10-K: QT Imaging Reports Soaring Revenue, Nasdaq Uplisting, and Key Global Distribution Deals

QT Imaging Holdings, Inc. announced a significant revenue increase, uplisted to Nasdaq, and secured major distribution agreements in the Middle East, despite widening net losses for fiscal year 2025.

Summary

• Revenue for the fiscal year ended December 31, 2025, surged by 288% to $18.9 million, up from $4.9 million in 2024, driven by the sale of 40 QT Breast Scanners in 2025 compared to 12 in 2024.
• Gross profit increased by 225% to $8.6 million in 2025 from $2.6 million in 2024, though gross margin decreased to 45% from 54% due to higher costs for Model B and Canon-manufactured scanners, and increased overhead allocation.
• Net loss widened significantly to $21.1 million in 2025, compared to $9.0 million in 2024, primarily due to non-cash expenses related to the Lynrock Lake Term Loan issuance ($6.6 million) and debt extinguishment/modification charges ($2.2 million).
• Cash used in operating activities improved slightly to $9.0 million in 2025 from $10.0 million in 2024.
• The company uplisted its common stock from the OTCQB Venture Market to the Nasdaq Capital Market, effective January 28, 2026, trading under the ticker symbol QTI.
• Secured an exclusive distribution agreement with Gulf Medical Co. for Saudi Arabia, with minimum order quantities (MOQs) projected to generate $11.2 million to $12.3 million in 2026.
• Signed an exclusive distribution agreement with Al Naghi Medical Co. for the UAE, with MOQs totaling 43 scanners (7 in 2026, 16 in 2027, 20 in 2028) representing over $24 million in revenue.
• Received FDA 510(k) clearance on March 10, 2026, for an enhanced configuration of the Breast Acoustic CT scanner, improving imaging coverage of posterior breast tissue.
• The AMA CPT Editorial Panel approved a new Category III CPT code, X579T, for 3D quantitative transmission volumetric ultrasound tomography of the breast, effective January 1, 2027.
• Completed several PIPE investments in 2025 and early 2026, raising approximately $18.9 million in gross proceeds.
• Entered into a Canon Manufacturing Agreement on March 28, 2025, appointing Canon Medical Systems Corporation (CMSC) as the exclusive manufacturer of QT Breast Scanners for NXC distribution.
• The accumulated deficit increased to $53.0 million as of December 31, 2025, from $31.9 million in 2024.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this as a mixed but cautiously optimistic report. While significant revenue growth and strategic advancements (Nasdaq uplisting, new FDA clearance, major distribution deals) are strong positives, the substantial increase in net loss and accumulated deficit due to non-cash expenses and ongoing operational losses temper the enthusiasm. The company's ability to secure funding and expand market reach is promising, but sustained profitability remains a key challenge.

Positives

• Revenue increased by 288% to $18.9 million in 2025, indicating strong sales growth for the QT Breast Scanner.
• Gross profit grew by 225% to $8.6 million in 2025.
• Successfully uplisted to the Nasdaq Capital Market, enhancing market visibility and access to capital.
• Secured significant exclusive distribution agreements with Gulf Medical Co. (Saudi Arabia) and Al Naghi Medical Co. (UAE), projecting substantial future revenue from minimum order quantities (MOQs) of over $35 million combined for 2026-2028.
• Received a new FDA 510(k) clearance for an enhanced Breast Acoustic CT scanner configuration, improving imaging capabilities.
• The AMA CPT Editorial Panel approved a new Category III CPT code (X579T) for 3D quantitative transmission volumetric ultrasound tomography of the breast, standardizing reporting and supporting future reimbursement.
• Cash and cash equivalents increased significantly to $10.4 million in 2025 from $1.2 million in 2024, bolstered by PIPE investments and the Lynrock Lake Term Loan.
• Net cash used in operating activities improved from $10.0 million in 2024 to $9.0 million in 2025.
• Entered into a manufacturing agreement with Canon Medical Systems Corporation (CMSC) to scale up production of QT Breast Scanners.

