iCAD’s ProFound AI™ for 2D Mammography Receives CE Mark Approval
Deep-learning,
artificial intelligence technology assists radiologists in detecting
breast cancer
Nashua, N.H. – July 11, 2019 – iCAD,
Inc. (NASDAQ: ICAD), a global medical technology leader providing
innovative cancer detection and therapy solutions, today announced its advanced
artificial intelligence technology and workflow solution, ProFound AI™ for 2D
Mammography, received CE Mark approval. The technology is the latest addition
to iCAD’s deep-learning ProFound AI™ platform, joining ProFound AI™ for Digital
Breast Tomosynthesis (DBT), which was CE Marked in March 2018, FDA-cleared in
December 2018, and Health Canada licensed in July 2018. The technology was
developed to support the detection of breast cancer through the identification
of soft tissue densities and calcifications.
“Europe contains 9% of the world’s population but has more than 23%
of the global cancer burden, with breast cancer being the most common cancer
among European women,”1,2 stated Stacey Stevens, President of iCAD.
“This CE Mark further validates our ProFound AI platform as a world-class artificial
intelligence solution that offers benefits to both radiologists and screening-aged
women in detecting breast cancer. iCAD is committed to improving patient care
worldwide and we are pleased to offer this powerful technology to a growing
number of hospitals, imaging centers and women across Europe.”
ProFound
AI for 2D Mammography is a high-functioning, deep-learning algorithm that analyzes each mammography image and provides critical
insight into each individual case, such as highlighting the most suspicious
areas and assigning unique Certainty of Finding and Case Scores, which can assist
radiologists in making clinical decisions and prioritizing caseloads. The
ProFound AI platform is built upon the latest in deep-learning artificial
intelligence and allows for continuously improved performance via ongoing
software updates.
“ProFound AI for 2D Mammography has the potential to assist
radiologists in their interpretation of 2D mammography images, as we have seen
with ProFound AI for DBT,” according to Axel
Gräwingholt, MD, Radiologie am
Theater, in Paderborn, Germany. “As breast cancer rates continue to rise, it
is imperative for radiologists to find cancers sooner, when they may be more
easily treated, with fewer callbacks and false positives, which can be
inconvenient and stressful for patients.”
For more information, visit www.icadmed.com.
References:
1.GLOBOCAN 2018: Estimated Cancer Incidence,
Mortality and Prevalence Worldwide in 2018. https://www.uicc.org/news/new-global-cancer-data-globocan-2018.
Accessed July 2019.
2.United Nations, Population division. World
Population Prospects, the 2019 revision.
https://www.un.org/development/desa/publications/world-population-prospects-2019-highlights.html.
Accessed July 2019.
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, 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.
###
Contacts:
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Relations:
Jeremy Feffer, LifeSci Advisors
+ 1-212-915-2568