Biophan Developing Advanced Solutions to Address Newly-Publicized MRI Safety Issues with Neurostimulators and Other Medical Devices
| Company's Proprietary Anti-Antenna and RF Filtering Technologies Address Concerns Covered in Recent Wall Street Journal Article |
“The growing recognition and concern for MRI safety for individuals with implantable devices, and the availability of solutions for significantly reducing heating and induced voltages, has the clear potential to one day lead to medical devices designed to be safe with MRI imaging”
Biophan Technologies, Inc. (OTCBB:BIPH), a developer of next-generation medical technology, announced today that its proprietary advanced solutions in the field of MRI safety present a range of potential solutions to serious safety risks associated with the use of MRI imaging of patients with implanted medical devices that have been widely reported in the media this week.
The Wall Street Journal reported on Thursday that the FDA has received several reports of serious injury, including coma and permanent neurological impairment, in patients with implanted neurological stimulators who underwent magnetic resonance imaging (MRI) procedures. These reports were related to devices that do not incorporate Biophan's technologies for MRI safety. The full advisory can be viewed on the FDA's web site at http://www.fda.gov/cdrh/safety/neurostim.html.
Biophan has been developing technology to address these issues to make medical devices safe and imageable with MRI systems. The Company currently possesses solutions for reducing MRI-induced heating of leads -- the electrical wires that are used in many medical devices, including pacemakers and neurostimulators. Neurostimulators are used to treat epilepsy, chronic pain and Parkinson's disease.
It is recognized that metal wire leads may act as antennas that collect energy generated by electromagnetic fields with MRI systems. Lead heating, as well as unwanted induced voltages, occurs when energy is picked up by the neurostimulator leads in the electromagnetic environment of an active MRI machine. A similar occurs for the metal leads used in cardiac pacemakers, which are also contraindicated for use with MRI.
Biophan holds a U.S. patent for anti-antenna technology as well as a license to an RF filter solution developed at Johns Hopkins University. By using this proprietary technology to modify the metal wire lead that connects the implantable device to tissue, the problems of both heating and induced electrical voltages can be reduced significantly.
"Manufacturers of implantable medical devices now have the option to address MRI safety solutions to improve patient safety, in addition to making their devices more competitive and avoiding potential future product liability claims," said Michael Weiner, CEO of Biophan
"The growing recognition and concern for MRI safety for individuals with implantable devices, and the availability of solutions for significantly reducing heating and induced voltages, has the clear potential to one day lead to medical devices designed to be safe with MRI imaging," stated Mr. Weiner. "This is what we set out to do when Biophan was founded. We are relieved to see increased attention on the real dangers reported so that precautions and appropriate solutions can be put in place. Recognizing the problem in this manner will speed the industry on the path towards solving it."
About Biophan Technologies
Biophan develops and markets cutting-edge technologies designed to make biomedical devices safe and compatible with the magnetic resonance imaging (MRI) environment. The Company develops enabling technologies for implanted medical systems such as pacemakers and interventional surgical devices such as catheters, guidewires, stents, and other implants to allow them to be safely and effectively imaged under MRI. The technology is also being used to create MRI contrast agents, and has expanded to include other applications, such as drug delivery and power systems derived from body heat. Four Biophan technologies include advances in nanotechnology and thin film coatings. Committed to growth through innovation and developmental leadership, Biophan and its licensors now hold a total of 114 U.S. patents, licenses, or applications. This total includes 36 issued U.S. patents, 6 recently-allowed applications that will issue as patents in the near future, and 72 pending applications at various stages of examination at the U.S. Patent and Trademark Office, plus international applications. The patents cover areas including nanotechnology (nanomagnetic particle coatings), radio frequency filters, polymer composites, thermoelectric materials for batteries generating power from body heat, and photonics. Biophan has joint development arrangements with Boston Scientific (NYSE:BSX) and NASA's Ames Center for Nanotechnology. Biophan's goal is to make all biomedical devices capable of safely and successfully working with MRI, and delivering other technologies which will improve quality of life. For more information, please visit 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.
