NASHUA, N.H. (May 27, 2015) – iCAD, Inc. (NASDAQ: ICAD), announced today that it is withdrawing its full year 2015 financial guidance due to general uncertainty related to reimbursement for non-melanoma skin cancer in the United States. The Company’s guidance was based on the assumption that there would be no changes to the reimbursement environment for fiscal 2015. The Company is proactively working to gain clarity on the issue and will provide an update on reimbursement when appropriate.
Ken Ferry, CEO of iCAD, said, “There continues to be a large population of patients that can benefit from our electronic brachytherapy technology, particularly in the treatment of non-melanoma skin cancer, where eBx provides significant advantages over traditional surgical techniques for certain patients. In the United States alone, we believe there are over one million non-melanoma skin cancer lesions per year that can be effectively treated utilizing electronic brachytherapy. We are working closely with Centers for Medicare and Medicaid Services (CMS), Medicare Administrative Contractors (MACs), professional medical societies and industry in order to gain clarity on reimbursement for skin eBx, which remains an important option for many physicians and patients throughout the country.”
Mr. Ferry added, “We have innovative and disruptive technologies in several large markets, including radiation therapy for skin and breast cancers, as well as a significant opportunity in 3D computer aided detection (CAD). We believe we are well positioned over the long-term to expand our market presence and penetration in both cancer detection and radiation therapy.”
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.
“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”, “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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