iCAD’s ProFound AI Reader Study Published in Radiology: Artificial Intelligence
First
and Only FDA-Cleared Digital Breast Tomosynthesis Software with Artificial
Intelligence Clinically Proven to Enhance Breast Cancer Screening, Reduce False
Positives and Slash Reading Time for Radiologists in Half
Nashua, N.H. – September 10, 2019 – iCAD, Inc. (NASDAQ:
ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced the results of its reader
study for ProFound AI™ for Digital Breast Tomosynthesis (DBT) were published in
the peer-reviewed journal, Radiology:
Artificial Intelligence. ProFound AI for DBT is the first and only FDA-cleared 3D tomosynthesis workflow solution using
artificial intelligence (AI) to aid in breast cancer detection. The study
showed the concurrent use of ProFound AI increased sensitivity by 8 percent,
reduced false positives and unnecessary recalls by 7 percent, and slashed
reading time for radiologists by 52.7 percent.1
“The publication of our reader study results in such
a renowned peer-reviewed journal is a significant milestone that further validates
ProFound AI as a world-class, deep-learning workflow solution that offers real-world
benefits to radiologists and patients alike,” said Michael Klein, Chairman and
CEO of iCAD. “This endorsement of our research substantiates ProFound AI as the
leading artificial intelligence breast cancer detection technology that empowers
clinicians to read DBT images in less time and find cancers earlier, when they
may be more easily treated.”
ProFound AI is a high-performing workflow
solution that assists radiologists by detecting malignant soft-tissue densities
and calcifications. The software rapidly and accurately analyzes each image, or
slice, and provides radiologists with crucial
information, such as Certainty of Finding lesion and Case Scores, which
can assist in clinical decision-making and prioritizing caseloads. Featuring the latest in deep-learning intelligence, the technology
allows for continuously improved performance via ongoing software updates.
“While screening with DBT has been shown to
increase cancer detection while also decreasing false positive recalls, the
exponentially larger number of images in a DBT study compared to 2D screening
studies almost doubles the reading time for radiologists,” said principal
investigator and lead author Emily F. Conant, M.D., professor and chief of
breast imaging from the Department of Radiology at the Perelman School of
Medicine at the University of Pennsylvania in Philadelphia. “This reader study
shows that the concurrent use of AI when reading DBT screening studies
optimizes efficiency while also improving accuracy.”
The reader study examined the performance of 24 radiologists, including 13
breast subspecialists, reading an enriched set of 260 DBT cases, both with and
without ProFound AI. The study found ProFound AI increased radiologist
performance, measured by mean area under the receiver operating
characteristic curve (AUC), from 0.795 to 0.852. ProFound AI also increased sensitivity
from 77.0 percent to 85.0 percent, increased specificity from 62.7 percent to
69.6 percent, and decreased the recall rate for noncancers from 38.0 percent to
30.9 percent. Reading time for radiologists decreased from 64.1 seconds to 30.4
seconds with ProFound AI.
ProFound AI for DBT was FDA cleared, CE marked, and Health Canada
licensed in 2018. For more information, visit https://www.icadmed.com/profoundai.html.
Reference:
1.)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
About
this study
Case
data were retrospectively collected in compliance with the Health Insurance
Portability and Accountability Act, with institutional review board approval
and waiver of informed consent. The study was financially supported by iCAD and
performed by Intrinsic Imaging.
About iCAD, Inc.
Headquartered in Nashua, N.H., iCAD is a global medical technology
leader providing innovative cancer detection and therapy solutions. For more
information, visit www.icadmed.com.
“Safe Harbor” Statement under the Private Securities
Litigation Reform Act of 1995
Certain statements contained in this News Release constitute
“forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. 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 defend itself in litigation matters, to
achieve business and strategic objectives, the risks of uncertainty of patent
protection, the impact of supply and manufacturing constraints or difficulties,
uncertainty of future sales levels, protection of patents and other proprietary
rights, the impact of supply and manufacturing constraints or difficulties,
product market acceptance, possible technological obsolescence of products, increased
competition, litigation and/or 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
(201) 423-4492
Jeremy
Feffer, LifeSci Advisors, Inc.
(212)
915-2568