FREDERICK, Md., April 16, 2014 /PRNewswire/
-- BioElectronics Corporation (OTC Pink: BIEL), the maker of
advanced consumer medical devices, announced reports on preliminary
results of a randomized, double blind, placebo controlled trial on
osteoarthritis of the knee (knee pain) using ActiPatch®
Therapy.
An abstract on the interim analysis of the osteoarthritis (OA)
knee pain study has been accepted by EULAR (European League against
Rheumatism) for their 2014 conference and will be published in the
June online only supplemental issue of the Annals of the
Rheumatic Diseases. The initial interim analysis showed
statistically significant results for the primary and secondary
outcomes measures. The study is being led by Doctor Gianluca Bagnato, Division of Rheumatology,
University Hospital Gaetano Martino, Messina, Italy. The final analysis of the full
study data set will be carried out soon.
Positive results from this trial will support our 510K
application for ActiPatch® Therapy, along with our recently
completed Plantar fasciopathy study, and lower back pain study,
which we expect to be completed in April with results available in
May. "The completion of these randomized, placebo controlled
trials, on pain resulting from three very distinct musculoskeletal
pathophysiological processes, is highly significant," commented
Andrew Whelan, BioElectronics CEO.
"The data from these high quality clinical trials will be available
before the FDA's May 21st
deadline for comments on proposed reclassification of our devices
to Class II. This schedule will allow us to submit the 510K
application without any delay once the final ruling is made by the
FDA."
Other Clinical Research
BioElectronics is conducting a
series of clinical research studies using its medical devices for
other musculoskeletal pain conditions that include, acute
nonspecific lower back pain, as well as the surgical indications of
postoperative recovery for 3rd molar extraction and
hernia repair. Details can be found at
http://www.bielcorp.com/clinical-evidence/ along with details of
previously completed and published clinical trials.
About BioElectronics Corporation
BioElectronics
Corporation is a leader in biophysics and the maker of an industry
leading family of disposable, drug-free, anti-inflammatory devices:
ActiPatch® Therapy, over-the-counter treatment for back
pain and other musculoskeletal complaints; RecoveryRx®
Devices for chronic and post-operative wound care;
Allay® Menstrual Pain Therapy; and HealFast®
Therapy for dogs, cats and horses. For more information,
please visit www.bielcorp.com.
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation