iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader in
innovative cancer-detection solutions, will present new studies
validating its artificial intelligence (AI) powered ProFound Breast
Health Suite for uncovering hidden heart or vascular disease and
predicting a woman’s risk for developing breast cancer in the next
one- or two-years. Researchers will present their findings at the
Radiological Society of North America’s (RSNA) annual meeting in
Chicago, Nov. 27 – 30, 2023.
Blending artificial intelligence with computer-aided detection
(AI CAD), the iCAD software platform, ProFound Breast Health Suite,
can screen a single mammogram for two of the top causes of death
for women: breast cancer and heart disease. ProFound AI improves
accuracy, streamlines clinical workflow and delivers results to
patients more quickly.
“The ProFound Breast Health Suite significantly increases cancer
detection rates with up to 2x enhanced clinical performance
compared to other AI platforms, and reduces the rate of false
positive results while accurately evaluating a woman’s breast
density and cancer risk,” said Dana Brown, president and CEO of
iCAD, Inc. “Our growing body of important research illustrates the
potential our newest solution, ProFound Heart Health, holds for the
assessment of calcium deposits in the breast arteries as a proxy
for hidden cardiovascular disease, the leading cause of death for
women worldwide. We believe iCAD’s ProFound AI has the power to
positively transform healthcare for clinicians and patients
alike.”
Catching cardiovascular disease through
mammography
Recent research shows that calcium deposits inside the blood
vessels of the breast correlate to hardening of the cardiovascular
arteries. In fact, women with breast arterial calcifications, or
BAC, are 51% more likely to develop heart disease. iCAD's report on
the existence of arterial calcification, along with
easy-to-understand visual representations that demonstrate the
extent of calcification, can help women work with their physicians
to further evaluate their cardiovascular health and identify any
potential need for intervention.
Chirag Parghi, M.D., chief medical officer of Solis Mammography,
and a pioneer in the use of mammography to assess BAC, will present
his team’s findings from a 15-site prospective study that reviewed
2D screening mammograms from 15,785 asymptomatic women, ages 20 to
97. He and his colleagues found the ProFound Heart Health AI
algorithm highly accurate in uncovering BAC in mammograms. The
calcium deposits appeared more common and widespread with age, as
expected.
“Radiologists currently rely on visual detection of breast
arterial calcifications, which is time-consuming and leads to a
national underreporting of BAC results in mammography reports,”
explained Dr. Parghi. “Our study suggests that AI can standardize
BAC detection on a large scale, speeding up the measurement process
and reducing variations between reviewers. By standardizing BAC
reporting, AI increases the ease of identifying women that may
benefit from additional cardiovascular screening.” Dr. Parghi’s
oral presentation will occur on Tuesday, Nov. 28, 9:30 - 10:30 am
CST: “AI Assessment of Breast Arterial Calcifications on
Mammography in a Large Screening Population” (Session
T3-SSBR05).
Accurately predicting personal breast cancer
riskAxel Gräwingholt, M.D., head of mammography
screening at Radiologie am Theater in Germany, will present his
team’s findings from a retrospective study of ProFound Risk for 2D
Mammography. He and his colleagues assessed ProFound Risk’s
effectiveness in identifying women at high risk for developing
breast cancer in the next two years based on microscopic changes on
their exams.
The researchers used ProFound Risk to screen the mammograms of
53,453 women who had received normal results two years earlier from
their radiologists. The program flagged 42.8% of the women, or
22,878 patients, at a higher risk for breast cancer.
ProFound Risk’s prediction proved correct. The average risk for
women in the study who developed breast cancer two years after
their mammogram was 2.4 times higher than for those who remained
cancer-free. The average risk for invasive cancers exceeded that of
ductal carcinoma in situ (DCIS), a slow-growing cancer of the milk
ducts.
“Our findings suggest AI enables radiologists to identify women
who would benefit from more frequent screenings, or suggest
supplemental screenings, without leading to overdiagnosis,” said
Dr. Gräwingholt. “ProFound Risk accurately pinpoints women at high
risk for breast cancer while helping us discover small, subtle and
aggressive cancers that often go undetected by the naked eye. We
believe this technology could greatly enhance the effectiveness of
breast cancer screening strategies worldwide.”
