iCAD announces positive study results comparing use of company’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® to Mohs surgery in treatment of early-stage non-melanoma skin cancer
Results of breakthrough study published in peer-reviewed Journal of Contemporary Brachytherapy showed no statistically significant difference in recurrence of cancer at mean follow-up of 3.4 years
NASHUA, NH – July 19, 2017 - 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 results of a matched-pair cohort study of 369 early-stage non-melanoma skin cancer (NMSC) patients treated with the Company’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® or Mohs micrographic surgery showed that rates of recurrence of cancer were virtually identical. Mohs micrographic surgery is accepted as the most effective technique for removing basal cell carcinoma and squamous cell carcinoma, the two most common skin cancers. The study results were published online in the peer-reviewed Journal of Contemporary Brachytherapy.
“In recent years, we have seen substantial clinical evidence indicating that electronic brachytherapy offers comparable results to Mohs surgery in appropriately selected early-stage non-melanoma skin cancer patients,” said Rakesh Patel, MD, lead investigator of the study, Radiation Oncologist and Medical Director, Department of Radiation Oncology, Good Samaritan Hospital, Los Gatos, CA. “These data provide an entirely new level of clinical research confirming that treatment with eBx can help patients achieve similar low rates of recurrence with excellent cosmetic outcomes compared to Mohs surgery.”
The study compared clinical outcomes of patients treated with eBx and Mohs surgery at different treatment centers. In the population of 369 patients, a total of 188 were treated with eBx and 181 with Mohs surgery. Data reflected treatment of 416 lesions (208 in the eBx group and 208 in the Mohs surgery group), including 226 basal cell carcinomas and 190 squamous cell carcinomas. At a mean follow up of 3.4 years, 99.5% of eBx patients and 100% of Mohs surgery patients remained recurrence free. Statistics provided by the American College of Mohs Surgery state that Mohs surgery has a success rate “up to 99 percent.” Overall incidence of toxicity was similar in both treatment groups. In addition, physician-rated cosmetic outcomes were either “excellent” or “good” in 97.6% of eBx-treated lesions and 95.7% of Mohs surgery-treated lesions.
“For appropriately selected NMSC patients, the Xoft System delivers a targeted therapeutic dose of radiation directly to the cancerous site in a painless, non-invasive procedure,” said Ken Ferry, CEO of iCAD. “The results of this landmark study can help more patients choose treatment with eBx with the confidence that recurrence rates are clinically shown to be similar to those observed with Mohs surgery, which has been considered the standard of care for early-stage NMSC for decades.”
Results from patients treated with eBx in this study are consistent with the results from a growing body of additional clinical research assessing outcomes with eBx in the treatment of early-stage NMSC. An earlier outcomes study of 297 lesions with up to 63 months of follow-up (mean 16.5 months) showed only one recurrence and excellent cosmesis in 100% of patients at years 4-5. A separate study of 524 lesions treated with eBx with mean follow-up of 12.5 months showed a 0.7% recurrence rate.
“Our goal in treatment of NMSC is to eliminate the lesion while preserving function in the region affected by cancer,” Dr. Patel added. “These results indicate that eBx can achieve these goals without putting patients at higher risk of recurrence or complications.”
The article may be viewed using the following link: https://www.termedia.pl/Comparison-of-electronic-brachytherapy-and-Mohs-micrographic-surgery-for-the-treatment-of-early-stage-non-melanoma-skin-cancer-a-matched-pair-cohort-study,54,30129,1,1.html
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, gynecological cancers and non-melanoma skin cancer.
About Xoft Axxent Electronic Brachytherapy System
The 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. The Axxent Hub is a cloud-based oncology collaboration software solution that enables centers to monitor treatment workflow and enhance communication between clinical specialists. 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® 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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