Negatives

• Net loss widened significantly to $21.1 million in 2025 from $9.0 million in 2024, primarily due to non-cash expenses.
• Gross margin decreased to 45% in 2025 from 54% in 2024, attributed to higher manufacturing costs for certain scanner models and increased overhead allocation.
• Accumulated deficit increased to $53.0 million as of December 31, 2025, highlighting continued unprofitability.
• Incurred $6.6 million in non-cash expense at the issuance of the Lynrock Lake Term Loan and $2.2 million in debt extinguishment and modification charges.
• The company has a history of net losses and negative cash flow from operations since inception and expects these to continue.
• The company is highly dependent on the successful development, marketing, and sale of its breast imaging device, with limited operating history and market adoption.
• The company obtained waivers from Lynrock Lake in February 2026 for non-compliance with certain debt covenants related to information reporting during the first three quarters of 2025.

Risks

• Significant operating losses and negative cash flow from operations, with no assurance of achieving or maintaining profitability.
• Limited operating history with current offerings makes it difficult to evaluate future business prospects and increases investment risk.
• Inability to attract new customers on a cost-effective basis could harm the business.
• Failure to successfully execute growth initiatives, business strategies, or operating plans.
• Forecasts and projections may prove incorrect or inaccurate, leading to actual results differing materially.
• Difficulty attracting and retaining qualified personnel, including key executive management.
• Management team has limited experience managing a publicly traded company, potentially diverting attention from business operations.
• Inadequate funding for development efforts could hinder the introduction of new products and features, impacting competitiveness.
• Reliance on internet infrastructure, third-party providers, and internal systems for solutions, with potential for failures or interruptions.
• Failure to successfully develop or introduce new products/features or integrate acquired products/services.
• QT Breast Scanner and future products may not achieve widespread market acceptance, impacting revenue generation.
• Recent changes in U.S. payment policies for imaging procedures could negatively impact utilization of imaging services.
• Need for additional indebtedness or equity/debt financings, which may not be available on acceptable terms or cause dilution.
• Extensive pre-market and post-market government regulations, with non-compliance leading to enforcement actions by the FDA.
• Products must be manufactured in accordance with federal, state, and foreign regulations; non-compliance by the company or third-party manufacturers could cause delivery delays.
• Inability to obtain and maintain intellectual property protections (patents, trade secrets) could adversely impact market competitiveness.
• Patents have limited lifespans, potentially expiring before or shortly after commercialization, limiting exclusionary rights.
• Future sales of common stock may depress stock price due to dilution from warrants and other equity issuances.
• Exposure to product liability claims, product recalls, and warranty claims, which could be expensive and harm reputation.
• Public warrants may expire worthless if not in-the-money, and terms may be amended adversely.
• Potential for redemption of unexpired public warrants prior to exercise at a disadvantageous time.
• Increased costs and demands on management due to public company compliance requirements.
• Unanticipated changes in effective tax rates or adverse outcomes from tax return examinations.
• Dependence on QT Imaging, Inc. for distributions, loans, and other payments to meet financial obligations.
• Geopolitical instability and military conflicts in the Middle East could disrupt global markets and adversely affect business and finances, particularly in Saudi Arabia and UAE.
• Mishandling of sensitive information or data security breaches could harm business, reputation, and lead to litigation/liability.
• Technological change may render products obsolete, impacting sales and operating results.
• Inability to sustain revenue growth or profitability due to market conditions or unforeseen factors.
• Marketing efforts, including social media, may expose the company to additional regulatory scrutiny and potential penalties.
• Failure to comply with anti-bribery and anti-corruption laws could lead to penalties and adverse consequences.
• Changes in accounting principles or their application could result in unfavorable accounting charges.
• Industry data, projections, and estimates relied upon may be inaccurate or unverified.

Future Outlook

The company aims to continue its technological innovation by building a biomarker-driven Cloud SaaS platform, transitioning from a hardware manufacturer to a precision imaging AI platform. It plans to expand market presence in the U.S. through strategic collaborations and direct initiatives, including a 'Women's Health = Women's Empowerment' campaign. International expansion is targeted for the GCC region, Europe, and other markets, supported by distribution partnerships and clinical evidence generation. The company expects to achieve clinical adoption and expanded FDA clearances by leveraging its installed base for data collection and analysis. Future funding requirements will depend on growth rate, R&D spending, sales and marketing expansion, and new product introductions, with plans to raise capital through equity, debt, and strategic alliances.

