attributable to the Company including, but not limited to, issues relating to design or performance of the Equipment (e.g., failure of the Equipment to meet its published specifications), orders by the FDA or another governmental organization to temporarily or permanently suspend shipments, and to activities or operations of the Company, or (ii) a final non-appealable judgment that would impair the Company’s ability to fulfill such manufacturing and distribution volumes as a result of (A) intellectual property infringement made by a third party relating to the Equipment or (B) other legal proceedings against the Company; or (b) the Company engage with any competitor or existing customers of NXC or its reseller or sales agent to sell the Equipment in violation of the terms of the Amended NXC Distribution Agreement, as amended. Furthermore, the First Amendment to A&R Distribution Agreement provides that in the event NXC is prevented from selling the Equipment due to actions of or attributable to the Company, the Company and NXC will discuss in good faith. The Company also agreed to introduce at least one new product improvement per year to the Equipment, that the Company will also timely correct all Equipment bugs or other defects as necessary to address performance issues, and that any increases of the price of the Equipment shall be upon mutual agreement of the parties. Also, in the event of an Equipment Recall (as such term is defined in the First Amendment to A&R Distribution Agreement), the First Amendment to A&R Distribution Agreement provides both parties shall promptly consult and cooperate with the other party, including with respect to the appropriate action to be taken in connection with such Equipment Recall, and mutually agree to appropriately modify the MOQs for the respective quarter or until the Equipment Recall is corrected with mutual agreement with NXC.

Gulf Medical Distribution Agreement

On August 21, 2025, the Company entered into a distribution agreement (the “Gulf Medical Distribution Agreement”) with GMC. Under the terms of the Gulf Medical Distribution Agreement, the Company shall authorize and grant to GMC the exclusive right to market, advertise and sell the QT Breast Scanner and other products and services covered by the Gulf Medical Distribution Agreement (the “GMC Approved Products”) in the Kingdom of Saudi Arabia (the “GMC Territory”).

The term of the Gulf Medical Distribution Agreement commenced on August 21, 2025, and shall remain in force through August 21, 2028 (the “Initial Term”). If GMC has met the GMC Minimum Purchase Requirements (as defined below) during the Initial Term, the Gulf Medical Distribution Agreement shall automatically be extended for an additional one-year term. GMC agrees to meet or exceed the purchase requirements and/or revenue goals for the GMC Approved Products set forth in the Gulf Medical Distribution Agreement (the “GMC Minimum Purchase Requirements”) during the Initial Term. In the event GMC fails to meet these Minimum Purchase Requirements in any year during the Initial Term, the Company may, at its sole option, (a) terminate GMC’s exclusive distributorship rights for the sale and promotion of the GMC Approved Products granted under the Gulf Medical Distribution Agreement and appoint other distributors for the GMC Approved Products in the GMC Territory, or (b) terminate the Gulf Medical Distribution Agreement. Should the Company elect to so terminate GMC’s exclusive distributorship in the GMC Territory, the Company may continue to sell the GMC Approved Products to GMC for GMC to distribute on a non-exclusive basis in the GMC Territory in accordance with the terms and conditions of the Gulf Medical Distribution Agreement, and GMC’s ongoing obligations with regard to the GMC Minimum Purchase Requirements for the GMC Approved Products shall terminate. Should the Company be unable to furnish GMC with sufficient quantities of the GMC Approved Products, as may be requested by GMC in its GMC Release Orders (as defined below) submitted to the Company in accordance with the terms of the Gulf Medical Distribution Agreement, then the GMC Minimum Purchase Requirement shall be reduced by the quantity of GMC Approved Products that the Company is unable to deliver as requested.

GMC shall secure all required governmental approvals, permits, licenses, customs clearances, and authorizations required for shipment to and use of the QT Breast Scanners in the GMC Territory. The Company shall provide training and professional services to GMC during the term of the Gulf Medical Distribution Agreement and shall retain all intellectual property rights.

At any time during the term of the Gulf Medical Distribution Agreement, GMC may submit to the Company a blanket purchase order (the “GMC Blanket Purchase Order”) with any client’s requirements for the GMC Approved Products for review and written acceptance by the Company. Thereafter, over the course of the client’s project GMC may submit to the Company one or more release orders for GMC Approved Products to meet the client’s requirements under the applicable GMC Blanket Purchase Order (each, a “GMC Release Order”). If the Company reasonably anticipates being able to meet such requirements, such order shall be deemed approved so long as it conforms to the terms of the Gulf Medical Distribution Agreement. Any terms and conditions in an order that are inconsistent with or in addition to the terms and conditions of the Gulf Medical Distribution Agreement shall be rejected and considered null and of no effect, unless expressly agreed to by the Company in writing. Upon receipt and acceptance of each order, the Company will provide the minimum number of days to ship the QT Breast Scanners and then deliver the QT Breast Scanners to the destinations designated in such orders. GMC will bear all risks of loss or damage to the QT Breast Scanners upon delivery to the designated destinations.

The Company will deliver the GMC Approved Products to GMC’s destination(s) designated in the applicable GMC Release Order. The Company may make partial shipments, to be separately invoiced and paid for when due and GMC may not reject partial shipments. Any delay in delivery of any installation of GMC Approved Products will not relieve GMC of its obligation to accept the remaining deliveries. GMC will be solely responsible for all shipping, packaging, duties, fees, brokerage, insurance and customs clearance and export documentation, as applicable, and for payment of all costs and charges related thereto, except that the Company will arrange the initial packaging and shipping.

All quotations, estimates, invoices and payments for GMC Approved Products that GMC purchases from the Company shall be in United States Dollars. Except as GMC and the Company may otherwise mutually agree in writing, provided that GMC maintains a credit limit with the Company’s credit insurance provider that has been approved in writing by the Company, GMC shall pay the Company fifty percent (50%) of the total price of the GMC Release Order upon order placement and fifty percent (50%) within 45 days from the date of shipping of the GMC Approved Products to GMC’s designated location(s), or in any of the agreed upon payment terms. For certain orders as agreed upon by the Parties, GMC shall deliver an irrevocable letter of credit to the Company to secure payment, with such irrevocable letter of credit for any particular order to be based upon the size of the order. GMC will pay all sales, use and other taxes due on sales of GMC Approved Products in the GMC Territory. GMC is not responsible for any taxes outside the GMC Territory.

The Company has provided for a limited warranty of at least one year, and up to five years, depending on the purchase price paid by a client of GMC for a GMC Approved Product.

The Gulf Medical Distribution Agreement can be terminated only with the approval of both parties and, upon termination, GMC shall be permitted to sell any QT Breast Scanners that it holds in accordance with the Gulf Medical Distribution Agreement.

On February 25, 2026, the Company amended the Gulf Medical Distribution Agreement (the “Amended Gulf Medical Distribution Agreement”) to require GMC to pay the Company fifty percent (50%) of the total price of the GMC Release Order upon order placement and fifty percent (50%) within 45 days from the date of shipping of the GMC Approved Products to GMC’s designated location(s), or in any of the agreed upon payment terms. For certain orders as agreed upon by the Company and GMC, GMC shall deliver an irrevocable letter of credit to the Company to secure payment, with such irrevocable letter of credit for any particular order to be based upon the size of the order. The second payment of the fifty percent (50%) will be 30 days following customer acceptance if GMC provides secure payment through an irrevocable letter of credit from an acceptable financial institution. The Amended Gulf Medical Distribution Agreement also established pricing for approved products sold on purchase orders on the Company’s form.

Al Naghi Distribution Agreement

On January 19, 2026, the Company entered into an exclusive distribution agreement (the “Al Naghi Distribution Agreement”) for the Company’s QTI Breast Acoustic CT scanners and QTI Cloud SaaS Platform (the “Al Naghi Approved Products”) in the UAE (the “Al Naghi Territory”) with Al Naghi, a leading distributor of medical devices. The Al Naghi Distribution Agreement provides for committed, minimum order quantities of seven scanners in 2026 (starting in the second quarter of 2026), increasing to 16 scanners in 2027 and 20 scanners in 2028, for a total minimum of 43 scanners representing revenue of more than $24 million.

The term of the Al Naghi Distribution Agreement commenced on January 19, 2026, and shall remain in force until January 19, 2029 (the “Al Naghi Initial Term”). If Al Naghi has met the Al Naghi Minimum Purchase Requirements (as defined below) during the Al Naghi Initial Term, the Al Naghi Distribution Agreement shall automatically be extended for an additional one-year term. Al Naghi agrees to meet or exceed the purchase requirements and/or revenue goals for the Al Naghi Approved Products set forth in the Al Naghi Distribution Agreement (the “Al Naghi Minimum Purchase Requirements”) during the Al Naghi Initial Term. In the event Al Naghi fails to meet these Al Naghi Minimum Purchase Requirements in any year during the Al Naghi Initial Term, the Company may, at its sole option, (a) terminate Al Naghi’s exclusive distributorship rights for the sale and promotion of the Al Naghi Approved Products granted under the Al Naghi Distribution Agreement and appoint other distributors for the Al Naghi Approved Products in the Al Naghi Territory, or (b) terminate the Al Naghi Distribution Agreement. Should the Company elect to so terminate Al Naghi’s exclusive distributorship in the Al Naghi Territory, the Company may continue to sell the Al Naghi Approved Products to Al Naghi for Al Naghi to distribute on a non-exclusive basis in the Al Naghi Territory in accordance with the terms and conditions of the Al Naghi Distribution Agreement, and Al Naghi’s ongoing obligations with regard to the Al Naghi Minimum Purchase Requirements for the Al Naghi Approved Products shall terminate. Should the Company be unable to furnish Al Naghi with sufficient quantities of the Al Naghi Approved Products, as may be requested by Al Naghi in the Al Naghi Release Orders (as defined below) submitted to the Company in accordance with the terms of the Al Naghi Distribution Agreement, then the Al Naghi Minimum Purchase Requirement shall be reduced by the quantity of Al Naghi Approved Products that the Company is unable to deliver as requested.

Al Naghi shall secure all required governmental approvals, permits, licenses, customs clearances, and authorizations required for shipment to and use of the QT Breast Scanners in the Al Naghi Territory. The Company shall provide training and professional services to Al Naghi during the term of the Al Naghi Distribution Agreement and shall retain all intellectual property rights.

