Risk factors

Neuraxis (NRXS) risk factors

Item 1A of every Neuraxis, Inc. 10-K on file, and what changed from one year to the next.

  • FY2025 10-K risk factors

    50 risks, 2 reworded since the prior year. Neuraxis shifted from a sole manufacturer to relying on two contract manufacturers for product production. The AMA accepted a Category I CPT Code for PENFS replacing the old CAT III code, with utilization effective January 1, 2026.

    Filed Mar 19, 2026
  • FY2024 10-K risk factors

    50 risks. Neuraxis faces significant operating losses since 2011 while trying to commercialize neuromodulation therapies for children like the IB-Stim device. The business heavily relies on third-party manufacturers, single-source component suppliers, and adequate insurance reimbursement codes. Extensive FDA and international regulations govern clinical trials, quality systems, marketing, and ongoing product compliance.

    Filed Mar 20, 2025