NeuroOne® Announces First in Human Ablations Completed with OneRF™ Ablation System

Rhea-AI Summary

NeuroOne Medical Technologies (Nasdaq: NMTC) announced the successful use of its OneRF Ablation System to perform five ablations on a patient with multifocal epilepsy at a prestigious hospital in Jacksonville, Florida. This was achieved using ten Evo sEEG electrodes, which identified seizure-triggering brain areas, and targeted ablations were confirmed by post-ablation sEEG recordings. The procedure was performed at the bedside, saving time and costs associated with operating room use. The OneRF Ablation System is NeuroOne’s first therapeutic device and third FDA 510(k)-cleared device. CEO Dave Rosa highlighted the system's potential to reduce operating room usage and foresees the expansion of its applications with future FDA submissions.

NeuroOne now offers a complete line of thin film electrode technology for diagnostic brain mapping and RF ablation. The estimated brain ablation market is over $100 million worldwide and is expected to grow significantly due to unmet clinical needs.

Positive

• Successful completion of five ablations on a single patient using the OneRF Ablation System.
• Procedure performed at bedside, reducing time and cost compared to operating room procedures.
• First therapeutic device and third FDA 510(k)-cleared device for NeuroOne.
• Potential for future FDA submissions leveraging the OneRF generator for additional ablation applications.
• The brain ablation market is estimated at over $100 million and growing rapidly.

Negative

• None.

Medical Research Analyst

The successful first human use of NeuroOne's OneRF™ Ablation System is a notable event in the field of neurological medical devices. The system's ability to perform ablations at the patient's bedside demonstrates a significant improvement in procedural efficiency and patient care. Traditionally, such procedures would necessitate an operating room, which increases both time and healthcare costs.

The fact that this procedure was done at the patient's bedside implies a reduction in operating room time, which can have a domino effect on hospital resource management. Additionally, the utilization of the same electrodes for both diagnostic and therapeutic purposes simplifies the process and potentially reduces the risk of infection or complications arising from multiple invasive procedures.

From a broader perspective, this innovation could address a substantial unmet need in treating multifocal epilepsy, a condition with significant morbidity. The system's temperature control safety feature is also a noteworthy advancement, ensuring patient safety during ablations.

In summary, this development positions NeuroOne as a key player in the neurosurgical device market, potentially leading to increased adoption of their technology.

Financial Analyst

NeuroOne's announcement regarding the OneRF™ Ablation System marks a key milestone, impacting the company's market position and financial outlook. The successful procedure not only validates the product's efficacy but also opens up new revenue streams. The potential cost savings from bedside procedures can be a strong selling point, attracting healthcare providers looking to optimize their operational efficiency.

Moreover, with the brain ablation market estimated to be worth at least $100M globally and growing, NeuroOne is well-positioned to capture a significant market share. This new product adds a therapeutic dimension to their portfolio, which previously focused mainly on diagnostic tools. The dual functionality of the OneRF™ System can drive adoption and thus revenue growth, especially as it leverages existing FDA-cleared devices like the Evo® electrodes.

However, it is important to monitor the company's ability to scale production and manage regulatory pathways for further FDA submissions. These factors will play a significant role in determining the long-term financial impact on NeuroOne.

Five ablations performed successfully in one patient

Procedure performed at patient’s bedside saving time and cost associated with the operating room

EDEN PRAIRIE, Minn., June 25, 2024 (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, today announced that the OneRF Ablation System was recently used at a prestigious hospital located in Jacksonville, Florida to successfully complete five ablations in one patient.

The patient was suffering from multifocal epilepsy, a condition whereby seizures are triggered from multiple areas of the brain. In this procedure, ten Evo^® sEEG electrodes, were placed in various locations of the patient’s brain. Four electrodes identified problematic areas of the brain that were triggering seizures. Ablations were performed at the targeted areas using the temperature control safety feature, and two of these ablations occurred at different contacts on one electrode. Using the same electrodes, the successful ablations were confirmed by post ablation sEEG recordings demonstrating lack of brain activity at the point of tissue ablation. The procedure was performed at the patient’s bedside saving both the time and cost of having to conduct the procedure in an operating room.

“It was exciting for the Company to witness the first clinical ablations performed using the OneRF Ablation System. The ability to safely perform these procedures at the patient’s bedside will reduce operating room time and cost, freeing up the operating room to conduct additional procedures,” said Dave Rosa, CEO of NeuroOne. “We look forward to additional procedures utilizing the system with the goal of providing a safe therapy for patients to both monitor and ablate problematic brain tissue. In the future, the Company intends to leverage the OneRF generator with future FDA submissions for additional ablation applications.”

The OneRF^™ Ablation System is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device. NeuroOne now boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF^™ Ablation System, NeuroOne’s other FDA-cleared devices include the Evo^® cortical and sEEG electrode product lines which are used primarily for stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.

NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.

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 www.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 additional procedures to be performed, the potential for future FDA submissions for additional ablation applications, and the ability of the OneRF Ablation System to reduce hospital stays, reduce the number of surgeries, or reduce adverse events, business strategy, market size, potential growth opportunities, and future operations. 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 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.

“Caution: Federal law restricts this device to sale by or on the order of a physician”

Contact:

800-631-4030
ir@nmtc1.com

FAQ

What recent achievement was announced by NeuroOne Medical Technologies (NMTC)?

NeuroOne announced the successful use of its OneRF Ablation System to perform five ablations on a patient with multifocal epilepsy.

When and where were the first in human ablations performed using the OneRF Ablation System?

The ablations were performed in June 2024 at a prestigious hospital in Jacksonville, Florida.

How did the OneRF Ablation System save time and costs during the procedure?

The procedure was performed at the patient's bedside, avoiding the need for an operating room.

What is the significance of the OneRF Ablation System for NeuroOne?

It is their first therapeutic device and third FDA 510(k)-cleared device, expanding their product line.

What is the estimated market size for brain ablation systems?

The brain ablation market is estimated to be over $100 million worldwide and is rapidly growing.