Management Comments

• "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 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."
• "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."
• "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."
• "We expect that our research and development expenses will increase substantially for the foreseeable future as we continue to invest in the development of the QT Breast Scanner."
• "We believe that the additional cash received from the Lynrock Lake Term Loan, the PIPE investments, and the additional expected revenue from MOQs per the Amended NXC Distribution Agreement and new distribution partners in the Gulf region, Gulf Medical and Al Naghi Medical Co., will be sufficient to fund our current operating plan for at least the next 12 months."

Industry Context

StockSavvy.ai notes that QT Imaging operates in the rapidly evolving and highly competitive global medical imaging market, estimated at over $40 billion annually, with breast imaging alone projected to reach $13.2 billion by 2034. The company's focus on non-ionizing, compression-free 3D ultrasound technology positions it to address limitations of traditional mammography (radiation, discomfort, reduced efficacy in dense breasts) and MRI (cost, claustrophobia, contrast agents). The shift towards AI-enabled quantitative imaging and precision medicine platforms, valued at around $1 billion, aligns with QT Imaging's strategy to build a biomarker-driven Cloud SaaS platform. The company's partnerships with established players like Canon Medical Systems Corporation and regional distributors in the GCC region are crucial for market penetration against larger, entrenched competitors like General Electric, Siemens, and Philips.

Comparison to Industry Standards

• QT Breast Scanner offers superior performance compared to traditional mammogram with respect to specificity (false positives), potentially reducing unnecessary emotional trauma, invasive follow-up procedures, and healthcare costs. For every 1,000 screening mammograms, 150 women are recalled for more tests, but only three are diagnosed with cancer, highlighting mammography's low positive predictive value.
• The technology has the potential to offer superior specificity compared to screening breast MRI for younger women (under 40) at above-average risk, by reducing false positives and sparing patients from undue emotional distress and unnecessary biopsies.
• QT Breast Scanner provides a lower price point than conventional high-energy imaging equipment (CT, MRI, PET), which typically require large capital investments, specialized facilities, and advanced certifications.
• Unlike mammography or digital breast tomosynthesis, QT Breast Scanner does not use ionizing radiation, and unlike MRI, it does not require contrast agents, allowing for more frequent monitoring without practical or clinical restrictions.
• A multi-reader, multi-case study found that QTscans improved non-cancer recall rates by 16% (p-value = 0.03) compared to full-field digital mammography (FFDM), without substantially affecting cancer recall rates.
• A study demonstrated QTscans are highly accurate at diagnosing cyst versus solid lesions, with mean sensitivity of 93.3% and specificity of 85.8%, suggesting improvement over 2D handheld ultrasound (HHUS) which has low specificity and high false positives.
• A pilot study comparing QTscans to MRI for high-risk screening showed 65% exact BI-RADS agreement and 90% binary agreement, suggesting comparable effectiveness in identifying positive findings, and potential as an alternative when MRI is not feasible.
• The QT Breast Scanner has no reports of adverse effects from over 30,000 scans performed to date, contrasting with potential side effects of X-ray mammography (radiation, compression) and MRI (claustrophobia, contrast agents).

Management Changes

Corporate Governance

Legal Proceedings

• Not currently subject to any material legal proceedings, nor is any material legal proceeding threatened against the company or any of its officers or directors in their corporate capacity.

Related Party Transactions

• **Convertible Notes Payable (2020 Notes)**: Three convertible notes issued in July 2020 to three stockholders (related parties) for up to $3.5 million principal, bearing 5-8% annual interest. Maturity extended to October 21, 2027. Convertible into common stock at lower of $43.77/share or offering price in a $5.0M equity financing. Outstanding amount $3.2 million principal and $0.7 million accrued interest as of December 31, 2025.
• **Working Capital Note**: Promissory note issued to a stockholder (related party) on May 3, 2023, for $0.3 million, subsequently amended six times to an aggregate principal of $0.7 million as of December 31, 2025. Interest-free, maturity extended to October 1, 2027.
• **April 2025 Private Placement**: On April 24, 2025, the company completed a PIPE investment of $0.5 million from Dr. Avi Katz (Chairman) and Dr. Raluca Dinu (CEO), issuing 261,644 shares of common stock and warrants to purchase 523,286 shares.
• **January 2026 Private Placement**: On January 22, 2026, the company entered into a private placement with the Chairman of its Board of Directors, issuing 24,107 shares and warrants for 48,214 shares for $0.2 million.
• **Sublease Agreement with QT Imaging Center**: On January 23, 2025, the company subleased office space to QT Imaging Center (formerly operated by Dr. John Klock, a director) for a rental fee of approximately $6,000 per month, determined to be fair market value. The sublease term is one year, auto-renewing month-to-month, expiring with the prime lease in April 2027.
• **Data Use and License Agreement with QT Imaging Center**: On April 3, 2024, the company granted a license to QT Imaging Center to use de-identified health information for research and analytical processes.

