Prospective trial shows that intraoperative radiation therapy (IORT) is a clinically effective, faster and easier alternative to whole breast radiation therapy following breast-conserving surgery for selected low-risk patients at a median follow-up of 36 months
NASHUA, N.H., (January 7, 2019) – iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced the results of a long-term study conducted at Hoag Memorial Hospital Presbyterian with the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of early-stage breast cancer using intraoperative radiation therapy (IORT). With a median follow-up of 36 months, outcomes published in the Annals of Surgical Oncology showed that breast cancer recurrence rates of patients who were treated with IORT using the Xoft System were comparable to those seen in the cornerstone, randomized TARGIT-A and ELIOT trials, which evaluated IORT using different technology. To date, this study presents analysis of the largest series of early-stage breast cancers treated with IORT using the Xoft System published in a peer-reviewed journal.
“The publication of this important clinical data represents a significant milestone for our company in continuing to expand the growing body of research highlighting the Xoft System’s tremendous clinical value to patients and clinicians alike,” said Stacey Stevens, Executive Vice President and Chief Strategy and Commercial Officer at iCAD. “As members of our global installed base of clinical users increasingly report positive outcomes on the safety and efficacy of IORT with the Xoft System, their insights continue to validate our commitment to this advanced technology’s potential to improve patients’ lives through shorter treatment times, fewer side effects, and reduced costs.”
The prospective study, Intraoperative Radiation Therapy (IORT):A Series of 1000 Tumors, was led by Melvin J. Silverstein, MD, Medical Director of the Hoag Breast Center, Gross Family Foundation Endowed Chair in Oncoplastic Breast Surgery at Hoag, and Clinical Professor of Surgery at the Keck School of Medicine in Los Angeles, California. Hoag is a nonprofit, regional health care delivery network in Orange County, California that treats more than 30,000 inpatients and 425,000 outpatients annually. The Hoag IORT series is currently the largest single facility IORT series with the Xoft System in the United States. Researchers from Hoag have also published three additional studies on IORT with the Xoft System in peer-reviewed journals since 2016.
“On average, IORT can reduce 30 days of treatment to less than 30 minutes. The benefits are obvious,” said Melvin Silverstein, MD. “Eliminating weeks of radiation therapy reduces emotional stress and allows patients to quickly return to their normal life. The results of this study have important implications for breast cancer patients around the world considering their treatment options.”
The study reviewed results of 1,000 early-stage breast cancers in 984 patients enrolled in a prospective trial from June 2010 to August 2017. Patients included individuals 40 years of age and older, with lymph node negative cancer and with favorable pathology. All tumors were treated with breast-conserving surgery and IORT using the Xoft System. With a median follow-up of 36 months, there have been 28 ipsilateral local recurrences, ten of which were DCIS and 18 invasive. There have been four regional nodal recurrences and one distant recurrence. There have been no breast cancer related deaths. The low recurrence and complication rates reported support the continued study of IORT in appropriately selected women with low-risk breast cancer.
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.
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.
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ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
LifeSci Advisors, on behalf of iCAD, Inc.
Jeremy Feffer, (212) 915-2568