iCAD, Inc. Reports Use Of Xoft Axxent Electronic Brachytherapy System In The Treatment Of More Than 15,000 Non-Melanoma Skin Cancer Lesions
NASHUA, N.H., Nov. 23, 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 that the company's Xoft® Axxent® Electronic Brachytherapy (eBx®) System has been used in the treatment of more than 15,000 non-melanoma skin cancer (NMSC) lesions. An analysis of the 7,000 lesions collected through the Xoft System's Axxent Hub cloud-based software shows that the average age of patients treated is 74.9 years, indicating that clinicians are treating an age-appropriate group of patients for whom this technology represents an advantageous treatment option.
"NMSC continues to be a global health problem and is now the most common type of cancer diagnosed in the United States with an estimated 3.5 million new cases each year.i Based on the available and expanding body of literature demonstrating that this therapy is safe and effective for appropriate patients, we are working to make sure that both patients and clinicians have the comprehensive and accurate information they need about the benefits of eBx," said Ken Ferry, CEO of iCAD. He added, "Xoft has also been a leader in the effort to establish new CPT codes specifically for use of eBx in the treatment of NMSC, which are expected to be implemented in January 2016."
While National Comprehensive Cancer Network guidelines suggest that the standard of care in treatment of NMSC is Mohs surgery, several considerations can make eBx with the Xoft System an important option to achieve positive results for many patients. Factors that may support the use of eBx include treatment of lesions in anatomically challenging locations such as the face, head or neck, medical conditions that contribute to difficulties in wound healing or other medical comorbidities that may preclude patients from surgery, treatment with anticoagulants or with pacemakers, risk of scarring, and patient preference.
In recent years, researchers have conducted extensive clinical research on the use of brachytherapy, including several studies of the use of eBx with the Xoft System to treat NMSC. To date, research on use of the Xoft System in NMSC has involved more than 1,200 patients and 1,700 lesions. The control rates of NMSC after HDR eBx cited are consistently very high (>95%), excellent cosmesis, low toxicity and minimal long-term side effects for appropriate patients.
In October 2015, Ajay Bhatnagar, MD, MBA, medical director of 21st Century Oncology of Arizona, presented updated data from an ongoing clinical study of early-stage NMSC patients who were treated with the Xoft System and followed up to five years. Among 200 patients with a mean average age of 77 years who had a total of 297 lesions and were treated with the Xoft System, researchers reported only one recurrence of cancer to date with a mean follow up of 16.5 months.
"Treatment of NMSC with eBx using surface applicators resulted in excellent local control (99%) and good to excellent cosmesis up to five years post treatment," according to Dr. Bhatnagar. "In addition to its proven efficacy, many patients are also pleased to have a painless and non-invasive treatment option that results in little to no scarring and allows them to return to their normal daily activities immediately."
About Xoft Axxent Electronic Brachytherapy System
The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in Canada 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 Canada 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.
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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, 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.
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i Rogers HW, Weinstock MA, Harris AR, et al. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol 2010;146:283-287.
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SOURCE iCAD, Inc.