At any time during the term of the Al Naghi Distribution Agreement, Al Naghi may submit to the Company a blanket purchase order (the “Al Naghi Blanket Purchase Order”) with any client’s requirements for the Al Naghi Approved Products for review and written acceptance by the Company. Thereafter, over the course of the client’s project, Al Naghi may submit to the Company one or more release orders for Al Naghi Approved Products to meet the client’s requirements under the applicable Al Naghi Blanket Purchase Order (each, a “Al Naghi Release Order”). If the Company reasonably anticipates being able to meet such requirements, such order shall be deemed approved so long as it conforms to the terms of the Al Naghi Distribution Agreement. Any terms and conditions in an order that are inconsistent with or in addition to the terms and conditions of the Al Naghi Distribution Agreement shall be rejected and considered null and of no effect, unless expressly agreed to by the Company in writing. Upon receipt and acceptance of each order, the Company will provide the minimum number of days to ship the QT Breast Scanners and then deliver the QT Breast Scanners to the destinations designated in such orders. Al Naghi will bear all risks of loss or damage to the QT Breast Scanners upon delivery to the designated destinations.

The Company will deliver the Al Naghi Approved Products to Al Naghi’s destination(s) designated in the applicable Al Naghi Release Order. The Company may make partial shipments, to be separately invoiced and paid for when due and Al Naghi may not reject partial shipments. Any delay in delivery of any installment of Al Naghi Approved Products will not relieve Al Naghi of its obligation to accept the remaining deliveries. Al Naghi will be solely responsible for all shipping, packaging, duties, fees, brokerage, insurance and customs clearance and export documentation, as applicable, and for payment of all costs and charges related thereto, except that the Company will arrange the initial packaging and shipping.

All quotations, estimates, invoices and payments for Al Naghi Approved Products that Al Naghi purchases from the Company shall be in United States Dollars. Except as Al Naghi and the Company may otherwise mutually agree in writing, provided that Al Naghi maintains a credit limit with the Company that has been approved in writing by the Company, Al Naghi shall pay the Company fifty percent (50%) of the total price of the Release Order upon order placement and fifty percent (50%) within 45 days from the date of shipping of the Al Naghi Approved Products to Al Naghi’s designated location(s), or in any of the agreed upon payment terms. For certain orders as agreed upon by the parties, Al Naghi shall deliver an irrevocable letter of credit to the Company to secure payment, with such irrevocable letter of credit for any particular order to be based upon the size of the order. Al Naghi will pay all sales, use and other taxes due on sales of Al Naghi Approved Products in the UAE. Al Naghi is not responsible for any taxes outside the UAE.

The Company has provided for a limited warranty of at least one year, and up to five years, depending on the purchase price paid by a client of Al Naghi for an Al Naghi Approved Product.

During its validity period, the Al Naghi Distribution Agreement can be terminated only with the approval of both parties and, upon termination, Al Naghi shall be permitted to sell any QT Breast Scanners that it holds in accordance with the Al Naghi Distribution Agreement.

Selectively Consider Offshore Marketing Opportunities

In 2026, the Company will remain focused on realizing and maximizing its potential in the U.S. market as well as in the markets of the Kingdom of Saudi Arabia and the UAE, while also exploring additional distribution arrangements in other GCC countries that accept U.S. product registration. The Company plans to pursue commercialization in Europe and countries recognizing EU registration starting at the end of 2026 and continuing through 2027, utilizing selective distribution arrangements. Additionally, opportunistic sales agency–based deals will continue to be pursued in countries accepting U.S. registration, with the objective of establishing key opinion leaders (KOLs) to drive market creation and evidence generation. These opportunistic deals will be carefully curated, as they may require specialized service support models through existing distribution partners.

Coverage and Reimbursement

Over the past few years, the growth rate of advanced imaging volumes has slowed in part due to additional patient-related cost-sharing programs and an increasing trend of third-party payors intensifying their utilization management efforts, for example, through benefit managers who require prior authorizations to control the growth rate of imaging services generally. The Company expects that these trends will continue.

By way of example, in the U.S., the Protecting Access to Medicare Act of 2014 required the Centers for Medicare & Medicaid Services (“CMS”), in conjunction with medical specialty societies, to adopt appropriate use criteria (“AUC”) for certain advanced diagnostic imaging services, including MRI, CT, nuclear medicine (including PET). Beginning in 2020, payment is made to the furnishing professional for an applicable advanced diagnostic imaging service only if the claim indicates that the ordering professional consulted a qualified clinical decision support mechanism, as identified by the Department of Health and Human Services (“HHS”), as to whether the ordered service adheres to the applicable AUC. Applicable settings include physician offices, hospital outpatient departments, including emergency departments, ambulatory surgical centers and independent diagnostic testing facilities. Advanced imaging services ordered by certain physicians identified as having outlier-ordering partners will be subject to prior authorization for applicable imaging services provided to Medicare beneficiaries. The outlier methodology used by CMS will be subject to future notice and comment rulemaking before the prior authorization component is implemented. The Company cannot predict the full impact of this project.

The Company is pursuing a phased, multi-year strategy to establish appropriate Current Procedural Terminology (“CPT”) coding and reimbursement pathways for its QT Breast Scanner and related technology. In 2026, the Company will continue to use the unlisted CPT code 76999, supported by robust documentation and clinical evidence, to facilitate payer education and reimbursement on a case-by-case basis. In parallel, the Company has submitted an application for a New Technology Ambulatory Payment Classification (“New Tech APC”) to the CMS in September 2025, seeking hospital outpatient reimbursement under the Medicare Outpatient Prospective Payment System (“OPPS”) framework. This approach will allow the Company to expand clinical use while building the necessary data and adoption to support formal code creation. In November 2025, the Company applied for a Category III CPT code from the American Medical Association (“AMA”), which is designed to support emerging technologies and procedures while further evidence is gathered. On Feb 23, 2026, the AMA CPT (Current Procedural Terminology) Editorial Panel approved a new Category III CPTTM code for 3D quantitative transmission volumetric ultrasound tomography of the breast. The new Category III code, X579T, represents a significant milestone in the clinical and commercial advancement of QT Imaging’s technology, recognizing the distinct clinical service enabled by its radiation-free, compression-free, 3D breast imaging platform. The new CPT code ensures standardized reporting of this emerging imaging service, supporting data collection, utilization tracking and continued evaluation by clinicians, payers and health systems. The code is scheduled for release on July 1, 2026, with an effective date of January 1, 2027. This staged strategy reflects a deliberate and structured path toward eventual Category I CPT code status, ensuring alignment with payer requirements, coding norms, and clinical integration milestones.

Third-party payors may impose limits on coverage or reimbursement for diagnostic imaging services, including denying reimbursement for tests that do not follow recommended diagnostic procedures or can only be billed using an unlisted or miscellaneous code. To the extent the Company’s customers will depend on third-party payors, unfavorable coding, coverage and reimbursement policies may constrict the profit margins of the Company’s provider customers, which may force us to lower the Company’s fees to attract and retain customers. If the Company is required to request new billing codes that more precisely identify and describe the Company’s imaging services, coverage is limited or reimbursement rates are inadequate, a healthcare provider might find it financially unattractive to own diagnostic imaging systems. It is possible that third-party payor coding, coverage and reimbursement policies will affect the need or prices for the Company’s products in the future, which could significantly affect the Company’s financial performance and the Company’s ability to conduct the Company’s business.

Industry & Market Opportunity

Doctors and hospitals increasingly rely on medical imaging to screen for and diagnose cancer, guide and monitor treatment such as drugs, radiation, and surgery, and enable minimally invasive procedures. As a result, medical imaging represents a substantial market opportunity. The global medical imaging market is estimated at more than $40 billion annually, with roughly $10 billion attributable to the United States.14 Global cancer screening, with an approximately $160 billion market size in 2025, is expected to grow at a CAGR of 12% and reach approximately $470 billion in 2033.15

Breast Imaging

Breast cancer detection and diagnostic technologies (including mammography, MRI, and ultrasound, as well as genetic testing and image guided breast biopsy) are a significant part of the medical imaging market and are estimated to represent a $6.04 billion global market in 2025, is projected to reach $13.2 billion in 2034, with an ongoing CAGR of roughly 9%.16 The market is segmented by technology, primarily between ionizing breast imaging (e.g., mammography) and non-ionizing breast imaging, which includes ultrasound and MRI. The non-ionizing segment is expected to grow at a faster rate 17 than the ionizing segment due to technological advances such as better segmentation of anatomical detail, higher sensitivity to small breast lesions in women with dense breast tissue 18, and fewer false positives.

The current standard of care for imaging in breast cancer screening, diagnosis, and treatment is far from satisfactory and may involve certain side effects. There are adverse effects to the use of medical imaging methods such as ionizing radiation, mammography, and MRI. Generally, the process starts with X-ray mammography, the primary screening tool for women. Mammography uses radiation, which in sufficient cumulative doses can increase the risk of cancer; and is uncomfortable or too painful for patients as it involves breast compression. Another adverse effect is the inefficiency of mammography in detection of cancer in women with dense breasts. There is a psychological adverse effect of callbacks for adjunct screening and diagnosis include ultrasound, MRI, and may include biopsies. This process is expensive, time consuming, and can be mentally and physically trying for women. Also, the use of three imaging modalities in the process speaks to the weakness of any one in adequately screening for breast cancer. MRI may take place in a closed environment which may cause claustrophobia, require sedation or general anesthesia and may require injection of a heavy-metal contrast agent. The use of sedation or anesthetic drugs risks severe compromise of respiratory and cardiac function.

Regarding CT, the harmful effects of radiation used in ionizing radiation exposure raises the risk of cancer, including leukemia, breast cancer, thyroid cancer and brain cancer. These issues make MRI preferred to CT for all but trauma evaluation.

14 See, e.g. Fortune Business Insights, Medical Imaging Market Size, Share & Industry Analysis, By Type (MRI, CT, X-ray, Ultrasound, Molecular Imaging), By Application, By End User, and Regional Forecast, 2025–2032 (updated 2024), available at: https://www.fortunebusinessinsights.com/industry-reports/medical-imaging-equipment-market-100382.

