Material Event (Form 8-K)

Item 8.01 Other Events.

FDA 510(k) Clearance

NeurAxis, Inc. ("NeurAxis" or the "Company") today announced that it has received U.S. Food and Drug Administration (the "FDA") 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation ("PENFS") technology for the treatment of functional abdominal pain ("FAP") associated with functional dyspepsia ("FD"), and FD related nausea symptoms, in patients aged 8 years and older. The FDA reviewed the clinical literature supporting the use of NeurAxis' PENFS technology, including randomized controlled trials and real-world evidence demonstrating the device's safety and effectiveness in pediatric patients and individuals up to 21 years of age. Based on this comprehensive review, the FDA extrapolated the data to adults, supporting the use of PENFS in patients aged 8 years and older. This expanded indication marks the first FDA clearance or approval for treatment specifically addressing FD in the adult patient population.

At The Market Offering Agreement

As previously disclosed, on August 29, 2025, the Company entered into an At The Market Offering Agreement (the "Agreement") with Craig-Hallum Capital Group LLC (the "Sales Agent") under which the Company may offer and sell, from time to time at its sole discretion, shares of its $0.001 par value common stock (the "Common Stock"), having an aggregate offering price of up to $3,300,000, through the Sales Agent as its sales agent.

Pursuant to the Agreement, sales of the Common Stock, if any, will be made under the Company's effective Registration Statement on Form S-3 (File No. 333-283798), previously filed with the Securities and Exchange Commission on December 13, 2024 and declared effective on February 11, 2025, and the prospectus supplement relating to this offering, filed on August 29, 2025 (the "August Prospectus Supplement"), by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including privately negotiated transactions.

From August 29, 2025 through October 23, 2025 the Company did not sell any shares of Common Stock pursuant to the Agreement.

On October 23, 2025, the Company filed a prospectus supplement to amend the August Prospectus Supplement to increase the number of shares of Common Stock that may be sold pursuant to the Agreement to $6,270,000.

The legal opinion of Lucosky Brookman LLP relating to the legality of the issuance and sale of the shares of Common Stock pursuant to the Agreement, is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.