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iCAD Secures Chinese Regulatory Approval for Digital Mammography CAD Technology

^{Published on 2011-05-12 09:45:34 - Market Wire}
 

NASHUA, N.H.--([ BUSINESS WIRE ])--iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, announces that it has secured regulatory approval for its [ SecondLook^® Digital ] by the State Food and Drug Administration (SFDA) in the Peoplea™s Republic of China. The approval allows iCADa™s SecondLook Digital computer-aided detection (CAD) technology to be sold with [ GE Digital Mammography Systems ] in order to assist radiologists in distinguishing potential cancers from other anomalies on a mammogram.

"Detection of Breast Cancer with Full-Field Digital Mammography and Computer-Aided Detection"

aAcross the globe, film-based mammography systems are being upgraded to the new standard-of-care, full-field digital mammography. Computer-aided detection is an important tool used in conjunction with digital mammography that highlights areas warranting closer evaluation,a said Ken Ferry, President and CEO of iCAD. aWe are honored to now have regulatory approval to provide women in China with access to iCADa™s SecondLook technology and we look forward to working with GE Healthcare as our partner in the country.a

iCADa™s SecondLook Digital utilizes advanced pattern recognition technology and is extremely proficient in helping the radiologist detect subtle cancers, or those that are most likely to be missed. Using a sophisticated algorithm, the CAD software identifies and marks suspicious areas on a mammogram for the radiologist to review. As part of its regulatory approval in China, the product went through testing by the SFDA.

aWe congratulate iCAD on securing regulatory approval for its SecondLook Digital CAD solution in the Peoplea™s Republic of China. GE Healthcare continues to make significant progress in providing solutions for breast cancer detection and diagnosis globally, and we are excited to now offer women in China the benefit of SecondLook Digital CAD as part of our mammography solution. These tools can potentially help healthcare professionals diagnose breast cancer at an earlier stage a" which ultimately benefits the patient,a said David Caumartin, GE Healthcarea™s General Manager Mammography.

CAD technology has been included in several peer-reviewed studies, including an article titled aDetection of Breast Cancer with Full-Field Digital Mammography and Computer-Aided Detection,a in the American Journal of Roentgenology (Volume 192, Issue 2). The study found the following:

• CAD with full-field digital mammography showed a high sensitivity in identifying cancers.
• The SecondLook CAD correctly marked 94% of biopsy-proven cancers.
• The sensitivity of iCADa™s SecondLook CAD was not dependent on the size of the tumor; it was equally accurate with small and large lesions.

SecondLook CAD for digital mammography was designed and developed using thousands of cancer and normal studies, providing a powerful digital CAD performance. More information can be found at [ www.icadmed.com ].

About GE Healthcare:

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our ahealthymaginationa vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries.

For more information about GE Healthcare, visit our website at [ www.gehealthcare.com ]. For our latest news, please visit [ http://newsroom.gehealthcare.com ].

About iCAD, Inc.

iCAD, Inc. is an industry-leading provider of advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier. iCAD offers a comprehensive range of high-performance, upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography, Magnetic Resonance Imaging (MRI) and Computed Tomography (CT). iCAD recently acquired Xoft, Inc., developer of the Axxent^® eBxa" electronic brachytherapy system (eBx). Axxent uses non-radioactive miniaturized X-ray tube technology and is FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer. The Axxent System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated including Intraoperative Radiation Therapy (IORT). 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 aforward-looking statementsa 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 Companya™s ability to defend itself in litigation matters, the Companya™s ability to identify a replacement for the Axxent FlexiShield Mini, the risks relating to the Companya™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 iCADa™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 Companya™s filings with the Securities and Exchange Commission. The words abelievea, ademonstratea, aintenda, aexpecta, aestimatea, aanticipatea, alikelya, 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 SECa™s website at [ http://www.sec.gov ].