Healthcare Industry News:  Xoft Axxent 

Devices Oncology

 News Release - November 9, 2011

iCAD Announces Recent Adoption of Its Xoft Electronic Brachytherapy System by Leading U. S. Hospitals

Demand for iCAD’s Intraoperative Radiation Therapy Solution Continues to Grow Nationally

NASHUA, N.H.--(Healthcare Sales & Marketing Network)-- iCAD, Inc. (Nasdaq:ICAD ), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, today announced that its Xoft Axxent® eBx™ electronic brachytherapy system for intraoperative radiation therapy (IORT) has been recently adopted at leading hospitals across the country. Facilities that have chosen the Xoft Axxent eBx System for IORT include Diablo Valley Oncology/Hematology (Pleasant Hill, Calif.), Exeter Hospital (Exeter, N.H.), Memorial Hospital Chattanooga (Chattanooga, Tenn.), Florida Hospital Tampa (Tampa, Fla.), Rockford Memorial Hospital (Rockford, Ill.), Rose Medical Center (Denver, Colo.) and Vanderbilt Medical Center (Nashville, Tenn.)

“The recent adoption of the Axxent eBx System is an increasing endorsement of electronic brachytherapy and IORT as a safe and effective method of radiation treatment,” said Ken Ferry, President and CEO of iCAD. “The growing demand for IORT offers patients expanded access to potentially lifesaving radiation therapy for their cancer treatment and an alternative to long-term radiation therapy.”

IORT enables doctors to administer a high dose of radiation to the tumor bed during a lumpectomy, which reduces or eliminates the need for follow-up radiation treatments and also minimizes radiation exposure to healthy tissue and organs, such as the ribs, lungs, heart and opposite breast. The current standard of care for early stage breast cancer consists of lumpectomy, medical therapy, and a five to seven week course of daily Whole Breast External Beam Radiation Therapy (WBEBRT) delivered by linear accelerators inside a heavily shielded room. With IORT, a single dose of intraoperative radiation may be as effective in treating the tumor as 10–20 daily radiation doses.1

“Radiation therapy is a critical element of breast cancer treatment for most patients, however historically it has required weeks of daily treatments, which can be a burden on the patient’s life and, in some cases, affect her ability to comply with the treatment,” said Dr. Barbara Schwartzberg, Chair of Cancer Services at Rose Medical Center. “The Xoft Axxent eBx System gives us the ability to provide a full course of radiation treatment at the time of surgery, creating opportunities for our physicians to treat breast cancer patients in a manner that is less disruptive and less burdensome on the patient’s lifestyle. Most importantly, this is a great improvement in patient care, and it may also lower the cost of treatment."

The Xoft Axxent eBx 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 Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. The Xoft Axxent eBx System is also cleared for use in accelerated partial breast irradiation (APBI).

About iCAD, Inc.

iCAD, Inc. is an industry-leading provider of advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier. iCAD offers a comprehensive range of high-performance, upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography, Magnetic Resonance Imaging (MRI) and Computed Tomography (CT). iCAD recently acquired Xoft, Inc., developer of the Axxent® eBx™ electronic brachytherapy system (eBx). Axxent uses non-radioactive miniaturized X-ray tube technology and is FDA-cleared for treatment of early stage breast cancer, skin cancer and endometrial cancer. The Axxent System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated including Intraoperative Radiation Therapy (IORT). 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.

1 Vaidya, J., Joseph D, Tobias, D., Bulsara, J., Wenz, M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. The Lancet July 2010: Vol. 376, 91-102


Source: iCAD

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