NeuroOne® Patient Surpasses One Year Milestone of Seizure Freedom Following Treatment with OneRF® Ablation System

Rhea-AI Summary

NeuroOne Medical Technologies Corporation announced a significant milestone as Clara, one of their early patients treated with the OneRF® Ablation System, has remained seizure-free for over a year. Prior to treatment in June 2024, Clara experienced up to 10 seizures daily. The OneRF® Ablation System, which is FDA 510(k)-cleared, is unique as the first device allowing both diagnostic and therapeutic applications using the same sEEG electrode, with bedside ablation capability. The technology has shown promising results in seizure reduction or elimination for most treated patients. NeuroOne is now expanding the technology's applications, having filed a 510(k) submission for a Trigeminal Nerve Ablation System to treat facial pain in April 2025. Clara's successful treatment has enabled her to pursue college full-time and enjoy daily activities previously impacted by seizures.

Positive

• First and only FDA 510(k)-cleared device combining diagnostic and therapeutic applications in one sEEG electrode
• Demonstrated successful seizure reduction or freedom in most treated patients
• Expanding technology applications with 510(k) submission for facial pain treatment
• Proven long-term effectiveness with one-year milestone of complete seizure freedom in early patient

Negative

• None.

Insights

Medical Device Analyst

NeuroOne's OneRF System shows promising clinical success with one-year seizure freedom in an early patient, signaling potential market growth.

The announcement of Clara's one-year seizure freedom milestone represents significant clinical validation for NeuroOne's OneRF® Ablation System. This is particularly noteworthy as she previously experienced up to 10 seizures daily before treatment. The system's unique FDA-cleared dual functionality—using the same sEEG electrode for both diagnosis and treatment—creates a compelling competitive advantage in the neuromodulation market.

The technology's bedside ablation capability is a meaningful differentiator compared to traditional epilepsy treatments that often require separate diagnostic and therapeutic procedures in different clinical settings. Early clinical outcomes suggesting that most patients have experienced seizure reduction or freedom is particularly promising, though I note this is still anecdotal data rather than from a formal clinical trial.

NeuroOne's expansion strategy into facial pain treatment through their Trigeminal Nerve Ablation System shows a clear commercialization pathway beyond epilepsy. The April 2025 510(k) submission to the FDA indicates regulatory momentum. The company is executing a classic medical device strategy: establish clinical credibility in an initial indication before expanding to adjacent applications using the same core technology platform.

While this single patient success story isn't sufficient to project broad market adoption, the dramatic improvement from multiple daily seizures to complete seizure freedom demonstrates the potentially transformative impact of the technology. The high-profile media coverage on Fox News and Good Morning America further amplifies awareness among both patients and healthcare providers, potentially accelerating clinical adoption.

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.

IR Contact
MZ Group – MZ North America
NMTC@mzgroup.us

FAQ

What is NeuroOne's OneRF Ablation System and how does it work?

The OneRF Ablation System is an FDA 510(k)-cleared device that uniquely combines diagnostic and therapeutic capabilities in a single sEEG electrode, allowing for monitoring, mapping, and ablation procedures at the patient's bedside.

How effective has the NMTC OneRF Ablation System been in treating seizures?

The system has demonstrated effectiveness in most treated patients, with one early patient remaining completely seizure-free for over a year after previously experiencing up to 10 seizures daily.

What are NeuroOne's future plans for the OneRF technology?

NeuroOne is expanding the technology's applications, having filed a 510(k) submission in April 2025 for a OneRF Trigeminal Nerve Ablation System to treat facial pain.

What makes NeuroOne's OneRF Ablation System unique in the market?

It is the first and only FDA 510(k)-cleared device that uses the same sEEG electrode for both diagnostic and therapeutic applications, allowing for bedside ablation procedures.

How has the OneRF Ablation System impacted patient Clara's life?

Clara has been completely seizure-free since her treatment in June 2024, enabling her to attend college full-time and participate in daily activities that were previously affected by her frequent seizures.