NeurAxis (NRXS) 2nd Annual Lytham Partners Healthcare Investor Summit summary

Corporate milestones and market focus

• Transitioned from pediatric-only to also serving adults, with multiple FDA indications and ongoing clinical trials for PENFS in both groups.

• Secured a Category I CPT code effective January 2026, enabling streamlined billing and increased insurance coverage.

• Achieved over 100 million covered lives, primarily in pediatrics, and expanded commercial payer coverage.

• 2025 revenue expected to exceed $3 million, with gross margin around 84% and 5,000 units sold.

• Focus remains on functional abdominal pain and functional dyspepsia in both pediatric and adult populations.

Clinical data and product differentiation

• Only FDA-cleared treatment in pediatric guidelines for gut-brain interaction disorders.

• 16 investigator-initiated publications, including double-blind, placebo-controlled trials and large registries.

• IB-Stim demonstrated an NNT of 3, outperforming standard IBS drugs in adults (NNT 6-14).

• Largest pediatric registry showed 61% of patients had failed at least four medications before IB-Stim.

• Device is non-drug, non-surgical, and used in outpatient settings for patients aged 8-21.

Commercial strategy and insurance coverage

• Category I CPT code brings RVUs to physicians, credibility, and streamlined billing.

• Insurance coverage now includes about 40-50% of the non-Medicare US population.

• 17 insurance plans in place, with 100 million covered lives, mainly in pediatrics.

• Focused on expanding policy coverage to more payers and increasing awareness among physicians.

• Expectation that increased coverage will raise ASP and gross margins as more devices are reimbursed at full price.