iCAD, Inc. (Nasdaq: ICAD), a leading provider of advanced imaging and radiation therapy for the early identification and treatment of cancer, today announced that more than 4,000 non-melanoma skin cancer (NMSC) patients have been treated using the Xoft® Axxent® Electronic Brachytherapy System® demonstrating continued growth and utilization of the system among radiation oncologists and dermatologists. In addition, a growing body of clinical evidence provides ongoing support for the use of the Xoft System for this skin cancer application. The Xoft System offers an alternative, pain-free treatment option for patients who may not be candidates for surgery or who are concerned with cosmetic outcomes associated with surgery. The Xoft System is the only electronic brachytherapy (eBx ®) system with peer-reviewed published data in support of this application. “These latest milestones demonstrate the growing clinical support for the Xoft System as an attractive, non-surgical alternative to treat non-melanoma skin cancer,” said Ken Ferry, President and CEO of iCAD. “Through strategic partnerships and a growing customer base, the Xoft System is now available to an expanded patient population at both radiation oncology and dermatology centers across the country. The increased adoption of the Xoft System by leading clinicians combined with positive clinical data supports the continued growth and more widespread adoption of electronic brachytherapy.” Recently, significant clinical data has been presented at prestigious medical conferences highlighting the demonstrated success of eBx in the clinical treatment of NMSC. These include:
- 72nd American Academy of Dermatology (AAD) Annual Meeting (March 2013-Denver) Positive three-year follow up data were presented by Ajay Bhatnagar, MD, MBA, Cancer Treatment Services Arizona, Affiliate of 21st Century Oncology, Adjunct Assistant Professor of Radiation Oncology, University of Pittsburgh School of Medicine and DermEbx. Dr. Bhatnagar presented clinical outcomes data on 187 patients with 275 NMSC lesions treated using eight fractions with the Xoft System, showing excellent cosmesis, low toxicity, and no recurrences at three years post-treatment.
- American Brachytherapy Society (ABS) Annual Meeting (April 2013-San Diego) Clinical outcomes data were presented by Stephen Doggett, MD, a board certified radiation oncologist with Aegis Oncology. Dr. Doggett’s study included 561 lesions in 364 patients treated with the Xoft System and showed that NMSC treatable lesions normally treated with standard fractionation teletherapy, Mohs or excision can be treated with eight fractions of eBx with comparable cure and complication rates and excellent cosmetic results 19 months following treatment of the first patient.
- Also at ABS, poster presentations by Sujatha Pai, MD, MS, DABMP, Director, Division of Medical Physics at Radion, Inc. and Rakesh Patel, MD, Director, The Targeted Radiation Institute of VMOC in Pleasanton, Calif., provided a comparative dosimetry analysis including the Xoft System for skin applications and the Air Kerma strength and output of the Xoft Axxent source as related to the development of a robust Quality Assurance program.
The Xoft System enables clinicians to deliver radiation treatment under radiation oncology supervision in virtually any clinical setting with minimal shielding, making it a viable treatment option across multiple therapeutic areas. The unique mobility of the system allows it to be easily transported to multiple locations and stored when not in use.About Non-Melanoma Skin Cancer NMSC, identified as either basal cell carcinoma or squamous cell carcinoma, is not only the most common type of skin cancer, it is the most common type of cancer in humans. These cancers commonly appear on sun-exposed areas of the body such as the face, ears, neck, lips, and backs of the hands. NMSC affects approximately 2.2 million Americans each year. About Xoft Axxent Electronic Brachytherapy System The Xoft System is an isotope-free radiation treatment cleared by the U.S. Food and Drug Administration and CE marked in the EU for use anywhere in the body, including for the 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. 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 gynecological cancers. For more information, call (877) iCADnow, or visit www.icadmed.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: (not latest)x` 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 .