FDA clears NeuroOne (NASDAQ: NMTC) OneRF Trigeminal Nerve Ablation System

Rhea-AI Filing Summary

NeuroOne Medical Technologies Corporation reported that on August 18, 2025 it received U.S. Food and Drug Administration 510(k) clearance for its OneRF® Trigeminal Nerve Ablation System. This clearance allows the company to market the device for procedures that create radiofrequency lesions to treat pain, and for lesioning nerve tissue in functional neurosurgical procedures. The authorization gives NeuroOne regulatory approval to commercialize this system in the United States for these specific neurosurgical applications.

Positive

• FDA 510(k) clearance achieved for the OneRF® Trigeminal Nerve Ablation System, allowing U.S. marketing for radiofrequency lesioning to treat pain and for functional neurosurgical procedures.

Negative

• None.

Insights

Medical device and regulatory analyst

FDA 510(k) clearance gives NeuroOne a new cleared neurosurgical pain treatment device to commercialize.

NeuroOne Medical Technologies Corporation received U.S. Food and Drug Administration 510(k) clearance to market its OneRF® Trigeminal Nerve Ablation System. The clearance covers use in procedures that create radiofrequency lesions for the treatment of pain and for lesioning nerve tissue in functional neurosurgical procedures, which moves this product from development into a cleared commercial stage in the U.S.

This type of regulatory milestone is significant because it formally authorizes marketing for defined clinical uses, a key hurdle for any medical device. It positions the company to pursue clinical adoption in pain management and functional neurosurgery, though actual uptake will depend on surgeon acceptance, reimbursement dynamics, and competitive technologies not described here.

Future company disclosures may detail how quickly physicians adopt the OneRF® Trigeminal Nerve Ablation System and what revenue contribution, if any, it delivers relative to NeuroOne’s broader product portfolio.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

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

Understanding 8-K Material Events →

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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): August 18, 2025

NeuroOne Medical Technologies Corporation

(Exact name of registrant as specified in its charter)

Delaware		001-40439		27-0863354
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

7599 Anagram Dr., Eden Prairie, MN 55344

(Address of principal executive offices and zip code)

952-426-1383

(Registrant’s telephone number including area code)

(Registrant’s 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, par value $0.001 per share		NMTC		The Nasdaq Stock Market LLC

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.

On August 18, 2025, NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Administration 510(k) clearance to market its OneRF^® Trigeminal Nerve Ablation System for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

1

SIGNATURES

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

	NEUROONE MEDICAL TECHNOLOGIES CORPORATION
Dated: August 18, 2025
	By:	/s/ David Rosa
		David Rosa
		Chief Executive Officer

2

FAQ

What did NeuroOne Medical Technologies Corporation (NMTC) announce in this 8-K?

NeuroOne Medical Technologies Corporation announced that it received U.S. Food and Drug Administration 510(k) clearance to market its OneRF® Trigeminal Nerve Ablation System for specific neurosurgical uses.

What is the OneRFae Trigeminal Nerve Ablation System cleared to do?

The OneRFae Trigeminal Nerve Ablation System is cleared for procedures to create radiofrequency lesions for the treatment of pain, and for lesioning nerve tissue for functional neurosurgical procedures.

What type of FDA authorization did NeuroOne (NMTC) receive?

NeuroOne received U.S. Food and Drug Administration 510(k) clearance, which allows it to market the OneRFae Trigeminal Nerve Ablation System in the United States for the cleared indications.

Does this filing disclose any financial results for NeuroOne Medical Technologies Corporation?

No, this filing focuses on the regulatory milestone of receiving FDA 510(k) clearance for the OneRFae Trigeminal Nerve Ablation System and does not include financial results.

How might the FDA 510(k) clearance affect NeuroOne's business?

The 510(k) clearance allows NeuroOne to market the OneRFae Trigeminal Nerve Ablation System for pain treatment and functional neurosurgical procedures, enabling potential commercial use of this device in the U.S.

When did NeuroOne receive the FDA 510(k) clearance mentioned in the 8-K?

NeuroOne stated that it received U.S. Food and Drug Administration 510(k) clearance on August 18, 2025.