New and Real-World Clinical Evidence Confirms ProFound AI Increases Cancer Detection and Reveals Critical Clues to Inform Clinical Decisions
New research presented at American Roentgen Ray Society (ARRS) meeting continues to validate unique value iCAD’s deep-learning breast AI solution offers to clinicians and patients
NASHUA, N.H., April 20, 2023 – iCAD, Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions, today
announced new real-world research confirms ProFound AI® has been proven to
increase cancer detection rates and provide vital clues for breast imagers’
clinical decisions through two studies. One study demonstrated that ProFound AI
improved radiologists’ performance in detecting breast cancer and providing
better accuracy, without increasing abnormal interpretation rates or the rate
of recalls. The second study highlighted that the lesion and Case Scores
provided by ProFound AI offer important information about the algorithm’s
confidence in identifying malignancy, with sequential changes in these scores
offering significant additional insights. These studies were presented at the
American Roentgen Ray Society (ARRS) meeting, which took place April 16-20 in
Honolulu, HI.
“The body of evidence supporting our Breast AI Suite grows
as leading facilities and academic institutions worldwide continue to validate
the unmatched results and benefits our technologies offer,” said Dana Brown,
President and CEO of iCAD, Inc. “The studies presented at the ARRS meeting confirm
that ProFound AI not only improves radiologists’ performance and aids in the
detection of breast cancer, but also reveals valuable clues over time through
Case Scores, which can help clinicians make more informed clinical decisions
and personalize patient care.”
Real-world study confirms iCAD’s AI increases cancer detection,
without increasing recalls
In a scientific poster presentation titled “Effect of
Artificial Intelligence Software on Digital Breast Tomosynthesis Screening
Cancer Detection, Abnormal Interpretation Rates, and Positive Predictive Value
Among Subspecialized Breast Radiologists: Cumulative Real-World Evidence,” researchers
at the University of Florida-Jacksonville, FL examined the performance of five
breast imaging radiologists for one year at a site with iCAD’s ProFound AI
compared with the performance of the same five radiologists during the same
year at two sites that did not have ProFound AI. iCAD’s ProFound AI increased
cancer detection rates and positive predictive value for cancer among abnormal
interpretations (PPV1), without increasing abnormal interpretation rates across
the radiologists studied. Researchers concluded ProFound AI resulted in
clinically relevant increases in cancer detection, without increasing the rate
of recalls.
“As digital breast tomosynthesis (DBT) becomes the
standard of care for screening mammography, radiologists are facing an
exponential increase in the amount of data they are tasked with interpreting
each day. We were curious to learn if ProFound AI could help us read DBT with
greater accuracy after a year of use,” said the study’s lead author, Haley
Letter, M.D. “This real-world evidence confirms ProFound AI can increase cancer
detection and improve accuracy in a clinical setting.”
“ProFound AI acts as another pair of eyes that alerts our
team to areas that may need further evaluation, while also helping us to avoid
calling women back unnecessarily, which can cause a lot of stress for women,” said
another researcher on the study, Hector Diaz de Vellegas, D.O., Assistant
Professor and Medical Director, Wildlight, University of Florida-Jacksonville,
FL. “By improving accuracy, ProFound AI may also improve screening
effectiveness, which can ultimately offer peace of mind to both clinicians and
patients alike.”
ProFound AI’s Case Scores provide important clues for
clinicians to personalize care
In an educational poster presentation titled “Implications
of Change in an AI-Derived Case Score on Sequential Years of Digital Breast
Tomosynthesis Screening,” Samantha Zuckerman, M.D., M.B.E., Assistant Professor
of Clinical Radiology (Breast Imaging), University of Pennsylvania, will
discuss how examining ProFound AI’s lesion and Case Scores over time may
provide important clues that can help inform clinical decisions. ProFound AI generates
a lesion score and a Case Score on a scale of 0-100. The higher the lesion
score or Case Score, the more certain the algorithm is that the abnormality
could represent a malignancy. Analyzing changes of ProFound AI lesion and Case Scores
over sequential rounds of screening and correlating to key clinical outcomes of
screening with example true positive (TP), true negative (TN), false positive (FP)
and false negative (FN) cases, researchers concluded ProFound AI may alert
radiologists to both the location of specific, suspicious lesions, as well as
the case-level likelihood of malignancy. Additionally, researchers found an
increase in case level and/or lesion level score over sequential screens may
also aid radiologists in the detection of screen-detected cancers and identify
patients at higher risk for developing breast cancer.
“ProFound AI’s lesion and Case Scores offer critical
information about the algorithm’s confidence regarding whether a lesion or case
is malignant, but looking at these scores sequentially offers a wealth of
knowledge that could have a significant impact on patient care,” said Dr.
Zuckerman. “Our research confirms that significant changes in lesion and Case Scores
over time may reveal additional clues to clinicians that may help inform
important clinical decisions, such as whether to call a woman back for a biopsy
or additional imaging.”
Built with the latest in deep-learning AI, ProFound AI
became the first AI solution for DBT to be FDA cleared in 2018. With up to two
times the improvement in clinical performance compared to leading competitors,[1]
ProFound AI offers unrivaled accuracy, as well as multi-vendor compatibility
and unique workflow advantages. In a large reader study, iCAD’s ProFound AI was
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.[2]
With more than 7,500 licensed installations in more than
20 countries, including some of the world’s largest imaging institutions such
as Radiology Partners, SimonMed, and Solis Mammography, iCAD’s breast cancer screening
technology is the most widely used technology of its kind.
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.
Contact:
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Inquiries:
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Relations
[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
Accessed 1-19-22. FDA 510K submissions K182373, K201019, K193229
[2] Conant,
E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of
Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial
Intelligence. 1 (4). Accessed via
https://pubs.rsna.org/doi/10.1148/ryai.2019180096