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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 |
