by
Barbara Kram, Editor | October 04, 2005
Mahwah, NJ, September 21, 2005 - DOBI Medical International, Inc. today announced that it has added its twentieth trial site to its pre-market approval (PMA) clinical trial studying its Dynamic Optical Breast Imaging (DOBI) system. The results of the clinical trial will serve as the basis for the PMA application to the U.S. Food and Drug Administration. The company has contracted with three more sites and is in discussion with several others.
Michael Silver Ph.D., Vice President of Clinical Research at DOBI Medical International said, "We continue to make progress toward our goal of completing our clinical trial, the subject of the fifth module and final submission towards satisfying the requirements for full review of our PMA application by the FDA. A number of clinical centers around the country have expressed interest and enthusiasm in participating in our clinical trial, which targets women 50 and under in the U.S. They share our commitment for developing new technology that will have an impact on improved breast cancer diagnosis, particularly for this generally underserved age group."
The trial is designed to gather clinical data relative to the use of the company's ComfortScan system as an adjunct to mammography to help physicians diagnosis possible breast cancer. The ComfortScan system is a noninvasive, nonionizing (non X-ray) device that uses light-emitting diodes (LEDs), proprietary software and gentle external pressure to identify angiogenesis, the growth of new blood vessels, in the breast. Angiogenesis has been linked with malignant tumors and other breast diseases.
The trial began last fall with three U.S. sites. The company selects a site based on its represented ability to enroll a satisfactory number of patients under the age of 50, perform mammography, and provide pathology results from biopsies. Diagnostic analysis will take place upon completion of the data gathering phase of the study.
For more information on DOBI Medical International or the ComfortScan system, visit
www.dobimedical.com.
