Key Developments: iCAD Inc (ICAD.PH)
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14 Feb 2013
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Latest Key Developments (Source: Significant Developments)
icad Inc Announces FDA Clearance of Cervical Applicator for Xoft Electronic Brachytherapy System
icad Inc announced that the Company received U.S. Food and Drug Administration (FDA) clearance for its new cervical applicator for use with its Xoft Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina. The regulatory clearance of Xoft`s cervical applicator will help address an unmet need for improved cervical cancer treatment on a global level. According to the World Health Organization, cervical cancer is the second most common cancer in women worldwide, with about 500,000 new cases and 250,000 deaths each year. Xoft`s cervical applicator is designed to treat locally advanced stage cervical cancer in combination with the Xoft System by delivering the prescribed radiation dose to the uterus, and cervix, endometrium and vagina with reduced radiation exposure to the surrounding healthy tissue. Brachytherapy is an important component in the curative management of cervical cancer and significantly improves survival. The Xoft System is a mobile, isotope-free alternative to radionuclide-based high-dose radiation (HDR) brachytherapy and eliminates several logistical shortcomings associated with isotope, linear accelerator and external beam x-ray based radiation systems. Xoft also recently received FDA clearance for an upgraded Xoft System controller capability that will support the cervical applicator and offer enhanced platform features. Full Article
iCAD, Inc. Completes $15 Million Financing
iCAD, Inc. announced that it has entered into a five year, $15 million debt facility agreement (the Agreement) with Deerfield Management Company LP, a healthcare investment fund. Under the terms of the Agreement, the Company will issue a $15 million principal amount senior secured 5.75% note; will enter into a Revenue Purchase Agreement; and will issue warrants to purchase 2,250,000 shares of iCAD Common Stock, plus an additional 500,000 shares of Common Stock if the Agreement is extended. Full Article
iCAD, Inc. Announces Distribution Agreement With Carestream
iCAD, Inc. announced that it has entered into a global distribution agreement with Carestream Health. Under the agreement, iCAD’s MRI product suite of SpectraLook, PrecisionPoint, VividLook, OmniLook, and VersaVue Enterprise, and iCAD’s SecondLook Digital Multi-Vendor mammography CAD solution will be available for purchase with Carestream’s market-leading Vue PACS. iCAD’s MRI and mammography solutions assist radiologists in distinguishing potential cancers as part of their overall analysis of MRI and mammography studies. Full Article
iCAD, Inc. Announces Distribution Agreement With Hitachi For MR Image Analysis And Guided Biopsy Solution
iCAD, Inc. announced that it has entered into a distribution agreement with Hitachi Medical Systems. With this agreement, iCAD’s SpectraLook with PrecisionPoint image analysis solution for breast MRI will be available for purchase with Hitachi’s Oasis and Echelon MRI systems. iCAD’s MRI solution will assist radiologists in distinguishing potential cancers in the breast as part of their overall analysis of MRI studies and streamline the planning and performance of MRI-guided percutaneous breast biopsies. Full Article
iCAD, Inc. Reaffirms FY 2011 Revenue Guidance
iCAD, Inc. reaffirmed fiscal 2011 revenue guidance to a range $30 million to $32 million. According to I/B/E/S estimates, analysts were expecting the Company to report revenue of $30 million for fiscal 2011. Full Article
iCAD, Inc. Lowers FY 2011 Revenue Guidance
iCAD, Inc. announced that for fiscal 2011, it expects total revenue to be in the range of $30 million to $32 million. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $31 million for fiscal 2011. Full Article

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