15 See, e.g. Fortune Business Insights, Medical Imaging Market Size, Share & Industry Analysis, By Type (Magnetic Resonance Imaging, Computed Tomography, X-ray, Ultrasound, and Molecular Imaging), By Application (Cardiology, Neurology, Orthopedics, Gynecology, Oncology, and Others), By End User (Hospitals, Specialty Clinics, Diagnostic Imaging Centers, and Others), and Regional Forecast, 2026-2034 (Feb. 2026), available at: https://www.fortunebusinessinsights.com/industry-reports/medical-imaging-equipment-market-100382.

16 See, Fortune Business Insights, Breast Imaging Market Size, Share & Industry Analysis, By Product, Technology, End User, and Regional Forecast, 2026–2034 (2025), available at: https://www.fortunebusinessinsights.com/industry-reports/breast-imaging-market-100218.

17 See, Grand View Research, Magnetic Resonance Imaging Market Size, Share & Trends Analysis by Architecture, by Field Strength, by Application (Brain & Neurological, Vascular), by End Use, by Region, and Segment Forecasts, 2025-2030, available at: https://www.grandviewresearch.com/industry-analysis/magnetic-resonance-imaging-market (last visited 2026).

18 National Cancer Institute, Dense Breasts: Answers to Commonly Asked Questions (“Breasts contain glandular tissue, fibrous connective tissue, and fatty breast tissue. Breast density describes the relative amount of these tissues as seen on a mammogram, available at: https://www.cancer.gov/types/breast/screening/dense-breasts (Dec. 2, 2025).

The QT Breast Scanner has no reports of adverse effects from the more than 30,000 scans performed to date. Similar to other ultrasound devices, due to the low frequency of the waves of those scanners, there are no known significant risks reported in general clinical practice. The QT Breast Scanner does not require potentially harmful ionizing radiation or anesthesia and is done in an open environment thereby decreasing stress and the necessity of sedation. The QT Breast Scanner does not cause breast implant displacement or rupture.

The Company’s opportunity in breast imaging is to speed the time to diagnosis for women with cancer, and to provide assurance for women who do not have the disease with a better patient experience and lower cost than the current standard of care.

While the Company believes women will embrace its technology, the Company is focused on achieving clinical adoption through the medical community, which requires continuing research on the clinical efficacy of the images rendered by the QT Breast Scanner known as a QTscan® image and development of key opinion leaders (“KOLs”) who can speak to the clinical value of its machines in practice.

There are three primary technologies within the non-ionizing breast imaging segment: Automated Breast Ultrasound Systems or ABUS (as defined below); Breast Ultrasound Tomography Systems; and Photoacoustic Imaging.

Automated Breast Ultrasound Systems (“ABUS”)

ABUS are an emerging and rapidly growing segment of the breast imaging market. ABUS systems are designed to improve cancer detection in women with dense breast tissue by providing standardized, operator-independent whole-breast ultrasound imaging as a supplement to mammography. Increasing recognition of the limitations of mammography for women with dense breasts, along with regulatory requirements for breast density notification in many jurisdictions, has driven growing clinical adoption of ABUS technology. As a result, the global ABUS market is estimated to exceed $1 billion in the mid-2020s and is projected to grow at a CAGR of roughly 13–16% in the coming years, reflecting continued expansion of breast cancer screening programs and demand for supplemental imaging modalities.19

ABUS technologies typically use a reflection transducer 20 (5-15 MHz) and not transmitting setup, in a “motorized” arrangement. The major developers of such systems include: 1) the Acuson S2000 ABVS (sold by Siemens); 2) the Invenia System (sold by GE Healthcare); 3) a manual video loop AWBS System (sold by Sono-Cine); and 4) a motorized single transducer Sofia System (sold by Hitachi.). All of these systems produce B-mode reflection images 21.

Breast Ultrasound Tomography Systems

These technologies use traditional reflection transducers 22 in an “array” configuration around the breast: 1) Mastoscopia (Greece); 2) the KIT system (research only) from Karlsruhe University in Germany; and 3) the Delphinus System.

Photoacoustic Imaging

Photoacoustic imaging systems utilize lasers to excite tissues and produce acoustic energy that subsequently create images of the breast vasculature.23 Such systems include both photoacoustic tomography (“PAT”) and photoacoustic imaging (“PAI”) systems. While the PAT systems allow volumetric imaging by reconstructing stacks of 2D images, the PAI systems only allow superimposition of photoacoustic signal information on top of conventional B-mode ultrasound. Note that in comparison to ultrasound, photoacoustic imaging systems inherently lack the ability to image the tissue anatomy and

19 See, Future Market Insights, Automated Breast Ultrasound Systems Market Outlook 2025–2035, available at:

https://www.futuremarketinsights.com/reports/automated-breast-ultrasound-system-market (2025).

20 A medical reflection transducer, also known as an ultrasound transducer, is a device that converts electrical energy into sound waves, and the back again into electrical energy. It is used in medical imaging to produce images of internal organs and tissues in the body, and it is used in various medical imaging techniques such as ultrasound, echocardiography and Doppler imaging. See, e.g., ECG & ECHO Learning, The Ultrasound Transducer, available at https://ecgwaves.com/topic/the-ultrasound-transmitter-probe/ (last visited Apr. 4, 2023); see also, FDA, Ultrasound Imaging Sept. 28, 2022), https://www.fda.gov/radiation-emitting-products/medical-imaging/ultrasound-imaging.

21 B-mode ultrasound, also known as 2D ultrasound, is a type of ultrasound imaging where “a linear array of transducers simultaneously scans a plane through the body that can be viewed as a two-dimensional image on screen.” See, NIH, National Library of Medicine, Carovac A., Smajlovic F., Junuzovic D., Application of Ultrasound in Medicine, 19(3) Acta Inform Med. 168-171 (Sept. 2011), available athttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564184/.

22 Medical reflection transducer, also known as an ultrasound transducer, is a device that converts electrical energy into sound waves, and the back again into electrical energy. It is used in medical imaging to produce images of internal organs and tissues in the body, and it is used in various medical imaging techniques such as ultrasound, echocardiography and Doppler imaging. See, e.g., ECG & ECHO Learning, The Ultrasound Transducer, available at https://ecgwaves.com/topic/the-ultrasound-transmitter-probe/ (last visited Apr. 4, 2023); see also, FDA, Ultrasound Imaging Sept. 28, 2022), https://www.fda.gov/radiation-emitting-products/medical-imaging/ultrasound-imaging.

23 Breast vasculature refers to the blood vessels that supply and drain blood from the breast tissue. The breast is a highly vascularized organ, and the blood supply comes from a network of arteries and veins that run throughout the breast tissue. See, NIH, National Library of Medicine, Yusuf S. Khan, Hussain Sajjad, Anatomy, Thorax, Mammary Gland, available at https://www.ncbi.nlm.nih.gov/books/NBK547666/ (last updated July 25, 2022).

essentially only image the vasculature (i.e., blood, which is a strong absorber of light). For PAT systems, there is no clinical trial data available (to our knowledge) and no PAT systems have been approved for clinical use. For PAI systems, the Imagio Breast Imaging has been used in clinical trials and is FDA cleared to be used as an adjunct to conventional handheld breast ultrasound.

All of these technologies face challenges to expansion, including FDA clearances and insurance reimbursement. However, the shortcomings of other imaging methods such as ionized radiation exposure, high costs and deployment challenges of MRI, and the inefficiency of mammography in detection of cancer in women with dense breasts, are sufficiently compelling for industry to address these obstacles, and these shortcomings will continue to create an opportunity for development and commercialization of advanced screening systems such as the Company’s.

Company’s Products & Product Roadmap

QT Breast Scanner

The Need: A safe, painless imaging device that provides conclusive breast health assessment

Background:

Breast cancer is the most commonly diagnosed women’s cancer in the United States, according to the National Cancer Institute. The American Cancer Society estimates that in 2022, 287,850 women in the United States have been diagnosed with invasive and in situ (early stage) breast cancer, and breast cancer has claimed the lives of 40,920 women.24 The American Cancer Society further estimates that one out of every eight women will develop breast cancer at some point during her life and one in every 42 women who turns 50 today will have a diagnosis of breast cancer before she turns 60.

There are several dominant screening and diagnostic technologies that are used both independently and dependently to locate cancers at an early stage and improve treatment outcomes. Each of the currently available non-surgical modalities for breast cancer detection has various clinical limitations. Screening methods and technologies include: (i) breast self-examination and clinical breast examination; (ii) mammography, including screening mammography, diagnostic mammography, and mammography with computer aided detection; (iii) Hand-Held Ultrasound (“HHUS”) and (iv) MRI.

24 See, American Cancer Society, Breast Cancer Facts & Figures, available athttps://www.cancer.org/research/cancer-facts-statistics/breast-cancer-facts figures.html (last visited Feb. 10, 2023).

Mammography is the dominant imaging modality in today’s standard of care. The American Cancer Society recommends that women of average risk have the option to begin mammography at age 40, get mammograms every year from age 45-54, and have mammography every other year starting at age 55.25 Despite those recommendations, only 65% of women over 40 in the United States have had a mammogram in the previous two years, and only 58% of women between 40 and 49 had a mammogram in the previous two years,26 even though screening mammography is 100% covered under the Affordable Care Act. This is in part due to the limitations of mammography, both in terms of sensitivity and reliability for dense breast tissue, where 10-15% of cases have inconclusive results requiring further testing, as well as concerns about safety. Mammography is also problematic in women who have breast implants. For these women, problems include painful mammograms, delayed detection of cancer from interference in imaging breast tissue, and an unwillingness to perform mammograms due to fear of implant rupture, dislocation or capsular contracture.

The Company’s goal is to provide highly accurate, 100% safe, radiation-free and painless breast imaging that can be used to:

1)identify cancer early to minimize invasiveness and increase effectiveness of treatment; and

2)eliminate unnecessary intervention (additional imaging and biopsies) for women with benign breast conditions.

The Product, QT Breast Scanner

The QT Breast Scanner is a fixed, stationary, mechanical scanner used to evaluate the breast without the use of either ionizing radiation or compression associated with mammography, or the injections required for breast MRI. With the QT Breast Scanner, the patient lies comfortably on a table which contains an opening through which the breast is immersed in a warm water bath (see Image 1) and gently immobilized using a magnetic retention pad fixed to a magnetic rod.

