Bioelectronics Corp (BIEL)

[Sooah]

You're welcome. Don't listen to folks who sold BIEL last year and have fallen asleep on the developments. In a nutshell, today's FDA Docket basically sets new standards for SWT clearance because BIEL's products are now treated as Shortwave Therapy (SWT) not Shortwave Diathermy devices. The old classification of pulsed shortwave devices was developed in 1970 and the standard for clearance depended on mechanism of action applying stringent standards that apply to high risk medical devices that fall into Class 3. In other words, FDA's classification for SWT/SWD was really outdated and had to be revised based on the Agency obtaining new, modern scientific evidence last year (at the FDA's Medical Advisory Committee, Orthopedic and Rehabilitation Panel where BIEL presented).

It is really a shame that the US FDA has not given BIEL clearance when health agencies in 40 countries have.

Now that there are guidelines set for special and general controls, BIEL can apply for clearance under Class 2 and submit additional, new data from the clinical studies that have been completed as of the end of last year. Take a look at what they have to submit per BIEL's shareholder update:

Significant progress has been made on this front, with clinical trials on three musculoskeletal pain conditions, plantar fasciitis, acute lower back and osteoarthritis of the knee. Two studies are being conducted on postoperative pain, hernia recovery and 3rd molar extraction. An independent study is also being conducted on venous stasis ulcer wound healing and pain management. All the clinical research is being conducted by well respected, and widely published clinical researchers. At this time the plantar fasciitis study has just been completed.

The primary end point of this study was disability and pain at six months after ActiPatch therapy. The results show excellent improvement at the 6 month time point, indicative of tissue remodeling and healing. The subjects had chronic plantar fasciitis presenting with symptoms for an average of 29 months prior to joining the study with high levels of pain and disability.

Rapid progress has also been made on the acute lower back pain and osteoarthritis of the knee studies. These studies will be wrapped up by the end of 2013. Interim results for the acute lower back pain study were very promising. We are hopeful that together the results from these three clinical trials as a series of diverse musculoskeletal pain conditions will allow us to compliment and support our continuing efforts with the US FDA to gain market clearance for ActiPatch. The two postoperative pain clinical studies will be completed in first half of 2014.

Supplementing these clinical studies are two peer reviewed publications which will be published in 2014.

"The Case for OTC Shortwave Therapy, Safe and Effective Devices for Pain Management" will be published in the January issue of Pain Management, author Ian Rawe, Ph.D. Director of Research, BioElectronics.

"Non-thermal Pulsed Shortwave Therapy", authors: Kenneth McLeod, Ph.D. and Sree Koneru. This paper will support our efforts to achieve the goal of ActiPatch market clearance from the FDA as it provides physiological data in response to non-thermal pulsed shortwave therapy.
The Clinical studies are being conducted at excellent medical institutions: Tufts Dental School, University of Chicago Medical School, University of British Columbia, University Hospital Ghent, Belgium, University Hospital G. Martin, Messina, Italy and University of Otago, Dunedin, New Zealand.

Did I read that BIEL has no new clinical data to submit to the FDA? Wrong again, it seems.