NeurAxis (NRXS) investor relations material

Corporate overview and market expansion

• Focus on neuromodulation therapies for gut-brain interaction disorders, initially in pediatrics, now expanding to adults.

• Secured a Category I CPT code effective January 1, 2026, after an 8-year process.

• Insurance coverage expanded to 120 million lives after recent Cigna and Anthem policy wins.

• Revenue for H1 2026 reached $3.5M, up from $1.8M in H1 2025, with gross margins rising from 84% to 86%.

• Adult market entry underway, but insurance coverage currently limited to pediatric indications.

Clinical development and data

• Multi-site RCT for adults launching in fall 2026 at major centers, targeting 350–400 patients.

• Over 1,000 published patients and 21 studies support efficacy, including head-to-head trials against pharmaceuticals.

• Largest pediatric registry conducted with 300 patients, showing sustained efficacy 6–12 months post-treatment.

• IB-Stim device demonstrated superior outcomes to standard drugs, with a number needed to treat of 3 versus 6–14 for IBS drugs.

• Functional disability scores improved significantly, moving patients from moderate to minimal disability.

Technology and commercialization

• IB-Stim device is a wearable neuromodulation product, priced at $1,200 per unit, with each patient typically using four.

• Device targets cranial nerves to modulate brain pathways, offering long-term relief without pharmaceuticals.

• Commercial strategy includes expanding W2 sales force and leveraging over 30 insurance policy coverages.

• IP portfolio extends through 2039, with U.S.-based manufacturing and backup supply chain.

• Total addressable market estimated at $5B for pediatrics and $2B for adults, pending adult RCT results.