FREDERICK, Md., May 23, 2013 /PRNewswire/ -- BioElectronics
Corporation (OTC Pink: BIEL), the maker of very effective, safe
consumer medical devices, comments on the FDA panel meeting for
non-thermal shortwave diathermy:
The FDA's Public Advisory Panel Reclassification – Pulsed
Shortwave Therapy Meeting was held on May
21, 2013 in Gaithersburg,
MD, USA. The focus of the meeting was very narrow, in
that the FDA had instructed the panel to focus solely on the
application of non-thermal shortwave diathermy for the treatment of
postoperative pain and edema and the treatment of edema following
blepharoplasty. Industry representatives, including
BioElectronics President Andy
Whelan, presented a compelling case for
reclassification. The recommendation from the FDA's advisory
panel was reclassification from Class III to Class II with special
controls including a requirement for new clinical data. At this
time it is not clear if the requirement for new clinical data
applies to existing products. The FDA will make a final
decision on the recommendations of the panel in due course, though
BioElectronics believes that the FDA will follow the panel's
recommendations.
"Overall, we see the advisory panel and the FDA's
recommendations as a positive and potentially significant
development," stated Ian Rawe,
BioElectronics Director of Clinical Research. "After decades
of use and research, the FDA now believes that the available
evidence suggests that shortwave devices can be safely regulated.
If existing cleared devices are compelled to submit new clinical
data, our 3rd Molar Extraction clinical study at Tufts Dental School, Boston, meets all the FDA's clinical research
standards. This study is evaluating both postoperative pain and
edema, with edema being quantified with a 3D digital imaging system
(http://www.3dmd.com/). Therefore, because of these expected
developments and with expanded clinical research in place we are
confident of moving forward."
We also continue to press our Petitions in the FDA's
Commissioner's Office of Science Integrity for our musculoskeletal
and menstrual pain market clearances and we are optimistic that
this reclassification concession will help expedite market
clearances.
About BioElectronics Corporation
BioElectronics (www.bielcorp.com) is an award winning developer
and manufacturer of advanced medical devices. Its products are
ActiPatch® Therapy, for over-the-counter treatment of back pain and
other musculoskeletal ailments, the Allay™ Menstrual Cycle Pain
Therapy, and RecoveryRx™ for surgical procedures and wound
care.
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation