FREDERICK, Md., May 21, 2013 /PRNewswire/ -- BioElectronics Corp.
(PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free
consumer electronic devices, announced that CEO, Andrew J. Whelan is presenting today to the
FDA's Medical Advisory Committee, Orthopedic and Rehabilitation
Panel compelling arguments for reclassifying the company's products
for over the counter sales.
"It's been 37 years since the FDA developed its medical device
classification schema," Whelan said. "While the old
classification of pulsed shortwave devices probably made sense in
the 1970s, it is out of date in light of the dramatic advances in
research and it would be lamentable if U.S. consumers were denied
access to this safe, drug-free and cost-effective
technology."
Whelan attributed the FDA classification decision to a lack of
an understandable mechanism of action of pulsed shortwave
technology at that time. "While pulsed shortwave diathermy
has been in use for more than 80 years using large, high-voltage,
clinic-based machines and is routinely used in the United Kingdom in 11% of all physical therapy
sessions," Whelan explained. "The safety record is
unassailable." The FDA's own executive summary prepared for
the meeting reported that in more than 17 years of its record
keeping there were only 5 reports of adverse effects from any of
these systems, (including high power systems) none of which were
life-threatening or could be attributed to the
devices.[i]
"We've sold hundreds of thousands of our miniature, low-power
devices and have never had an adverse effect reported." Whelan
said. Nonetheless, in the absence of a clear demonstration of
a mechanism of action, the FDA was put in a position of having to
classify all pulsed shortwave device products into Class III.
In the rest of the world, this technology is readily
available. Whelan reported that BioElectronics has
over-the-counter clearance from health agencies in 40 countries
around the world.
Recent studies have demonstrated a clear mechanism of action for
pulsed shortwave diathermy. Whelan was assisted in the
explanation to the panel by a researcher from the State University of New York in Binghamton, Sree
Koneru. Working at the Department of
Bioengineering at the Watson School Koneru's experiment
demonstrated the activation of motor nerves with non-thermal RF
diathermy.
The hierarchy of nerve firing tells us that the initial response
to the stimulus is sensory nerves activation. We now know that
BioElectronics devices stop pain though well established and
understood electrical nerve stimulation. The effect is
achieved through a proven physical phenomenon of stochastic
resonance. This demonstrated physiological mechanism of
action is a major breakthrough for shortwave therapies that are
considered non-thermal by the FDA.
There is significant public support for Whelan's position.
As part of its stakeholder review process, the FDA received 248
comments asking the FDA to reclassify ActiPatch to an
over-the-counter class.[ii]
http://www.regulations.gov#!documentDetail;D=FDA-2012-N-0378-0003
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch® Therapy,
over-the-counter treatment for back pain and other musculoskeletal
complaints, RecoveryRx(TM) Devices for chronic and post-operative
wound care, HealFast®Therapy (www.healfasttherapy.com) and the
Allay(TM) family of inexpensive, disposable drug-free
anti-inflammatory devices. For more information please see
http://www.bielcorp.com.
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
[i] FDA Executive Summary – page 24 - Executive
Summary: May 21, 2013 (PDF - 903KB)
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm
[ii] ibid, page 18 – External Stakeholder Responses to FDA's
July 6 Proposed Rule Call for
PMAs.
SOURCE BioElectronics Corp.