Bioelectronics Corp (BIEL)

[GetSeriousOK]

Ilfeld's detailed description of the ActiPatch study:

The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants pilot study with two primary aims:

Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures.

Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures. This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials.

https://clinicaltrials.gov/study/NCT05399355

And here's his detailed description for the SofPulse study:

The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants study with two primary aims:

Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures.

Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures.

https://clinicaltrials.gov/study/NCT05796583

He doesn't use the word "pilot" in the SofPulse description, but it's a Pilot Study with almost the same goals. One notable difference: in the ActiPatch study he states that a goal is to "provide an idea of the optimal surgical procedures amenable to this analgesic technique," which I think he accomplished a year ago, leading him to cherry-pick three procedures for the subsequent SofPulse trial.

Will the CMS accept either study for the NOPAIN Act requirement? I don't think Ilfeld needs to PUBLISH the results in a journal; I think it's a question of whether the CMS accepts a pilot study as clinical proof. If the results are overwhelming, I think they will accept it, but if the results are not overwhelming, I think the CMS will require further proof.

I'm sure JGD will now try to claim that BIEL's old Survey proves a reduction in opioid use. We've been through this more than once. BIEL's survey doesn't come close to satisfying the CMS requirement because:

1. The CMS wants CLINICAL data, not a non-clinical survey.

2. BIEL's survey asked questions about all analgesic use and gathered data about opioids at the BEGINNING, but they did not measure opioid use or ask specific questions about opioids at the end.