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Biophan Technologies to Begin Animal Testing of MRI-Safe Pacemaker.


Business Editors & Health/Medical Writers

BIOWIRE2K

ROCHESTER, N.Y.--(BUSINESS WIRE)--Sept. 3, 2002

Biophan Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:BIPH BIPH Bogomoletz Institute of Physiology (National Academy of Sciences; Ukraine) ) announced today the availability of the first units of Biophan's MRI-safe temporary pacemaker for animal testing.

Animal studies will be conducted with a leading medical institution in the northeast.

The objectives of these tests are to validate the ability of Biophan's MRI-safe pacemaker to effectively and safely pace the heart while undergoing an MRI 1. (application) MRI - Magnetic Resonance Imaging.
2. MRI - Measurement Requirements and Interface.
 scan.

The animal testing will help confirm the unique MRI safety and compatibility advantage provided by Biophan's photonic pacemaker.

The data obtained from these studies will also be used to accelerate the development of additional product extensions for other market segments, such as implantable and MRI-safe cardioverter-defibrillators and neurostimulation systems. Initial physiologic data are expected to be available in 4Q 2002. These results will subsequently be incorporated into Biophan's 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.
 application, in process, to enable subsequent testing in humans.

Biophan's Temporary Pacemaker is designed to be used during an MRI scan to allow a patient with an implanted pacemaker or cardioverter-defibrillator to safely undergo the MRI procedure. Today's pacemakers and defibrillators are contraindicated by the FDA for use with MRI machines, and as a result, nearly five million people with these implanted devices are not able to undergo an MRI diagnostic scan. The Temporary Pacemaker uses the Company's proprietary photonic pacemaker lead and an MRI-safe, wearable pacemaker. In the event of a failure or malfunction of the patient's implanted device, the Temporary Pacemaker can take over the function of pacing the heart and ensure patient safety. After the MRI scan is completed, if the implanted pacemaker pulse generator Pulse generator

An electronic circuit capable of producing a waveform that rises abruptly, maintains a relatively flat top for an extremely short interval, and then rapidly falls to zero.
 or lead has been damaged, the Temporary Pacemaker can pace the patient's heart until such time as the implanted pacemaker and/or lead can be replaced.

"The Temporary Pacemaker is our solution to this problem until such time in the future as pacemaker manufacturers are able to redesign their devices to operate safely in an MRI machine," 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. "As our Temporary Pacemaker proves the efficacy of our solution, we anticipate licensing our technology and providing proprietary critical components to pacemaker manufacturers. We envision the day when all implanted and intraventional devices will be MRI safe, and to receiving a royalty stream from the over forty-five pending and issued patents we have filed or licensed exclusively from third parties."

Biophan is developing multiple technology solutions to improve the MRI safety and compatibility of implanted and intraventional medical devices. The technology solutions include a photonic catheter that uses a biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function.  semiconductor laser and a biocompatible fiber-optic cable; an RF-filtered electrode tip for pacing and sensing the heart, developed at Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C.  and licensed exclusively to Biophan; and nanomagnetic and carbon composite electromagnetic shielding technologies, licensed exclusively to Biophan for medical applications.

"MRI safety for implanted 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 is inevitable. We intend to be the primary supplier of solutions that provide this advance in biomedical product capability, starting with pacemakers and progressing to neurostimulators, pain control devices, bladder control devices, implantable drug pumps, invasive catheters and guidewires, intraluminal imaging coils for use in MRI scans, and other biomedical devices," Mr. Weiner explained.

About Biophan Technologies

Biophan, based in Rochester, New York This article is about the city of Rochester in Monroe County. For the town in Ulster County, see Rochester, Ulster County, New York.
Rochester, once known as The Flour City, and more recently as The Flower City or
, is engaged in designing, developing, and marketing new technology and related products to enable cardiac pacemakers and the other life sustaining medical devices to be 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) and other equipment using magnetic fields magnetic fields,
n.pl the spaces in which magnetic forces are detectable; created by magnetostrictive ultrasonic scalers to cause the tips of instruments such as ultrasonic scalers to vibrate.
 and radio waves. This MRI-compatible technology will be utilized in temporary and implantable pacemakers, implantable cardioverter-defibrillators and other medical equipment. For more information, please visit www.biophan.com.

Safe Harbor Statement:

Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. 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 the Company's MRI technologies; the approval of the Company's patent applications; the successful implementation of the Company's research and development programs; the acceptance by the market of the Company'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 the Company's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Company's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:Biophan Technologies to Begin Animal Testing of MRI-Safe Pacemaker.
Publication:Business Wire
Geographic Code:1USA
Date:Sep 3, 2002
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