Biophan Announces Details of Study on Pacemaker Safety
Thursday May 27, 9:30 am ET
Study Indicates Efficacy of Company's Biomedical Technologies
ROCHESTER, N.Y.--(BUSINESS WIRE)--May 27, 2004--Biophan Technologies, Inc. (OTCBB: BIPH - News), a leading developer of next generation biomedical technology, announced today details of a recent study on pacemaker safety. The details, released last week at the 2004 Heart Rhythm Society annual meeting in San Francisco, are available at http://www.biophan.com/pacinglead.php.
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The study indicated that a standard pacemaker lead, attached to a pacemaker, will heat up at temperatures varying from as low as 2.2 degrees Centigrade, to as high as 29.2 degrees Centigrade in a standard (1.5 Tesla) MRI machine. The higher temperatures are well in excess of the FDA recommended maximum temperature limit of 2.0 degrees Centigrade.
Additionally, examination of the pacemaker electronics revealed that the exposure to the MRI procedure introduced several anomalies into the operation of the pacemaker, which could also interfere with proper pacemaker performance.
"There has been some misunderstanding and debate about the potential for heating and other dangers associated with pacemaker exposure to MRI. Various researchers have reported different findings," stated Michael Weiner, CEO of Biophan. "This study demonstrates that there are many variables that can affect the performance of a pacemaker during an MRI procedure, such as the position of the device in the patient and the position of the patient in the MRI machine. We have demonstrated that the heating occurs not within the pacing lead, but at the electrode-heart interface where it has the potential to significantly damage heart tissue which can then interfere with the safe operation of the pacemaker."
The study also evaluated several of Biophan's solutions to the heating problem, including an RF filter, which consistently reduced the heating to within acceptable FDA guidelines under all MRI test conditions. The study was performed by Biophan's research team and electrophysiologists from a leading western New York university. Additional studies of other pacemaker safety problems are planned.
Biophan is in discussions with several pacemaker manufacturers concerning adaptation of its technology in future pacemaker and defibrillator products. The study was performed to collect the information that will be needed by the manufacturers when they seek approval from the FDA to market an MRI-safe pacemaker.
About Biophan Technologies
Biophan Technologies develops and markets cutting-edge technologies designed to make biomedical devices--such as cardiac pacemakers, surgical and diagnostic tools--safe and compatible with magnetic resonance imaging (MRI) equipment. The Company develops enabling technologies for implanted medical systems such as pacemakers, and interventional surgical devices such as catheters and guidewires, as well as stents and other implants that can be safely and effectively imaged under MRI. The technology is also being used to create enhanced MRI contrast agents. Committed to growth through innovation and developmental leadership, Biophan and its licensors have nine issued U.S. patents and over fifty patents pending, in areas including nanotechnology (nanomagnetic particle coatings), radio frequency filters, polymer composites, and photonics. Biophan's technology will help realize its goal of one day making all biomedical devices capable of safely and successfully working with MRI. For more information, please visit www.biophan.com.
Cautionary Statement Regarding Forward-Looking Statements and Disclaimer
Certain statements included in this press release may constitute forward-looking statements. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors including, but not limited to: the development of Biophan's MRI technologies; the approval of Biophan's patent applications; the successful implementation of Biophan's research and development programs; the acceptance by the market of Biophan's products; competition 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. 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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Contact:
Biophan Technologies, Inc.
Carolyn Hotchkiss, 585-214-2407
Press Interviews:
Michael Weiner, 585-214-2441
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Das ist Mr. Weiner,na gut Hauptsache er arbeitet weiter so akkurat
