Bioelectronics Corp (BIEL)

[Simpsonly]

August 20, 2015
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM459368.pdf

Brilliantly written report, by a brilliant Task Force made up of dedicated professionals, on how medical devices are, and perhaps should be, evaluated. I see this as a major step in continuing FDA philosophy, that only very few years ago it was transparently stated that CDRH needed to bolster its forces in order to deal with the plethora of emerging medical devices, and this report is a major piece on how to do it. It further strengthens that medical devices, wherever possible, and not drugs is the era we are in. How does that impact us and BIEL?

Seems to me the paradigm shift in treatment of pain continues. As readers here will know, I have long been impressed by the professional humility of FDA's CDRH in saying a few years ago, "we need to hire new people and improve ourselves, so we can assess and manage the medical device space better." Because of the unique position of BIEL and ActiPatch, a miniature, battery powered, safe and efficacious, chemical--free analgesic device that also promotes healing, it becomes easier to see why ActiPatch initially floored the pretty bright folks at FDA. We may think this has taken a long time and we have all been impatient in varying degrees, but the emergence of a legitimate disruptive technology takes time and my take is that FDA is coming like a runaway freight train, soon.