Message #87 From:
NewsBot Date: January 8, 2007 05:33:00 AM
BTN News Biophan Publishes Findings from Workshop with FDA to Define Methods for Measuring MRI Safety of Medical Implants
ROCHESTER, N.Y.--(BUSINESS WIRE)--Biophan Technologies, Inc. (OTCBB: BIPH;
FWB: BTN), a developer of next-generation biomedical technology,
published a report written with the U.S. Food and Drug Administration
(FDA) entitled “Biophan Technologies CRADA
Workshop on the Safe Use of Implantable Medical Devices in Magnetic
Resonance Imaging (MRI) Systems – Summary from
Initial Workshop.” The paper was authored by
Howard Bassen, Ph.D. of the FDA, Jeffrey Helfer, Biophan VP Engineering,
and Andreas Melzer, M.D., CEO of Biophan Europe. The findings come from
a recent workshop designed to research and define methods for measuring
MRI safety of medical implants; the workshop was hosted by Biophan and
the United States Food and Drug Administration’s
(FDA) Office of Science and Engineering Laboratories (OSEL) in
Rockville, Maryland.
Michael Weiner, President and CEO of Biophan stated, “There
is a significant danger when placing patients who have certain medical
implants in an MRI environment, and these risks are not widely
understood. The ultimate goal of the Cooperative Research and
Development Agreement (CRADA) is to define standardized measurement
methods for testing MRI safety of devices such as pacemakers and
neurostimulators.” Mr. Weiner continued, “Biophan
has the technology to make MRI procedures safe for patients who have
these implants, so that individuals who vitally need to have an MRI can
do so without putting their lives at risk. However, agreement is needed
on what constitutes device safety and how to properly determine if a
device is safe.”
The CRADA, titled “Measurements and Computer
Modeling to Evaluate the Safety of Medical Implants by Examining Leads
of Cardiac Rhythm Management and Neurostimulation Devices in the
Presence of Electromagnetic Fields from Magnetic Resonance Imaging,”
began with a workshop attended by leading device manufacturers and
medical, scientific, and industry experts from around the world.
Workshop participants discussed cardiac rhythm management and
neurostimulation devices and their behavior in an MRI environment. The
group focused on factors perceived as most relevant to device safety,
including lead heating and induced voltages, and how to properly measure
these effects.
The report summarizes the many safety-related factors identified by
workshop participants, including device design, MRI scanner, and patient
parameters.
The next phase of the CRADA will involve experiments to identify worst
case conditions for testing MRI safety, to establish device safety
guidelines, and to define measurement methods. The test methods will be
offered to standards-setting groups for testing MRI compatibility. The
test methods may also be considered by the FDA when evaluating MRI
safety of selected devices.
“The poor understanding of device performance
in the MRI environment means that these devices remain contraindicated
for use with MRI. Many people either miss an opportunity to have an MRI
because of the presence of an implant, denying them of a potentially
life-saving diagnosis, or receive a scan despite the presence of an
implanted device, creating the potential for MRI-induced injury. The
CRADA between Biophan and the FDA will help clear the way for approval
of devices designed to be MRI safe, and help ensure the availability of
MRI diagnostic procedures to everyone who needs them. We are excited to
be working with the FDA in this process,”
stated Jeffrey Helfer, Biophan VP of Engineering.
About Biophan
Biophan is dedicated to providing technologies that offer innovative and
competitive advantages to the medical device industry. The Company’s
technologies, which improve the MRI safety and image compatibility of
medical devices, are licensed to leading device manufacturers. In
addition, the Company is commercializing the MYOTECH MYO-VAD™,
a new, cardiac support system which has significant potential to improve
the treatment of many forms of heart disease. Biophan is traded on the
OTC market under the symbol BIPH, and is also listed on the Frankfurt
Stock Exchange under the symbol BTN. For more information on Biophan,
please visit our website at www.biophan.com.
Certain statements included in this press release may constitute
forward-looking statements within the meaning of applicable securities
laws. These statements reflect what Biophan anticipates, expects, or
believes may happen in the future. Biophan's actual results could differ
materially from the outcome or circumstance expressed or implied by such
forward-looking statements as a result of a variety of factors
including, but not limited to: Biophan's ability to develop its
technologies; the approval of Biophan's patent applications; the
successful implementation of Biophan's research and development
programs; the ability of Biophan to demonstrate the effectiveness of its
technology; the acceptance by the market of Biophan's technology and
products incorporating such technology; the ability of Biophan to
effectively negotiate and enter into contracts with medical device
manufacturers for the licensing of Biophan's technology; competition;
the ability of Biophan to raise capital to fund its operating and
research and development activities until it generates revenues
sufficient to do so; and the timing of projects and trends in future
operating performance, as well as other factors expressed from time to
time in Biophan's periodic filings with the Securities and Exchange
Commission (the "SEC"). As a result, this press release should be read
in conjunction with Biophan's periodic filings with the SEC, which are
incorporated herein by reference. The forward-looking statements
contained herein are made only as of the date of this press release, and
Biophan undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
