iCAD’s AI solution minimizes interval cancers and
overcomes challenges associated with digital breast tomosynthesis


NASHUA, N.H., May 3, 2023 – iCAD, Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions, today
announced it will showcase its Breast AI Suite of cancer detection, density
assessment and risk evaluation solutions at the world’s largest breast imaging
conference, the Society of Breast Imaging (SBI) Symposium, taking place May 4-7
in National Harbor, MD. Attendees are invited to visit the iCAD booth #507 to
see the Company’s Breast AI Suite in action and learn how leading clinicians
worldwide are overcoming imaging challenges, including decreasing the incidence
of interval cancers.


“While mammography screening has improved in recent
decades and the introduction of digital breast tomosynthesis (DBT) offers many
clinical advantages, it also creates enormous amounts of data. Processing this
volume of data can weigh heavily on radiologists and imaging teams,” said Dana
Brown, President and CEO of iCAD, Inc. “iCAD’s Breast AI Suite offers a 360-degree
solution of cancer detection, density assessment, and risk evaluation technologies
that are uniquely positioned to address the top challenges clinicians face
today. Not only is our solution clinically proven to improve accuracy and
efficiency for radiologists reading mammography, it offers critical information
about a woman’s present and future breast health, which can help clinicians
find more interval breast cancers at their earliest stage possible.”


Interval cancers, or those that are diagnosed in between
screening exams after a “normal” mammogram, tend to be larger and more
aggressive, diagnosed at a later stage and with worse prognoses than those
found on screening mammograms. In a study of 69,025 women, interval
breast cancers accounted for one-fourth of breast cancers in routinely screened
women. These interval cancers were six times more likely to be grade III and
had 3.5 times increased hazards of breast cancer death compared with
screen-detected cancers.[1]


Laura Dean, MD, breast radiologist, Cleveland Clinic,
recently discussed minimizing interval cancers with AI in a presentation at the
Siemens Healthineers Innovations for Healthcare Professionals Education
Symposium in New Orleans, LA.


“DBT has improved mammography screening considerably,
particularly in the U.S., where it is available at 82% of breast imaging sites.[2]
However, DBT has introduced new challenges for radiologists reading
mammography, as it generates an exponential amount of data to review, compared
to 2D mammography. AI is becoming ubiquitous in our daily lives, from
smartphones to smart homes, but it is particularly well-suited for reading DBT,”
said Dr. Dean. “Interval cancers tend to grow and possibly spread more quickly,
making them among the most dangerous to miss. AI helps us to review every pixel
of even the most complicated datasets more closely, and with greater accuracy
and efficiency, which helps us detect more cancers earlier and hopefully
decrease the incidence of interval cancers.”


A growing body of clinical evidence confirms the unique
value iCAD’s Breast AI Suite offers to clinicians and patients alike. According
to a retrospective analysis of 37,367 women published in the Journal of Medical Screening, ProFound® AI for 2D Mammography may reduce interval
breast cancer rates, as the technology found 93% of interval cancers—including eight
out of nine cancers that presented with minimal signs and six out of six that
were false negatives, or missed in the screening round.[3] Additionally,
a study published in Science Translational Medicine suggests ProFound AI Risk offered high accuracy
in estimating future risk for both screen detected and interval cancers, as
well as invasive and in-situ cancers, in both women with dense and non-dense


The flagship product in iCAD’s Breast AI Suite is ProFound
AI, which became the first technology of its kind to be FDA cleared in 2018.
Built with the latest in deep-learning AI, ProFound AI for Digital Breast
Tomosynthesis is clinically proven to improve radiologists’ sensitivity by 8%,
reduce the rate of false positives and unnecessary callbacks by 7%, and slash
reading time by more than half. iCAD’s Breast AI Suite also includes PowerLook
Density Assessment, which automates the process of breast density reporting and
empowers clinicians to further personalize breast cancer screening
recommendations for patients.


