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iCAD Announces New Clinical Data on the Xoft Electronic Brachytherapy System for Early-Stage Breast Cancer Treatment Demonstrating Positive Results

Multi-center research presented at ASTRO 2018 shows IORT with the Xoft System is safe with low recurrence and low morbidity in the treatment of breast cancer

Company marks 20 years of innovations in targeted cancer care at the conference

NASHUA, N.H. and SAN ANTONIO, Oct. 23, 2018 (GLOBE NEWSWIRE) -- (Booth #3457) iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced new clinical research demonstrating positive outcomes supporting the use of the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of early-stage breast cancer. Preliminary results demonstrated that IORT using the Xoft System is safe with excellent local control and cosmesis, and low morbidity. The analysis of the international, multi-center trial was unveiled during an oral presentation at the 60th American Society for Radiation Oncology (ASTRO) annual meeting at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“We are pleased that clinical results from our global installed base continue to highlight the therapeutic value of this state-of-the-art treatment option,” said Ken Ferry, CEO of iCAD. “In addition, it is an honor to mark our 20th year of innovations in targeted cancer care among healthcare providers who are making an important difference each day in the lives of their patients. We look forward to continuing to partner with radiation oncology leaders worldwide to precisely and effectively treat cancer in the years to come.”

In the presentation, A.M. Nisar Syed, MD, Principal Study Investigator, and Medical Director, Radiation Oncology & Endocurietherapy, MemorialCare Cancer Institute, Long Beach Memorial Medical Center, and Professor of Radiation Oncology, UCI Medical Center and Harbor-UCLA School of Medicine, detailed clinical techniques and outcomes of IORT using the Xoft System at the time of breast conserving surgery with findings based upon ASTRO suitability criteria. The trial enrolled 1,201 patients between May 2012 and July 2018 at 28 international and United States-based institutions. With a median follow up of 2 years, less than one percent of patients had cancer regrowth (ipsilateral recurrence) or developed new primary cancers in the other breast. Treatment was well tolerated with grade 3, 4 and 5 adverse events occurring in only 37 patients. Mean treatment time was 10.5 minutes.

“Our research continues to demonstrate significant promise in the treatment of early-stage breast cancer with IORT using the Xoft System. Preliminary outcomes show that a single fraction of radiation with the Xoft System yields excellent results in patients meeting specific selection criteria,” said A.M. Nisar Syed, MD. “By greatly reducing the number of treatment patients receive as compared to traditional radiation therapy, IORT provides valuable advantages to patients including shorter treatment times, fewer side effects, reduced costs and improved quality of life.”

In addition to the new data release at the annual meeting, iCAD hosted a series of in-booth expert presentations and peer-to-peer learning opportunities led by the following global experts:

  • Paulo Costa, MD, Radiation Oncologist, Instituto CUF Porto, Breast Surgery Unit Senhora da Hora, Matosinhos, Portugal
     
  • Charles Wesley Hodge, MD, Radiation Oncologist, Florida Hospital Celebration Health, Celebration, Fla.
     
  • Chun-Shu Lin, MD, Chief, Department of Radiation Oncology, Tri-Service General Hospital, Taipei City, Taiwan
     
  • A.M. Nisar Syed, MD, Medical Director, Radiation Oncology & Endocurietherapy, MemorialCare Cancer Institute, Long Beach Memorial Medical Center, Long Beach, Calif.

IORT with the Xoft System uses a miniaturized X-ray source to deliver one precise, concentrated dose of radiation to a tumor site at the time of breast-conserving surgery (lumpectomy). The treatment can be completed in as little as eight minutes, making it possible for appropriately selected patients to replace six to eight weeks of post-operative EBRT with a single treatment. The Xoft System is cleared by the U.S. Food and Drug Administration, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer, and gynecological cancers. It has been used to successfully treat more than 15,000 patients worldwide. For more information, please visit www.xoftinc.com.

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.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, 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, 2017, 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:

Media Inquiries:

ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
paul@arpr.com

Investor Relations:
LifeSci Advisors, on behalf of iCAD, Inc.
Jeremy Feffer, (212) 915-2568
jeremy@lifesciadvisors.com 

Tuesday, October 23, 2018 - 14:01