Bioelectronics Corp (BIEL)

[GetSeriousOK]

the "one device" they've approved so far is the ON-Q Pump, described as "Elastomeric infusion pump, non-opioid pain management delivery system, including catheter and other system component(s)", HCPCS code C98X4.

If you're interested, here's the clinical study they used to show that the ON-Q Pump meets the NOPAIN Requirements:

Ding DY, Manoli A 3rd, Galos DK, Jain S, Tejwani NC. Continuous Popliteal Sciatic Nerve Block Versus Single Injection Nerve Block for Ankle Fracture Surgery: A Prospective Randomized Comparative Trial. J Orthop Trauma. 2015;29(9):393-398. https://pubmed.ncbi.nlm.nih.gov/26165259

Here's the link:
https://pubmed.ncbi.nlm.nih.gov/26165259/

only 50 patients, but you'll notice it was not a pilot study or case study. The researchers analyzed the data and calculated a P-score for the results and it was under 0.05 which is the generally accepted value for "statistical significance."

"Intervention: Participants were randomized to receive either a popliteal sciatic nerve block as a single shot (SSB group) or a continuous infusion through an On Q continuous infusion pump (On Q group)."

"Results: For all time points after discharge, mean postoperative pain scores and number of pain pills taken were lower in the On Q group versus the SSB group. Pain scores were significantly lower in the On Q group at the 12 hours postoperative time point (P = 0.002) and at 2 weeks postoperatively. The number of pain pills taken in the first 72 hours was lower in the On Q group (14.9 vs. 20.0; P = 0.036)."

Maybe they'll approve more devices. The NOPAIN Act goes from Jan. 1st 2025 through Dec 31st 2027.