iCAD Receives FDA Approval For Powerlook Tomo Detection

First to market with innovative digital breast 3D tomosynthesis cancer detection and workflow solution, built on deep learning technology that improves efficiency and reduces reading time for radiologists

NASHUA, N.H.  – March 27, 2017 – iCAD (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that PowerLook® Tomo Detection received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). PowerLook Tomo Detection is a first-of-its-kind, concurrent-read computer aided detection solution for digital breast 3D tomosynthesis and is the latest innovation available on the PowerLook® Breast Health Solutions platform.

“As the use of 3D mammography continues to grow in the U.S. and abroad, iCAD remains committed to delivering innovative solutions that help radiologists be more efficient and confident when reading tomosynthesis exams,” said Ken Ferry, CEO of iCAD. “FDA approval of PowerLook Tomo Detection is a significant milestone for the Company and we are positioned to rapidly advance our commercial plan for this innovative technology in the U.S. with the potential to greatly improve clinical workflow and patient care in the years ahead.”

2D digital mammography typically produces four images per exam while digital breast 3D tomosynthesis can produce hundreds of images, significantly increasing exam interpretation time for radiologists. PowerLook Tomo Detection improves radiologists’ efficiency by automatically analyzing each tomosynthesis plane and identifying suspicious areas. The suspicious areas are naturally blended onto a 2D synthetic image to provide radiologists with a single enhanced image that is used to more efficiently navigate the large tomosynthesis data set.

“iCAD has taken a refreshing new approach to computer aided detection. This innovative workflow solution detects suspicious areas on the tomosynthesis planes and that information is used to deliver an enhanced image that focuses the radiologist on the specific areas that need further investigation,” said Justin Boatsman, MD, Medical Director and diagnostic radiologist, Intrinsic Imaging, LLC, who took part in the U.S. clinical study.  “This not only helps reduce the reading time and improve the reading experience for radiologists, but it can also provide radiologists with an added level of confidence.”

In a U.S., clinical study conducted from October 2015 to January 2016, radiologists were able to significantly reduce reading time when reading 3D tomosynthesis exams with PowerLook Tomo Detection. The study included 20 radiologists reading 240 tomosynthesis cases both with and without the PowerLook Tomo Detection technology. Reading time was reduced by up to 37 percent with an average reduction of 29 percent when using PowerLook Tomo Detection, with no statistically significant impact on sensitivity, specificity or recall rate. Another European clinical study was completed with six radiologists reading 80 cases and showed similar results and was the basis for CE Mark of PowerLook Tomo Detection in April 2016.

“This innovative software in PowerLook Tomo Detection is built on the latest deep learning technology to significantly improve detection rates,” said Jeff Hoffmeister, MD, Vice President and Medical Director at iCAD. “The use of deep learning has enabled us to achieve a high detection rate of 92.3 percent.” Deep learning is a branch of machine learning that uses sophisticated algorithms that are trained to recognize the visual characteristics of a cancer by analyzing actual patient images. The current version of the algorithm was trained using thousands of images.

PowerLook Tomo Detection, currently available on GE Healthcare digital breast tomosynthesis systems, also received CE Mark and Health Canada approval in 2016, and is currently being used by multiple high volume breast imaging centers in Europe.

About iCAD, Inc.

iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com.

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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.

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iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast and colorectal cancers.

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