UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S.
Employer Identification No.) |
| (Address of principal executive offices) |
Registrant’s
telephone number, including area code:
| 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 | ||
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 7.01. | Regulation FD Disclosure. |
Senior management and certain members of the Board of Directors of Neuraxis, Inc. (the “Company”), have begun using the materials included in Exhibit 99.1 to this report (the “Investor Presentation”) in connection with presentations to existing stockholders of the Company, potential investors of the Company, and the investment community. While some of the materials in the Investor Presentation were previously utilized by the Company in the free writing prospectus filed with the Securities and Exchange Commission (the “SEC”) on July 26, 2023, the specific Investor Presentation attached hereto is first being used effective as of August 17, 2023. The Investor Presentation provides an overview of the Company’s strategy, performance and future objectives. The Investor Presentation is incorporated into this Item 7.01 by reference and will be available on the Company’s website at http://neuraxis.com/.
Without limiting the generality of the foregoing, the “Forward-Looking Statements” disclosure contained in the Investor Presentation is incorporated by reference into this Item 7.01.
On August 17, 2023, the Company issued a press release providing a summary of the revenue generated by the Company’s IB-Stim™ technology from 2019 through March 31, 2023.
The information contained in this Item 7.01 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and such information is not incorporated by reference into any registration statements or other document filed under the Securities Act of 1933, as amended or the Exchange Act, regardless of the general incorporation language contained in such filing, except as shall be expressly set forth by specific reference to this filing.
Investors and others should note that the Company routinely announces material information to its investors using filings with the SEC, the Company’s Investor Relations page on its website at http://neuraxis.com/, https://ir.neuraxis.com/, press releases, public conference calls, public webcasts, its feed on “X” (formerly known as Twitter) (https://twitter.com/NeurAxisInc), its Facebook page (https://www.facebook.com/IBStim.Stimulator), its YouTube page, https://www.youtube.com/@ib-stim, and its Instagram page (https://www.instagram.com/ib_stim_stimulator/). The information posted on the Company’s website or social media channels is not incorporated by reference in this report or in any other report or document the Company files with the SEC. While not all of the information that the Company posts to its Investor Relations page on its website or to social media channels is of a material nature, some information could be deemed to be material. Therefore, the Company encourages investors, the media and others interested in the Company to review the information it makes public in these channels.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit Number | Exhibits | |
| 99.1 | Neuraxis, Inc. Investor Presentation (August 17, 2023) | |
| 99.2 | Press Release of Neuraxis, Inc. entitled “NeurAxis Announces Over $8 Million in IB-Stim™ Revenue” | |
| 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: August 17, 2023 | NEURAXIS, INC. | |
| By: | /s/ Brian Carrico | |
| Name: | Brian Carrico | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
Exhibit 99.2
NeurAxis Announces Over $8 Million in IB-Stim™ Revenue
CARMEL, Ind., Aug. 17, 2023 (GLOBE NEWSWIRE) — NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced it has generated over $8 million in revenue following the commercial launch of its proprietary IB-Stim™ technology. Sales began after NeurAxis received FDA clearance for IB-Stim™ in the pediatric treatment of functional abdominal pain and irritable bowel syndrome. NeurAxis is conducting clinical trials with IB-Stim™ for four additional pediatric indications, including chronic nausea, post-concussion syndrome, chemotherapy induced nausea and vomiting, and cyclic vomiting syndrome.
Approximately $2 million of the over $8 million in IB-Stim™ revenue through March 31, 2023 was generated in 2020 and 2019.
Brian Carrico, Chief Executive Officer of NeurAxis, said, “We are pleased to have reached over $8 million in sales of our proprietary IB-Stim™ technology and look forward building upon our momentum with the funds received from our recently completed IPO. We continue to drive increasing adoption of our IB-Stim™ therapy, supported by a significant and growing body of positive clinical data and commercial large health insurance company payor support. We believe the growing movement of patients gravitating towards non drug related therapies, especially for children, will continue to fuel our rapidly increasing adoption and the market for our new indications.”
Forward Looking Statements
This document contains certain “forward-looking statements”. All statements other than statements of historical fact are “forward-looking statements” for purposes of federal and state securities laws, including, but not limited to, any projections of earnings, revenue or other financial items; any statements of the plans, strategies, goals and objectives of management for future operations; any statements concerning proposed new products and services or developments thereof; any statements regarding future economic conditions or performance; any statements or belief; and any statements of assumptions underlying any of the foregoing.
Forward looking statements may include the words “may,” “could,” “estimate,” “intend,” “continue,” “believe,” “expect” or “anticipate” or other similar words, or the negative thereof. These forward-looking statements present our estimates and assumptions only as of the date of this document. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the dates on which they are made. We do not undertake to update forward-looking statements to reflect the impact of circumstances or events that arise after the dates they are made. You should, however, consult further disclosures and risk factors we include in our filings with the Securities and Exchange Commission.
About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com.
The estimated revenues generated in 2019 and 2020 reflect our estimated financial results which were not audited nor reviewed by an independent registered public accounting firm.
Contacts:
Company
NeurAxis, Inc.
info @neuraxis.com
Investor Relations
Gilmartin Group
IR@neuraxis.com