Dr. Gräwingholt’s oral presentation will occur on Monday, Nov.
27, 8:00 – 9:00 am CST: “Real-World Use of AI Risk Scores to
Identify Women at High Risk for Breast Cancers with Sub-analyses
Based on Histopathology and Time of Detection” (Session
M1-SSBR03).
Other presentations of note:
- Emily Conant, M.D., professor of Radiology and Vice Chair of
Faculty Development in the Department of Radiology at the
University of Pennsylvania, Perelman School of Medicine, will
deliver an Industry Summit presentation, “From Pixels to Practice:
Harnessing Innovations in Breast AI to Improve Patient Outcomes.”
showcasing promising early testing results from iCAD’s newest 4th
generation AI for breast cancer detection Monday, Nov. 27, 3:30 –
3:45 pm CST (AI Showcase Theater)
- Thu Ha Dao, M.D., a radiologist at Hôpitaux Universitaires
Henri Mondor in France, will deliver a poster presentation on
Sunday, Nov. 26 from 12:15 – 12:45 pm CST: “Evaluation of a
Deep-learning based Software Tool to Automatically Detect and
Quantify Breast Arterial Calcifications in Digital Mammograms.”
(Session S3B-SPBR-1)
- Mikael Eriksson, Ph.D., a postdoctoral researcher of medical
epidemiology and biostatistics at the Karolinska Institute in
Sweden, will deliver a poster presentation on Monday, Nov. 27 from
12:45 – 1:15 pm CST: “Multi-national validation of a clinical
image-based AI-risk model for individualizing breast cancer
screening.” (Session M5B-SPBR-4)
- iCAD staff will showcase the ProFound Breast Health Suite in an
interactive exhibit for attendees demonstrating how to add and
scale AI in their radiology practices. (RSNA South Hall, Booth
3940). Solutions demonstrated include:
- ProFound Detection*: both the current cleared breast cancer
detection 3.0 version and future 4.0 version (4.0 not yet FDA
cleared) will be available to observe for their ability to detect
tumors; as well as the newest 2D version developed in collaboration
with Google Health (not yet FDA cleared or CE marked).
- ProFound Density: a solution for objective, standardized
assessments of breast density.
- ProFound Risk**: predicting a woman’s one- and two-year risk
for developing breast cancer.
- ProFound Heart Health***: a new solution for measuring
cardiovascular calcium deposits, alerting to possible vascular or
heart disease (pending FDA clearance).
iCAD will also host a series of “Meet the Experts” sessions
throughout the annual meeting featuring radiology, research, and
technology leaders in breast imaging AI who will be available to
share their experience with the ProFound Breast Health Suite. To
learn more about iCAD’s presence at RSNA or to RSVP for an event,
please visit https://web.icadmed.com/RSNA-2023.html
*ProFound Detection version 4.0 and ProFound Detection for 2D in
partnership with Google are not yet submitted for FDA clearance or
available for sale in the U.S. or CE Marked. **ProFound Risk is CE
Marked, Health Canada Licensed, and available for investigational
use only in the U.S.***ProFound Heart Heath is available for
investigational use only, pending regulatory approval in the U.S.
and Europe.
About iCAD, Inc.iCAD, Inc.
(NASDAQ: ICAD) is a global leader on a mission to create a
world where cancer can’t hide by providing clinically proven
AI-powered solutions that enable medical providers to accurately
and reliably detect cancer earlier and improve patient
outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading
ProFound Breast Health Suite provides
AI-powered mammography analysis
for breast cancer detection, density assessment and risk
evaluation. The ProFound Breast Health Suite is cleared by the U.S.
Food & Drug Administration (FDA) and has received CE mark and
Health Canada licensing. Used by thousands of providers serving
millions of patients, ProFound is available in over 50 countries.
In the last five years alone, iCAD estimates reading more than 40
million mammograms worldwide, with nearly 30% being
tomosynthesis. For more information, visit
www.icadmed.com.
Forward Looking
StatementsCertain 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.
CONTACTS
Media inquiries: pr@icadmed.comInvestor Inquiries:
ir@icadmed.com
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