Medifocus, Inc. receives Authorization Approval from Health Canada to launch its pivotal Phase III clinical study of focused microwave heating for treatment of breast cancer...( VANCOUVER June 9 / Medifocus Inc. (TS...),Health

VANCOUVER, June 9 /PRNewswire-FirstCall/ - Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has been granted the Investigational Testing Authorization (ITA) from Health Canada's Medical Device Bureau (MDB) for initiating Medifocus' pivotal trial with the Microfocus APA 1000 Breast Thermotherapy System for the treatment of breast cancer. This ITA application has been reviewed by MDB and has fulfilled Part 3 of the Medical Devices Regulations and is now authorized to conduct the pivotal trial in Canada. ITA is similar to the "No Objection Letter" issued by the Therapeutics Product Directorate for pharmaceutical products.

The Company's pivotal clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using its focused microwave heat energy in combination with neo-adjuvant chemotherapy over chemotherapy alone on large breast cancer tumor. The full ITA approval was obtained after the Research Ethics Boards (REB) of the Ville Marie Medical Center and of the St. Mary's Hospital in Montreal, both granted clearance to begin the pivotal study. Ville Marie is one of the most active comprehensive breast cancer centers in Quebec and the St. Mary's Hospital is a teaching hospital of the McGill University. Dr. Kyserlingk, the director of Ville Marie Medical Center, will be the principal investigator in Canada for the pivotal study. A total of 238 patients will be entered into the study.

The basis of this ITA-approved pivotal study was from the data analyzed from an FDA allowed phase II multi-center randomized study using the Microfocus APA 1000 Thermotherapy System on large breast tumors. The data showed that the median tumor shrinkage in the Thermo-chemo arm was 88.4% and for the Chemotherapy alone arm the median tumor shrinkage was only 58.8%. This increase in median tumor shrinkage was statistically significant with a P value equal to 0.048. In addition, the data indicated th
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