The QT Breast Scanner

Image 1

Surrounding the warm water bath is a dual modality reflection and transmission ultrasound array that rotates 360 degrees around the breast (see Image 2 & Image 3) to produce 3D images. The ultrasound array produces low energy, low frequency sound waves (non-radiation “pressure waves”) through the breast and reflecting from the breast, with both collecting volumetric (3D) data. Reflection data is collected on the transducer facing side, and the transmission data is collected on the back side of the breast. The transmission data quantitatively measures the velocity of these pressure waves through the breast. This information can be used to generate a true 3D image of the breast and all its tissues.

The QT Breast Scanner differs from the handheld ultrasound used in breast imaging in that it utilizes reflection and transmission data from low-frequency sound waves, providing increase in diagnostic information using the speed of sound characteristics of the breast and acquiring in true 3D a very accurate rendering of the breast tissue. The QT Breast Scanner

25 See, American Cancer Society, American Cancer Society Recommendations for the Early Detection of Breast Cancer, available athttps://www.cancer.org/content/cancer/en/research/infographics-gallery/breast-cancer-screening-guideline.html (last visited Feb. 10, 2023).

26 U.S. Department of Health and Human Services, “Health, United States, 2016”, Table 70.

provides sub-millimeter, high-definition, image resolution enabling identification of normal and abnormal breast structures and the accurate depiction of the precise shape and location of findings.

Technology uniquely quantifies breast density using transmission information to further personalize a patient’s management recommendations. Surface-to-volume ratios and volumetric doubling time growth rate characteristics can be calculated to determine significance of lesions and improve specificity of the ultrasound.

Image 2: Schematic of transmission and reflections modes

The QT Breast Scanner creates true 3D images of the patient’s breast viewable in the Quantitative Transmission Ultrasound Viewer (known as QTviewer®), a software product designed for healthcare professionals to view the transmission (speed of sound) and reflection images. This application can display correlated Digital Imaging and Communications in Medicine (“DICOM®”) images in multiple orientations (coronal, sagittal, and axial). QTviewer can manipulate image views and analyze pixel data with various functions. The QTviewer has additional functionality which enables the user to measure mass size and volume as well as fibroglandular tissue volume.27

27 See, American Association for Cancer Research, R. Natesan, J. Wiskin, S. Lee, B. H. Malik, Quantitative Assessment of Breast Density: Transmission Ultrasound is Comparable to Mammography with Tomosynthesis (Dec. 3, 2019), available athttps://aacrjournals.org/cancerpreventionresearch/article/12/12/871/47203/Quantitative-Assessment-of-Breast-Density.

Image 3 below is a still image of the viewer for a patient with a lesion. The transmission (top panel) and reflection (bottom panel) images as seen in coronal, axial, and sagittal representations.

Image 3

The QT Breast Scanner is the current version of the QT Breast Scanner and is FDA-cleared “for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The QT Scanner 2000 Model A software also calculates the breast fibroglandular tissue volume (FGV) value and the ratio of FGV to total breast volume (TBV) value as determined from reflection-mode and transmission-mode ultrasound images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.”28 The QT Breast Scanner has current applicability as a supplementary imaging device (not as a replacement for screening mammography) and for determining the ratio of fibroglandular tissue volume to total breast volume which is a measure of breast density; near-term applicability for automatic segmentation of lesions followed by measuring lesion stability/growth, and diagnosing lesions using artificial intelligence; and medium- to long-term applicability for breast cancer screening as shown in Table 1.

Table 1

Cloud SaaS Platform

QTI Precision Pathway creates value around each QT Breast Scanner by combining the hardware system with a SaaS-based subscription membership program. By integrating software updates, advanced analytics, secure collaboration, and enterprise-grade workflow tools into a recurring subscription model, the program enables institutions to maximize the

28 U.S Department of Health and Human Services, Food and Drug Administration, 510(k) number K253898.

clinical, operational, and economic utility of their scanners while providing predictable costs and scalable digital capabilities.

QTI Precision Pathway is a tiered software membership program designed to enhance the clinical, operational, and economic performance of QT Breast Scanner installations. It provides structured access to software updates, analytical tools, advanced visualization, collaborative data platforms, and workflow optimization features. The tiered structure allows customers to align system capabilities with the scale and complexity of their clinical or research environment.

Via this platform, QT Breast scanner systems remain technologically current via periodic software updates delivered through a centralized platform. Updates apply to both system software and the associated QTviewer components. Updates to the QTI Olea Viewer platform are provided only when the customer maintains an active subscription at the applicable membership level. Software updates generally include version upgrades for previously purchased features, while baseline quantitative analysis capabilities—such as reflection, transmission, density measurement, and doubling time—are included during the membership period. Additional analytical or imaging capabilities introduced after system purchase, based on geometric, elastic, and spectral physiologic biomarkers or other advanced features, may require a separate one-time scanner purchase and/or an annual QTI Olea Viewer subscription to enable associated workflows.

Participation requires customers to execute applicable data access and privacy agreements, including a QTI Business Associate Agreement where required, and to permit secure remote system access for software updates and technical support. Customers are also responsible for maintaining required annual scanner maintenance to remain eligible for updates and related services.

The program is designed to support both individual site deployments and enterprise-level implementations. Institutions can expand participation as operational needs evolve, allowing additional sites or capabilities to be incorporated without disrupting existing workflows.

The membership framework also provides a predictable economic model for managing software lifecycle costs, with pricing scalable to system utilization and institutional growth.

QTI Precision Share is a secure, enterprise-grade knowledge-sharing platform powered by Intelerad’s image management technology. It enables seamless collaboration and structured data exchange to accelerate innovation in quantitative imaging biomarkers, enhance patient care through improved access to validated biomarkers, and support next-generation precision diagnostics via collaborative research and real-world evidence generation.

QTI Precision Share is integrated at different levels across the QTI Precision Pathway tiers, with Advanced and Enterprise tiers offering connectivity and workflow integration with the QTI Olea Viewer platform.

QTI Olea Viewer, powered by Olea Medical’s multimodality platform, delivers an integrated environment for next-generation quantitative imaging biomarkers. It unifies advanced visualization, intelligent reporting, and automated precision diagnostics into a single ecosystem, providing clinicians with deeper insights, streamlined workflows, and data-driven decision support.

Seamlessly connected to QTI Precision Share, the QTI Olea Viewer supports secure, enterprise-grade collaboration. Updates require an active subscription at the applicable membership level and are included in Advanced and Enterprise tiers, with server allocations and pricing aligned to the membership.

Membership Value by Tier

Core Membership: The Core tier is foundational and must be purchased for every QTI Breast Scanner covered under the QTI Precision Pathway. It provides ongoing system software updates and baseline quantitative capabilities to maintain long-term system relevance and compatibility with evolving technology standards.

Operational Membership: Operational membership includes all Core benefits and adds connected viewing, collaborative interpretation, and structured data sharing across sites. It includes access to enhanced pricing benefits and membership in QTI Precision Share at the Operational level, enabling workflow coordination and secure data exchange.

Advanced Membership: Advanced membership includes all Operational benefits and expands analytical capabilities with an advanced portfolio of quantitative biomarkers, automated analysis tools, and enhanced reporting. It provides integrated connectivity between QTI Precision Share and the QTI Olea Viewer for up to two servers. Customers must maintain an annual QTI Olea Viewer subscription, with preferred pricing available for additional servers. Advanced membership also includes enhanced program discounts and QTI Precision Share at the Advanced level.

Enterprise Membership: Enterprise membership includes all Advanced benefits and is designed for institution-wide deployment, supporting multi-user access, high-volume processing, and enterprise-grade analytics. It provides connectivity between QTI Precision Share and the QTI Olea Viewer for all servers within the enterprise, with preferred subscription pricing for additional servers. Enterprise membership includes QTI Precision Share at the Enterprise level and access to enhanced program discounts.

In summary, the Company believes that QTI Precision Pathway, combined with QTI Precision Share and the QTI Olea Viewer, enhances the long-term value of installed QT Breast Scanners by enabling continuous technological improvements, supporting interoperability, and providing a flexible framework for expanding digital and analytical capabilities over time.

Manufacturing

Prior to the third fiscal quarter of 2025, the Company’s products have solely been manufactured in Novato, California. With the entry into the Canon Manufacturing Agreement as discussed below, the Company is, beginning with the third fiscal quarter of 2025, manufacturing the QT Breast Scanners in parallel between Novato, California and using CMSC as a contract manufacturer pursuant to the Canon Medical Agreement. The products are designed under the FDA’s design control guidelines and manufactured in accordance with the Company’s quality management system.

The Company’s devices are made up of custom designed components and off-the-shelf components, both of each are supplied by the Company’s approved vendors in the U.S.

For those QT Breast Scanners manufactured by the Company in Novato, California, the subassemblies are manufactured at the Company and verified prior to the final assembly of the device. The controls software and image reconstruction software are loaded on the imaging devices at the Company’s facility in Novato. Prior to shipping, 100% of the products are verified for functionality, performance, and safety.

The Company intends to scale up its production by initially using CMSC, and may also look at strategic original equipment manufacturing (“OEM”) agreements for large production throughput.

The suppliers that the Company purchases from and engages with are limited to those that are approved by our Quality Assurance department, which maintains an Approved Supplier List. The Company categorizes suppliers into three groups: (i) non-critical, (ii) important, and (iii) critical. For example, our “non-critical” suppliers include general distributors and/or suppliers of commercially available “off-the-shelf” items such as mechanical and electrical standard hardware, blank label stock, seals and labeling pouches, and our “important” suppliers include custom component suppliers, test facility providers and consultants.

Before a supplier is classified as “critical,” the Company assesses the supplier’s: (a) specific or proprietary core competencies, (b) tooling costs and lead time, and (c) product delivery lead time. Any supplier whose processes or products are required by the Company to be validated are classified as “critical.” Another factor that the Company considers is the lead time to approve an alternative supplier. As of the date of this annual report, although there are various suppliers in the U.S. and abroad that can produce high quality ultrasound transducers for the Company, the Company has only engaged in the supplier validation and approval process with one such supplier which manufactures ultrasound transducer subcomponents in accordance with the Company’s specifications. Because the Company has validated this supplier, but has not undertaken the significant commitment of resources to validate and approve other such suppliers of ultrasound transducers, despite the fact that the Company could choose to do so, it considers this supplier as being “critical” on our Approved Supplier List but not a principal supplier. In addition, as of the date of this annual report, the Company does not have written agreements in place with this critical supplier, and is operating under an individual purchase order platform, on an as-needed-basis; however, the Company may enter into such agreements in the future.

