BioElectronics Chairman Updates Investors - Seite 2

COMPLETED STUDIES NOW UNDER PEER REVIEW

There are two randomized controlled studies that have been completed. The first was an investigator sponsored study to treat chronic post-amputation pain with our nonthermal, pulsed shortwave (radiofrequency) therapy using our model 088 device. This study used a cross-over design where the subject got both the active and sham device for 4 weeks and after each of these four-week periods the subjects record the change in average residual and phantom limb pain.  This study is complete and the results are now in press and will appear in the Regional Anesthesia and Pain Medicine journal.  The abstract will be presented at the American Society of Regional Anesthesia conference in March. Pending publication, we intend to pursue marketing into this pain market given its size (over 1.5 million people have lost a limb). Importantly, up until now there is no effective way of treating phantom limb pain.

The second completed double-blind randomized controlled study looked at increasing the quality of life of canines suffering from symptoms of osteoarthritis. This clinical trial studied 60 canines and found significant improvements in a) behavioral measures often associated with pain and b) range of motion in the affected limbs. In fact, 96% of the treated dogs showed significant improvements in one or both of these measures compared to 4% for the dogs that got the placebo device. The paper documenting these results is currently under third round peer review at the Veterinary Medicine and Science journal. The authors anticipate hearing back within a month as the last request for changes indicated the need for only minor revisions.   Based on these positive results, the Company has already designed and ordered new veterinary packaging and plans to commence selling into the veterinary market.

MANUFACTURING

The Company, working with its Chinese manufacturer, recently redesigned the manufacturing process to increase the reliability and shelf life of its current OTC product. The Company also did a proof-of-concept production run of its newly designed RecoveryRx product that is 50% more powerful and has a larger antenna thereby increasing the size of the surgical incision that can be treated. The plan is to test market these devices in the near future.