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.

"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, 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”, “would”, “could”, “consider”, “project”, “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, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:

For iCAD investor relations:

LifeSci Advisors
Bob Yedid, (646)-597-6989
Bob@lifesciadvisors.com

or

For iCAD media inquiries:

Berry & Company Public Relations, LLC
Lynn Granito, 212-253-8881
lgranito@berrypr.com

 

 

  1.  https://www.skincancermohssurgery.org/in-the-news/auc
  2. Bhatnagar A. Electronic brachytherapy for the treatment of non-melanoma skin cancer: results up to 4 years. Int J Radiat Oncol Biol Phys 2014; 90 Suppl: S756.
  3. Doggett S, Brazil J, Limova M et al. Electronic brachytherapy management of atypical fibroxanthoma: report of 8 lesions. J Contemp Brachytherapy 2017; 9:1-3.

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