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iCAD, Inc. (ICAD) Receives FDA Clearance for Its Digital Mammography System


6/21/2013 7:03:22 AM

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iCAD Receives FDA Approval for FujiFilm Aspire HD Digital Mammography System

NASHUA, N.H.--(BUSINESS WIRE)-- iCAD, Inc. (ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced approval by the U.S. Food and Drug Administration (FDA) for use of the Company’s SecondLook® mammography computer-aided detection (CAD), on the next generation PowerLook Advanced Mammography Platform (AMP)™, for FujiFilm’s Aspire™ HD Full-Field Digital Mammography System.

“We are quite pleased to be able to expand our long standing partnership with market leader FujiFilm to offer customers our next generation mammography computer-aided detection platform, PowerLook Advanced Mammography Platform with FujiFilm’s family of Aspire HD Full-Field Digital Mammography Systems,” said Ken Ferry, CEO of iCAD. “This FDA approval further validates SecondLook Digital CAD with PowerLook AMP as a leading tool in cancer detection allowing us to deliver the most advanced and comprehensive imaging solutions to the radiology community.”

PowerLook AMP provides radiologists with the ability to customize their CAD solution to meet the needs of their individual work environment. The technology expands on iCAD’s SecondLook Digital algorithm and is the CAD platform upon which all future breast imaging CAD offerings from iCAD will be built. SecondLook’s CAD metrics offer industry-leading tissue and lesion characteristics to support the breast imager’s workflow. In addition, PowerLook AMP is the first product of its kind to integrate Matakina’s Volpara® Volumetric Breast Density assessment.

iCAD’s PowerLook AMP also provides the most powerful flexible DICOM connectivity solution, enabling universal compatibility with leading PACS and Review Workstations. Additional modules are expected to be released and integrated into PowerLook AMP in the future.

About iCAD, Inc.

iCAD is an industry-leading provider of Computer-Aided Detection (CAD) technologies, advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of common cancers. iCAD offers a comprehensive range of high-performance, upgradeable CAD solutions for mammography and advanced image analysis and workflow solutions for Magnetic Resonance Imaging, for breast and prostate cancers and Computed Tomography for colorectal cancer. iCAD’s Xoft System, offers radiation treatment for early-stage breast cancer that can be administered in the form of intraoperative radiation therapy or accelerated partial breast irradiation. The Xoft System is also cleared for the treatment of non-melanoma skin cancer and endometrial cancer. For more information, call (877) iCADnow, or 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, the risks relating to the Company’s acquisition of Xoft including, the expected benefits of the acquisition may not be achieved in a timely manner, or at all; the Xoft business operations may not be successfully integrated with iCAD’s and iCAD may be unable to achieve the expected synergies, business and strategic objectives following the transaction, the risks of uncertainty of patent protection; the impact of supply and manufacturing constraints or difficulties; product market acceptance; possible technological obsolescence; increased competition; customer concentration; 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”, 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:

For iCAD

Kevin Burns, 937-431-7967

kburns@icadmed.com

or

For iCAD investor relations

LHA

Anne Marie Fields, 212-838-3777 x6604

afields@lhai.com

or

For iCAD media inquiries

Schwartz MSL

Helen Shik, 781-684-0770

iCAD@schwartzmsl.com

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