Regulatory approval enables commercialization of QT Imaging's technology in Israel and supports expansion of clinical research collaborations

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 the Israeli Ministry of Health has granted registration for the Company's scanner, authorizing commercialization of the system in Israel through February 2, 2028. The approval is based on the Company's existing U.S. FDA clearance and applicable Israeli regulatory requirements.

QT Imaging’s Breast Acoustic CT™ Scanner produces true 3D, radiation-free and compression-free images of the breast using low-energy sound waves. The system provides quantitative imaging biomarkers derived from the intrinsic acoustic properties of breast tissue. The system is FDA-cleared as an adjunctive breast imaging device for women 18 years of age and older.

"This regulatory milestone is another important step in QT Imaging's international commercialization strategy," said Dr. Raluca Dinu, QT Imaging’s Chief Executive Officer. "Israel is internationally recognized for its leadership in breast cancer research, clinical innovation, and precision medicine. We are excited to bring our technology to Israeli clinicians while expanding collaborations with leading academic and clinical institutions."

The registration also supports QT Imaging's expanding clinical activities through its collaboration with Rambam Health Care Campus, Israel’s leading academic medical center. The planned clinical study will evaluate QT Imaging's Breast Acoustic CT technology in women with hereditary risk for breast cancer. Israel represents an important setting for hereditary breast cancer research because of its established national BRCA1/2 screening program and longstanding expertise in hereditary cancer management.⁽¹⁾

"Our collaboration with Rambam provides an opportunity to generate important clinical evidence in a population where hereditary breast cancer has been extensively studied," added Dr. Dinu. "We believe quantitative Breast Acoustic CT imaging has the potential to complement existing breast imaging modalities by providing objective tissue characterization without exposing patients to ionizing radiation or breast compression."

⁽¹⁾Greenberg R, Aharonov-Majar E, Isakov O, et al. Carrier screening program for BRCA1/BRCA2 pathogenic variants among Ashkenazi Jewish women in Israel: An observational study. Genetics in Medicine Open. 2023;1:100824. https://doi.org/10.1016/j.gimo.2023.100824).

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 that use 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 QT Imaging’s quality and regulatory compliance and its ability to scale manufacturing, expand commercialization globally, and support a growing customer base, 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.

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