NeuroOne's OneRF® Ablation System has successfully kept a patient seizure-free for over a year, enhancing her quality of life.
Quiver AI Summary
NeuroOne Medical Technologies Corporation has announced that Clara, an early patient treated with their OneRF® Ablation System, has successfully remained seizure-free for over a year after previously experiencing up to ten seizures daily. The treatment, which took place in June 2024, has significantly improved Clara's quality of life, allowing her to pursue activities like attending college and enjoying family meals. The OneRF® system is the first FDA-cleared device to use a single electrode for both diagnosis and treatment, enabling at-the-bedside monitoring and ablation. CEO Dave Rosa expressed optimism about the technology's potential for other applications, including treating facial pain with a new device submitted for FDA clearance. Clara's positive experience highlights the promising outcomes associated with the OneRF® platform, which aims to enhance the care of patients with neurological disorders.
Potential Positives
- Clara, an early patient treated with the OneRF® Ablation System, has successfully remained seizure-free for over a year, indicating the technology's efficacy and positive patient outcomes.
- The OneRF® Ablation System is the first FDA 510(k)-cleared device able to perform diagnostic and therapeutic procedures using the same electrodes, enhancing its value and versatility in patient care.
- The company received positive media coverage, with features on prominent platforms like Fox News and Good Morning America, potentially increasing visibility and market interest in their technology.
- The CEO's statement underscores the milestone as a validation of the OneRF® platform's intended benefits, paving the way for potential expansion into new treatment applications, including facial pain management.
Potential Negatives
- Despite a successful outcome for one patient, the press release highlights that results may not be representative of all patient outcomes, which could raise concerns about the consistency and reliability of the OneRF® Ablation System.
- The company faces various known and unknown risks, including compliance with Nasdaq listing requirements and uncertainties in capital requirements, which could jeopardize future operations.
- The forward-looking statements underscore the company's significant uncertainty regarding the scalability of technology and the ability to achieve market acceptance, indicating potential challenges ahead.
FAQ
What is the OneRF® Ablation System?
The OneRF® Ablation System is an FDA-cleared device for diagnosing and treating neurological disorders using sEEG electrodes.
How has the OneRF® Ablation System improved patient outcomes?
It has demonstrated significant seizure reduction and freedom in most patients, enhancing their quality of life.
Who is Clara and what is her experience with the OneRF®?
Clara is a patient who has been seizure-free for over a year after treatment with the OneRF® System.
What future applications are being explored for the OneRF® technology?
NeuroOne plans to leverage the technology for other applications, including treating facial pain with the Trigeminal Nerve Ablation System.
What should I know about NeuroOne Medical Technologies Corporation?
NeuroOne focuses on developing minimally invasive solutions for various neurological disorders and aims to enhance patient care effectiveness.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$NMTC Insider Trading Activity
$NMTC insiders have traded $NMTC stock on the open market 5 times in the past 6 months. Of those trades, 2 have been purchases and 3 have been sales.
Here’s a breakdown of recent trading of $NMTC stock by insiders over the last 6 months:
- RONALD W. MCCLURG (Chief Financial Officer) purchased 200,000 shares for an estimated $100,000
- DAVID A ROSA (CEO and President) purchased 100,000 shares for an estimated $50,000
- MARK CHRISTIANSON (Business Development Director) has made 0 purchases and 3 sales selling 21,019 shares for an estimated $13,109.
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- NANTAHALA CAPITAL MANAGEMENT, LLC removed 798,762 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $659,697
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Full Release
Patient Treated with OneRF ® Ablation System Previously Experienced up to 10 Seizures a Day
EDEN PRAIRIE, Minn., June 23, 2025 (GLOBE NEWSWIRE) -- 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 that Clara—an early patient treated with the Company’s patented OneRF ® Ablation System—has successfully surpassed the one year milestone of being seizure free.
Clara was one of the first patients to undergo treatment using NeuroOne’s OneRF ® platform. Since the procedure in June 2024, Clara has been completely seizure-free, which has greatly improved her quality of life.
Videos of Clara’s journey can be found on the company’s website , as well as features on Fox News and Good Morning America .
The OneRF ® Ablation System is the first and only FDA 510(k)-cleared device that uses the same sEEG electrode for both diagnostic and therapeutic applications. It not only provides monitoring, mapping and ablation, but also provides the ability to perform the ablation at the patient’s bedside. To date, the technology has demonstrated seizure reduction or seizure freedom for most patients that have received an ablation with the OneRF System.
“This milestone further validates the intended benefits of our OneRF ® platform,” said Dave Rosa, CEO of NeuroOne. “Our next step is to leverage the technology for other applications, including our OneRF ® Trigeminal Nerve Ablation System to treat facial pain, for which we filed a 510(k) submission to the FDA in April 2025.”
“Around this time last year, I was having multiple seizures every day, which interfered with so many things in my life,” stated Clara. “However, since the procedure, I completely stopped having seizures. I’ve started college full time. I’ve gone fishing. I’ve enjoyed peaceful dinners with my family. My life has changed for the better, and I couldn’t be more grateful.”
Dr. Brin Freund, who has overseen Clara’s epilepsy treatment, stated: “Our interaction with the OneRF ® Ablation System has been positive and shown excellent results for Clara. I believe there is a compelling case for further clinical and research opportunities using this platform to expand treatment capabilities.”
About NeuroOne
NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, monitoring, ablation, drug delivery and brain stimulation 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 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,” “forecasts,” “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 our ability to scale our technology across multiple markets, our ability to create partnerships with top-tier strategic partners for other potential applications, including spinal cord stimulation for back pain management and our drug delivery program, and our business strategy, market size, and other potential growth opportunities. 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 for 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 related to whether the Company will continue to maintain compliance with all Nasdaq continued listing requirements, risks that our strategic partnerships may not facilitate the commercialization or market acceptance of our technology; whether due to supply chain disruptions, labor shortages or otherwise; 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.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Disclaimer: This recounts one patient’s experience and may not be representative of all patient outcomes.
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