QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis
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Twenty-four breast radiologists participated in a study of 177 selected cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality). The study found that QTI’s Breast Acoustic CTTM is similarly effective as digital breast tomosynthesis (DBT), also known as 3D mammography, in that the area under receiver operating characteristic curve (AUC) was statistically non-inferior for QTI scan compared with DBT for the AUC difference margin of -0.05. This means that QTI technology is non-inferior to DBT in the detection of breast lesions as a whole, with high specificity in determining benign cysts and thus decreasing benign recall rates. Statistical analysis was performed by Dr. Yulei Jiang from the Department of Radiology of the University of
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“We are encouraged by the consistent high performance of QTI’s technology, especially in women with dense breasts. Along with the previously published results and from comparison of QTI’s scans with mammography, these trial results will be valuable for our planned FDA submission for a screening indication in younger women identified with above-average risk for developing breast cancer and who have not yet reached the age for conventional mammography-based screening,” said Dr. Bilal Malik, Chief Science Officer. The results of the study comparing QTI’s technology performance with mammography were published in Academic Radiology, in December 2020: An Exploratory Multi-reader, Multi-case Study Comparing Transmission Ultrasound to Mammography on Recall Rates and Detection Rates for Breast Cancer Lesions - Academic Radiology
According to Jennifer Simmons, MD, Breast Surgeon, and Integrative Oncologist at Real Health MD, “Accurate and safe breast cancer screening is crucial for the
About QT Imaging
QT Imaging Holdings, Inc. is a public (NASDAQ: QTI) medical device company engaged in research, development, and commercialization of innovative body 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.
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 Securities Exchange Act of 1934, as amended. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology, and include (without limitation) statements regarding the strategic partnership between QT Imaging Holdings and our previously disclosed distribution partner, the QTI Breast Acoustic CTTM System, submission to the FDA for a screening indication, plans for QT Imaging Holdings, new product development and introduction, and product sales growth and projected revenues. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. These risks include, but are not limited to: the ability of the parties to sell and deploy the QTI Breast Acoustic CTTM System, 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. Additional factors that could cause actual results to differ are discussed under the heading “Risk Factors” and in other sections of QT Imaging’s (and its predecessor, GigCapital5, Inc.) filings with the SEC, and in its other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to QT Imaging Holdings as of the date hereof, and QT Imaging Holdings assumes no obligation to update any forward-looking statement.
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American Cancer Society. Breast Cancer Facts and Figures 2022-2024. |
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For media inquiries, please contact:
Susan Schaffler
Head of Communications
Susan.Schaffler@qtimaging.com
Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com
Source: QT Imaging Holdings, Inc.
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