Canon Letter of Intent

QT Imaging entered into the Canon Letter of Intent with CMSU and CMSC pursuant to which CMSC purchased and acquired two QT Breast Scanners in the first half of 2024. The Canon Letter of Intent provided that CMSC would conduct, and pursuant to the Feasibility Study Agreement (as described below), CMSC conducted, feasibility studies on the QT Breast Scanners that it acquired, including product quality validation, development and manufacturing studies, clinical evaluation, regulatory investigation and marketing validation (the “Feasibility Study”) The Feasibility Study was completed in the second half of 2024.

The Canon Letter of Intent provided that upon successful conclusion of the Feasibility Study, we and CMSC intended to engage in a good faith discussion to develop a binding OEM manufacturing agreement with CMSC, which we have now done, as discussed below.

CMSC will also use QT Breast Scanners that it acquired to perform clinical trials towards the possibility of it pursuing the regulatory approval process in Japan.

CMSC and QT Imaging have also discussed other potential terms between them.

Feasibility Study Agreement with Canon Medical Systems Corporation

On March 28, 2024, the Company entered into the Feasibility Study Agreement with Canon. The term of the Feasibility Study Agreement commenced on March 28, 2024 and by its terms, remained in force until the end of December 2024. In connection with the Feasibility Study Agreement, Canon initiated studies to evaluate the business, technical, and clinical values of the Company’s QT Scanner including product quality validation, development and manufacturing studies, clinical evaluation, regulatory investigation, and market validation. Canon has no right to reverse engineer the QT Scanner and may only modify and disassemble the QT Scanner as necessary to conduct the Feasibility Study.

Under the terms of the Feasibility Study Agreement, the Company provided support for the Feasibility Study as agreed with CMSC from time to time during the term of the Feasibility Study Agreement and used its commercially reasonable efforts to facilitate the feasibility study. Both parties confirmed that the support provided by the Company did not result in significant costs to the Company, as it only provided technical materials and knowledge that it already possessed and did not involve the creation of new materials or engineering. Each party was responsible for covering its own expenses related to the Feasibility Study and the support, except if the parties agreed in writing otherwise, one party shall pay to the other party an amount reasonable under the circumstances.

The Feasibility Study Agreement provided that all know-how and intellectual property embodied in the QT Breast Scanner are owned by the Company and all rights not expressly granted to the Company are reserved.

Canon Manufacturing Agreement

On March 28, 2025, the Company entered into the Canon Manufacturing Agreement with CMSC. Pursuant to the terms of the Canon Manufacturing Agreement, the Company appointed CMSC as the exclusive manufacture of the QT Breast Scanners to be distributed by NXC pursuant to the Amended NXC Distribution Agreement. CMSC’s manufacturing of the QT Breast Scanners shall not include the final testing process for the QT Breast Scanners, and CMSC shall not have any responsibility for the QT Breast Scanner as a manufacturer of medical equipment for FDA purposes.

In order for CMSC to manufacture the QT Breast Scanners, the Company shall sell components to CMSC in a timely manner, in accordance with agreed-upon terms and conditions. The Company shall cooperate with and support CMSC to allow CMSC to procure components through its own supply chain. The parties shall negotiate in good faith specific procedures to phase out CMSC’s purchase of components from the Company, with the target date of the fourth quarter of 2025, although this is not a commitment. The terms for purchasing components (or subassemblies), including components for service, by the Company from CMSC shall be mutually agreed upon by the parties.

The Company shall provide forecasts to CMSC in accordance with the “Forecast Policy” attached to the Canon Manufacturing Agreement. No later than forty-five days prior to the end of each calendar quarter, CMSC will notify the Company in writing if CMSC is unable to deliver a sufficient number of QT Breast Scanners to satisfy the forecast for the following quarter. If CMSC is unable to deliver a sufficient number of QT Breast Scanners due to CMSC’s willful misconduct, CMSC will sell back to the Company all components necessary for the Company to engage in Novato Manufacturing of the QT Breast Scanners for the following quarter at the Company’s facility in Novato, California sufficient to cover the QT Breast Scanner shortfall back at the same purchase price that CMSC paid to purchase such components. CMSC shall bear risk of loss, all fees and shipping costs for the components incurred in connection with such Novato Manufacturing.

No later than forty days prior to the end of each calendar quarter, the Company shall notify CMSC in writing indicating whether or not the Company wishes to engage in Novato Manufacturing of the QT Breast Scanners for the following quarter for the purpose of meeting the forecast for such quarter. If the Company provides such notice to CMSC within the 40-day period, stating that the Company wishes to engage in Novato Manufacturing, the Company may purchase from CMSC (if the Company does not already have) any components held by CMSC necessary as determined by the Company for the Company to be able to manufacture the QT Breast Scanners via the Novato Manufacturing, at the same purchase price that CMSC paid to the Company to purchase such components. The Company shall bear all risk of loss, fees and shipping costs for the components incurred in connection with the Novato Manufacturing.

From time to time during the term of the Canon Manufacturing Agreement, but no later than thirty days prior to the delivery date specified in the purchase order, the Company may issue to CMSC a purchase order for any of the QT Breast Scanners necessary to meet the forecast, for the actual quantities to be delivered by CMSC. Each purchase order shall specify delivery dates that respect the “Forecast Policy.” The purchase prices applicable to the purchase orders as of the date of the Canon Manufacturing Agreement shall be separately agreed between the parties in writing. CMSC may reject any purchase order that requests delivery dates that are not in compliance with such Forecast Policy. Unless the Company is manufacturing QT Breast Scanners as Novato Manufacturing, any failure by CMSC, as a result of CMSC’s conduct, to manufacture and deliver QT Breast Scanners as specified in an accepted purchase order necessary to satisfy the forecasts later than seventy-five days from the delivery date as specified in the accepted purchase order shall result in liquidated damages per missed or delayed QT Breast Scanner of $220 thousand, with NXC not being obligated to pay for the missed MOQ sale. Such failure by CMSC shall also not provide any grounds for NXC to terminate the Amended NXC Distribution Agreement or otherwise cancel the binding nature of the MOQs as provided in the Amended NXC Distribution Agreement. All title to and risk of loss of the QT Breast Scanners shall pass from CMSC to the Company when the QT Breast Scanners have been delivered to the Company in Novato, California, under the Incoterms 2020 trade term, DDP. The Company shall make payment of the QT Breast Scanners to CMSC within ninety days after the issuing date of an original copy of the invoice to be issued by CMSC.

Prior to the delivery of the QT Breast Scanners, CMSC shall inspect and test all the QT Breast Scanners in accordance with the outgoing test procedures to be approved in writing by the Company and as specified in the specifications or otherwise to be separately agreed upon between the parties in writing. The Company shall perform the visual, quantity and/or quality inspection of the QT Breast Scanners upon their receipt. If any of the QT Breast Scanners delivered is found deficient in quantity (as set forth in the accepted purchase order), or is defective in material and workmanship or inconformity with the specifications, and such deficiency, defect or non-conformity is caused by CMSC, the Company may submit a written claim notice to CMSC with sufficient supporting evidence, including but not limited to photographs and reasonably detailed explanation. CMSC shall, at its sole discretion, either (i) deliver additional QT Breast Scanners to fulfil the required quantity or deliver replacement of the QT Breast Scanners, or (ii) offer an equitable reduction in the purchase price of the QT Breast Scanners delivered, subject to mutual agreement between the parties. CMSC is providing a warranty on the QT Breast Scanners that they shall be free from defects in material and workmanship and conform to the specifications for a period of (i) twelve months from the delivery date of each QT Breast Scanner from the Company to NXC, or (ii) twelve months from the installation date for the QT Breast Scanners directly sold to end users by the Company. If any defects in material and workmanship, or non-conformity of the specifications occur during the warranty period and the Company provides a timely claim, CMSC shall, at its sole discretion (i) send a replacement of a part(s), (ii) send a brand new QT Breast Scanner as a replacement, (iii) repair the defective QT Breast Scanner(s) and return them to the Company, or (iv) refund the equivalent price to the purchase price. CMSC shall only be responsible for recalls resulting from the manufacturing process of the QT Breast Scanners or materials and parts procured by CMSC (other than materials and parts procured from the Company).

All intellectual property rights, including but not limited to patents, copyrights, know-how, and trade secrets (the “IPR”), which each party has owned before entry into the Canon Manufacturing Agreement or develops separately from the performance of the manufacture of the QT Breast Scanners under this agreement, shall remain the exclusive property of the Company or CMSC respectively. All IPR in and to any invention, whether patentable or not, conceived and reduced to practice in the performance of the manufacture of the QT Breast Scanners under the Canon Manufacturing Agreement shall be owned solely by CMSC; provided, that to the extent that such invention is based on the Company’s confidential information and is exercised on the QT Breast Scanners which are manufactured by CMSC and delivered to the Company, such as manufacturing process flow, CMSC agrees not to assert any IPR in and to such invention against the Company, its affiliates and customers as to the QT Breast Scanners. All IPR to and in any invention, whether patentable or not, if agreed between the parties to have been conceived and reduced to practice jointly by the Company and CMSC in the performance of the manufacture of the QT Breast Scanners shall be owned jointly and equally by the Company and CMSC, and both parties shall have the right to use, utilize and exploit such IPR in accordance with applicable laws involved without a prior consent of or any payment or consideration to the other party.

