BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive,
disposable drug-free anti-inflammatory devices, today announced it filed
an application with the U.S. Food and Drug Administration (FDA) for
reclassification to Class II of its existing device which was given FDA
Class III approval in 2002. Additionally, based on information provided
during a recent meeting with FDA personnel, the Company will also be
filing an application for Pre-Marketing Approval (PMA).
“We have assembled a substantial amount of compelling documentation to
present to FDA that outlines not only the extreme safety of our
products, but also the high level of efficacy”
Reclassification will help facilitate over-the-counter (OTC) clearance
in United States of its ActiPatch® and Allay™ products. BioElectronics
products are currently cleared for sale in dozens of countries including
Canada, China, Japan, Korea and Australia. BioElectronics devices also
have the CE Mark (European Common Market) certification for OTC sales
and have been approved by Health Canada. BioElectronics’ devices are
currently considered thermal pulsed electromagnetic field (PEMF) therapy
devices, but additional evidence shows the devices do not produce heat
and should be classified as non-thermal devices.
“We have assembled a substantial amount of compelling documentation to
present to FDA that outlines not only the extreme safety of our
products, but also the high level of efficacy,” said Andrew Whelan, CEO
of BioElectronics. “Our products have been used by hundreds of thousands
of individuals worldwide without a single safety complaint. The vast
majority of these users had enjoyed substantial pain relief and
decreased recovery intervals after injury or surgery. Thousands of
others have received pain relief and accelerated healing of chronic
musculoskeletal complaints. We have also completed and have several
ongoing Institutional Review Board (IRB) supervised clinical studies
sponsored by prominent physicians, which has clearly demonstrated the
high efficacy of our products. We believe the examiners at FDA will be
impressed by the compelling case we will present to them seeking
reclassification. We strongly believe our products are Class II devices,
which should receive OTC clearance in order to help the millions of
American pain sufferers who are seeking pain relief and alternatives to
potentially dangerous OTC drugs such as acetaminophen and ibuprofen.”
Based on information provided to the Company by FDA personnel,
BioElectronics has decided to also file a Pre-Market Approval (PMA)
application.
“We believe there are significant benefits to our Company and its
shareholders to have our devices cleared via the PMA process as it
effectively allows us to define a completely new space within the
medical device and pain management markets,” Whelan said. “Clearance
under PMA will also allow us to better control our trade secrets and
would prevent any would-be competitor from using our device as a
predicate in order to receive clearance, ultimately making it much more
difficult for anyone to compete with us in the domestic market place. We
plan to immediately begin the PMA clearance process while our other
applications run in parallel.”