Press Release

QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis

April 16, 2024

NOVATO, Calif.–(BUSINESS WIRE)–QT Imaging Holdings, Inc. (NASDAQ:QTI) a medical device company engaged in research, development, and commercialization of innovative body imaging systems is proud to announce positive data regarding the diagnostic performance of QTI’s Breast Acoustic CTTM Scans for mass detection from its second blinded multi-reader multi-case study. The study was published in Academic Radiology, online, in January 2024: A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions – Academic Radiology

“Accurate and safe breast cancer screening is crucial for the 40% of women in US with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs. This study suggests that these requirements are now being met.”

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 Chicago.

While fewer than 5% of women with breast cancer are diagnosed before the age of 40(1), those cancers are usually aggressive, and the young patients suffer from poor survival outcomes. Unfortunately, routine screening mammograms are not recommended for women under 40 because risks outweigh potential benefits at this young age. Fortunately, the now published results suggest that QTI’s technology can be a much-needed potential alternative to mammography for women too young to undergo mammography screening.

“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 40% of women in US with dense breasts. Standardization and broad accessibility of any technology are essential to minimize the financial and emotional impacts of unnecessary biopsies and call backs. This study suggests that these requirements are now being met.” Dr. Simmons, who has been caring for women with breast disease for over 20 years, knows the increasing need for safe imaging in the younger population. “Cancers are occurring in much younger women today than when I started to practice. We need a safe imaging solution for young women. I am hopeful that QTI’s technology is that solution.”

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.

Reference:

(1)

American Cancer Society. Breast Cancer Facts and Figures 2022-2024. Atlanta, GA: American Cancer Society, 2022. (link)

 

Contacts

For media inquiries, please contact:
Susan Schaffler
Head of Communications
Susan.Schaffler@qtimaging.com

Stas Budagov
Chief Financial Officer
Stas.Budagov@qtimaging.com