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iCAD Receives FDA Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis

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Breast Density Assessment Software Built on Artificial Intelligence

NASHUA, N.H., Aug. 08, 2018 (GLOBE NEWSWIRE) --  iCAD (NASDAQ:ICAD), a global leader in medical technology providing innovative cancer detection and therapy solutions, announced today FDA clearance of its latest Artificial Intelligence software solution; PowerLook Density Assessment Version 3.4. The software is compatible with iCAD's digital breast tomosynthesis (DBT) platform on both GE and Hologic systems, enhancing the Company's comprehensive suite of breast health solutions available in a single platform.

"At iCAD, we continually strive to provide radiologists with the most advanced, accurate and efficient software solutions designed for the early detection of breast cancer," said Ken Ferry, CEO of iCAD.  "Breast density plays a critical role in both risk assessment and accuracy, as mammography sensitivity is reduced to approximately 48 percent from an average of 98 percent in those women with dense breasts.  Our cutting-edge technology rapidly produces consistent breast density results while reducing the risk of reader variability, enabling radiologists to more easily identify women who might benefit from additional screening."

According to a recent study published in the Annals of Internal Medicine, between 40-50 percent of women in the United States are considered to have dense breasts, which can increase tumor aggressiveness, as well as mask the presence of tumors in a mammogram.

iCAD's PowerLook Density Assessment 3.4 delivers automated, rapid and reproducible assessments of breast density to help identify patients that may experience reduced sensitivity to digital mammography due to dense breast tissue. This innovative technique, based on machine learning, calibrates the patient's breast density to the appropriate category corresponding to the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) reporting system. 

"Since implementing PowerLook Density Assessment, our radiologists have been able to provide more consistent breast density results for our patients during screenings.  We must consider many aspects of each patient's case at once, but PowerLook Density Assessment allows us to focus on our primary goal of finding breast cancer.  Density matters and we believe the greater accuracy of assessment with iCAD's PowerLook Density Assessment will result in greater patient satisfaction and improve patient care," stated Dr. Beth Ingram, MD, Radiology, Interventional at Reid Health, Indiana.

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, 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:
ARPR
Erin Bocherer, (855) 300-8209
erin@arpr.com

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Investor Relations:
LifeSci Advisors
Jeremy Feffer, (212) 915-2568
jeremy@lifesciadvisors.com

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