QT Imaging Receives UAE Regulatory Clearance
Allows for Commercial Deployment of the Company's Radiation-Free Breast Imaging Technology Under Distribution Agreement with Al Naghi Medical Co., Supports $24 Million Revenue Pipeline Through 2028
QT Imaging Holdings, Inc. (NASDAQ:QTI) ("QT Imaging" or the "Company"), a medical device company dedicated to transforming breast health management through innovative, radiation-free imaging technology, today announced that its Breast Acoustic CT™ scanner has received official classification and clearance from the United Arab Emirates (UAE) Emirates Drug Establishment (EDE) for use as a medical device in that country.
This clearance allows for the importation and distribution of our scanner through EDE-licensed medical warehouses, ensuring compliance with UAE healthcare infrastructure standards and enabling marketing to licensed healthcare facilities across the country. It also represents a significant step in QT Imaging's global strategy and reinforces its commitment to expanding access to advanced compression-free, 3D technology offering a more comfortable and radiation-free alternative for breast imaging.
In January 2026, QT Imaging signed an exclusive distribution agreement with Al Naghi Medical Co., a leading provider of medical devices in the UAE, for the QTI scanner and the QTI Cloud Platform, establishing a $24 million revenue pipeline through 2028. According to national data cited by Elobaid et al.1, breast cancer accounts for 25% of all cancer cases in the UAE and 43% of cancers among women, underscoring the urgent need for safe and effective breast imaging solutions.
"The UAE represents a highly attractive and fast-growing healthcare market, and this regulatory clearance is a pivotal milestone in our expanding global commercial presence," said Satrajit Misra, QT Imaging's Chief Commercial Officer. "It opens the door for commercial deployment in the region by our distributor Al Naghi Medical, positions us to build strong partnerships with leading healthcare providers and also complements our existing presence in Saudi Arabia through Gulf Medical."
With a strong emphasis on innovation and regulatory alignment, QT Imaging is actively advancing its commercialization efforts globally. UAE regulatory clearance underscores the Company's ability to navigate diverse regulatory environments and deliver compliant, cutting-edge solutions to international markets. Along with QT Imaging's exclusive distribution agreement with Gulf Medical Co. for Saudi Arabia, the Company now has a commercial presence in the two largest healthcare markets in the Middle East.
About QT Imaging
QT Imaging Holdings, Inc. (NASDAQ:QTI) is a medical device company engaged in the research, development, and commercialization of innovative imaging systems using low frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient's experience. For more information on QT Imaging Holdings, Inc., please visit the Company's website at www.qtimaging.com and follow us on LinkedIn.
Breast Acoustic CT™ is a trademark of an affiliate of QT Imaging Holdings, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act of 1934, as amended. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook," and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the QT Imaging Breast Acoustic CT Scanner, including its commercialization in the UAE and Saudi Arabia, manufacturing (including large scale) and further development, advanced image reconstruction software performance of software enhancements, plans for QT Imaging, new product development and introduction, product sales growth and projected revenues, QT Imaging's industry, future events, and other statements that are not historical facts. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of QT Imaging's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by you or any other investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control. These forward-looking statements are subject to a number of risks and uncertainties, including those relating to: the ability of the Company to sell and deploy the QT Imaging Breast Acoustic CT™ Scanner; the ability to extend product offerings into new areas or products; the ability to commercialize technology; unexpected occurrences that deter the full documentation and "bring to market" plan for products; trends and fluctuations in the industry; changes in demand and purchasing volume of customers; unpredictability of suppliers; the ability to attract and retain qualified personnel and the ability to move product sales to production levels; changes in domestic and foreign business, market, financial, political, and legal conditions; the uncertainty of projected financial information; delays caused by factors outside of our control; changes in our ability to successfully receive purchase orders and generate revenue under our existing contracts with partners and distributors; our ability to realize the benefits of the strategic partnerships; the identified material weakness in our internal controls over financial reporting (including the timeline to remediate the material weakness); the rollout of the business and the timing of expected business milestones; the effects of competition on our future business; our ability to obtain and access financing in the future; our ability to pay our debt obligations as they come due; and those factors discussed in the Company's reports and other documents filed with the SEC, including under the heading "Risk Factors." If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that QT Imaging presently does not know or that QT Imaging currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect QT Imaging's expectations, plans or forecasts of future events and views as of the date of this release. QT Imaging anticipates that subsequent events and developments will cause QT Imaging's assessments to change. However, while QT Imaging may elect to update these forward-looking statements at some point in the future, QT Imaging specifically disclaims any obligation to do so. Accordingly, undue reliance should not be placed upon the forward-looking statements.
1 Y. Elobaid, T. C. Aw, J. N. W. Lim, S. Hamid, and M. Grivna, "Breast Cancer Presentation Delays Among Arab and National Women in the UAE: A Qualitative Study," SSM Popul Health 2 (2016): 155–163.
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