iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader
providing innovative cancer detection and therapy solutions, today
announced its ProFound AI® Breast Suite is a winner of the U.S.
General Services Administration’s (GSA) “AI Healthcare Challenge”
award. iCAD presented its portfolio of breast cancer detection,
density assessment and risk evaluation solutions at the
competition, focused on improving health outcomes in a range of
areas, including using AI to detect cancers earlier and improve
outcomes.
“It is an honor for iCAD’s technology to be recognized as a
winner of this challenge, as it is further testament to the unique
value our ProFound AI Breast Suite offers to both clinicians and
patients. Our detection solution is already trusted by our
government and military, as last year the U.S. Department of
Defense (DoD) determined it met the DoD’s stringent cybersecurity
prevention thresholds and granted the technology an Authorization
to Operate (ATO), allowing its use in DoD healthcare facilities,
which care for military servicemembers, retirees and family
members,” said Dana Brown, President and CEO of iCAD, Inc. “With
unrivaled accuracy, performance and speed, ProFound AI is
revolutionizing breast cancer screening and detection, leading to a
better experience for both patients and their radiologists. Our
density and risk evaluation solutions further personalize screening
by providing clinicians and their patients with a more holistic
view of their breast health and individual risk of developing
breast cancer. With breast cancer affecting one in eight women
during their lifetime,1 it is essential for women to have access to
this technology, as it is clinically proven to improve cancer
detection and reduce false positives and unnecessary callbacks,
which can be stressful for women.”
Built with the latest in deep-learning AI, ProFound AI rapidly
analyzes each 3D mammography image, detecting both malignant soft
tissue densities and calcifications with unrivaled accuracy. With
up to 2x the clinical performance improvement for radiologists
compared to leading competitors, ProFound AI was clinically proven
in a large reader study to increase radiologist sensitivity by an
average of 8%, increase specificity by 7%, reduce recall rate in
non-cancers by 7.2%, and slash reading time by 52.7%.2,3
In a clinical study, ProFound AI Risk for 3D Mammography was up
to 2.4 times more accurate for short-term risk assessments than
traditionally used risk models, such as Gail and Tyrer-Cuzick.4
ProFound AI Risk for 2D Mammography is more accurate than
Tyrer-Cuzick v8 for both short-term and long-term risk
assessments.5 In a clinical study, ProFound AI Risk for 2D
Mammography accurately identified 20% of breast cancers as
high-risk, compared to 7.1% for Tyrer-Cuzick.5 iCAD’s Density
Assessment solution aids in accurate and consistent density-based
stratification and reporting and offers the highest matching
accuracy for dense and non-dense assessment on the market.6
The GSA launched the Applied AI Healthcare Challenge earlier
this year as a prize competition seeking diverse and practical
solutions to help federal agencies provide the highest level of
medical care. The challenge awarded four grand prizes of $25,000
each for winning prototypes, for a combined sum of $100,000. iCAD
was also featured as part of the Cancer Focus Area at the Applied
AI Healthcare Challenge Industry Day on May 2, where 10 industry
vendors were selected out of 53 entrants to discuss their
technologies at the event.
“For more than two decades, our innovative artificial
intelligence solutions have empowered providers and professionals
to accurately, reliably, and quickly detect cancer and improve
outcomes – optimizing every patient’s opportunity to live longer,
better lives. Some of the most prestigious academic hospitals and
imaging centers around the world trust our technology to detect
cancer sooner, and with greater accuracy,” said Ms. Brown. “We
remain steadfast in our mission to create a world where cancer
can’t hide by offering the most pervasive and personalized breast
AI technologies, and we look forward to continuing to expand access
to this technology and enhancing care for more women
worldwide.”
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
+1-201-423-4492jburns@icadmed.com
Investor Inquiries:iCAD Investor Relationsir@icadmed.com
1 American Cancer Society. Key Statistics for Breast Cancer.
Accessed via
https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html2
FDA 510K submissions K182373, K201019, K193229
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
Accessed 1-19-22.3 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.20191800964 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 DOI:
10.1126/scitranslmed.abn3971.5 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: 10.1200/JCO.22.01564.6 iCAD data on file.
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