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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):
November 7, 2023
NeuroOne Medical Technologies Corporation
(Exact name of registrant as specified in its charter)
Delaware |
|
000-54716 |
|
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 November 7, 2023, NeuroOne Medical Technologies
Corporation (the “Company”) issued a press release announcing that it has responded to the U.S. Food and Drug Administration’s
(FDA) questions regarding the Company’s previous submission of a 510(k) application for its OneRF™ Ablation System. The Company
expects to receive additional communication back from the FDA in thirty days or less. A copy of this press release is filed herewith as
Exhibit 99.1 to this Current Report and is incorporated herein by reference.
Item 9.01 Financial Statements and
Exhibits.
(d) Exhibits
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: November 7, 2023 |
By: |
/s/ David Rosa |
|
|
David Rosa |
|
|
Chief Executive Officer |
2
Exhibit 99.1
NeuroOne® Provides Progress Update on FDA 510(k)
Submission for OneRF™ Ablation System
Feedback from responses to FDA anticipated
in 30 days
Commercialization remains on track in first
half of 2024 pending FDA clearance
Product potential for transformative improvement
in neurosurgery as first known sEEG-guided RF system that records and ablates nervous tissue with the added benefit of temperature control
EDEN PRAIRIE, Minn., November 7, 2023 (GlobeNewswire)
-- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) (“NeuroOne” or the “Company”), a medical technology
company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today that
it has responded to the Food and Drug Administration’s (FDA) questions regarding the Company’s previous submission of a 510(k)
for its OneRF™ Ablation System. The Company expects to receive additional communication back from the FDA in thirty days
or less.
The OneRF system uses the already implanted sEEG
electrodes to record brain activity and allow for ablation of nervous tissue when connected to the Company’s proprietary radio frequency
(RF) generator. If cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents the first step in bringing to market an
innovative RF ablation system in the field of neurology and neurosurgery.
As the Company’s first therapeutic device,
OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator
with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the
ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the
potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays
for patients. NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential
to grow multiple fold based on large addressable patient populations with unmet clinical needs.
Dave Rosa, CEO of NeuroOne, commented, “We
remain bullish on the potential for this technology to cause a paradigm shift in how patients are treated in ablation procedures. The
potential to reduce hospital stays, additional procedures, complications and cost gives us confidence that this will have a meaningful
impact in the market. We hope to complete discussions with the FDA in the near future as we prepare for a targeted commercial launch in
the first half of 2024.”
About NeuroOne
NeuroOne Medical Technologies Corporation is a
developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation
and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed
back surgeries, and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The Company may
also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence.
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 presentation 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 development of the Company’s
electrode technology program, applications for, or receipt of, regulatory clearance, the receipt and/or timing of additional feedback
from the FDA relating to the Company’s OneRF ablation system, the receipt and/or timing of regulatory approval of the Company’s
OneRF ablation system, the ability of the OneRF ablation system to offer a safer option for patients, the timing and extent of product
launch and commercialization of our technology, clinical and pre-clinical testing, what the future may hold for electrical stimulation
and NeuroOne’s potential role, business strategy, market size, potential growth opportunities, future operations, future efficiencies,
and other financial and operating information. 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;
whether due to supply chain disruptions, labor shortages, 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 relate to clinical trial patient enrollment and the results of clinical trials; that we may be unable 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.
Under FDA review - pending clearance
Contact:
800-631-4030
ir@nmtc1.com
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