The Company grants to CMSC a personal and exclusive license to use, utilize (including copy, amend, revise and modify) and exercise the IPR owned by the Company solely for enabling it to manufacture the QT Breast Scanners sold to NXC and provide maintenance support for them, provided that (i) such exclusive license may be sublicensed to NXC and other subsidiaries of CMSC and/or authorized maintenance companies (with such authorization to be provided in writing by the Company, but not to be unreasonably refused, withheld, or delayed) that provide maintenance services on an outsourced basis (the “Approved Parties”) solely for the QT Breast Scanners distributed by NXC pursuant to the Amended NXC Distribution Agreement, whether or not the QT Breast Scanners are distributed before, on, or after the entry into the Canon Manufacturing Agreement; otherwise such license shall be nonexclusive, non-sublicensable and non-transferable, and (ii) CMSC shall refrain from using its license to amend, revise and modify the QT Breast Scanners, including the source code(s) of software (which shall be held in escrow pursuant to the terms of a separate escrow agreement among the parties and an escrow agent (the “Escrow Agreement”)), unless the Company becomes party to an event of any bankruptcy or other insolvency proceeding (a “QTI Bankruptcy”).

If there is a QTI Bankruptcy, CMSC may use its license in accordance with the following: in the event of a QTI Bankruptcy and rejection or termination of the Canon Manufacturing Agreement in a QTI Bankruptcy, all source code(s) will be released by the escrow agent to CMSC and CMSC may exercise its rights to amend, revise and modify such source code(s) (A) to enable CMSC to manufacture (x) up to 100 QT Breast Scanners to be sold to NXC or (y) in the event that 100 QT Breast Scanners have yet to be sold to NXC by December 31, 2026, QT Breast Scanners until December 31, 2026, whichever occurs earlier, and (B) to enable CMSC and the Approved Parties until the earlier of (i) the end of the five-year lifetime of the QT Breast Scanners sold to NXC pursuant to the Amended NXC Distribution Agreement and (ii) December 31, 2031 (such earlier date, the “Maintenance Term”) to support the continuous workable operation, but not for upgrades or improvement of performance, of QT Breast Scanners that were distributed by NXC before, on, or after the Canon Manufacturing Agreement. Following the expiration of the Maintenance Term, CMSC shall return to the Company or its successor physical material released to CMSC by the escrow agent and use commercially reasonable efforts to erase electronically submitted material released to it by the escrow agent, provided, however, that CMSC shall be permitted to retain information stored on backup or archival media pursuant to bona fide security measures or for legal compliance. In the event that prior to a QTI Bankruptcy, CMSC terminates the Canon Manufacturing Agreement, other than because the Company has substantially failed to comply with any provision of the Canon Manufacturing Agreement and that such non-compliance has not been cured within thirty business days from the date of the Company’s receipt of the written notice from CMSC, in the event of a QTI Bankruptcy there shall be no release of source code(s). Furthermore, in the event that prior to a QTI Bankruptcy, CMSC terminates this agreement because the Company has substantially failed to comply with any provision of the Canon Manufacturing Agreement and that such non-compliance has not been cured within thirty business days from the date of the Company’s receipt of the written notice from CMSC and there is a subsequent QTI Bankruptcy, the usage by CMSC of the source code released to CMSC pursuant to this Article 9.3.2 shall be limited to subpart (B) set forth in the first sentence of this paragraph. Furthermore, if the Company terminates the Canon Manufacturing Agreement in the event that CMSC substantially fails to comply with any provision of the Canon Manufacturing Agreement and that such non-compliance has not been cured within thirty business days from the date of its receipt of the written notice from the Company, then there shall be no release of source code(s) to CMSC.

Unless earlier terminated in accordance with the terms of the Canon Manufacturing Agreement, this agreement shall remain effective until December 31, 2026. In case both parties mutually agree the extension of the Canon Manufacturing Agreement in writing, the Canon Manufacturing Agreement shall be extended for one year after the expiration of the Canon Manufacturing Agreement. In the event of “Change of Control” of a party, either party shall have the right to, at its sole discretion, terminate the Canon Manufacturing Agreement in its entirety upon forty-five business days’ prior written notice to the other party. Such notice shall be provided prior to the expiration of the then current term of the Canon Manufacturing Agreement. In the event of the termination or expiration of the Canon Manufacturing Agreement, CMSC will honor all of the outstanding accepted purchase orders, and both parties will cooperate to fulfill such orders. In the event that either party substantially fails to comply with any provision of the Canon Manufacturing Agreement and that such non-compliance has not been cured within thirty business days from the date of its receipt of the written notice from the other party, then the other party shall have the right to terminate the Canon Manufacturing Agreement upon giving a written notice. The Canon Manufacturing Agreement also provides other grounds for its termination prior to December 31, 2026, including by CMSC if NXC’s sales of the QT Breast Scanner are adversely affected due to any failures or other circumstances attributable to the Company that the Company is or is reasonably expected to be unable to remedy (including but not limited to Epidemic Failures; the submission of Medical Device Reports (MDRs) to the FDA regarding the QT Breast Scanner; any action by the Company (either voluntarily or upon an order or request by the FDA) to conduct a Field Correction, Market Withdrawal, Stock Recovery, or Recall (as such terms are defined by the FDA); any action by the Company or any regulatory authority to temporarily suspend shipments or manufacturing of QT Breast Scanners; or issues related to the Company’s business operations) within six months from the date of the onset of such an event. For these purposes, “Epidemic Failures” means a malfunctioning of five or more QT Breast Scanners collectively presumed to have a common underlying cause based on a reasonable evaluation. Following a termination or expiration of the Canon Manufacturing Agreement, the provisions with respect to the grants of licenses to the IPR of the Company will survive up to the earlier of (a) the end of the five-year lifetime of the QT Breast Scanners sold to NXC and (b) December 31, 2031.

Clinical Studies

The Company has conducted or collaborated on several clinical studies to evaluate the imaging performance of the Company’s Breast Acoustic CT scanner. These include clinical studies that compared the Company’s technology with standard breast imaging modalities: full-field digital mammography (“FFDM”), digital breast tomosynthesis (“DBT”), and MRI. We highlight several of the most significant studies below, which span three related areas of performance: recall rates, diagnostic characterization, and supplemental screening.

Recall Rates:

Background: Mammography has a low positive predictive value. Overlying fibroglandular tissue can mask a cancer, especially for women with dense breasts. It can also cause summation artifacts, resulting in false-positive findings and more recalls. Studies show that mammography leads to unnecessary follow-up procedures — such as handheld ultrasound or MRIs and biopsies — leading to unnecessary patient anxiety, costs, and time. For every 1,000 screening mammograms, 150 women are called back for more tests but only three are diagnosed with cancer. Given the need to reduce unnecessary recalls, the Company evaluated the recall rates of the Company’s Breast Acoustic CT scanner compared with mammography.

Study:

1. Bilal Malik, PhD, Elaine Iuanow, MD, and John Klock, MD. An Exploratory Multi-reader, Multi-case Study Comparing Transmission Ultrasound to Mammography on Recall Rates and Detection Rates for Breast Cancer Lesions. Academic Radiology Vol 29 – Supplement 1 S10-S18, Jan 2022; https://doi.org/10.1016/j.acra.2020.11.0.11 and https://www.academicradiology.org/article/S1076-6332(20)30646-2/fulltext. In consultation with Cytel (Cambridge, MA), the Company designed, conducted, and funded this retrospective trial.

An exploratory, multi-reader, multi-case study evaluated radiologists’ performance on lesion detections and non-cancer recall rates for the Company’s Breast Acoustic CT platform versus standard full-field digital mammography, using retrospective data from two case collection clinical trials conducted at five sites between 2006-2018. All subjects received both FFDM and QTscans within 90 days. Data were analyzed in a reader study with full factorial design involving 22 radiologists and 108 breast cases (42 normal, 39 pathologically-confirmed benign, and 27 pathologically-confirmed cancer).

This MRMC study found that the readers’ mean rate of detecting lesions of any type was 4% higher (p-value > 0.05) with QTscans compared with FFDM. The study also found that QTscans significantly decreased the mean non-cancer recall rate by 16% (p-value = 0.03) at the expense of a 2% decrease in the mean cancer recall rate (p-value > 0.05), compared with FFDM. In summary, this exploratory MRMC study indicates that QTscans improve non-cancer recall rates without substantially affecting cancer recall rates.

Diagnostic Characterization:

Background: Patients often go through follow-up procedures, such as a HHUS scan, to identify whether screening mammography (FFDM or DBT) findings are due to a cyst or solid lesion. HHUS can improve cancer detection, particularly for the peripheral regions of the breast and axilla. However, HHUS is not suitable for primary breast screening, and its 2D nature leads to a low specificity and high number of false positives. HHUS is also very operator dependent, with reproducibility issues that impact diagnostic accuracy. Thus, an alternative, more accurate, automated imaging modality is needed to distinguish between cysts and solids.

Many patients also require additional follow-up imaging, such as an MRI, to further identify and characterize lesions in order to distinguish between benign and malignant masses. For example, mass morphology (such as irregularity and circulatory), dimensions, and characteristics are commonly used to differentiate benign from malignant breast masses. Critical to diagnosis and treatment decisions, alternative breast imaging options are needed for mass characterization when an MRI is not feasible due to availability or patient contraindications.

Studies:

2. Elain Iuanow, MD, Kathleen Smith, MBA, Nancy A. Obuchowski, PhD, Jennifer Bullen, MS, and John C. Klock, MD. Accuracy of Cyst Versus Solid Diagnosis in the Breast Using Quantitative Transmission (QT) Ultrasound. Academic Radiology Vol 24, Issue 9, Sept 2017; https://doi.org/10.1016/j.acra.2017.03.024 and https://www.academicradiology.org/article/S1076-6332(17)30207-6/fulltext. This work was performed by the Company and the Cleveland Clinical Foundation. It was supported by the Company and a grant from the National Cancer Institute R01CA138536.

A retrospective multi-reader, multi-case receiver operating characteristics study evaluated the diagnostic accuracy in determining whether a breast lesion is a cyst versus a solid, using the Company’s Breast Acoustic CT platform as an adjunct to mammography. Fourteen readers performed blinded, randomized reads with digital mammography and QTscan images — assigning both a binary classification of cyst versus solid and a confidence score (0-100; where 0 represents 0% confidence that lesion is solid or 100% that it is a cyst). A 95% bootstrap confidence interval (CI) was also computed for the readers’ mean receiver operating characteristic area, sensitivity, and specificity.

