Healthcare Industry News: Xoft Axxent
News Release - October 29, 2012
iCAD Reports Growing Adoption of Its Xoft Electronic Brachytherapy System by Leading U.S. Regional HospitalsNASHUA, N.H.--(Healthcare Sales & Marketing Network)--iCAD, Inc. (ICAD), a leading provider of advanced imaging and radiation therapy for the early identification and treatment of cancer, today announced growing demand for and adoption of its Xoft® Axxent® Electronic Brachytherapy System® for intraoperative radiation therapy (“IORT”). Two new facilities have purchased the Xoft System including Florida Hospital Celebration Health (Celebration, Fla.) and Yuma Regional Medical Center (Yuma, Ariz.).
The Xoft System is FDA-cleared for the treatment of early stage breast cancer, endometrial cancer, skin cancer and for the treatment of other cancers or conditions where radiation therapy is indicated. As a platform technology, the Xoft System is designed to deliver isotope-free radiation therapy directly to cancer sites during surgery with minimal radiation exposure to surrounding healthy tissue.
“The continued adoption of the Xoft System emphasizes that it is increasingly being used nationwide, in large and small communities, at large and small hospitals and underscores the growing demand for IORT and other electronic brachytherapy treatments. In fact, Xoft System sales in the third quarter of this year equaled total sales in all of fiscal year 2011,” said Ken Ferry, President and CEO of iCAD. “Xoft provides radiation oncologists with an advanced, potentially life-saving radiation therapy option that can dramatically reduce treatment times, while providing more convenient and cosmetically desirable outcomes.”
Florida Hospital Celebration Health is using the Xoft System to deliver IORT for breast cancer. IORT delivers a single, prescribed, targeted dose of isotope-free radiation directly to the tumor cavity during surgery, thereby minimizing radiation to healthy tissue and organs and eliminating the need for a shielded treatment environment. Typical radiation therapy methods for breast cancer include whole breast radiation, which involves daily treatments for five to seven weeks, and partial breast irradiation where 10 treatments are delivered over a period of five days. Florida Hospital Celebration Health is also participating in the company’s 10 year post-market IORT study of the Xoft® Axxent® Electronic Brachytherapy System® for early stage breast cancer.
Yuma Regional Medical Center is also using the Xoft System as an alternative non-surgical procedure for treating patients with squamous and basal cell carcinoma -- the most common forms of skin cancer. Compared to traditional treatment, the Xoft System is a non-invasive procedure that safely delivers radiation to the surface of the skin, while minimizing exposure to surrounding healthy tissue. The current standard of care for these types of skin cancers typically includes several kinds of surgery, topical treatments and radiation therapy. With traditional external beam therapy, patients often receive 30-35 doses over the course of several months. With the Xoft System, treatment can be completed in just 8-10 doses, greatly reducing the number of daily visits or surgical intervention that traditional therapies require.
Xoft® Axxent® Electronic Brachytherapy System® is an isotope-free radiation treatment cleared by the FDA for use anywhere in the body, including for the treatment of early stage breast cancer, endometrial cancer and skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System can be administered as a single course of radiation therapy during surgery in the form of intraoperative radiation therapy (IORT) or in the form of partial breast irradiation (APBI). The Xoft System does not require a shielded environment and the system’s relatively small size and mobility enable it to be used in virtually any clinical setting. A post-market study is underway to assess the safety and efficacy of IORT with the Xoft System. Xoft, Inc. is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com.
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”, “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.
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