iCAD’s Breast AI Suite Empowers Customers to Lead the Way in Support of FDA’s National Breast Density Reporting Standard
iCAD showcases Breast AI Suite at National Consortium
of Breast Centers (NCoBC) 32nd Annual Conference
NASHUA, N.H., March 23, 2023 – iCAD, Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions, today
announced its technologies are empowering customers to lead the way in breast
care, while supporting the national breast density reporting standard recently established
by the U.S. Food and Drug Administration (FDA). The Company will be showcasing
its Breast AI Suite at the National Consortium of Breast Centers (NCoBC) Annual
Conference in Las Vegas, NV from March 25-27 in the iCAD booth (#106).
“We applaud the FDA for its recent decision to implement
a national breast density reporting standard. This is a significant advancement,
as nearly 50% of all women aged 40 and over have dense breasts, one of the
strongest and most prevalent breast cancer risk factors,”[i],[ii]
said Dana Brown, President and CEO of iCAD, Inc. “However, dense breast
notifications are only as effective as the assessments themselves, as studies
show wide variation in visual assessment agreement, and radiologists may even
disagree with their own assessment year to year.[iii] This can be confusing for patients,
lead to unnecessary additional imaging, and increase patient and facility
costs.”
“With thousands of installations in more than 20
countries, iCAD’s breast health solutions are trusted by the country’s largest
and most prestigious imaging centers and hospitals. Our technologies not only meet
the needs recently outlined by the FDA, but they have long been used worldwide
to enhance patient care and personalize results. With our Breast AI Suite, our
customers are well-equipped to provide accurate breast density assessments, and
we expect more facilities to demand this technology as they work to bring care
standards in line with new federal regulations,” Ms. Brown added.
The Company’s Breast AI Suite offers a 360-degree
solution of clinically proven cancer detection, density assessment, and risk
evaluation technologies, including PowerLook® Density Assessment, the world’s first multi-vendor deep-learning algorithm
for standardizing breast density assessments using synthesized 2D images.
PowerLook Density Assessment removes the challenges of subjectivity in breast
density reporting, offering accurate and reproducible breast density
assessments. This innovative solution analyzes the woman’s breast anatomy and
categorizes her breast density within the appropriate BI-RADS® 5th edition
density category, automating the process of breast density reporting and
empowering clinicians to further personalize breast cancer screening
recommendations for patients. In a large study, PowerLook Density Assessment
correctly classified density and demonstrated substantial agreement with
radiologists for 99.8% of cases.[iv]
“Last year we adopted iCAD’s Breast AI Suite, which
includes PowerLook Density Assessment, across the majority of our enterprise as
we see tremendous value in offering the highest level of sophistication to our
mammography interpretation,” said Chirag Parghi, M.D., Chief Medical Officer,
Solis Mammography, the largest independent provider of breast screening and
diagnostic services in the United States. “At the heart of the FDA guidelines
is a campaign to inform our patients about their anatomic composition of their
breasts and we are partnering with iCAD to offer a complete understanding of
this composition. Women need to be
informed of their breast density as it is directly associated with their
individual risk of breast cancer.”
Dense breasts can make it challenging to detect breast
cancer during annual screenings as overlapping tissue can camouflage breast
cancer, even with digital breast tomosynthesis (DBT) exams. Women with dense
breasts have a 20% higher risk of developing breast cancer compared to women
with non-dense breasts.[v]
“As an early adopter of iCAD’s
technology, I have been using PowerLook Density Assessment for nearly five
years now and I cannot imagine reading mammography without it,” said Randy
Hicks, M.D., MBA, owner and CEO of Regional Medical Imaging (RMI). “PowerLook
Density assessment not only offers incredibly accurate and reliable results,
but it has streamlined our process for reporting breast density results, both
to techs and to patients. With this technology, we are more than prepared to offer
patients critical information about their breast health that easily meets or
exceeds what is now required by the FDA. We are proud to offer iCAD’s
technology on every mammogram across all nine RMI locations, and we have found
that it considerably improves operational efficiency, clinician confidence, and
patient care.”
“For more than 10 years, Radiology Partners has been
committed to providing the highest quality breast screening across our
enterprise of more than 3,000 facilities. The recent FDA decision to implement
a national reporting standard further validates what we have known for some
time: understanding a patient’s breast density is a key component to preserving
her breast health. We believe AI is essential to our ability to deliver the
most informed results to our patients, which is why we decided to adopt iCAD’s comprehensive
solution. We look forward to offering these leading technologies to further
strengthen clinical performance and patient care nationwide,” said Nina
Kottler, M.D., Associate CMO for Clinical Artificial Intelligence at Radiology
Partners, the largest radiology practice in the U.S.
In addition to establishing partnerships with the
nation’s leading imaging facilities, iCAD has also joined forces with several patient
advocacy organizations focused on raising awareness of the importance of
knowing one’s breast density.
“For 13 years, my mammograms came back ‘normal,’ but I
had a walnut-sized tumor growing in my breast that was not visible on
mammograms due to my breast density,” said Cynthia Jordan, founder and CEO, Learn Look Locate. “As a breast cancer
survivor and patient advocate, I have worked tirelessly to raise awareness of
this important issue, and this long-awaited FDA decision comes as a relief. Women
across the country will now be equally offered information that could save
their lives. With technology like iCAD’s, we can ensure more women avoid
situations like mine and are empowered to take control of their breast health.”
“With the FDA’s implementation of a national breast
density reporting standard, now more than ever, hospitals and imaging centers nationwide
need technology that can not only automate results, but also improve accuracy,”
said Ms. Brown. “When it comes to breast health, knowledge is power and our world-leading
AI solutions put that power back in the hands of providers, ensuring patients
receive the right screening at the right time to detect disease as early as
possible. This is critical, because when breast cancer is detected early,
clinicians have more options to fight it, treatment can be shorter and less
invasive, the impact can be minimized, and ultimately, lives can be saved. We
look forward to sharing our world-class portfolio with the NCoBC community again
this year.”
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
[i] National
Cancer Institute. Dense Breasts: Answers to Commonly Asked Questions. Accessed
via https://www.cancer.gov/types/breast/breast-changes/dense-breasts.
[ii] Engmann
NJ, Golmakani MK, Miglioretti DL, Sprague BL, Kerlikowske K, Breast Cancer
Surveillance C. Population-Attributable Risk Proportion of Clinical Risk
Factors for Breast Cancer. JAMA Oncology 2017; 3:1228-1236.
[iii]
Sprague B, Conant E, Onega T et al. Variation in Mammographic Breast Density
Assessments Among Radiologists in Clinical Practice: A Multicenter
Observational Study. Ann Intern Med. 2016; 165(7):457-464.
doi:10.7326/M15-2934.
[iv] iCAD
data on file.
[v] Beidler LB, Kressin NR, Wormwood JB,
Battaglia TA, Slanetz PJ, Gunn CM. Perceptions of Breast Cancer Risks Among
Women Receiving Mammograph Screening. JAMA Netw Open. 2023;6(1):e2252209.
doi:10.1001/jamanetworkopen.2022.52209