VANCOUVER, British Columbia--(BUSINESS WIRE)--Medifocus Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that it has received from the Food and Drug Administration (FDA) an Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical trial upon obtaining institutional review board (IRB) approval from the clinical sites, using the Company’s Microfocus APA 1000 System for the treatment of breast cancer. Medifocus had already announced on June 9, 2009 that Health Canada had granted full Investigational Testing Authorization (ITA) approval to allow the initiation of the same pivotal Phase III study in Canada.
