Biophan Announces Issuance of New U.S. Patents; Expands Intellectual Property Portfolio into Cardiac Pacing
These two newly issued patents are for methods of signaling the heart, which improve the function of implanted cardiovascular devices. The first, U.S. Patent 7,020,517, teaches a means of detecting and responding in a manner that avoids the onset of ventricular fibrillation, the heart rhythm that causes sudden death. The method uses a low voltage electrical signal, which can be built into a low cost pacemaker and provide some protection against fibrillation events. The technology can also be deployed in a cardio-defibrillator as a means of controlling fibrillation to avoid the need for the more powerful and potential painful and disorienting 800 volt charge traditionally used in implantable defibrillators. Michael Weiner, Biophan CEO, notes that "in our work on redesigning pacemakers and defibrillator devices to be MRI safe and in researching the literature we found that fibrillation of the heart oftentimes occurs when the electrical signals in the heart, normally somewhat chaotic and non-linear, become smooth and linear. Research by the U.S. Navy showed in animal trials that fibrillation could be avoided in a percentage of cases when a non-linear signal was applied to the heart. Our patent teaches incorporating a circuit for detecting a change in the non-linearity of the heart's electrical signal that a pacemaker circuit is monitoring, and when the signal changes in a way that indicates the potential onset of fibrillation, the non-linear signal is sent to the heart." There are three benefits to this approach:
“This algorithm is another. Now that the patent has issued, we are publicizing the existence of this invention so that device manufacturers can consider incorporating it into a wide range of devices”
-- Pacemakers that are predominantly used to prevent inappropriate slowing or stopping of the heart can be equipped with the ability to sense the pre-fibrillation phase that precedes sudden death and provide therapy using a low voltage pulse without requiring significant changes to existing low voltage pacemaker power design.
-- This new technology can be readily integrated with existing implantable cardioverter-defibrillators (ICDs).
-- This may provide for a painless therapy option to complement existing anti-tachycardia pacing algorithms in today's ICDs.
Some patients suffer anticipatory anxiety of an event that causes their defibrillator to fire. In Biophan's improved device design, the low voltage signal is applied first, before the more powerful 800 volt jolt, to see if the fibrillation event can be avoided entirely. If not, after several attempts, the circuitry signals the more powerful and traditional cardio-defibrillator technology to trigger.
The second patent, U.S. 7,054,686, teaches use of a high frequency pulse sequence in place of a single pacing signal so that stimulation of the heart can occur with lower energy, a technique with the potential to improve battery life of implantable devices. "Our work on the biothermal battery, which we previously announced, is one example of a means of improving the time between replacement of implantable devices," Mr. Weiner said. "This algorithm is another. Now that the patent has issued, we are publicizing the existence of this invention so that device manufacturers can consider incorporating it into a wide range of devices".
"We are also today announcing a patent application still in its prosecution phase which is complementary to these two. U.S. Application 2004-0186545A1 teaches an improved means of providing high risk hospitalized patients who require temporary pacing, with access to advanced life-saving, anti-tachycardia pacing and defibrillation should they develop ventricular fibrillation while in the hospital," Mr. Weiner explained. "The technology advances the standard of care for patients who need a temporary pacing system and who are either not ready for a permanent ICD implantation due to an acute illness, or only need the pacing back up for a short period of time. The device is designed to be placed using the same standard approach for the placement of a 'temporary pacing wire' but provides the additional benefit of treating sudden death. We believe that a new standard of care in the near future will require all temporary pacing technologies to provide the option for treating sudden death."
Biophan is commencing discussions with both cardiovascular; research organizations for collaborative R&D and animal trials, and with pacemaker and defibrillator companies for the pursuit of licensing of the technology, once a patent issues.. "This is the type of innovation which, if successful, can have a substantial impact on the pacemaker and defibrillator industry. The issuance of these patents comes at a fortuitous time, as we are in licensing negotiations with major pacemaker companies for incorporation of our MRI safe technologies into their designs, and these innovations expand the potential patient advantages," said Mr. Weiner.
Biophan develops and markets cutting-edge technologies for the medical device industry that provide competitive advantages. The Company's founding goal was to make all biomedical devices capable of safely and successfully working with magnetic resonance imaging (MRI), problems which the Company has solved and begun to license to leading device manufacturers. The Company's mission has expanded to provide other technologies which will improve the delivery of healthcare. Biophan's technologies enable medical systems such as pacemakers, interventional surgical devices such as catheters and guidewires, and implants such as stents to be safely and/or effectively imaged under MRI. The Company is helping to commercialize the MYO-VAD(TM), a novel, MRI-compatible ventricular assist device which has significant potential to improve the treatment of many forms of acute and chronic heart disease. Other applications in development include drug delivery and power systems which derive energy from body heat. Committed to growth through innovation and developmental leadership, Biophan and its licensors now hold a total of over 200 U.S. and foreign patents, licenses, or applications. This total includes 56 issued U.S. patents, and over 100 pending applications at various stages of examination at the U.S. Patent and Trademark Office. The patents cover areas including nanotechnology (nanomagnetic particle coatings), medical device designs, radio frequency filters, polymer composites, thermoelectric materials, and photonics. Biophan has joint development and licensing agreements with Boston Scientific Corporation and NASA's Ames Center for Nanotechnology. Biophan is traded on the OTC market under the symbol BIPH, and is also listed on the Frankfurt Stock Exchange under the symbol BTN.
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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.