quelle: www.yahoo.com/finance
"Biophan Publishes Findings from Workshop with FDA to Define Methods for Measuring MRI Safety of Medical Implants
Monday January 8, 8:33 am ET
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.
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The report can be viewed at http://www.biophan.com/crada_workshop0107.
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(TM), 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.
Cautionary Statement Regarding Forward-Looking Statements
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."
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