8-K: QT Imaging Secures Exclusive UAE Distribution Deal

QT Imaging Holdings, Inc. entered an exclusive distribution agreement with Al Naghi Medical Co. for its breast imaging scanners and cloud platform in the United Arab Emirates, projecting over $24 million in revenue.

Summary

• QT Imaging Holdings, Inc. (QTIH) signed an exclusive Distribution Agreement with Al Naghi Medical Co. (NMC) for the United Arab Emirates (UAE) territory.
• The agreement grants NMC exclusive rights to market, advertise, and sell QT Breast Acoustic CT Scanners and QTI Cloud Platform SaaS subscriptions in the UAE.
• The initial term of the agreement is three years, from January 19, 2026, to January 19, 2029, with an automatic one-year extension if NMC meets Minimum Purchase Requirements.
• NMC is committed to minimum order quantities of 7 scanners in 2026 (starting Q2), 16 scanners in 2027, and 20 scanners in 2028, totaling 43 scanners.
• This agreement is expected to generate more than $24 million in revenue for QT Imaging.
• NMC is responsible for securing all required governmental approvals, permits, licenses, customs clearances, and authorizations for the Approved Products in the UAE.
• QTIH will provide training and professional services to NMC, while retaining all intellectual property rights.
• NMC will bear all risks of loss or damage to the Approved Products upon delivery to designated destinations and is responsible for all shipping, packaging, duties, fees, brokerage, insurance, and customs clearance.
• Payments for Approved Products will be in United States Dollars, with 50% due upon order placement and 50% within 45 days of shipping, or via an irrevocable letter of credit for certain orders.

Sentiment

Score: 8

Explanation: The exclusive distribution agreement in a significant new market with substantial revenue potential and a strong local partner is a highly positive development. The technology addresses a critical health need, enhancing the company's growth prospects. Risks associated with distribution agreements and forward-looking statements are present but are typical for such ventures.

Positives

• Secures exclusive distribution rights for QT Imaging's products in the United Arab Emirates, a significant and growing healthcare market.
• Establishes a clear revenue runway with committed minimum order quantities totaling 43 scanners and over $24 million in revenue.
• Partners with Al Naghi Medical Co., a leading and established medical device distributor in the UAE, enhancing market penetration.
• Addresses a critical health need in the UAE, where breast cancer prevalence is high and diagnosis occurs at a younger median age (48-49 years) compared to Western countries.
• Leverages the U.S. FDA-cleared QTI Breast Acoustic CT scanner, which offers non-invasive, 3D imaging without compression, contrast, or ionizing radiation, aligning with patient comfort and safety.
• Expands the reach of the QTI Cloud Platform SaaS, designed to transform breast health through biomarkers and imaging intelligence, offering advanced AI/ML capabilities.

Negatives

• NMC's failure to meet Minimum Purchase Requirements could result in the termination of its exclusive distributorship rights or the entire Distribution Agreement.
• QT Imaging's inability to furnish sufficient quantities of Approved Products would reduce NMC's Minimum Purchase Requirements, potentially impacting revenue.
• NMC is solely responsible for all shipping, packaging, duties, fees, brokerage, insurance, and customs clearance, which could introduce complexities or costs for the distributor.
• NMC bears all risks of loss or damage to the Approved Products once delivered to its designated destination(s).

Risks

• Actual results may differ materially from forward-looking statements due to various risks and uncertainties.
• Risks include research results from the use of the QTI Breast Acoustic CT scanner, outcomes of clinical studies, and the ability of QT Imaging to sell and deploy the scanner.
• Regulatory matters in the UAE, the ability to extend product offerings into new areas, and the ability to commercialize technology pose risks.
• Unexpected occurrences that deter the full documentation and bring-to-market plan for products could impact performance.
• Trends and fluctuations in the industry, changes in demand and purchasing volume of customers, and unpredictability of suppliers are potential challenges.
• The ability to attract and retain qualified personnel and to move product sales to production levels are ongoing risks.
• NMC's failure to meet Minimum Purchase Requirements could lead to the termination of exclusivity or the entire agreement.

Future Outlook

QT Imaging expects to penetrate the second largest healthcare market in the Middle East through this agreement. The company believes its QTI Breast Acoustic CT scanner can help change the current breast cancer screening paradigm in the UAE, promoting earlier detection and improved prognoses, especially given the younger median age of diagnosis in the region. Shipments of scanners are anticipated to commence in the second quarter of 2026.

Management Comments

• Dr. Raluca Dinu, QT Imaging's Chief Executive Officer, stated, "We are excited to gain access to this significant market by partnering for the distribution of our technology with NMC, one of the leading medical device distributors in the UAE."
• Dr. Dinu also commented, "By making breast imaging accurate, comfortable, and stress-free, we believe that our QTI Breast Acoustic CT scanner can help change the current breast cancer screening paradigm in the UAE, promoting earlier detection and improved prognoses."

Industry Context

The agreement positions QT Imaging to address a significant public health challenge in the UAE, where breast cancer accounts for 25% of all cancer cases and 43% of cancer cases diagnosed in women. The median age of breast cancer diagnosis in the UAE is approximately 48-49 years, nearly a decade younger than in Western countries, making QT Imaging's non-invasive technology particularly well-suited for younger women and potentially promoting earlier detection. The partnership with a leading regional distributor like Al Naghi Medical aligns with industry trends of leveraging established local networks for market entry in specialized medical device sectors.

Stakeholder Impact

• Shareholders: Potential for significant revenue growth and market expansion, positively impacting stock value.
• Customers (Patients in UAE): Access to a non-invasive, comfortable, and radiation-free breast imaging technology, potentially leading to earlier detection and improved prognoses.
• Employees: Potential for increased workload, training opportunities, and overall company growth.
• Al Naghi Medical Co.: Gains exclusive rights to distribute innovative medical technology in the UAE, strengthening its market position.
• Regulatory Authorities (UAE): Introduction of a new, FDA-cleared medical device requiring local approvals and oversight.

Next Steps

• NMC will secure all required governmental approvals, permits, licenses, customs clearances, and authorizations for the Approved Products in the UAE.
• QT Imaging will provide training and professional services to NMC.
• Shipments of QTI Breast Acoustic CT scanners to the UAE are expected to commence in Q2 2026.
• Minimum purchase order requirements will be revised 6 months after acquiring the application from MOHAP and commencing commercial activities to better forecast demand.

Key Dates

Recommendation

The exclusive distribution agreement with a leading medical distributor in the UAE represents a significant strategic win for QT Imaging. The committed minimum order quantities translate into a substantial revenue pipeline exceeding $24 million, providing clear visibility for growth. The QTI Breast Acoustic CT scanner addresses a critical and unmet need in the UAE, particularly given the younger demographic affected by breast cancer, positioning the company for strong market adoption. This expansion into a key international market, coupled with an innovative, FDA-cleared technology, significantly enhances the company's long-term value proposition and growth trajectory, making it a compelling 'strong buy' for investors.

Keywords

QT Imaging, Al Naghi Medical, UAE, Distribution Agreement, Breast Acoustic CT Scanner, QTI Cloud Platform, Medical Device, Breast Cancer Screening, Healthcare Technology, Middle East Market