NeuroOne® Successfully Completes Feasibility Study with its OneRF™ Ablation System
NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) announced the successful completion of an animal feasibility study for its OneRF™ ablation system, which uses existing sEEG diagnostic electrodes for brain lesioning. The study, guided by Dr. Jamie Van Gompel at the Mayo Clinic, confirmed successful RF ablations that may improve procedure safety. The company plans to submit a 510(k) application for FDA clearance in Q2 2023. Additionally, NeuroOne is advancing therapeutic electrode technologies targeting markets worth $500 million to $6 billion.
- Successful completion of a feasibility study for the OneRF ablation system.
- Potential to improve safety in brain ablation procedures with temperature monitoring technology.
- 510(k) application expected to be submitted to the FDA in Q2 2023.
- Exploration of addressable markets valued between $500 million and $6 billion for therapeutic electrode technologies.
- None.
Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, MN
Company on track to submit OneRF 510(k) application to the FDA in the second quarter of calendar year 2023
EDEN PRAIRIE, Minn., Dec. 6, 2022 /PRNewswire/ -- 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 it has successfully completed a feasibility study with its OneRF™ ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
The study evaluated the Company's new RF ablation system in an animal model. The study used NeuroOne's FDA cleared sEEG electrodes combined with a proprietary RF generator and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed. This allows clinicians to set temperature and time for each ablation. Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an MRI scan.
"This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation. The addition of this feature may improve the safety of the procedure. We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful. We look forward to the FDA submission of the device in the second calendar quarter of 2023." said Dave Rosa, CEO of NeuroOne.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between
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. For more information, visit https://www.n1mtc.com .
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 potential for NeuroOne's technology to be a major improvement in the field, the potential for NeuroOne's technology to improve safety of procedures, the timing and success of any FDA regulatory submissions, potential market size, commercialization activities, and potential regulatory clearance/approval of brain tissue ablation and chronic stimulation use for DBS and spinal cord stimulation for chronic back pain. 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 the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all, whether due to supply chain disruptions, labor shortages, the impact of COVID-19 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 the COVID-19 pandemic will continue to adversely impact our business; 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"
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What is the OneRF system developed by NeuroOne (NMTC)?
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