Medifocus, Inc. Files Response to its Investigational Device Exemption (IDE) With the Food and Drug Administration (FDA) in the United States for its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer

VANCOUVER-(Business Wire)-September 17, 2009 - Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has filed a comprehensive response to its IDE application with the FDA in the United States to obtain clearance to initiate a pivotal phase III clinical trial using the Company’s Microfocus APA 1000 System for the treatment of breast cancer in the USA and worldwide. This response was the result of a letter received from the FDA dated July 13, 2009 requesting clarification, recommendations and additional information from Medifocus.

The pivotal clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, of using focused microwave heat energy delivered by the Microfocus APA 1000 system in combination with neo-adjuvant chemotherapy on large breast cancer tumors. A total of 238 patients will be entered into the study. This randomized study will require half (119) to be treated with our focused heat plus chemotherapy and the other half (119) with the chemotherapy alone.

The basis of this pivotal study was provided by 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% while for chemotherapy alone, 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 that for the thermo-chemo treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for the chemotherapy alone. The Company’s focused heat treatment, once commercialized, may be in a position to help these patients to improve their chance of breast conservation thus reducing the need for mastectomy.

Medifocus announced on June 9, 2009 that Health Canada had granted full ITA approval to allow the initiation of the same pivotal studies in Canada and commercialization of the system. Medifocus is actively working with Ville Marie Medical Center in Montreal to begin their recruitment and enrolling of patients to start the pivotal trial.

Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated:

Medifocus will work closely with the FDA and believes the FDA will eventually allow clearance for Medifocus to start the pivotal studies in the USA. This clearance will be a significant strategic milestone for the Company towards global commercialization of the Microfocus APA 1000 thermotherapy system for the treatment of breast cancer. It is the Company’s strategy to conduct the USA and Canada studies simultaneously using the same study design and clinical protocol so that patient data obtained from both USA and Canada can be shared and used towards obtaining commercial approval for the system from both Canada and the USA.

About Medifocus, Inc.

Medifocus owns a patented microwave focusing technology platform the Adaptive Phased Array ("APA") system, which can precisely target and concentrate microwave energy to destroy cancer tumors without demaging healthy tissue when used alone or in conjunction with chemotherapy or radiation. The ability to target tumors with a precision controlled dose of heat can be used to destroy tumors at higher temperatures, to treat tumors in combination with chemotherapy and/or radiation at moderate temperatures for increased effectiveness over those treatments alone. While the core technology has been licensed from the Massachusetts Institute of Technology (MIT), Medifocus has completed the development of a dedicated commercial cancer treatment system for the treatment of breast cancer. Please visit www.medifocusinc.com for more details.

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