Bioelectronics Corp (BIEL)

[TruthBeSaid]

Peer-reviewed Clinical Study Results:

Pink, Fuente, There have been two recent proper "double Blinded, Randomized, Placebo Controlled, Clinical Trials" with sufficient statistical power showing clinically and statistically significant results (since last attempts at approval):

(1) Osteoarthritis (published June 2104; the one pink termed "appears to have been abandoned altogether")

AB0777 Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: Preliminary Results of A Double Blinded, Randomized, Placebo Controlled, Clinical Trial

(2) Marathon runners muscle soreness (published 2012)

http://vbn.aau.dk/files/70103539/EFORT12_3384.pdf : "Pulsed electromagnetic field therapy reduces delayed onset muscle soreness in marathon runners. A doubleblind randomized placebo controlled study."

The studies were conducted by groups that are experts in their respective field, search the web for their research publications.
The second group (Aalborg University Hospital) is also conducting one other study on Venous Ulcer which is due for completion in Jan 2015.

All these trials are registered with clinicalTrails.gov.

Note too that the bar for class II is lower than for class III. Typically only 15-20% of 510Ks need clinical trial data at all. For the proposed SWT category, FDA has indicated that they will need clinical trial data, but it is easy to see that the bar will be lower. I don't know how much you know about results of trials, but the results here are beyond question for significance: the p- values are 0.028, 0.017 in the Marathon runner results and 0.001 and 0.002 in the knee osteoarthritis study. A value < 0.05 is generally considered significant ( odds of 1 in 20 due to chance) and will be acceptable to the FDA for class II. We have much better efficacies (1 in 40 to 1 in 1000 that they are occurring due to chance). As far as I can see the chances of 510K clearance is very good. The management should do everything they can not to blow these, I hope they do. If you understand these, take look at the links I provided and tell me what you think. I appreciate your opinions.