Bioelectronics Corp (BIEL)

[GetSeriousOK]

The problem is the word "pilot," not the word "study." Pilot studies don't have endpoints. This one had "Aims" (bolding emphasis mine)

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

Another possible issue is the fact that the 120 participants are split into eleven indications. For any given indication, there were presumably about ten participants. You like to define medical study terms -- please define "underpowered" for us.

Another possible issue: timing. Ilfeld's amputation study completed on 08/10/2023 was published on 02/21/2024. That's about six months. We don't know when the opioid study completed, but assuming it was completed on the estimated date 04/03/2024, the projected publication date for the opioid study in 12/2024. BIEL will then have to submit that evidence to the CMS and wait to see if they accept it as adequate evidence for reimbursement under the NOPAIN Act. How long will the CMS take to decide?

And will Ilfeld publish the ActiPatch Study by itself, or will he wait for the SofPulse study to finish and publish them together? Let's remember that Ilfeld is independent -- he doesn't work for BIEL, as Whelan has been quick to point out, and his decisions and publication dates are not influenced by whether they help or hurt BIEL. Nine months into the ActiPatch study (in April 2023), Ilfeld started the SofPulse study to focus on only THREE of the indications studied in the ActiPatch study, and he ended the ActiPatch study early in Oct 2023 with only 120 of the projected 200 participants.

Those three indications are:

* primary knee arthroplasty
* primary hip arthroplasty
* cholecystectomy

https://clinicaltrials.gov/study/NCT05796583

In summary, if all of BIEL's hopes and dreams are pinned on this one PILOT Study.... that's not good, IMO.