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NeuroOne (NMTC) logs animal success as brain drug device nears human tests

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

NeuroOne Medical Technologies Corporation (NMTC) reported successful completion of three large-animal procedures using its next-generation StereoCED™ platform for targeted brain drug delivery and electrophysiological monitoring. In two procedures, the company’s electrodes both delivered a study agent and recorded intracranial activity from the same targeted brain regions, which NeuroOne believes is a first in convection-enhanced delivery.

The procedures were conducted at the University of Minnesota as part of a preclinical epilepsy research program and were designed to establish technical feasibility and validate the robotic-assisted surgical and drug delivery workflow. NeuroOne states that development of StereoCED™ devices for animal use finished ahead of schedule, enabling earlier-than-anticipated sales, and expects to recognize related StereoCED™ revenue from this research program in fiscal Q4 2026. Development of devices for human investigational use is reported to be on track, with release planned by the end of fiscal Q4 2026 and a planned launch of human investigational clinical studies later in the quarter.

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Filing Explained

The August 27 8-K adds that StereoCED™’s Drug Delivery System is not approved or cleared for commercial use by any regulatory agency; the completed work remains preclinical, with human studies only planned.

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.
Large-animal procedures completed 3 procedures Number of separate large-animal procedures performed using the StereoCED™ platform
Procedures with dual drug delivery and recording 2 procedures Procedures where electrodes both delivered a study agent and recorded intracranial activity
StereoCED™ revenue timing fiscal Q4 2026 Expected period for recognizing related StereoCED™ revenue from the research program
Planned release timing for human investigational devices end of fiscal Q4 2026 Target timing for release of StereoCED™ devices for human investigational use
convection-enhanced delivery medical
"represents a first in the field of convection-enhanced delivery"
Convection-enhanced delivery is a medical technique that uses a gentle, controlled push of fluid to carry a drug directly into a specific part of the brain or spinal cord, producing wider and more uniform distribution than simple injection. For investors, it matters because the method can increase a therapy’s effectiveness and reduce side effects by concentrating medicine where it’s needed, which can materially affect clinical trial results, regulatory chances and commercial value.
intracranial electrophysiological activity medical
"recorded intracranial electrophysiological activity from the same targeted regions"
stereoencephalography (sEEG) medical
"build on the thousands of successful human sEEG implantations from our epilepsy franchise"
intracerebral drug delivery medical
"translating targeted intracerebral drug delivery from concept toward a potential therapeutic"
electrophysiological recordings medical
"in two cases high-quality electrophysiological recordings were obtained"

FAQ

What did NMTC announce regarding its StereoCED™ platform on August 27, 2026?

NeuroOne Medical Technologies Corporation (NMTC) announced the successful completion of three large-animal procedures using its next-generation StereoCED™ platform for targeted brain drug delivery and electrophysiological monitoring, supporting the technical feasibility of its robotic-assisted workflow in a preclinical epilepsy research program.

How many large-animal procedures were completed with NeuroOne’s StereoCED™ platform?

NeuroOne reported successful completion of three separate large-animal procedures using its StereoCED™ platform. In two of these, the company’s drug delivery electrodes both delivered a study agent into targeted brain tissue and recorded intracranial electrophysiological activity from the same regions.

When does NMTC expect to recognize StereoCED™ revenue from this research program?

NeuroOne states that it expects to recognize the related StereoCED™ revenue from this preclinical research program in fiscal Q4 2026, following earlier-than-anticipated sales enabled by completing development of StereoCED™ devices for animal use ahead of schedule.

What is the timeline for NeuroOne’s StereoCED™ devices for human investigational use?

NeuroOne reports that development of StereoCED™ devices for human investigational use remains on track, with release planned by the end of fiscal Q4 2026 and a planned launch of the StereoCED™ platform for human investigational clinical studies later in that quarter.

Where were the StereoCED™ large-animal procedures conducted and for what purpose?

The large-animal procedures were conducted at the University of Minnesota as part of an ongoing preclinical epilepsy research program. They were designed to establish technical feasibility and validate the integrated surgical and drug delivery workflow of NeuroOne’s StereoCED™ system.

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false 0001500198 0001500198 2026-08-27 2026-08-27 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

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 27, 2026

 

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 27, 2026, NeuroOne Medical Technologies Corporation (the “Company”) issued a press release announcing that three procedures in large animals were performed using the Company’s StereoCED™ platform. A copy of the above referenced press release is filed as Exhibit 99.1 to this Current Report on Form 8-K. 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release, dated August 27, 2026
104   Cover Page Interactive Data File (embedded with Inline XBRL document).