The latest addition to iCAD’s Breast AI Suite, ProFound
AI Risk, is the world’s first clinical decision support tool that provides an
accurate short-term breast cancer risk estimation that is truly personalized
for each woman, based only on her mammogram.[4],[5]
This first-in-kind solution uniquely combines age, breast density and subtle
mammographic features, offering superior performance and accuracy in assessing both
short- and long-term risk compared to traditional, commonly-used breast cancer
risk models.[3],[6]


“Breast cancer continues to be one of the greatest
threats to women’s health worldwide, but iCAD’s Breast AI Suite arms clinicians
with more intelligence than ever to personalize screening based on individual
risk, which can help them detect cancers at their earliest possible stages,
when they may be more easily treated,” said Ms. Brown. “Using our suite of
tools together provides clinicians with the latest defense in the fight against
breast cancer – not only does it empower them to perform at a higher level, but
it offers valuable information about patients’ individual risk of developing
breast cancer that can help clinicians tailor screening regimens. This
translates to finding more cancers and we look forward to sharing our powerful solutions
with the clinical community at the SBI Symposium this week.”


About iCAD, Inc.

Headquartered in Nashua, NH, iCAD® is a global medical
technology leader providing innovative cancer detection and therapy solutions.
For more information, visit www.icadmed.com.


Forward-Looking Statements 

Certain statements contained in this News Release
constitute “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements about the
expansion of access to the Company’s products, improvement of performance,
acceleration of adoption, expected benefits of ProFound AI®, the benefits of
the Company’s products, and future prospects for the Company’s technology
platforms and products. Such forward-looking statements involve a number of
known and unknown risks, uncertainties and other factors which may cause the
actual results, performance, or achievements of the Company to be materially
different from any future results, performance, or achievements expressed or
implied by such forward-looking statements. Such factors include, but are not
limited, to the Company’s ability to achieve business and strategic objectives,
the willingness of patients to undergo mammography screening in light of risks
of potential exposure to Covid-19, whether mammography screening will be
treated as an essential procedure, whether ProFound AI will improve reading
efficiency, improve specificity and sensitivity, reduce false positives and
otherwise prove to be more beneficial for patients and clinicians, the impact
of supply and manufacturing constraints or difficulties on our ability to
fulfill our orders, uncertainty of future sales levels, to defend itself in
litigation matters, protection of patents and other proprietary rights, product
market acceptance, possible technological obsolescence of products, increased
competition, government regulation, changes in Medicare or other reimbursement
policies, risks relating to our existing and future debt obligations,
competitive factors, the effects of a decline in the economy or markets served
by the Company; and other risks detailed in the Company’s filings with the
Securities and Exchange Commission. The words “believe,” “demonstrate,”
“intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,”
“seek,” and similar expressions identify forward-looking statements. Readers
are cautioned not to place undue reliance on those forward-looking statements,
which speak only as of the date the statement was made. The Company is under no
obligation to provide any updates to any information contained in this release.
For additional disclosure regarding these and other risks faced by iCAD, please
see the disclosure contained in our public filings with the Securities and
Exchange Commission, available on the Investors section of our website at
http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.





Media Inquiries:

Jessica Burns, iCAD




Investor Inquiries:

iCAD Investor



[1] Niraula
S, Biswanger N, Hu P, Lambert P, Decker K. Incidence, Characteristics, and
Outcomes of Interval Breast Cancers Compared With Screening-Detected Breast
Cancers. JAMA Netw Open. 2020;3(9):e2018179.

[2] MQSA
National Statistics. Accessed via https://www.fda.gov/radiation-emitting-products/mqsa-insights/mqsa-national-statistics.

Graewingholt A, Rossi PG. (2021). Retrospective analysis of the effect on
interval cancer rate of adding an artificial intelligence algorithm to the reading
process for two-dimensional full-field digital mammography. J Med Screen. 0(0)

Accessed via

Eriksson, M et al. A risk model for digital breast tomosynthesis to predict
breast cancer and guide clinical care. Science Translational Medicine. 14
(644). 2022 May 11. Accessed via

[5] Eriksson
M, Czene K, Strand F et al. Identification of Women at High Risk of Breast
Cancer Who Need Supplemental Screening. Radiology. 2020 Sept 8,

[6] Eriksson
M, CzeneK , Vachon C, Conant E, Hall P. Long-Term Performance of an Image-Based
Short-Term Risk Model for Breast Cancer. Journal of Clinical Oncology. DOI: