Clinical research following patients up to five years indicates positive outcomes and few recurrences
NASHUA, NH – November 23, 2015, 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 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, 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 and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. 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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