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Biophan Announces Successful Animal Testing Of MRI-Safe Temporary Photonic Pacemaker.


Business Editors, Health/Medical Writers

ROCHESTER, N.Y.--(BUSINESS WIRE)--Jan. 28, 2003

Biophan Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:BIPH BIPH Bogomoletz Institute of Physiology (National Academy of Sciences; Ukraine) ) announced today that its MRI-safe temporary photonic pacemaker has been successfully animal tested and has convincingly demonstrated that it can effectively pace a heart.

The test was conducted by the Greatbatch Enterprises Corporation, in conjunction with the Downstate down·state  
n.
The southerly section of a state in the United States.

adv. & adj.
To, from, or in the southerly section of a state.



down
 Medical Center, on Biophan's behalf.

"I am impressed with the outstanding engineering and functionality of the photonic pacing device," said Dr. Robert Rubin, M.D., who served as Principal Investigator for the animal test. "The photonically powered pacemaker also recovered the heart from a complete cardiac arrest cardiac arrest
n.
Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation.


Cardiac arrest
A condition in which the heart stops functioning.
," Dr. Rubin explained.

"This animal test, combined with prior MRI 1. (application) MRI - Magnetic Resonance Imaging.
2. MRI - Measurement Requirements and Interface.
 safety testing of the photonic lead by Dr. Frank Shellock (http://www.biophan.com/magnetic.php) of The Institute for Magnetic Resonance magnetic resonance, in physics and chemistry, phenomenon produced by simultaneously applying a steady magnetic field and electromagnetic radiation (usually radio waves) to a sample of atoms and then adjusting the frequency of the radiation and the strength of the  Safety, Education, and Research, demonstrates convincingly that a photonic pacemaker can effectively pace a heart, while eliminating the serious problems related to induced electrical currents and heating of the lead/tissue interface" 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.

The Company plans discussions with 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.
 regarding the additional requirements necessary to bring the technology to market.

This successful in vivo demonstration of the photonic temporary pacemaker, combined with the earlier safety studies, demonstrates the clinical efficacy and safety of one of Biophan's technologies designed to make medical implantable devices, such as pacemakers, MRI-compatible and MRI-safe. By replacing the problematic metallic conductor in existing pacemakers and other implanted metallic devices with a fiber-optic cable, Biophan's photonic technology platform eliminates the causes of MRI-safety related problems which resulted in a strict contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable.

con·tra·in·di·ca·tion
n.
 by the FDA in 1997, preventing pacemaker recipients from undergoing MRI exams.

In an independently conducted study(1), 17% of pacemaker patients were found to have medical conditions for which an MRI would have been recommended if the pacemaker had not been present. Once available for sale, Biophan's temporary pacemaker will provide an option for this population of pacemaker patients to more safely undergo an MRI examination.

A graphic depiction of the device may be viewed at http://www.biophan.com/pacemaker.php

Biophan is developing several complementary solutions to the very serious problem of MRI safety, which can be combined as needed to meet the specific safety requirements of a broad array of implanted and interventional medical devices. The Company's MRI safety solutions include: MRI-safe photonic pacemaker using fiber-optic leads; nanomagnetic particle thin film shielding; carbon composite polymers; novel MRI shield designs enabled by the previous materials, RF filtering; and MRI machine control means.

This wide toolkit of solutions is currently being offered to biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 manufacturers for a variety of applications. Biophan realizes that certain medical applications may be better served with one solution than another and wants to provide the medical industry with solutions for a wide variety of implanted medical devices, such as pacemakers, implanted cardioverters-defibrillators (ICDs), neurostimulation probes, drug infusion pumps, as well as interventional medical devices used with MRI, such as guide wires, catheters, biopsy probes, and endoscopes.

Biophan has extensive intellectual property coverage for its MRI-safe solutions. These include 3 issued U.S. patents licensed exclusively to Biophan by 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 scientists at other leading universities. Biophan has 45 pending patent applications with over 2,000 claims covering its photonic and shielding solutions.

Biophan is in discussions with several major manufacturers of these devices, exploring licensing arrangements.

About Greatbatch Enterprises:

Greatbatch Enterprises is an R&D company based in Clarence, New York Clarence is a town located in the northeastern part of Erie County, New York, United States. The population was 26,123 at the 2000 census. Clarence is also the name of a postal district in the south part of the town with ZIP code 14031. , owned and operated by pacemaker inventor, Wilson Greatbatch.

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 and radio waves. This MRI safe and 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.

1. Sergio L. Pinski, Richard G. Trohman, Interference in Implanted Cardiac Devices, Part II. PACE 2002; Volume 25, Number 10, pages 1496-1509.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Business Wire
Geographic Code:1USA
Date:Jan 28, 2003
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