Biophan Announces Details of Study on Pacemaker Safety; Study Indicates Efficacy of Company's Biomedical Technologies.Business Editors/Health/Medical Writers BIOWIRE2K ROCHESTER, N.Y.--(BUSINESS WIRE)--May 27, 2004 Biophan Technologies, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BIPH BIPH Bogomoletz Institute of Physiology (National Academy of Sciences; Ukraine) ), a leading developer of next generation biomedical technology Biomedical technology involves the application of engineering and technology principles to the domain of living or biological systems. Usually biomedical denotes a greater stress on problems related to human health and diseases. , announced today details of a recent study on pacemaker safety. The details, released last week at the 2004 Heart Rhythm Noun 1. heart rhythm - the rhythm of a beating heart cardiac rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the Society annual meeting in San Francisco, are available at http://www.biophan.com/pacinglead.php. 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 centigrade /cen·ti·grade/ (sen´ti-grad) having 100 gradations (steps or degrees); see under scale. cen·ti·grade adj. Celsius. , to as high as 29.2 degrees Centigrade in a standard (1.5 Tesla) MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. machine. The higher temperatures are well in excess of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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
Western New York refers to the westernmost region of New York State. 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 defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. devices--such as cardiac pacemakers, surgical and diagnostic tools--safe and compatible with magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (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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