Osteoarthritis Study shows ActiPatch® Therapy Significantly Relieves Knee Pain
Clinical Results Open Significant Market Opportunity for BioElectronics Corp.
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 21(st) 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 3(rd) 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.
SOURCE BioElectronics Corporation