QT Imaging Announces Second Blinded Screening Trial Finding Its Technology Similarly Effective as Digital Breast Tomosynthesis
16 Abril 2024 - 9:30AM
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
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)
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version on businesswire.com: https://www.businesswire.com/news/home/20240416583782/en/
For media inquiries, please contact: Susan Schaffler Head
of Communications Susan.Schaffler@qtimaging.com
Stas Budagov Chief Financial Officer
Stas.Budagov@qtimaging.com
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