Biophan to study MRI safety with US Food and Drug Agency
8 May 2006
Rochester, N.Y., USA. Biophan Technologies, Inc. (OTCBB: BIPH; FWB: BTN)
has entered into a research partnership with the US Food and Drug
Administration (FDA) to help improve patient safety in magnetic resonance
imaging (MRI) environments.
Under a Cooperative Research and Development Agreement (CRADA), Biophan
will collaborate with the FDA's Science and Engineering Laboratories in the
Center for Devices and Radiological Health, to help develop guidelines and
standards for assessing the safety of cardiac pacemaker and neurostimulation
leads used in the MRI environment. The agreement is part of the government's
initiative to address these public safety concerns.
"Biophan is very gratified to be working with the FDA to research these
areas and to help to extend the benefits of MRI to all those who need it,"
said Michael Weiner, CEO of Biophan Technologies. "The sad reality is that
more than half of all recipients of pacemakers and other implanted devices
today are estimated to be denied access to MRI post-implantation. This
amounts to hundreds of thousands of people who are denied the benefits of
MRI. Biophan believes that this is an untenable situation that must be, and
can be, effectively remedied. The Company has a wide range of solutions for
and has extensive scientific expertise in the issues involved."
The CRADA between Biophan and the FDA could lead to a variety of
solutions for the healthcare industry, Mr. Weiner noted, including: a new
generation of medical devices, manufactured to be fully MRI safe;
enhancements to currently existing medical devices, to enable MRI safety;
and either new or modified MRI technologies to enhance the safety of these