BioElectronics Corporation says 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 and the results have been accepted in the Annals of the Rheumatic Diseases and presented at the European League against Rheumatism 2014 conference.
"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."
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.