Suggestion for BIEL would be to design a wearable glove for this. I'm not envisioning how this thing gets applied to a single digit. Acupuncture tries to treat the body wholistically, maybe the human hand should be considered as a whole, not just the thumb. Meaning perhaps the thumb hurts, but the wrist is the actual source of the trouble. Just a thought.
We know from the 2 Arthritis Clinical Trials, Knee and Cervical (neck), used for the Musculoskeletal Clearance, that ActiPatch is effective in reducing Arthritis Pain. So why did the Thumb Trial, treating a much smaller area than the Knee and Cervical Trials, fail to show significant results?
<<<<< Another failed clinical trial >>>>>
One issue that I noticed is that the Thumb Trail did not specify a specific a number of hours for treatment, stating only "PEMF device wear overnight daily for four weeks". If that is interpreted as, sleeping hours, that could be 7-8 hours a day. Both the Knee, minimum of 12 hours with reporting, and the Cervical, 24 hours a day except when bathing, had specific instructions. Being a low powered PEMF/PSWT device ActiPatch relies on the cumulative effects of its therapy.
Another possible issue is placement of the ActiPatch. I did not see any images of how the device was placed over the thumb.
Musculoskeletal 510k Clinical Data: The clinical data in this 510(k) includes results from three IRB approved, randomized, controlled studies. Additionally, usability testing was conducted to support the OTC use of the device.
• A randomized, controlled trial on chronic cervical osteoarthritis (neck pain): This was a randomized, active-treatment controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with cervical osteoarthritis. The active-treatment control was an NSAID of the Cox-2inhibitor family. There were 200 intent-to-treat patients, out of which 197 completed the four-week study. There were 142 women (71%) and 58 (29%) men in the study, with an average age of 45 years. The primary endpoint for efficacy was reduction in pain (VAS score) while at rest and being active, over four weeks, when compared to the beginning of the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with COA in the device treatment group, and that the treatment differences between device-treatment and NSAID-treatment groups was significant (p<0.05).
• A randomized controlled trial on osteoarthritis of the knee: The osteoarthritis of the knee study was a double-blinded, randomized, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with knee osteoarthritis. The placebo treatment was a device that was identical to ActiPatch but did not produce an electromagnetic field when turned on. There were 66 intent-to-treat patients, out of which 60 patients completed the four-week study. There were 43 women (71.6%) and 17 (16.4%) men in the study, with the following average demographics at baseline: 68 years of age, BMI of 27.4 and disease duration of 12.1 years. The primary effectiveness endpoints were improvements in pain level over the four weeks as measured by the before and after VAS score and WOMAC scores, and the primary safety endpoint was all treatment-related adverse events during the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with KOA in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
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