Healthcare Industry News:  hyperthermia therapy 

Devices Oncology FDA

 News Release - March 9, 2010

Medifocus, Inc. Announces That It Has Received Approval to Initiate Its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer from the Food and Drug Administration (FDA), Investigational Device Exemption (IDE) Application

VANCOUVER, British Columbia--(HSMN NewsFeed)--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.

Medifocus' pivotal Phase III clinical trial design is based on results from four (4) clinical studies performed in the USA with the Company's Microfocus APA 1000 Breast Cancer Thermotherapy System. The patient data leading to the design of the pivotal trial were summarized and published online December 22, 2009 in the journal Annals of Surgical Oncology. The article is titled "Focused Microwave Thermotherapy for Preoperative Treatment of Invasive Breast Cancer: A Review of Clinical Studies" by William C. Dooley, MD, Hernan I. Vargas, MD, Alan J. Fenn, PhD, Mary Beth Tomaselli, MD, and Jay K. Harness, MD.

As summarized in the above mentioned review article, the clinical data showed that when the Medifocus focused heat treatment was added to Standard of Care (SoC) chemotherapy, the median tumor shrinkage in the thermo-chemotherapy 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-chemotherapy 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.

The pivotal Phase III clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using the Company’s focused microwave heat energy in combination with neo-adjuvant (pre-operative) chemotherapy over chemotherapy alone on large breast cancer tumors. A total of 238 patients will be entered into the pivotal study at six medical institutions in the USA and Canada as approved by the FDA. Institutional Review Board (IRB) approval will be required at the participating USA medical institutions.

Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., and former founder and CEO of Celsion Corp. (Nasdaq:CLSN) stated: "Medifocus has worked closely with the FDA during the last several months, and the IDE clearance allows Medifocus to start the pivotal studies in the USA and Canada. This FDA clearance is 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 countries."

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 damaging 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 exclusively 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.

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Forward-Looking Statements and Information:

This news release contains forward-looking statements, which may not be based on historical facts. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.

Source: Medifocus

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