Using the readers’ binary classification of cyst or solid lesions, this MRMC study found that the mean sensitivity was 93.3% (95% CI: 83.7, 99.5) and the mean specificity was 85.8% (95% CI: 70.1, 98.5). When the readers’ confidence scores were used to distinguish a cyst versus a solid, the mean receiving operating characteristics area was 0.92 (95% CI: 0.927, 0.985). In summary, this MRMC study demonstrates that QTscans are highly accurate at diagnosing a cyst versus a solid lesion, suggesting that QTI technology can be used as an adjunct to mammography to improve specificity in breast evaluation.

3. Maria L. Anzola, David Alberico, Joyce Yip, James Wiskin, Bilal Malik, Raluca Dinu, Belinda Curpen, Michael L. Oelze, and Gregory J. Czarnota. Quantitative Volumetric Analysis Using 3D Ultrasound Tomography for Breast Mass Characterization. Tomography 2025, 11, 111; https://doi.org/10.3390/tomography11100111 and https://www.mdpi.com/2379-139X/11/10/111. This study was conducted by the Sunnybrook Health Sciences Centre in Toronto, Canada and registered on ClinicalTrials.gov (NCT06175078). It was funded by the National Institute of Health grant RO1CA273700-01.

This prospective, single-center, observational, early validation study evaluated the use of QTscans in detecting, characterizing, and measuring the volume of breast masses in comparison to MRI. The study was conducted in a cohort of 20 female patients: 16 patients with biopsy-proven malignant breast tumors and 4 patients with biopsy-proven benign lesions. The comparative analysis between QTscans and MRI evaluated key quantifying metrics for breast mass characterization, including breast mass morphology, dimensions, and characteristics.

This study’s findings indicate some differences in lesion characterization between the two imaging modalities. Nevertheless, QTscans demonstrated good performance in identifying relatively small tumors, multiple lesions, satellite lesions, intraductal extensions, and calcifications, as well as offering valuable diagnostic insights. MRI with contrast offered a broader distribution in size classification, providing useful insight into areas for continued development and optimization for QTI technology. In summary, the study found good overall agreement between MRI and QTscans for assessing breast mass volume in most cases. These results suggest that QTscans could excel in specific diagnostic scenarios — particularly when evaluating advanced or multifocal disease — and may serve as an important alternative breast imaging option when MRI is not feasible due to availability or patient contraindications.

Supplemental Imaging:

Background: Mammography (FFDM and DBT) are the standard screening modality for breast cancer. In addition, supplemental screening with MRI is also standard for women at elevated risk of breast cancer — based on risk factors such as a personal or family history, first-degree family genetics, history of radiation to the chest before age 30, and/or having dense breasts. In the US, 40%-50% of women ages 40-74 have dense breasts, and it’s even more common for young women. Having dense breasts means that a women’s breasts have a higher portion of glands, ducts, and connective tissue compared to fatty tissue, which makes it more difficult for a mammogram to detect cancer. Although MRIs can locate breast lesions missed by mammography and in younger women, breast MRIs also have limitations. In particular, some women cannot get breast MRIs because they are allergic to the gadolinium-based contrast agents, have impaired renal function, or are pregnant or breast feeding. An alternate breast imaging modality is needed for supplemental screening, particular for women with high risk.

Studies:

4. Yulei Jiang, PhD, Elaine Iuanow, MD, Bilal Malik, PhD, and John Klock, MD. A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions. Academic Radiology Volume 31, Issue 6, June 2024; https://doi.org/10.1016/j.acra.2023.12.038 and https://www.academicradiology.org/article/S1076-6332(23)00716-X/fulltext. This study was conducted by the Company and the University of Chicago. It was funded in part by the National Cancer Institute grant RO1CA138536.

This prospective, case-collection study was conducted at four clinical sites. It enrolled adult women with either normal or abnormal mammograms who received a standard clinical digital breast tomosynthesis followed by a QTscan within 90 days. The study collected and analyzed a total of 177 single-breast image cases (66 with cancer atypia or solid mass and 111 normal or with nonsolid benign abnormality). After receiving QTI training, 24 radiologists interpreted the 177 cases for QTscans first and then for DBT synthesized 2D-views two weeks later. The readers reported up to three findings per case, identifying a recall or no recall decision and confidence score of that decision for each finding. A MRMC ROC analysis was performed to test for the noninferiority of QTscans to DBT. The sensitivity and specificity were estimated from the readers’ call-back versus no call-back decisions.

This MRMC ROC study demonstrated that the Company’s Breast Acoustic CT scanner is noninferior to DBT in terms of ROC analysis and the Area Under the Curve (mean AUC for QTscan of 0.746 vs. 0.700 for DBT; p-value < 0.05). While sensitivity slightly decreased for QTscans (70.6% for QTscans vs. 85.2% for DBT), specificity improved significantly (60.1% for QTscans vs. 37.2% for DBT). The study also showed the recall rate of benign cysts improved substantially. In summary, this MRMC observer performance study demonstrates that QTscans improve recall and lesion detection with higher specificity and less false positives compared with DBT, suggesting QTI technology’s potential as a supplemental imaging tool, particularly for women too young to undergo mammography.

5. Zohaib Lakhani MD, Chidi Nwachukwu MD, Francisco Maldonado MD, Gina Hesley MD, Tiffany Sae-Kho MD, Sharmilla Giri MS, Nicolas Larson MS PhD, Matthew Urban PhD, Taylor Pierson RT(R)(M)(BS), and Christine Lee MD PhD. Comparison of Quantitative Transmission Imaging and MRI for High-Risk Screening of Breast Cancer: A Pilot Study. Conference Abstract. This study was conducted by Mayo Clinic in Rochester, MN (CLS-20587117) and registered at Mayo Clinic (https://www.mayo.edu/research/clinical-trials/cls-20587117) and ClinicalTrials.gov (NCT07216274).

This prospective pilot study evaluated the effectiveness of QTscans compared with MRI as a supplemental screening tool for patients with a high risk of breast cancer. The study enrolled 26 women with an elevated lifetime risk of breast cancer (>20%) from July to October, 2025. All patients underwent a bilateral breast MRI and QTscan, where the QTscan was performed within 30 days of the MRI. Images of both modalities were independently interpreted by four breast radiologists with 2-24 years of experience. For each finding, the radiologists recorded imaging characteristics, size, and location and assigned a Breast Imaging Reporting and Data System (BI-RADS) score. Agreement between paired MRI and QTscan BI-RADS scores was evaluated for the ordinal (BI-RADS 1-5) and the binary categories of negative (BI-RADS 1-2) or positive (BI-RADS 3-5).

In this study, the radiologists recorded up to three imaging findings per breast with a total of 104 breast images analyzed for the entire cohort of 26 patients. Across both imaging modalities, 71/104 breast images had no findings, 30/104 had one finding, and 3/104 had two findings. The study found exact BI-RADS agreement between QTscan and MRI in 34/52 breasts (65%), with a weighted Cohen’s kappa of 0.28 (-0.093, 0.594). It observed binary agreement in 47/52 breasts (90%) with unweighted Cohen’s kappa of 0.23 (-0.083, 0.781). One BI-RADS 4 MRI finding with benign pathology on biopsy was classified as BI-RADS 3 on a QTscan. In summary, this pilot study demonstrated that the high absolute agreement between MRI and QTscans, suggesting their comparable effectiveness in identifying positive findings.

Government Regulation

Our existing product, the QT Breast Scanner, products under development, and our operations are subject to extensive regulation by the FDA, and other federal and state authorities in the U.S., as well as comparable authorities in foreign jurisdictions. Our products do not emit radiation, but are subject to regulation as medical devices in the U.S. under the FDCA and as implemented and enforced by the FDA, and under comparable regulatory schemes in foreign jurisdictions.

FDA Regulation of Medical Devices

The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed within the U.S. are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.

FDA Premarket Clearance and Approval Requirements

Subject to certain exceptions, each medical device commercially distributed in the U.S. requires either FDA clearance of a 510(k) premarket notification, or approval of a pre-market approval application (“PMA”). Under the FDCA, medical devices are classified into one of three classes-Class I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse medical events and truthful and non-misleading labeling, advertising and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to the FDA’s premarket notification and clearance process in order to be commercially distributed.

510(k) Clearance Marketing Pathway

The current QT Breast Scanner is a Class II device, and the Company expects products under development such as the QT Infant Scanner and the QT Orthopedic Scanner will also be Class II devices subject to premarket notification and clearance under section 510(k) of the FDCA. To obtain 510(k) clearance, the Company must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a predicate device already on the market. A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device), and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition, the FDA collects user fees for certain medical device submissions and annual fees and for medical device establishments. For fiscal year 2025, the small business user fee for a 510(k) premarket notification application is $9,280. If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k) marketing clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval orde novo reclassification. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), ade novo request or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or until PMA approval is obtained or ade novo request is granted. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

Over the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements for clinical data and a longer review period, or could make it more difficult for manufacturers to utilize the 510(k) clearance process for their products. For example, in November 2018, the FDA officials announced forthcoming steps that the FDA intends to take to modernize the premarket notification pathway under Section 510(k) of the FDCA. Among other things, the FDA announced that it planned to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates. These proposals included plans to potentially sunset certain older devices that were used as predicates under the 510(k) clearance pathway, and to potentially publish a list of devices that have been cleared on the basis of demonstrated substantial equivalence to predicate devices that are more than 10 years old. In May 2019, the FDA solicited public feedback on these proposals. The FDA requested public feedback on whether it should consider certain actions that might require new authority, such as whether to sunset certain older devices that were used as predicates under the 510(k) clearance pathway. These proposals have not yet been finalized or adopted, and the FDA may work with Congress to implement such proposals through legislation.

More recently, in September 2019, the FDA finalized guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process. The FDA intends to develop and maintain a list of device types appropriate for the “safety and performance based” pathway and will continue to develop product-specific guidance documents that identify the performance criteria for each such device type, as well as the testing methods recommended in the guidance documents, where feasible.

Post-Market Regulation

After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:

•establishment registration and device listing with the FDA;

•QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

•labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or approved products;

•requirements related to promotional activities;

•clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices;

•medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

•correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

•the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.

