# EDGAR Filing Document

**Accession Number:** 0001933567
**File Stem:** 0001493152-25-019186
**Filing Date:** 2025-10
**Character Count:** 11874
**Document Hash:** e58c1840491667a9f9b7a9af1ef1f846
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-019186.hdr.sgml**: 20251024

**ACCESSION NUMBER**: 0001493152-25-019186

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251023

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251024

**DATE AS OF CHANGE**: 20251024

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Neuraxis, INC
- **CENTRAL INDEX KEY:** 0001933567
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 455079684
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41775
- **FILM NUMBER:** 251414383

**BUSINESS ADDRESS:**
- **STREET 1:** 11611 N. MERIDIAN ST
- **STREET 2:** SUITE 330
- **CITY:** CARMEL
- **STATE:** IN
- **ZIP:** 46032
- **BUSINESS PHONE:** (812) 689-0791

**MAIL ADDRESS:**
- **STREET 1:** 11611 N. MERIDIAN ST
- **STREET 2:** SUITE 330
- **CITY:** CARMEL
- **STATE:** IN
- **ZIP:** 46032

?xml version='1.0' encoding='ASCII'?

**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)

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

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**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:

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

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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**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;***(d) Exhibits.***

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 5.1 | [Opinion of Lucosky Brookman LLP.](ex5-1.htm) |
| 23.1 | [Consent of Lucosky Brookman LLP (included in Exhibit 5.1)](ex5-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**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.

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

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## Exhibit 5.1

**Exhibit 5.1**

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| | |
|:---|:---|
| <br> ![](ex5-1_001.jpg) | **LUCOSKY BROOKMAN LLP**<br> 101 Wood Avenue South<br> 5th Floor<br> Woodbridge, NJ 08830<br> T - (732) 395-4400<br> F- (732) 395-4401 |
|  | 111 Broadway<br> Suite 807<br> New York, NY 10006<br> T - (212) 417-8160<br> F - (212) 417-8161<br> www. lucbro.com |

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October 24, 2025

Neuraxis, Inc.

11611 N. Meridian Street, Suite 330

Carmel, IN

**RE: Registration Statement on Form S-3 (File No. 333-283798)**

Ladies and Gentlemen:

We have acted as counsel to Neuraxis, Inc., a Delaware corporation (the "<u>Company</u>"), in connection with the preparation and filing with the Securities and Exchange Commission (the "<u>Commission</u>") under the Securities Act of 1933, as amended (the "<u>Securities Act</u>"), of: (i) the above-referenced effective registration statement (the "<u>Registration Statement</u>"); (ii) the prospectus supplement dated August 29, 2025 (the "<u>August Prospectus Supplement</u>"); and (iii) the prospectus supplement dated October 23, 2025 (the "<u>October Prospectus Supplement</u>" and, together with the August Prospectus Supplement, the "<u>ATM Prospectus Supplement</u>") relating to the offering and sale by the Company from time to time, through Craig-Hallum Capital Group LLC (the "<u>Sales Agent</u>") as the sales agent, of shares of common stock, par value $0.001 per share (the "<u>Common Stock</u>"), having an aggregate offering price of up to $6,270,000 (the "<u>Shares</u>"), to be issued pursuant to that certain At The Market Offering Agreement, dated as of August 29, 2025 (the "<u>ATM Agreement</u>") between the Company and the Sales Agent. The Shares are covered by the Registration Statement and we understand that the Shares are to be offered and sold in the manner described in the ATM Prospectus Supplement. This opinion is being delivered at the request of the Company and in accordance with the requirements of Item 601(b)(5) of Regulation S-K promulgated by the Commission.

For purposes of this opinion, we have examined such documents and reviewed such questions of law as we have considered necessary and appropriate for the purposes of our opinion set forth below. In rendering our opinion, we have assumed the authenticity of all documents submitted to us as originals, the genuineness of all signatures and the conformity to authentic originals of all documents submitted to us as copies. We have also assumed the legal capacity for all purposes relevant hereto of all natural persons and, with respect to all parties to agreements or instruments relevant hereto other than the Company, that such parties had the requisite power and authority (corporate or otherwise) to execute, deliver and perform such agreements or instruments, that such agreements or instruments have been duly authorized by all requisite action (corporate or otherwise), executed and delivered by such parties and that such agreements or instruments are the valid, binding and enforceable obligations of such parties. As to questions of fact material to our opinions, we have relied upon certificates of officers of the Company and of public officials.

Based upon and subject to the foregoing, we are of the opinion that the Shares have been duly authorized and, when issued and sold by the Company and delivered by the Company against receipt of the purchase price therefor, in the manner contemplated by the ATM Prospectus Supplement and the ATM Agreement, will be validly issued, fully paid and non-assessable. The opinions expressed herein are limited to the laws of the General Corporation Law of the State of Delaware and the laws of the State of New York, as currently in effect, and no opinion is expressed with respect to any other laws or any effect that such other laws may have on the opinions expressed herein.

We consent to the filing of this opinion with the SEC as Exhibit 5.1 to the Company's Current Report on Form 8-K filed on October 24, 2025, which is incorporated by reference into the Registration Statement. We also consent to the reference to our firm under the caption "Legal Matters" in the ATM Prospectus Supplement included in the Registration Statement and in each case in any amendment or supplement thereto. In giving this consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission promulgated thereunder.

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| |
|:---|
| Very Truly Yours, |
| */s/ Lucosky Brookman LLP* |
| Lucosky Brookman LLP |

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