Stakeholder Impact

• **Shareholders**: Experience significant dilution from past and future equity issuances (warrants, PIPE investments). Stock price volatility is a risk. No dividends are expected in the foreseeable future. Uplisting to Nasdaq may increase visibility and liquidity.
• **Employees**: Management changes (new CFO, CEO salary increase, RSU grants) impact executive team. The company's growth plans require attracting and retaining highly qualified personnel, which is a competitive challenge.
• **Customers (Hospitals, Clinics, Patients)**: Benefit from a novel, safe, painless, and radiation-free breast imaging technology. New FDA clearances and CPT codes aim to improve access and reimbursement. Distribution agreements expand product availability. However, market acceptance is uncertain, and reliance on third-party payors for reimbursement is a risk.
• **Suppliers/Manufacturers**: Canon Medical Systems Corporation is now an exclusive manufacturer for NXC distribution, indicating a key relationship. Reliance on a limited number of critical component suppliers poses supply chain risks.
• **Creditors**: Lynrock Lake Master Fund LP is a significant creditor with a senior secured term loan. The company's ability to meet debt obligations depends on achieving profitability and securing additional financing.

Next Steps

• Continue to improve high-quality, high-resolution, native 3D breast imaging technology and quantifiable analysis techniques.
• Build a biomarker-driven Cloud SaaS platform to transition into a precision imaging artificial intelligence platform.
• Partner with strategic business and distribution channels to address the U.S. market and expand into other regions (GCC, Europe, Australia, New Zealand, South Korea, South Asia, ASEAN).
• Perform small-scale manufacturing internally and partner strategically for large-scale manufacturing (e.g., with CMSC).
• Expand the market by supporting Direct-to-Consumer (DTC) and Direct-to-Practitioner (DTP) approaches to lower healthcare costs and increase access.
• Leverage intellectual property and know-how to develop other scanning medical imaging products (e.g., infant scanners, full-body scanners).
• Undertake a multigenerational outreach and advocacy campaign in the U.S. focused on 'Women's Health = Women's Empowerment'.
• Establish peer-review partnerships with respected medical organizations to collect data on QT Breast Scanner use and publish results.
• Pursue commercialization in Europe and countries recognizing EU registration starting at the end of 2026 and continuing through 2027.
• Explore additional distribution arrangements in other GCC countries (Kuwait, Qatar, Oman, Bahrain).
• Initiate registration activities for Europe later in 2026 to obtain a CE Mark.
• Continue to use unlisted CPT code 76999 in 2026 for payer education and case-by-case reimbursement, while building data for formal code creation.
• The new Category III CPT code X579T will become effective on January 1, 2027, supporting standardized reporting and evaluation.
• Monitor and upgrade internal controls over financial reporting as necessary or appropriate for the business.

Key Dates

Recommendation

QT Imaging Holdings, Inc. presents a compelling long-term growth story with its innovative, non-invasive breast imaging technology, significant revenue growth, and strategic market expansion through key distribution and manufacturing partnerships. The recent Nasdaq uplisting and new FDA/CPT clearances are positive catalysts for market acceptance and reimbursement. However, the substantial net losses, increasing accumulated deficit, and ongoing need for capital raise concerns about short-to-medium term financial stability. The company operates in a highly competitive and regulated industry, facing risks related to market adoption, reimbursement, and intellectual property. A 'hold' recommendation is appropriate as the company navigates its commercialization phase, balancing strong potential with significant financial and operational challenges. Investors should monitor progress on profitability, market penetration, and further regulatory milestones.

Keywords

Breast Imaging, Medical Device, Ultrasound Tomography, FDA Clearance, SaaS Platform, Artificial Intelligence, Machine Learning, Healthcare Technology, Diagnostic Imaging, Quantitative Imaging, Distribution Agreements, Nasdaq Uplisting, Capital Raise, Risk Factors, Financial Performance