FDA Approves High Sensitivity Breast Cancer Detection Software for Lower-cost iCAD Second Look 200 Product
iCAD, Inc., which designs, develops and markets Computer Aided Detection (CAD) imaging technology and systems for the early detection of breast cancer and other medical applications announced approval from the United States Food and Drug Administration (FDA) for release of iCAD’s new Second Look(R) 200 system for early detection of breast cancer with substantially improved cancer detection software. The new combination of Second Look 200 with iCAD’s Version 6.0 cancer detection software represents both the most sensitive cancer detection solution available, and the least expensive.
The Second Look 200 is specifically designed to make CAD accessible to smaller Breast Care Centers. It can easily analyze up to 15 cases per day, is fully automated, fits on a counter top and is priced below $70,000. Version 6.0 detection software offers up to 94% sensitivity to all breast cancers. Orders for the Second Look 200 are now being accepted by iCAD resellers. iCAD has indicated the Second Look 200 system will also be made available on a fee-per-procedure basis the company calls “ClickCAD(TM)”.
“The vast majority of CAD systems in use today have been installed in hospitals, women’s health centers and mammography clinics that perform twenty or more procedures per day,” noted W. Scott Parr, Chief Executive Officer of iCAD, Inc. “We believe our Second Look 200 solution is a category-defining CAD system, in the sense that it is the first product on the market that will allow lower-volume clinics to provide CAD services to women on a cost-effective basis. The Second Look 200 is simple to operate and self-training in nature, has been designed to fit within the limited space requirements of smaller mammography clinics, and will be priced well below currently available CAD systems.
“We believe the Second Look 200 system will appeal to the thousands of low volume mammography clinics that cannot afford CAD systems currently on the market,” continued Parr. “With the Second Look 200 system, we envision a significant expansion in market opportunity for our company within the emerging medical market for computer aided detection. Most importantly, this product will make the benefits of earlier computer aided detection of breast cancer affordable and accessible to an increasing number of women at risk.”
About iCAD, Inc.
iCAD develops, engineers, manufactures and markets computer aided detection (CAD) products for the early detection of breast cancer and other health-care related applications. Early detection of breast cancer can save lives and often permits less costly, less invasive and less disfiguring cancer treatment options than when the cancer is detected at a later stage. Computer-aided detection from iCAD can detect 23% of breast cancers, an average of 15 months earlier than screening mammography alone.
iCAD is the only independent, integrated digitizer hardware and CAD software company offering computer aided detection solutions. As such, iCAD is able to reduce costs at each step in the CAD product design, production and assembly process. The Company believes its vertical integration of CAD and hardware development results in better integration of software and film digitizer components, lower production costs and reduced administrative overhead. These achievements have allowed iCAD to progressively enhance its CAD product line, while reducing the costs of CAD to many customers and allowing more women to realize the benefits inherent in the early detection of breast cancer.
On December 31, 2003, iCAD merged with and acquired CADx Systems, Inc. and its parent company Qualia Computing, Inc., bringing together two of the three companies approved by the US Food and Drug Administration (FDA) to market computer aided (CAD) systems for the detection of breast cancer in the United States. The Company is headquartered in Nashua, New Hampshire and its common stock is listed on The Nasdaq Stock Market under the symbol “ICAD”. More information on iCAD’s products can be found at www.icadmed.com .
Second Look is a registered trademark of iCAD, Inc.
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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 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 other filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “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.
