NeurAxis (NRXS) Lytham Partners Fall 2024 Investor Conference summary

Company overview and strategy

• Focused on pediatric med tech with a decade of experience and a strong execution record on milestones.

• Built on the philosophy that robust research leads to policy coverage, reimbursement, and revenue growth.

• First to market with an FDA indication for pediatric functional abdominal pain associated with IBS, targeting a $9B pediatric and $23B total addressable market.

• Owns a Category III CPT billing code and is pursuing a permanent Category I CPT code, with major insurance coverage initiated.

• Operations and infrastructure are designed to scale, aiming for break-even and cash flow profitability in the first half of 2025.

Product pipeline and market expansion

• Commercializing IB-Stim for pediatric IBS, with submissions underway for functional dyspepsia and other GI indications.

• Preparing to submit for adult IBS indication to the FDA in 2025, expanding the addressable market.

• RED (rectal expulsion device) licensed from the University of Michigan, expected to clear FDA by December or January, with existing CPT code and reimbursement.

• Multiple double-blind, placebo-controlled trials in progress for additional indications.

• Several new indications expected to go through FDA in the next 12 months, potentially boosting revenues.

Clinical data and insurance coverage

• Device offers a non-drug alternative for pediatric GI disorders, with significant long-term data showing efficacy at 12 months.

• Supported by 16 investigator-initiated publications and strong academic society endorsements.

• Number needed to treat for IB-Stim is three, superior to many adult IBS drugs.

• Insurance coverage now includes 12 plans and 24 million covered lives, with more policies pending and expected to reach 36 million.

• Academic society guidelines and Category I CPT code are key to unlocking broader payer coverage.