Biophan receives patent on improved medical device safety under MRI

9 October 2005

Rochester NY, USA. Biophan Technologies, Inc. has received a patent for a device that detects electrical surges during magnetic resonance imaging. This can prevent incompatible implanted devices, such as a pacemaker, from causing harm to patients or medical staff due to dangerous electrical currents induced in the device during imaging.

Biophan has been issued US patent 6,949,929 "Magnetic Resonance Imaging Interference Immune Device". This patent covers active electronic circuits that can sense unwanted electrical energy in a medical device and creates an offsetting signal that effectively cancels it. The Company believes this technology could be critical to the safety of a patient with a pacemaker, defibrillator, or nerve stimulator, who may inadvertently be placed in a Magnetic Resonance Imaging (MRI) machine. The Company also believes the technology can reduce or eliminate unwanted energy induced in a guidewire or other long conductive surgical tool that would otherwise be useful in less invasive catheter-based interventional procedures.

The typical pacemaker stimulation signal level (about 3 volts) and duration (about 1 millisecond) are intentionally well above the stimulation threshold of most individuals in order to pace the heart and to provide reliable operation. There is considerable variability in this stimulation threshold, and for some patients it can be well below 1 volt. In a typical 1.5 Tesla MRI system, a pulsed gradient field operates at 300 pulses per minute. Under some MRI test sequences and with some pacemaker lead layouts, a signal approaching 1 volt at this speed can potentially induce a heartbeat of 300 beats per minute. If this is not caught immediately the resulting catastrophic loss of blood pressure can be fatal

The long and extremely thin metal guidewires used in advanced interventional surgical procedures can generate electrical arcs and extreme localized heating under certain MRI imaging conditions, potentially harming both the patient and the surgeon. The Company believes its technology, protected by Biophan's US 6,949,929 patent, may also be applied to solve this problem.

Biophan's latest patent is one of a wide set of technologies developed to eliminate patient risks caused by the combination of these devices and the MRI signals and improve the image quality of these devices in MRI. Other Biophan technologies may be used to enhance the MRI visualization of interventional surgical tools that would otherwise be invisible under MRI. This eliminates the need for x-ray imaging to guide these procedures, limiting patient exposure to ionizing radiation and toxic contrast agents.

Michael Weiner, President and Chief Executive Officer of Biophan Technologies, said, "We are extremely pleased with the issuance of this patent, which further builds our extensive portfolio of protected technologies to make medical devices safe under MRI. Our technological visibility to global manufacturers of pacemakers, defibrillators and neurostimulators continues to rise. We have made substantial progress in our discussions with these companies about the potential implementation of our patented technology. It is Biophan's mission to see that medical devices are made safe and compatible with MRI, eliminating contraindications on devices related to MRI, particularly where it may be critical to ensure optimal patient care."

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