NeurAxis FDA 510(k) clearance; increases ATM to $6.27M

NeurAxis (NRXS) reported two updates.

Accepted by SEC EDGAR 10/24/2025 - 08:22 AM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

NeurAxis (NRXS) reported two updates. First, the company received FDA 510(k) clearance for its percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain associated with functional dyspepsia, and FD-related nausea symptoms, in patients aged 8 years and older. The FDA reviewed randomized trials and real‑world evidence in pediatric and young adult populations and extrapolated to adults, marking the first clearance or approval specifically addressing FD in the adult population.

Second, NeurAxis updated its at‑the‑market program. The company previously established an ATM of up to $3,300,000 and disclosed that from August 29, 2025 through October 23, 2025 it sold no shares. On October 23, 2025, it filed a prospectus supplement to increase the ATM capacity to $6,270,000, providing flexibility to raise equity over time through Craig‑Hallum Capital Group as sales agent.

Positive

• FDA 510(k) clearance for PENFS in functional dyspepsia, including adults aged 8+, described as the first FDA clearance specifically addressing FD in the adult population.

Negative

• None.

Insights

Medtech regulatory and capital markets analyst

FDA clearance expands indication; ATM capacity increased.

NeurAxis obtained FDA 510(k) clearance for its PENFS device to treat functional abdominal pain associated with functional dyspepsia and related nausea in patients aged 8+ years. The agency relied on randomized trials and real‑world evidence up to age 21 and extrapolated to adults, which the company states is the first FDA clearance specifically addressing FD in the adult population.

Commercial uptake will depend on clinical adoption and reimbursement pathways, which are not detailed here. The clearance broadens the addressable patient population by explicitly including adults, but revenue impact will hinge on provider utilization and payer coverage.

On financing, the company maintained an at‑the‑market facility originally up to $3,300,000 with no shares sold through October 23, 2025, and increased the capacity to $6,270,000. This permits sales from time to time through Craig‑Hallum, with actual activity determined by market conditions and company decisions.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What FDA action did NeurAxis (NRXS) announce?

NeurAxis received FDA 510(k) clearance for its PENFS technology to treat functional abdominal pain associated with functional dyspepsia and FD‑related nausea in patients aged 8+.

Does the clearance include adult patients?

Yes. The FDA extrapolated pediatric and young adult data to adults, supporting use in patients aged 8 years and older and marking the first clearance specifically addressing FD in adults.

What is NeurAxis’s current ATM capacity?

The company increased its at‑the‑market program from $3,300,000 to $6,270,000 via a prospectus supplement filed on October 23, 2025.

Has NeurAxis sold any shares under the ATM?

No. From August 29, 2025 through October 23, 2025, the company did not sell any shares under the agreement.

Which sales agent and registration are used for the ATM?

Sales are through Craig‑Hallum Capital Group LLC under an effective Form S‑3 (File No. 333‑283798) and related prospectus supplements.

What exchange does NRXS trade on?

NeurAxis common stock trades on the NYSE American under the symbol NRXS.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): October 23, 2025

Neuraxis, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-41775		45-5079684
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

11611 N. Meridian St, Suite 330 Carmel, IN 46032

(Address of principal executive offices)

Registrant’s telephone number, including area code: (812) 689-0791

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		NRXS		NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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.

Item 9.01 Financial Statement and Exhibits

(d) Exhibits.

Exhibit No.		Description
5.1		Opinion of Lucosky Brookman LLP.
23.1		Consent of Lucosky Brookman LLP (included in Exhibit 5.1)
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 24, 2025	NEURAXIS, INC.
	By:	/s/ Brian Carrico
	Name:	Brian Carrico
	Title:	President and Chief Executive Officer