iCAD Announces FDA Clearance of Cervical Applicator for Xoft Electronic Brachytherapy System
NASHUA, N.H.--(BUSINESS WIRE)-- iCAD, Inc. (Nasdaq: ICAD ) , a leading provider of advanced imaging and radiation therapy technologies for the detection and treatment of cancer, today 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.
“The addition of the cervical applicator broadens our gynecological product offering to provide treatment for patients with cervical or endometrial cancers. This regulatory clearance further demonstrates the advantages of the Xoft System platform which is also being used today in the treatment of certain breast and skin cancers,” said Ken Ferry, iCAD’s CEO.
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.
About iCAD, Inc.
iCAD is a leading provider of 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.
Kevin Burns, 937-431-7967
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