Bioelectronics Corp (BIEL)

[srinsocal]

Now that is a surprise......

An anonymous poster said ActiPatch did not work.

I will take the opinion of the FDA and their panel medical experts over an anonymous poster any day of the week.

FDA 510k #192234
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).

• A randomized controlled trial on plantar fasciitis (heel pain): This
was a randomized, double-blinded, placebo-controlled study to
evaluate the safety and effectiveness of the ActiPatch medical
device to reduce the pain level of patients diagnosed with plantar
fasciitis. The placebo treatment was a device that was identical to
ActiPatch but did not produce an electromagnetic field when
turned on. A total of 70 patients were recruited into the study, and
all 70 completed the study. There were 52 women (74.4%) and 18
(25.6%) men in the study, with the following average
demographics at baseline: 51.5 years of age, BMI of 31.8 and
disease duration of 1.1 years. The primary effectiveness endpoint
was the daily morning (AM) VAS score, and the primary safety
endpoint was all treatment-related adverse events during the 7-day
study. The results indicate that ActiPatch significantly reduced
pain (measured by VAS pain) associated with PF in the device
treatment group, and that the treatment differences between active
and placebo treatment groups was significant (p<0.05).

• Usability testing was conducted in 46 men and women over the
age of 18 with a wide range of education levels who used the
RecoveryRx on the knee, lower back, or shoulder. The testing
showed that lay users understand the indications for use and when
not to use the device. In addition, the study showed that users
understand how to turn the device on, place it correctly on the right
part of the body, and how long to use the device.

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192234.pdf