NeurAxis (NRXS) Investor presentation summary

Business overview and market opportunity

• Focuses on neuromodulation therapies for chronic and debilitating GI conditions in both pediatric and adult populations, targeting disorders of gut-brain interaction (DGBIs).

• Holds first-to-market position with FDA-cleared PENFS technology for pediatric functional abdominal pain and IBS.

• Serviceable available market (SAM) exceeds $22B, with $8B in pediatric and $14B in adult indications.

• Addresses significant unmet need due to lack of FDA-approved therapies for children and limited efficacy of standard pharmacological treatments.

• Expanding portfolio includes next-generation devices such as the RED device for constipation, with FDA 510(k) clearance and a $2B market opportunity.

Clinical evidence and product efficacy

• PENFS (IB-Stim) is supported by robust clinical data, including over 1,000 published patients and multiple randomized controlled trials.

• Demonstrates significant improvement in global symptoms and functional disability in pediatric IBS patients, with sustained efficacy up to 12 months.

• Outperforms or matches standard medications in pain reduction and functional improvement, with a favorable safety profile.

• Number needed to treat (NNT) for IB-Stim is 3, compared to 6–14 for adult IBS drugs.

• Largest pediatric registry shows 61% of patients had failed ≥4 medications prior to PENFS, highlighting its role as a non-pharmacological alternative.

Commercialization, reimbursement, and financials

• Secured Category I CPT code for PENFS, effective January 1, 2026, streamlining billing and reimbursement.

• Over 101 million covered lives with major insurance payer coverage and strong policy momentum.

• 2025 revenue projected at over $3M, with Q1 2026 revenue at $1.6M and gross margins above 84%.

• List price for IB-Stim is $1,195, targeting ~33,000 pediatricians and ~10,000 adult gastroenterologists in the U.S.

• Cash position as of May 2026 is $7.1M, with no long-term debt and 19.8M shares fully diluted.