Retrospective analysis published
in Journal of Medical Screening suggests
that ProFound AI for 2D Mammography could have helped detect 48% of interval cancers
and 93% of subgroups that include false-negatives and minimal sign lesions


March 31, 2021 – iCAD, Inc. (NASDAQ: ICAD), a
global medical technology leader providing innovative cancer detection and
therapy solutions, today announced that
ProFound® AI for 2D Mammography might notably reduce the risk of interval breast cancer, according to a
retrospective analysis recently published in the 
Journal of Medical Screening.[1] 


The aim of the study was to determine if adding AI to reading
mammography as a supportive tool may help in decreasing the interval cancer
rate in population-based organized mammography screening programs in Germany.


“Interval breast cancers—cancers that are diagnosed after a negative
mammography screening, but before the next recommended screening exam, can be
linked to a poor prognosis such as cancer that has already spread, or a more
aggressive type of cancer, thus underscoring the need for iCAD’s deep-learning
algorithm that can analyze each mammography image and provide critical insight
into individual cases,”
said Michael Klein, Chairman and CEO of iCAD. “The data from
this retrospective analysis are very encouraging in Europe while also having an
impact on screening in the US. The results further stress the importance of our
ProFound AI platform as a world-class artificial intelligence (AI) solution
offering benefits to radiologists and women in improving breast cancer
detection rates, reducing false positives and unnecessary callbacks, and
providing more personalized screening for every woman.”  


In the retrospective analysis, which evaluated a screening period from 2011
and 2012, a total of 37,367 women between the ages of 50-69 were screened with
full-field digital mammography (FFDM). Of these, 29 cases of interval cancers with
full documentation were evaluated using ProFound AI for 2D Mammography. For
quality assurance, interval cancers with the prior screening mammogram were
classified in four categories by the radiologists: true interval cancers, minimal
sign cancers, missed cancers (false negative) based on the original screening
exam deemed as normal and dismissed, and occult cancers. The objective of the
study was to determine whether ProFound AI for 2D Mammography could identify
interval cancers that had either minimal signs in the original normal screening
or were missed in the original screening round where they had been dismissed as
a normal exam.


According to the lead author of the study, Axel Gräwingholt,
MD, Radiologie am Theater in Paderborn, Germany, “The results indicate that ProFound
AI for 2D Mammography found 93% of these cancers—eight out of nine cancers that
presented minimal signs and six out of six that were false negatives, or missed
in the screening round—demonstrating that some cancers could have been detected
earlier within the screening round where they were dismissed as normal and therefore
wouldn’ have been detected as interval cancers.”


“As a result, ProFound AI as a clinical tool for radiologists has the
potential to reduce interval cancer rates by detecting cancers that are already
present in the screening round but are perhaps undetected or missed by the
readers,” continued Dr. Gräwingholt. “
Using this technology at the screening level could
limit the number of false negatives and help to detect a large proportion of
the minimal sign cancers, which could ensure earlier treatment and better
chances of recovery for these women.”


“This study contributes to the growing body of evidence that
demonstrates the clear value ProFound AI for 2D Mammography can offer to
screening programs across Europe, benefiting both the patient and the clinician,”
said Michele Debain, Vice President of Europe,
Middle East and Africa at iCAD.“It is essential to detect
breast cancers as early as possible, as the cancer can grow, develop and spread. Earlier cancer
detection allows for earlier treatment, which in turn could lead to less stress
for the patient and lower costs for the national health systems. In addition,
the rate of interval cancers is typically used as a measure for the quality of
the national mammography screening program.” 


iCAD’s Breast
Health Solutions suite includes ProFound AI for Digital Breast Tomosynthesis (DBT)
and software solutions for 2D mammography, risk evaluation and breast density. In
2018, ProFound AI for DBT received its CE mark, Health Canada approval and was
the first 3D tomosynthesis software using AI to receive clearance from the U.S.
Food and Drug Administration (FDA). ProFound AI for 2D Mammography received a CE
mark in July 2019. In a reader study published in Radiology, ProFound AI for DBT was shown to offer
clinically proven time-savings benefits to radiologists, reducing reading time
by 52.7 percent, improving radiologist sensitivity by 8 percent, and reducing
false positives and unnecessary patient recall rates by 7.2 percent.[2]



Dr. Axel Gräwingholt’s Biography


Axel Gräwingholt is a radiologist specializing in breast imaging. He is a co-owner
of a private radiology institute in Germany with a screening unit for the
German official breast cancer screening program, and he is also involved in
several screening programs in Europe as a reader (Germany, Switzerland, Norway).
Dr. Gräwingholt also participated in the TOSYMA trial in Germany to assess the
value of tomosynthesis in organized screening programs. He is clinical co-chair
of the European guidelines for breast cancer (ECIBC), and he is a lecturer on
courses about mammography and tomosynthesis screening in different countries, including
Switzerland, Armenia, China and Greece.



About iCAD, Inc.


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


Forward-Looking Statements


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 benefits of the Company’s agreement
with Solis 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 and
on the SEC’s website at




Media inquiries USA:

Jessica Burns, iCAD  



Media inquiries Europe:

Emmanuelle Vella, iCAD  

+33 620 49 48 57


Investor Relations:

Jeremy Feffer,
LifeSci Advisors


[1] 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) 1-3.


[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).
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