Medifocus, Inc. Announces, VM Medical Center in Montreal Has Successfully Treated Its First Patient in Its Pivotal Phase III ...
12 December 2013 - 2:12AM
Marketwired
Medifocus, Inc. Announces, VM Medical Center in Montreal Has
Successfully Treated Its First Patient in Its Pivotal Phase III
Clinical Trial for Breast Cancer Treatment
VM Medical Center Is the Largest Non-Public Private Breast
Center in Canada
COLUMBIA, MD and TORONTO, ON--(Marketwired - Dec 11, 2013) -
Medifocus Inc. (OTCQX: MDFZF) (TSX-VENTURE: MFS) is
pleased to announce that VM Medical Center in Montreal, its
Principal Investigational Site in Canada for its APA-1000 Focused
Microwave Breast Thermotherapy System Pivotal Phase III clinical
study, has successfully treated its first patient
enrolled. Dr. John R. Keyserlingk, MD is the Principal
Investigator at the VM Medical Center in Montreal, Canada. The
VM Medical Center is the largest non-public private breast center
in Canada.
John R. Keyserlingk, MD, MSC, FRCSĀ©, FACS, Surgical Oncologist
and Director of the VM Breast and Oncology Center, stated, " I and
my multi-disciplinary team involved with breast cancer management
are very pleased to have treated our first patient of this Phase
III pivotal study for the treatment of Locally Advanced Breast
Cancer. Combining pre-operative microwave thermotherapy to the
involved breast, alongside our best chemotherapy, has the potential
to significantly reduce the tumour burden beyond what can be
provided by chemotherapy alone. When all, or nearly all, the tumour
cells have been eliminated by the time the patient undergoes
surgery, she then benefits from both best survival prognosis, and a
reduced need for total mastectomy, the latter usually required for
patients with large breast tumors. Upon successful completion of
the study, and if approved, this technology will offer our
patients, and many other breast cancer patients, additional and
greatly needed treatment options, including potentially reducing
the size of the surgical interventions. "
The Pivotal Phase III Breast Cancer treatment study has been
approved to be initiated by both the USA Food and Drug
Administration and the Canadian Bureau of Medical Devices (BMD).
The USA Principal Investigational site has already been initiated
at the University of Oklahoma Breast Institute under the
supervision of the Company's US Principal Investigator, Dr. William
C. Dooley, MD. The goal of the 238 patient Medifocus-sponsored
randomized Phase III study is to demonstrate that preoperative
focused microwave heat treatment and chemotherapy combined are more
effective than preoperative chemotherapy alone in the treatment of
large breast cancer tumors in the intact breast. Combining
heat with chemotherapy before surgery can potentially shrink the
tumor so that it can be removed in a breast conserving surgery
(lumpectomy), thus reducing the need of a mastectomy.
Dr. Augustine Y. Cheung, President and CEO, stated, "We are very
pleased to have initiated this site in Canada for the Medifocus
Breast Cancer Treatment System in our Pivotal Phase III
study. This event is another major milestone for Medifocus
towards the commercialization of our breast cancer treatment system
in the United States, Canada and worldwide."
Further details of the Medifocus Pivotal Phase III study are
published on the www.clinicaltrials.gov web site.
About Medifocus, Inc.
Medifocus owns two fully developed technology platforms with
comprehensive US and international patent protection: (1) The
Endo-thermotherapy Platform -- a catheter-basis focused heat
technology platform that utilizes natural body openings to deliver
precise microwave thermotherapy to the diseased sites. The U.S. FDA
approved Prolieve Thermodilatation System for the treatment of
Benign Prostatic Hyperplasia ("BPH") was developed based on the
Endo-thermotherapy and is currently generating revenue, and (2) The
Adaptive Phased Array (APA) Microwave Focusing Platform -- invented
by MIT, licensed to Medifocus, directs precisely focused microwave
energy at tumor center to induce shrinkage or eradication of tumors
without undue harm to surrounding tissue. The Company's APA 1000
Breast Cancer Treatment System, developed from the APA technology
platform, has received approval from the U.S. FDA and Health Canada
to conduct the pivotal Phase III clinical trials. The Company
believes that these two technology platforms can provide the design
basis for the development of multiple cancer treatment systems for
surface, subsurface and deep seated localized and regional cancers.
Please visit www.medifocusinc.com, www.prolieve.com and
http://www.facebook.com/pages/Medifocus-Inc-Company-Page/546315028715627
for more details.
About VM Medical Multidisciplinary Breast Center
Since its founding in 1994 VM Medical has established itself as
a leader in breast cancer diagnosis and care. The VM Medical
Multidisciplinary Breast Center's three units -- the VM Medical
Rapid Diagnostic Breast Center, the VM Medical Oncology Center and
the VM Medical Integrative Health & Wellness Center -- make up
what is today the largest private breast center in Canada. With
on-site direct digital (DR) mammography, MRI, PET-CT, nuclear
medicine, and our rapid pathology service, patients benefit from
both rapid diagnosis and rapid treatment. Last year alone our
multidisciplinary team of physicians diagnosed and treated over 450
new cases of breast cancer. The VM Medical Breast Center is
accredited by the Canadian Association of Radiologist, the American
College of Radiology and is an accredited member of the National
Consortium of Breast Centers.
Forward-Looking Statements and Information
This news release contains "forward-looking statements" and
"forward-looking information," which may not be based on historical
facts. Forward-looking statements and forward-looking information,
include, but are not limited to, information and statements with
respect to the benefit to Medifocus's future growth resulting from
the acquisition of additional intellectual property rights,
additional treatment possibilities and the expectation that sales
from ProlieveĀ® may accelerate as a consequence. Forward-looking
statements are frequently characterized by words such as "plan,"
"expect," "project," "intend," "believe," "anticipate", "estimate"
and other similar words, or statements that certain events or
conditions "may" or "will" occur. Forward-looking statements are
based on the opinions and estimates of management at the date the
statements are made. Such forward-looking statements and
forward-looking information 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 or forward-looking information. These
factors should be considered carefully and readers are cautioned
not to place undue reliance on such forward-looking statements and
forward-looking information. Except as required by applicable
securities laws, 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 or forward-looking
information contained herein to reflect future results, events or
developments.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Company Contact: John Mon COO Medifocus, Inc. Tel: 410-290-5734
jmon@medifocusinc.com Investor Relations Contact: Robert Giordano
Consulting for Strategic Growth 1 Tel: 917-327-3938
rgiordanonyc@gmail.com
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