NeurAxis (NRXS) Investor presentation summary

Commercial and financial progress

• H1 2026 revenue exceeded $3.5M vs. >$1.8M in H1 2025; gross margin was 86% vs. 84%.

• Category I CPT code for PENFS effective Jan. 1, 2026; coverage exceeded 28 plans and 100M lives in 2026.

• IB-Stim list price was $1,195; target channels include ~33K U.S. pediatricians, ~10K adult gastroenterologists and ~260 children's hospitals.

• Presentation cites significant expanded commercial payer coverage and a treatment recommended in guidelines for its cleared indications.

Product and market opportunity

• IB-Stim is a non-drug, non-surgical PENFS device for patients aged 8+ with functional abdominal pain associated with IBS or functional dyspepsia; treatment is 120 hours weekly for 4 weeks.

• Target pipeline SAM is $22B+: $8B pediatric and $14B adult; current treatments are described as off-label pharmacological options with adverse side effects.

• RED is an in-office, self-inflating balloon expulsion test for chronic constipation; it received FDA 510(k) clearance on Dec. 6, 2024.

• RED targets a ~ $2B market; CPT 91125 carries a 2026 Medicare national average payment of $347.

Clinical evidence and unmet need

• PENFS research spans 21 studies and 10 study types, including placebo-controlled, real-world, long-term, registry, safety and health-economic data; 13 children's hospital sites are cited.

• A pediatric registry covered 292 patients at 7 centers; 61% had failed at least 4 medications, with sustained abdominal-pain efficacy reported 6–12 months after treatment.

• In a randomized, double-blind trial, IB-Stim's number needed to treat was 3 for ≥30% pain improvement; the cited adult IBS drugs had NNTs of 6–14.

• The presentation cites no FDA-approved therapies for functional dyspepsia and only one peripherally acting drug approved for pediatric IBS; it also notes quality-of-life impacts and medication concerns.