ROCHESTER, N.Y. -- Biophan Technologies, Inc. (OTCBB: BIPH; FWB: BTN), a developer of next-generation biomedical technology, announced today that Biophan Europe GmbH has reported a series of important operational achievements for the year ended December 31, 2005. Dr. Michael Friebe, CEO of Biophan Europe, highlighted the Company's progress in developing proprietary solutions that enable fully compatible Magnetic Resonance Imaging (MRI) of stent based medical devices such as heart valves, coronary and peripheral stents, and vena cava filters, as well as new honors and recognitions that it has received.
"We are pleased to report that 2005 was a year marked by substantial new accomplishments in meeting our biomedical mission and overall strategic objectives," said Dr. Friebe. "Following our reorganization as a European subsidiary of Biophan Technologies in May, we have continued to make very encouraging progress on several major development fronts. Our scientific team led by Chief Technology Officer, Dr. Andreas Melzer, has also received gratifying new recognition from the international scientific community in the last year."
Biophan Europe is a global leader in developing modification technologies to make a range of implanted devices clearly imageable with MRI systems. In general, MRI is considered a superior imaging technology compared to relatively risky and invasive alternatives, including catheter labs and X-ray machines. Biophan Europes development program could dramatically improve interventional MRI and further enable minimally invasive surgical procedures. Currently, many implantable and surgical devices comprised of metal are contraindicated for use with MRI. In order to extend MRI to additional patients who need it, Biophan Europe has developed a variety of patented resonant circuit technologies to enable MRI imaging techniques to look "inside" stents and other implants, and to enable the MRI-guided implantation of the devices. Developed under the stewardship of Dr. Melzer, these potentially revolutionary capabilities would make virtually any stent fully visible with MRI, accompanied by certain changes in device design or material and proprietary AMRIS technologies (AMRIS is the previously registered name of Biophan Europe).
In addition, Biophan Europe reported the following key accomplishments for 2005:
MRI-Visible Stent Design:
Biophan Europe facilitated an exclusive license for Biophan Technologies with leading German biomedical researchers, Dr. Arno Bcker and Dr. Alexander Ruebben, for their breakthrough stent technology enabling accurate MRI in or around metallic stents. Together with the existing technologies already held by Biophan, including those obtained through the Company's recent acquisition of AMRIS GmbH, the exclusive license with Dr. Bcker and Dr. Ruebben will give Biophan licensing ownership to two of the most viable methods to create artifact-free images of stents and implants with MRI.
Advanced a series of highly successful and encouraging acute animal trials in pigs. These initial studies demonstrate the feasibility of MRI imageable stents as a solidly viable concept and to establish whether diagnosing restenosis, or the re-clogging of arteries through unwanted tissue growth, can be imaged using MRI.
Based on these results, Biophan Europe intends to launch chronic animal studies, the next major preclinical testing phase, expected to begin in Q2 2006.
MRI-Visible Vena Cava Filter:
Further advanced a successful preclinical animal study collaboration related to MRI-vena cava filter imageability with a major strategic development partner in Germany, the University of Aachen. The study is designed to show, first, that this device would inherently be an effective filter, and, second, that this filter, as well as all other procedural tools used for this implantation procedure, would be fully compatible under MRI guidance, and would show the filters status under MRI.
This first testing phase of the filter is expected to be completed in Q1 2006. With further development progress, Biophan Europe expects to accelerate this product line to market.
MRI-Visible Stent-Based Heart Valve:
Completed preclinical animal trials in December, successfully demonstrating the conceptual feasibility and MRI imageability of a stent-based heart valve in a joint project spearheaded by Dr. Andreas Melzer with the National Institutes of Health (NIH), in Bethesda, Maryland;
Based on these successful results, the first applications in which the heart valve will be implanted in human volunteers for further examination, are expected to begin in 2006.
MRI-Visible Occlusion Device:
Filed a number of significant patent applications to cover additional breakthrough technologies related to development of an MRI-visible occluder, an implant designed to cure heart wall defects.
Additional Intellectual Property Expansion:
Biophan Europe is also developing several additional product prototypes, for which patent protections have been filed. Additional details about these MRI-related technologies were not announced at this time.
Additional Honors and Recognition:
Published an article written by Dr. Friebe about the future of MRI systems in interventional medical procedures. The article appeared in the IAMERS Newsletter, published by the International Association of Medical Equipment Remarketers & Servicers (Oct. 2005);
Received a prominent award for a research presentation from the leading group, the European Society on MRI technology, which formally presented the honor at a scientific conference held in Basel, Switzerland (Sept. 2005);
Received substantial research grants during the year from the German government for continued studies of a proprietary vena cava filter technology.
Worked closely with Biophan Technologies on the execution of milestone, multimillion dollar licensing and equity agreements with Boston Scientific.
In response to the 2005 accomplishments, Michael Weiner, CEO of Biophan Technologies, said, "Our acquisition in May of what would become Biophan Europe was without doubt one of the past year's most important achievements. Biophan Europe's research has generated 15 additions to Biophans extensive intellectual property portfolio, further strengthening our MRI technology leadership. The acquisition also brought new world-class scientific personnel and additional access to the European research community, where some of the most exciting research into MRI is being conducted. We are delighted with the past years progress and look forward to additional advancements in 2006, both at Biophan Europe and at Biophan Technologies."
About Biophan Technologies
Biophan develops and markets cutting-edge technologies designed to make biomedical devices safe and image compatible with the magnetic resonance imaging (MRI) environment. The Company develops technologies that 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. Biophan is developing these same technologies to provide new MRI contrast agents. Other applications include drug delivery and power systems which derive energy from body heat. Biophan also has an equity position in MYOTECH, LLC to assist in development and commercialization of an MRI compatible cardiac assist device - the MYO-VAD(TM). Committed to growth through innovation and developmental leadership, Biophan and its licensors now hold a total of 156 U.S. patents, licenses, or applications, plus international applications. This total includes 45 issued U.S. patents, 7 recently-allowed applications that will issue as patents in the near future, and 104 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 which generate electricity from body heat, and photonics. Biophan has joint development and licensing agreements with Boston Scientific 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. Biophan is also listed on the Frankfurt Stock Exchange under the ticker symbol BTN.
For more information, please visit
www.biophan.com.