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iCAD Expands Use of the Xoft Electronic Brachytherapy System in Europe, Asia and Australia

Increased Global Demand for Leading-Edge Cancer Treatment Drives Adoption of Eight Xoft Systems for Intraoperative Radiation Therapy (IORT), Offering Significant Benefits to Patients and Clinicians

December 16, 2015 8:00 AM EST

NASHUA, N.H., Dec. 16, 2015 /PRNewswire/ -- iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced positive momentum for its Xoft® Electronic Brachytherapy (eBx®) System® in international markets with the adoption of eight systems for early-stage breast cancer treatment with intraoperative radiation therapy (IORT) during the third quarter of 2015. This includes four systems in Bulgaria, two systems in Taiwan, and the first systems sold in Turkey and Australia.  The Xoft System is now treating patients in seven countries around the world. Outside of the United States, 23 centers are actively treating patients with the Xoft System.

"Globally, an increasing number of treatment centers are striving to offer the most technologically advanced cancer treatments available," said Ken Ferry, CEO of iCAD. "We look forward to building on the momentum we have established with our international partners to continue to increase patient access to IORT in expanded markets worldwide in 2016."

The Xoft System is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, nonmelanoma skin cancer, and gynecological cancers. Using electronic brachytherapy, the Xoft System offers IORT, a procedure in which early-stage breast cancer is treated with just one dose of targeted radiation.  Traditional breast cancer treatment involves daily radiation five days per week, for six to eight weeks.  IORT allows radiation oncologists and breast cancer surgeons to work together to deliver a full dose of radiation at the time of lumpectomy for eligible patients. A growing body of favorable clinical data supports the use of IORT in candidates meeting specific selection criteria. iCAD is currently conducting one of the largest IORT clinical studies to date using the Xoft System, which compares Xoft IORT to traditional external beam radiation therapy. The Xoft System also offers a painless, non-invasive treatment for nonmelanoma skin cancer.

The Xoft System is able to treat a wide range of cancers as its proprietary miniaturized x-ray source can be inserted into a variety of applicators that are specifically designed for different treatment areas.  With IORT, the x-ray source is inserted into a flexible balloon-shaped applicator, then temporarily placed inside the lumpectomy cavity for the duration of the treatment, which can last as little as eight minutes.

"We look forward to offering treatment with the Xoft System to our patients, as the technology offers a number of unique benefits to patients and clinicians," said Prof. Toshko Delyinski, surgeon at the Dr. Georgi Stranski Hospital in Pleven, Bulgaria, one of the four new Xoft customers in the country. "For patients, the Xoft System offers added convenience, reduced treatment times and fewer side effects, as compared to traditional radiation therapy. Additionally, the Xoft System can be easily transported around the facility and requires minimal shielding, allowing it to be easily incorporated into any clinical practice."

About Xoft Axxent Electronic Brachytherapy SystemThe Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma 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 requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.

About iCAD, Inc.iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD's Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com.

About the Dr. Georgi Stranski HospitalDr. Georgi Stranski University Hospital in Pleven, Bulgaria was established more than 145 years ago and is the largest healthcare facility in North Bulgaria. The hospital is one of the leading centers for organ donors and transplantations in the country. Dr. Georgi Stranski University Hospital partners with the medical university in the city to provide a contemporary environment for students who want to be part of the healthcare industry. The hospital's clinic and wards serve as competence centers for the Northern region. In total, 430 doctors and 860 healthcare specialists provide general and specialty healthcare services. In November 2015, the hospital started treatments with its new linear accelerator and an electronic brachytherapy and intraoperative system to provide modern, multi-optional and interchangeable ways of treating cancer.  

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995Certain 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, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; 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", "seek", 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.

Contact:

For iCAD investor relations:The Ruth GroupZack Kubow, 646-536-7030www.theruthgroup.com[email protected]

or

For iCAD media inquiries:Berry & Company Public Relations, LLCJessica Burns, 212-253-8881[email protected]

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/icad-expands-use-of-the-xoft-electronic-brachytherapy-system-in-europe-asia-and-australia-300193546.html

SOURCE iCAD, Inc.



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