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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 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). |
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 |
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.