And I'm not trying to mislead investors. I'm merely trying to keep the pumpers honest, or at the very least, letting them know they aren't fooling EVERYONE.
The FDA accepted 3 Clinical Studies in BIEL's ActiPatch Musculoskeletal Clearance
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. Conclusion: The non-clinical data, clinical data, and extensive real-world registry data demonstrate that the ActiPatch is at least as safe and effective as the predicate device and can be used as an over-the-counter device for adjunctive treatment of musculoskeletal pain.
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