Bioelectronics Corp (BIEL)

[GetSeriousOK]

If it's any consolation, Ilfeld's pilot study for the SofPulse device probably won't satisfy the CMS either, because he's not calculating a P-value for the secondary outcome of measuring opioid use.

In the SofPulse trial, he's calculating a P-value for the Primary Outcome of pain reduction (which he didn't do in the ActiPatch study), but he's not statistically analyzing the Secondary Outcome data (opioid use). He says "Results of comparisons in secondary outcomes will be interpreted as suggestive, requiring confirmation in a future trial before considering them as definitive."

https://clinicaltrials.gov/study/NCT05796583

I have a theory. When designing a clinical study to prove the ActiPatch reduces opioid use, choose indications that are severely painful. Broken bones are painful -- the indication in that ON-Q Pump study was "fractured ankle surgery."

In the SofPulse study I think Ilfeld is trying to do that -- he omitted less painful indications like hernia repair, focusing instead on cholecystectomy and hip/knee arthroplasty. At the time he designed that SofPulse study he had seen results from the ActiPatch study (we know this because he wrote "Based on values from patients receiving sham in an (as-of-yet) unpublished pilot study.....") so he knew which indications had better results, IMO.

Staelin has time to get a good clinical study done before the end of the NOPAIN Act. It would cost money though. I wonder how successful the company has been in raising money. The first half of 2024 kind of flew by.