New Real-World Evidence Shows ProFound AI Improves Cancer Detection and Accuracy with Digital Breast Tomosynthesis, or 3D Mammography
Research presented at the 2022
SBI/ACR Breast Imaging Symposium confirms ProFound AI significantly enhances
radiologists’ screening performance
NASHUA,
N.H., May 18, 2022 — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing
innovative cancer detection and therapy solutions, today announced that new
research supporting ProFound AI® for Digital Breast Tomosynthesis (DBT) will be presented at the Society
of Breast Imaging (SBI/ACR) Breast Imaging Symposium, taking place May 16-19 in
Savannah, GA. The Company is also showcasing its complete suite of deep-learning
breast cancer detection, density assessment and risk evaluation solutions in the
iCAD booth (#504) during the meeting.
In an oral presentation today at 1:30 pm EDT,
Colleen Madden, MD, FACR, Assistant Clinical Professor of Radiology at IUH Ball
Memorial Hospital at Indiana University School of Medicine, will present
promising findings from a retrospective study titled, “Real-WorldBreast Cancer Detection Before and After the Implementation of an ArtificialIntelligence Detection System in a Digital Breast Tomosynthesis ScreeningProgram.” According to study findings, using
ProFound AI in clinical practice with DBT, or 3D mammography, significantly
enhanced radiologists’ screening performance, improved cancer detection rates
and reduced the rate of false positives.
“This
recent investigator initiated study confirms ProFound AI offers invaluable
insight that helps radiologists to identify cancers more efficiently and
accurately, which could dramatically improve outcomes for patients,” said
Stacey Stevens, President and CEO of iCAD, Inc. “iCAD is the only company to
provide a complete portfolio of unrivaled1 AI solutions designed to
help radiologists find cancers earlier, while reducing false positives and
unnecessary patient recalls,[1],[2] which can cause unnecessary stress
for a woman and her family.”
The first AI cancer detection software for DBT to be cleared
by the FDA, ProFound AI is clinically proven to offer superior performance,
reduce radiologists’ reading time by 52.7 percent, improve radiologists’
sensitivity by eight percent and reduce unnecessary patient recall rates by 7.2
percent.[2] The latest generation of
ProFound AI offers up to a 10% improvement in specificity performance, compared
to previous versions of the technology, while maintaining an industry-leading
high sensitivity level, and approximately 40% faster processing on the new
PowerLook platform.[3]
“Overall, this real-world study suggests
ProFound AI can help radiologists find more cancers, and with greater accuracy,
indicating that this innovative tool can not only enhance clinical performance but
also potentially improve outcomes for patients,” said Dr. Madden. “While AI
does not eliminate the need for radiologists, it does extend their capabilities
considerably, as it greatly assists clinicians in reviewing large DBT datasets
and ultimately providing quality care for our patients. We are pleased that
this study contributes to the growing body of research that demonstrates the
value AI offers in breast cancer screening.”
“We are committed to helping radiologists transform breast
cancer screening and detection by decreasing reading time and improving their
reading accuracy, with up to two times the improvement in clinical performance
compared to leading competitors,”[1] added
Stevens. “These latest data indicate ProFound AI significantly improves
radiologists’ performance and helps to reduce their workload, allowing for more
time with patients and for additional, potentially complex cases.”
iCAD’s Breast AI Suite also includes PowerLook® Breast
Density Assessment, which aids in accurate and consistent density-based
stratification and reporting, and ProFound AI® Risk, the world’s first and only
clinical decision support tool that provides an accurate short-term, breast
cancer risk estimation that is truly personalized for each woman, based on age,
breast density, and mammographic features.
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 and www.xoftinc.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 expected benefits of ProFound AI®, the
benefits of the Company’s products, external factors affecting the market for
our products, behavior of clients and prospective clients, 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.
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Inquiries:
iCAD Investor Relations
References :
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
Accessed 1-19-22. FDA 510K submissions K182373, K201019, K193229. - 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. - iCAD
data on file. Standalone performance varies by vendor. FDA Cleared.