NeurAxis (NRXS) Corporate presentation summary

Business overview

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

• First-to-market with FDA-cleared percutaneous electrical nerve field stimulator (PENFS) technology for pediatric functional abdominal pain (FAP) and IBS.

• Expanding clinical trials for additional pediatric and adult GI indications, with a robust pipeline and multiple FDA submissions planned.

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

• Operations and infrastructure are built to scale, with a seasoned management team and board.

Market opportunity and commercial strategy

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

• PENFS is the only FDA-cleared treatment recommended in guidelines for pediatric FAP/IBS, addressing significant unmet needs.

• Policy coverage in place for ~100M covered lives, with major insurance payer momentum and a list price of $1,195.

• Targeting ~260 children’s hospitals, 33,000 pediatricians, and 10,000 adult gastroenterologists in the U.S.

• RED device for constipation care adds a $2B market opportunity, with FDA 510(k) clearance and CPT reimbursement.

Clinical evidence and product differentiation

• Supported by highest GRADE evidence and ~1,000 published patients in peer-reviewed studies.

• Demonstrated efficacy in reducing pain and improving functional disability in pediatric IBS/FAP, outperforming standard pharmacotherapy.

• Largest pediatric registry shows sustained efficacy up to 6-12 months post-treatment, even in patients who failed multiple medications.

• PENFS shown to be equivalent or better than standard medications in head-to-head studies.

• Non-drug, non-surgical, outpatient device with strong safety profile and minimal side effects.