First-Year Data from ExBRT Trial Using Intraoperative Radiation Therapy (IORT) and Additional Data for Skin Electronic Brachytherapy to be Presented by Leading Physicians at ABS Meeting
NASHUA, N.H. and ORLANDO, FL (Booth # 107) (April 7, 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 first-year data from the company’s ExBRT (“A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System at the Time of Breast Conservation Surgery for Early-Stage Breast Cancer”) trial evaluating the Xoft System for the treatment of early stage breast cancer will be presented at the American Brachytherapy Society (ABS) Annual Meeting, April 9-11, in Orlando, FL. In addition, data for the treatment of non-melanoma skin cancer (NMSC) will be presented. The Xoft System’s suite of products and services for clinical practices will be showcased at the Xoft booth (#107) throughout the meeting.
“The presentation of this data represents a significant milestone for our company,” said Ken Ferry, CEO of iCAD. “The positive safety and efficacy results utilizing the Xoft System in these studies, combined with growing procedure volume, demonstrate that electronic brachytherapy continues to gain momentum as a viable treatment option with tangible benefits to clinicians and patients in a variety of clinical applications. It is particularly encouraging that the initial data from the ExBRT study is now being presented at medical meetings, which will serve as a catalyst to drive adoption of IORT in the treatment of breast cancer.”
Study findings by A.M. Nisar Syed, M.D., clinical professor of radiation oncology at the Long Beach Memorial Medical Center and co-principal investigator of the multi-center ExBRT study, will be presented in a snap oral presentation. The ExBRT study evaluates traditional external beam radiation therapy (EBRT) versus IORT using the Xoft System for early-stage breast cancer.
“Early results from the ExBRT study suggest that this short course of full dose radiation in a single treatment delivers good to excellent cosmetic results in 94% of cases and very few low-grade adverse events in select patients with early-stage breast cancer,” said Dr. Syed. “I am very encouraged by the results as IORT may also improve patient quality of life by greatly reducing the number of treatments patients receive when compared to EBRT.”
In addition, annual follow-up results of the first 565 non-melanoma skin cancer lesions treated by Stephen Doggett, MD with the Xoft System will be reported in a snap oral presentation. This data suggests that patients treated with the Xoft System experienced excellent cosmesis with few recurrences.
Researchers will present their findings in the following presentations:
Thursday, April 9, 2015:
- Electronic Brachytherapy for Skin Malignancies
Miscellaneous Session I: Skin Brachytherapy
Ajay Bhatnagar, MD, MBA, Cancer Treatment Services Arizona, LLC
1:00 to 2:00 p.m. in the Crystal Ballroom A/B
Friday, April 10, 2015:
- Feasibility and Early Outcomes of a Multi-Center Trial of Intra-Operative Radiation Therapy Using Electronic Brachytherapy at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
Breast Snap Oral #BSOR07
A.M. Nisar Syed, M.D., Long Beach Memorial Medical Center
4:24 p.m. in the Crystal Ballroom A/B
- Electronic Brachytherapy for Non-Melanomatous Skin Cancer: Report of Failures and Adverse Events; Annual Follow-Up Report of First 565 Lesions
Miscellaneous Snap Oral #MSOR08 Stephen Doggett, M.D., Aegis Oncology, LLC 4:28 p.m. in the Crystal Ballroom C/D/ E
- A Multi-Center Report of Non-Surgical Treatment of Non- Melanomatous Skin Cancer with HDR Electronic Brachytherapy
Miscellaneous Snap Oral #MSOR10
Rakesh Patel, The Targeted Radiation Institute at the VMOC
Robert Strimling, M.D., Strimling Dermatology, Laser and Vein Institute
4:36 p.m. in the Crystal Ballroom C/D/ E
The Company’s newly released whitepaper, “HDR Electronic Brachytherapy; A Non-Surgical Treatment Alternative for Non-Melanomatous Skin Cancer” will be available in the Xoft exhibit. It may also be downloaded at www.xoftinc.com.
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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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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