 

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 27, 2026    
  By: /s/ David Rosa
    David Rosa
    Chief Executive Officer

 

2

 

Exhibit 99.1

 

 

NeuroOne Announces Successful Robotic-Assisted Drug Delivery Using Next-Generation StereoCED™ Platform

 

Successful Large-Animal Procedures Build Momentum Toward Planned Launch of the StereoCED™ Platform for Human Investigational Clinical Studies Later This Quarter

 

Related StereoCED™ Revenue Expected to be Recognized in the Current Fiscal Quarter

 

EDEN PRAIRIE, Minn. – August 27, 2026 – NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, today reported the successful completion of three separate large-animal procedures using its next-generation StereoCED™ platform. In two of the three procedures, NeuroOne’s drug delivery electrodes both delivered a study agent directly into targeted brain tissue and recorded intracranial electrophysiological activity from the same targeted regions. This is a combination the Company believes has not been previously demonstrated and represents a first in the field of convection-enhanced delivery.

 

The procedures took place at the University of Minnesota as part of an ongoing preclinical epilepsy research program evaluating StereoCED™ for targeted drug delivery and electrophysiological monitoring in the brain. They were designed to establish technical feasibility and validate the integrated surgical and drug delivery workflow in a large-animal model.

 

During the procedures, researchers used a robotic platform to establish the planned trajectory, drill the access point, and place NeuroOne’s anchor bolt. The Company’s drug delivery electrode and catheter were then advanced to the targeted region of the brain, where the system delivered the study agent directly into targeted tissue.

 

NeuroOne believes the successful repeatability demonstrated across three procedures provides additional confidence as the Company advances toward the planned launch of StereoCED™ for human investigational clinical studies later this quarter.

 

Development of StereoCED™ devices for animal use finished ahead of schedule, which allowed the Company to begin sales earlier than anticipated. NeuroOne expects to recognize the related StereoCED™ revenue from this research program in fiscal Q4 2026. Development of devices for human investigational use remains on track, with release planned by the end of fiscal Q4 2026.

 

“These procedures accomplished our goals from a technical feasibility standpoint and build on the thousands of successful human sEEG implantations from our epilepsy franchise,” said Dave Rosa, President and Chief Executive Officer of NeuroOne. “Our technology was successfully implanted using a robotic workflow, drug delivery performed as intended, and in two cases high-quality electrophysiological recordings were obtained. With the core technology and workflow now demonstrated in a large-animal model, we believe we have taken an important step toward the planned launch of the StereoCED™ platform for human investigational clinical studies later this quarter.”

 

 

 

Dr. Sandipan Pati, Professor and Epilepsy Division Director at the University of Minnesota, added, “These successful procedures represent a key step in translating targeted intracerebral drug delivery from concept toward a potential therapeutic approach for patients with epilepsy. Looking ahead, our research will focus on evaluating whether therapeutic agents delivered directly into seizure-generating brain networks can modulate and suppress seizure activity. Ultimately, we believe this approach could enable more precise and individualized treatment while minimizing the systemic exposure and off-target effects associated with conventional drug delivery.”

 

About NeuroOne

 

NeuroOne Medical Technologies Corporation is a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders. NeuroOne markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo® Cortical Electrodes, Evo® sEEG Electrodes, OneRF® Ablation System (for brain), and OneRF® Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering diagnostic and therapeutic functions. The Company is engaged in research and development for drug delivery, basivertebral nerve ablation and spinal cord stimulation programs. For more information, visit nmtc1.com.

 

Forward Looking Statements

 

This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this press release may be a forward–looking statement that reflects NeuroOne’s current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words or phrases “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue, “focused on,” “committed to” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the recognition of the first StereoCED™ revenue, the timing of commercial sales, and the development for human investigational use. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that our partnerships may not facilitate the commercialization or market acceptance of our technology; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials; risks related to uncertainties associated with the Company’s capital requirements to achieve its business objectives and ability to raise additional funds: the risk that we may not be able to secure or retain coverage or adequate reimbursement for our technology; uncertainties inherent in the development process of our technology; risks related to changes in regulatory requirements or decisions of regulatory authorities; that we may not have accurately estimated the size and growth potential of the markets for our technology; risks related to our ability to protect our intellectual property rights; and other risks, uncertainties and assumptions, including those described under the heading “Risk Factors” in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.

 

IR Contact

 

MZ Group – MZ North America

NMTC@mzgroup.us

 

EVO sEEG-RF Electrode – Caution: Federal law restricts this device to sale by or on the order of a physician

 

* Disclaimer: NeuroOne’s StereoCED™ Drug Delivery System is not approved/cleared for commercial use by any Regulatory agency.

 

 

 

Filing Exhibits & Attachments

4 documents