Bioelectronics Corp (BIEL)

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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).

https://pmc.ncbi.nlm.nih.gov/articles/PMC4795538/

https://www.bielcorp.com/biel/wp-content/uploads/2021/01/Mohammad2021_Article_PulsedShortwaveTherapyInCervic.pdf