The Company’s manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file and complaint files. As a manufacturer, the Company will be subject to periodic scheduled or unscheduled inspections by the FDA. The Company’s failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, the Company’s manufacturing operations and the recall or seizure of its products, which would have a material adverse effect on the Company’s business. The discovery of previously unknown problems with any of the Company’s products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

•warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties;

•recalls, withdrawals or administrative detention or seizure of our products;

•operating restrictions or partial suspension or total shutdown of production;

•withdrawing 510(k) clearances or PMA approvals that have already been granted;

•refusal to grant export approvals for our products; or

•criminal prosecution.

Healthcare Regulatory Laws

Within the U.S., the Company’s products and its customers will be subject to extensive regulation by a wide range of federal and state agencies that govern business practices in the medical device industry. These laws include federal and state anti-kickback, fraud and abuse, false claims, transparency and anti-corruption statutes and regulations. Internationally, other governments also impose regulations in connection with their healthcare reimbursement programs and the delivery of healthcare items and services.

U.S. federal healthcare fraud and abuse laws will generally apply to the Company’s activities, among other reasons because the Company expects that its products will be covered under federal healthcare programs such as Medicare and Medicaid. The U.S. federal healthcare program Anti-Kickback Statute (the “Anti-Kickback Statute”) is particularly relevant because of its broad applicability. Specifically, the Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for, or to induce, either the referral of an individual, or the furnishing, arranging for or recommending a good or service for which payment may be made in whole or part under federal healthcare programs, such as the Medicare and Medicaid programs. Almost any financial interaction with a healthcare provider, patient or customer will implicate the Anti-Kickback Statute. Statutory exceptions and regulatory safe harbors protect certain interactions if specific requirements are met. However, only those interactions that represent fair market value exchanges generally are protected by a safe harbor or exception. The government can exercise enforcement discretion in taking action against unprotected activities. Further, a person or entity does not need to have actual knowledge of the Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act or federal civil money penalties statute. Penalties for Anti-Kickback Statute violations may include both criminal penalties such as imprisonment and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Exclusion would mean that diagnostic tests using the Company’s products would no longer be eligible for reimbursement under federal healthcare programs.

Many states have adopted laws similar to the Anti-Kickback Statute. Some of these state prohibitions apply to referral of patients for healthcare items or services reimbursed by any payor, not only federal healthcare programs. Insurance companies may also bring a private cause of action for treble damages against a manufacturer for a pattern of causing false claims to be filed under the federal Racketeer Influenced and Corrupt Organizations Act.

Another development affecting the healthcare industry is the increased use of the federal Civil False Claims Act and, in particular, actions brought pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In recent years, the number of suits brought against healthcare providers by private individuals has increased dramatically. In addition, various states have enacted false claim laws analogous to the Civil False Claims Act, although many of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare program.

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), among other things, created two new federal crimes: healthcare fraud and false statements relating to healthcare matters. The HIPAA healthcare fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment and/or exclusion from government-sponsored programs. The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony and may result in fines and/or imprisonment. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statutes or specific intent to violate them in order to have committed a violation.

Laws and regulations have also been enacted by the federal government and various states to regulate the sales and marketing practices of medical device and pharmaceutical manufacturers. The laws and regulations generally limit financial interactions between manufacturers and healthcare providers, require pharmaceutical and medical device companies to comply with voluntary compliance standards issued by industry associations and the relevant compliance guidance promulgated by the U.S. federal government and/or require disclosure to the government and/or public of financial interactions (so-called “sunshine laws”). Many of these laws and regulations contain ambiguous requirements or require administrative guidance for implementation. Manufacturers must adopt reasonable interpretations of requirements if there is ambiguity and those interpretations could be challenged. Given the lack of clarity in laws and their implementation, the Company’s activities could be subject to the penalty provisions of the pertinent federal and state laws and regulations.

Healthcare Reform

In the U.S. and certain foreign jurisdictions, there have been, and the Company expects there will continue to be, a number of legislative and regulatory changes to the healthcare system. In March 2010, the Patient Protection and Affordable Care Act, and the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”) was signed into law and substantially changed the way healthcare is financed by both governmental and private insurers in the United States. The ACA contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and fraud and abuse changes. Additionally, the ACA imposed, among other things, a new federal excise tax on the sale of certain medical devices, which, through a series of legislative amendments, was suspended, effective January 1, 2016, and subsequently repealed altogether on December 20, 2019, provided incentives to programs that increase the federal government’s comparative effectiveness research and implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models. Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and the Company expects there will be additional challenges and amendments to the ACA in the future.

Since its enactment, there have been judicial and Congressional challenges to certain aspects of the ACA, and the Company expects there will be additional challenges and amendments to the ACA in the future. By way of example, in 2017, Congress enacted the Tax Cuts and Jobs Act (the “TCJA”), which eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14, 2018, a Texas U.S. District Court Judge ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the TCJA, the remaining provisions of the ACA are invalid as well. On December 18, 2019, the U.S. Court of Appeals for the 5th Circuit ruled that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. However, the decision of the U.S. Court of Appeals for the 5th Circuit was appealed to the U.S. Supreme Court. On June 17, 2021, the U.S. Supreme Court held that the states that initially commenced the challenge to the ACA didn’t have standing to challenge the law, effectively ending this challenge. But it remains possible that future challenges to the ACA may be brought, and it is unclear how any future decisions and other efforts to repeal and replace the ACA will impact the ACA.

Other legislative changes have been proposed and adopted in the United States since the ACA was enacted, including aggregate reductions of Medicare payments to providers of 2% per fiscal year and reduced payments to several types of Medicare providers. The Company believes the overall escalating cost of medical products and services being paid for by the government and private health insurance has led to, and will continue to lead to, increased pressures on the healthcare and medical device industry to reduce the costs of products and services.

Data Privacy and Security

Medical device companies may be subject to U.S. federal and state and foreign health information privacy, security and data breach notification laws, which may govern the collection, use, disclosure and protection of health-related and other personal information. In the U.S., HIPAA imposes privacy, security and breach reporting obligations with respect to individually identifiable health information upon “covered entities” (health plans, health care clearinghouses and certain health care providers), and their respective business associates, individuals or entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HIPAA and its respective implementing regulations, including the final omnibus rule published on January 25, 2013, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information. HIPAA mandates the reporting of certain breaches of health information to HHS, affected individuals and if the breach is large enough, the media. Entities that are found to be in violation of HIPAA as the result of a breach of unsecured protected health information (“PHI”), a complaint about privacy practices or an audit by HHS, may be subject to significant civil, criminal and administrative fines and penalties and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance. The Health Information Technology and Clinical Health Act also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

Even when HIPAA does not apply, according to the Federal Trade Commission (the “FTC”), failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to what is required by the HIPAA Security Rule.

In addition, certain state and non-U.S. laws, such as the European Union’s General Data Protection Regulation (2016/679) (“GDPR”), govern the privacy and security of health information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Further, “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity, are also subject to certain HIPAA privacy and security standards. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. For example, California recently enacted legislation, the California Consumer Privacy Act (“CCPA”), which went into effect January 1, 2020. The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. Although the law includes limited exceptions, including for PHI maintained by a covered entity or business associate, it may regulate or impact the Company’s expected processing of personal information depending on the context. In Europe, the GDPR went into effect in May 2018 and introduces strict requirements for processing the personal data of European Union data subjects. Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. The State of Israel has also implemented data protection laws and regulations, including the Israeli Protection of Privacy Law of 1981.

Foreign Regulation

As the Company plans to market and deploy the QT Breast Scanner and products under development broadly across the globe, the Company will be subject to regulations applicable to medical and radiation-emitting devices in the jurisdictions in which the Company operates, which regulations vary among countries. While some countries’ regulations may not impose barriers to marketing and selling the Company’s products or only require certain notification, others may require that the Company obtains the clearance, registration or approval of a specified regulatory body. The process for obtaining such clearance, registration or approvals may involve additional testing and time. Furthermore, complying with foreign regulatory requirements can be expensive and time-consuming, and the Company will need to seek for regulatory clearances or approvals in each country in which the Company plans to market the Company’s products. In addition, depending on the country, if the Company modifies the Company’s products, the Company may need to apply for additional regulatory clearances or approvals before the Company is permitted to sell the modified product. Also, for maintaining the Company’s authorizations in a particular country, the Company will need to continue meeting quality and safety standards required in such country. The Company may seek additional regulatory approvals outside of the U.S. but as of the date of this registration statement/prospectus, the Company does not have sufficient information to determine when, if ever, the Company will receive regulatory approval from any other jurisdictions.

Following entry into the Gulf Medical Distribution Agreement, the Company has also begun the regulatory approval process with the Saudi FDA (“SFDA”), and is doing the same with the United Arab Emirates FDA (“MOHAP”), which has been given in March 2026. The Company also intends to do the same in the European Union in 2026 to obtain a CE Mark.

Finally, while regulatory clearance or approval by the FDA does not ensure registration, clearance or approval by regulatory authorities in other countries, registration or regulatory clearance or approval in one country, or denial thereof, may have effects on the regulatory process in others.

Intellectual Property, Patents & Trademarks

QT Imaging has multiple U.S., PCT, and European patents and patent applications and 4 registered U.S. trademarks. QT Imaging does not disclose its proprietary reconstruction algorithm technology. The details regarding this intellectual property is shown below.

The table below shows our utility patents and utility patent applications:

The table below shows our registered U.S. trademarks and trademark applications.

The Company is monitoring research laboratories, commercial companies or universities developing ultra-low frequency transmitted sound imaging using inverse scattering image reconstruction. Therefore, the Company believes that its patent and proprietary position is currently substantial and a very valuable asset.

Employees

As of December 31, 2025, the Company had 32 employees, of which 25 work in research, development, manufacturing, regulatory and operations, and 7 work in general and administrative capacities. In addition, 31 are full-time employees and 27 employees are located in Novato, CA. None of QT Imaging’s employees are represented by a labor union or are subject to a collective bargaining agreement.

Corporate and Available Information

Our corporate headquarters are located in Novato, California pursuant to a lease agreement that will expire on May 31, 2027. We believe that these facilities will be adequate for our near-term needs. If required, we believe that suitable additional or alternative space would be available in the future on commercially reasonable terms.

Our corporate website address is www.qtimaging.com. Information contained on our website is not a part of or incorporated by reference into this annual report or any other document we file with the SEC, and the inclusion of our website address in this annual report is inactive textual reference only.