BioElectronics Presents FDA Reclassification Panel

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  "While the old classification of pulsed shortwave devices probably made sense in the 1970s, it is out of date in light of the dramatic advances in research and it would be lamentable if U.S. consumers were denied access to this safe, drug-free and cost-effective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
[email protected]

[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.