Neuraxis, INC

Neuraxis, INC is a U.S.-based medical device company focused on neuromodulation therapies for pediatric and adult patients. Its product portfolio includes the IB-Stim device for functional abdominal pain associated with IBS in children and the RED device for identifying chronic constipation due to pelvic floor dyssynergia in adults.

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+32,9 %

2.05

1.96

— Neuraxis, INC
%
IB-Stim device70% PENFS neuromodulation therapy used for children and adolescents with functional abdominal pain associated with IBS.
RED device25% Office-based diagnostic device used to identify chronic constipation due to pelvic floor dyssynergia in adults.
Other indications and pipeline5% Development-stage uses and future indications for the company's neuromodulation platform.

The company sells primarily to healthcare companies, especially hospitals and clinics that purchase devices on a...

  • Hospitals and clinicsprimary

    Primary buyers of IB-Stim devices for treating pediatric functional abdominal pain and related conditions.

  • Healthcare companies and provider organizationsprimary

    Purchasers that place purchase orders and integrate the devices into clinical workflows.

  • Commercial insurers and reimbursed patientsprimary

    Not direct buyers, but critical to adoption because coverage determines patient access and volume.

  • Adult GI practicessecondary

    Users of RED for point-of-care identification of pelvic floor dyssynergia in constipation patients.

  • Self-pay and financially assisted patientssecondary

    Patients receiving discounted devices when insurance coverage is unavailable.

Neuraxis is headquartered in the United States and appears to operate primarily in the U.S. healthcare market...

  • •Headquartered in the United States
  • •Commercial activity centered on U.S. hospitals and clinics
  • •Reimbursement depends on U.S. commercial insurance coverage
  • •FDA regulatory pathway is central to U.S. market expansion

The company’s strategy is to expand insurance coverage for IB-Stim, which it describes as the main driver of customer...

01
Broaden insurance coverage for IB-Stimshort-term

Coverage determines patient access and is the main driver of device adoption and revenue.

02
Obtain FDA clearance for new indicationsmedium-term

Additional indications can expand the addressable market and increase device usage per patient.

03
Expand RED adoptionmedium-term

RED adds a second commercial product and broadens the company beyond a single indication.

The business depends on reimbursement adoption, regulatory clearance, and successful commercialization of a narrow...

critical

Going-concern and financing risk

The company has required external capital to fund operations and commercialization efforts.

Scope
Corporate liquidity
Materiality
high
high

Insurance reimbursement dependence

Commercial adoption is tied to insurer coverage, so slow payer acceptance can limit patient access and sales volume.

Scope
IB-Stim
Materiality
high
high

Regulatory approval risk

Future growth depends on FDA clearance for additional indications and product uses.

Scope
Pipeline indications
Materiality
high
high

Product concentration

Revenue is concentrated in a small number of devices and indications, increasing sensitivity to adoption changes.

Scope
IB-Stim and RED
Materiality
high
medium

Internal control and reporting risk

Reported material weaknesses and prior restatement increase the risk of financial reporting errors.

Scope
Financial reporting
Materiality
medium
Revenue recognition on device shipments
Net sales timing
Patient discounting and assistance programs
Net sales and gross margin
Inventory expiration and obsolescence
Cost of goods sold
Warrant liability fair value
Other income/expense
Internal control remediation and restatement risk
Financial statement reliability

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: 29.4.2026