NeurAxis, Inc.

What they do

Neuraxis develops and sells PENFS-based neuromodulation devices, primarily IB-Stim, for pediatric and adult GI conditions, and RED, a diagnostic device for rectal expulsion and hypersensitivity. The company sells directly to hospitals and clinics, with revenue derived from device sales.

Revenue drivers

• IB-Stim — Core revenue driver; sells for $1,195 per device, with each patient using four devices; indicated for functional abdominal pain with IBS, functional dyspepsia, and associated nausea.
• RED (Rectal Expulsion Device) — Office-based test for chronic constipation due to pelvic floor dyssynergia; smaller commercial contribution relative to IB-Stim.
• Federal Supply Schedule Contract — Awarded in December 2025; allows sale of IB-Stim to U.S. government entities, potentially expanding distribution.

Recent performance

Quarterly revenue rose from $811,414 in Q3 2025 to $968,127 in Q4 2025, then to $1.6M in Q1 2026 and $1.9M in Q2 2026. Net loss for Q2 2026 was $2.09M, compared to $1.69M in Q2 2025. For the six months ended June 30, 2026, net loss was $3.85M, slightly improved from $3.97M in the prior-year period. Annual revenue grew to $3.6M in 2025 from $2.7M in 2024, while net loss narrowed to $7.8M. Cash and equivalents stood at $8.3M as of June 30, 2026.

Strategy

The company is pursuing broader insurance coverage and reimbursement, leveraging the new AMA Category I CPT code effective January 1, 2026, which streamlines physician billing. It is expanding clinical trials for additional indications including post-concussion syndrome, cyclic vomiting syndrome, post-operative pain, and fibromyalgia. Management also aims to grow sales through hospital and clinic adoption and the federal supply schedule contract.

Risks

• Dependence on IB-Stim — Nearly all revenue comes from IB-Stim; failure to maintain clearance or commercialize would materially harm the business.
• Going concern uncertainty — Auditors have expressed substantial doubt about the company's ability to continue as a going concern, given recurring operating losses.
• Regulatory and reimbursement risk — Future revenue depends on obtaining and maintaining FDA clearances and securing coverage from private and governmental payers.
• Customer concentration — Two customers accounted for approximately 28% of sales in 2025, making revenue sensitive to order timing from a limited base.

Outlook

Management expects significant expenses and operating losses to continue as it seeks broader insurance coverage and FDA clearances for new indications. They anticipate gross profit to increase as net sales grow, driven by insurer acceptance and potential approval for other uses. Near-term growth is supported by the CPT code, federal supply schedule contract, and ongoing clinical trials.