iCAD Announces FDA Clearance of ProFound AI™ for Digital Breast Tomosynthesis
High-performance, cancer detection technology built on artificial
intelligence now available to healthcare facilities in the U.S.
New U.S. clearance based on clinical results demonstrating unprecedented
improvements in clinical performance and workflow efficiency
NASHUA,
N.H., (December 7, 2018) – iCAD, Inc. (NASDAQ:
ICAD), a global medical technology leader providing innovative cancer
detection and therapy solutions, today announced clearance by the United States
Food and Drug Administration (FDA) for their latest, deep-learning, cancer
detection software solution for digital breast tomosynthesis (DBT), ProFound
AI™, clearing the technology for commercial sales and clinical use in the
United States. The powerful solution built on artificial intelligence (AI) is
now available to healthcare facilities in the U.S., providing access to the
most cutting-edge breast cancer detection software in the marketplace today.
“Obtaining FDA clearance for ProFound AI opens
a new and substantial addressable market for iCAD. This enables us to offer
clinicians globally an unrivaled cancer detection and workflow solution built
on the latest advances in deep-learning,” said Stacey Stevens, Executive Vice
President and Chief Strategy and Commercial Officer at iCAD. “Clinical reader
study results and comprehensive stand-alone testing have shown unprecedented improvements
in both clinical performance and reading efficiency. We are proud to introduce
revolutionary technology that will fundamentally transform breast cancer
detection and patient care.”
The FDA clearance is based on positive
clinical results from a large reader study completed earlier this year and
presented at this year’s Radiological Society of North America (RSNA) annual
meeting at McCormick Place in Chicago. The research was performed with 24
radiologists who read 260 tomosynthesis cases both with and without iCAD’s ProFound
AI solution. The findings show impressive results including increased cancer
detection rates, reduced false positive rates and patient recalls, and a
significant decrease in interpretation times.
“This technology shows tremendous promise in assisting radiologists in
detecting cancers, reducing recalls and increasing efficiency when reading
tomosynthesis studies,” said Emily Conant, MD, Professor and Chief, Division of
Breast Imaging, Vice Chair of Faculty Development, Department of Radiology at
the Hospital of the University of Pennsylvania. “Clinical data shows that when
tomosynthesis readers use the ProFound AI algorithm, case-level
sensitivity is improved by 8 percent on average and reading times are
significantly decreased. Radiologists with various levels of expertise may
benefit from this AI-driven technology when reading large tomosynthesis data
sets.”
ProFound
AI is a high-performance, deep-learning, cancer detection and workflow solution
for DBT delivering critical benefits to radiologists, their facilities, and
their patients through improvement of cancer detection rates by an
average of 8 percent and decreasing unnecessary patient recall rates by an
average of 7 percent. The new technology is trained to detect malignant
soft-tissue densities and calcifications. It also provides radiologists with
scoring information representing the likelihood that a detection or case is
malignant based on the large dataset of clinical images used to train the
algorithm.
In addition to improving clinical performance related to breast
cancer detection and false positive rates, study results showed that ProFound
AI can reduce radiologists’ reading time by more than 50 percent on average. An
increase in reading time has been a significant challenge for radiologists when
moving from 2D to 3D mammography.
The solution is currently available for use with leading DBT
systems in the U.S., Canada and Europe. For more information, visit www.icadmed.com.
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.
“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, 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”, “would”, “could”,
“consider”, “project”, “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, including the 10-K for the year ended December 31, 2017,
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:
ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
Investor Relations:
LifeSci Advisors
Jeremy Feffer, (212) 915-2568