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 in Canada



    VANCOUVER, June 9 /CNW/ - 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 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 arm.
    Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated;
"The Company is excited about this significant milestone achievement in the
regulatory process. The approval initiates the final step towards the
commercialization of the Company's APA focused heat treatment system for
breast cancer. We believe that the increased efficacy in the shrinkage of
large breast tumors will facilitate increased breast conservation surgery
which is desired by both the patients and the surgeons. I look forward to
completion of the pivotal trial and obtain commercial approval in a timely
manner so that we can enter the huge global marketplace for breast cancer
treatment. According to the American and Canadian Cancer Societies, over 1.2
million new cases of breast cancer are diagnosed each year. Over 75% of these
newly detected breast cancer patients will be scheduled for complete breast
removal surgery unless the size of the tumor can be significantly reduced. Our
focused heat treatment, once commercialized, may be in a position to help
these patients to improve their chance of breast conservation. In the next few
months, Medifocus, Inc. will be adding additional study sites in Canada and
will begin enrollment of patients for the trial."

    About Medifocus, Inc.

    Medifocus owns a patented microwave focusing technology platform (the
Adaptive Phased Array ("APA") technology), which can precisely target and
control microwave energy to cause heating in cancerous tumors anywhere in the
body reliably and repeatedly. 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 and reduced toxicity and to trigger
the targeted release of therapeutic drugs and genes at tumor sites at lower
temperatures. While the core technology has been licensed from the
Massachusetts Institute of Technology, Medifocus has further refined the
precision of the microwave focusing and control ability and developed a
commercial system dedicated exclusively for the treatment of Breast Cancer.
Please visit www.medifocusinc.com for more details.

    %SEDAR: 00023463E




For further information:

For further information: Gilbert Chan, NAI Interactive Ltd,
gil@na-investor.com, (604) 488-8878, 1-866-833-5517; John Mon, Medifocus Inc.,
jmon@medifocusinc.com, Telephone (410) 290-5734

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