NeuroOne® Announces Breakthrough Case Completed with OneRF™ Ablation System at the University Hospitals in Cleveland
NeuroOne Medical Technologies (Nasdaq: NMTC) announced a breakthrough case using its OneRF™ Ablation System at University Hospitals in Cleveland. Forty-four ablations were successfully performed on one patient over two days, guided by sEEG recordings. The patient is reportedly seizure-free two months post-procedure, with improvements in mood and memory.
Dr. Michael Staudt, the lead neurosurgeon, expressed satisfaction with the system's performance and its potential to benefit many patients. CEO Dave Rosa highlighted the case's uniqueness, exceeding the range of ablations found in clinical literature. The OneRF™ Ablation System is NeuroOne's third FDA 510(k)-cleared device and first with a therapeutic indication. NeuroOne estimates the current brain ablation market at $100M worldwide with significant growth potential.
NeuroOne Medical Technologies (Nasdaq: NMTC) ha annunciato un caso rivoluzionario utilizzando il suo sistema di ablazione OneRF™ presso gli Ospedali Universitari di Cleveland. Quarantaquattro ablazioni sono state eseguite con successo su un paziente nell'arco di due giorni, guidate da registrazioni sEEG. Il paziente è senza crisi due mesi dopo la procedura, con miglioramenti nell'umore e nella memoria.
Il Dr. Michael Staudt, il chirurgo neurochirurgico principale, ha espresso soddisfazione per le prestazioni del sistema e il suo potenziale beneficio per molti pazienti. Il CEO Dave Rosa ha evidenziato l'unicità del caso, superando il numero di ablazioni riportato nella letteratura clinica. Il sistema di ablazione OneRF™ è il terzo dispositivo approvato dalla FDA 510(k) di NeuroOne e il primo con un'indicazione terapeutica. NeuroOne stima che il mercato attuale dell'ablazione cerebrale valga 100 milioni di dollari a livello mondiale con un significativo potenziale di crescita.
NeuroOne Medical Technologies (Nasdaq: NMTC) anunció un caso innovador utilizando su Sistema de Ablación OneRF™ en los Hospitales Universitarios de Cleveland. Se realizaron exitosamente cuarenta y cuatro ablaciones a un paciente en un lapso de dos días, guiadas por grabaciones de sEEG. El paciente está libre de crisis dos meses después del procedimiento, con mejoras en el estado de ánimo y la memoria.
El Dr. Michael Staudt, el neurocirujano principal, expresó su satisfacción con el rendimiento del sistema y su potencial para beneficiar a muchos pacientes. El CEO Dave Rosa destacó la singularidad del caso, superando el rango de ablaciones encontrado en la literatura clínica. El Sistema de Ablación OneRF™ es el tercer dispositivo aprobado por la FDA 510(k) de NeuroOne y el primero con una indicación terapéutica. NeuroOne estima que el mercado actual de ablación cerebral es de 100 millones de dólares a nivel mundial con un importante potencial de crecimiento.
NeuroOne Medical Technologies (Nasdaq: NMTC)는 클리블랜드의 대학 병원에서 OneRF™ 절제 시스템을 사용한 혁신적인 사례를 발표했습니다. 44회의 절제가 이틀에 걸쳐 한 환자에게 성공적으로 시행되었으며, sEEG 기록에 의해 안내되었습니다. 환자는 시술 후 두 달 만에 발작이 없으며, 기분과 기억력에서도 개선이 있었습니다.
주요 신경외과 의사인 마이클 스타우트 박사는 시스템의 성능과 많은 환자에게 도움이 될 가능성에 대한 만족감을 표명했습니다. CEO 데이브 로사는 이 사례가 임상 문헌에서 발견된 절제 범위를 초과하였다고 강조했습니다. OneRF™ 절제 시스템은 NeuroOne의 세 번째 FDA 510(k) 승인 장비이며, 치료적 적응증이 있는 첫 번째 장비입니다. NeuroOne은 현재의 뇌 절제 시장이 전 세계적으로 1억 달러에 달하며, 상당한 성장 잠재력이 있다고 추정하고 있습니다.
NeuroOne Medical Technologies (Nasdaq: NMTC) a annoncé un cas révolutionnaire utilisant son système d'ablation OneRF™ dans les hôpitaux universitaires de Cleveland. Quarante-quatre ablations ont été réalisées avec succès sur un patient sur deux jours, guidées par des enregistrements sEEG. Le patient est sans crise deux mois après la procédure, avec des améliorations de l'humeur et de la mémoire.
Le Dr Michael Staudt, le neurochirurgien principal, a exprimé sa satisfaction quant aux performances du système et à son potentiel en faveur de nombreux patients. Le PDG Dave Rosa a souligné l'unicité du cas, qui dépasse la fourchette d'ablations trouvées dans la littérature clinique. Le système d'ablation OneRF™ est le troisième dispositif approuvé par la FDA 510(k) de NeuroOne et le premier avec une indication thérapeutique. NeuroOne estime que le marché actuel de l'ablation cérébrale vaut 100 millions de dollars dans le monde avec un potentiel de croissance significatif.
NeuroOne Medical Technologies (Nasdaq: NMTC) hat einen bahnbrechenden Fall mit seinem OneRF™ Ablationssystem in den Universitätskliniken in Cleveland vorgestellt. Vierundvierzig Ablationen wurden innerhalb von zwei Tagen erfolgreich an einem Patienten durchgeführt, unterstützt durch sEEG-Aufzeichnungen. Der Patient ist nach dem Eingriff seit zwei Monaten anfallsfrei und hat Verbesserungen in Stimmung und Gedächtnis erfahren.
Dr. Michael Staudt, der leitende Neurochirurg, äußerte seine Zufriedenheit mit der Leistung des Systems und seinem Potenzial, vielen Patienten zu helfen. CEO Dave Rosa hob die Einzigartigkeit des Falls hervor, der die in der klinischen Literatur dokumentierte Anzahl an Ablationen übersteigt. Das OneRF™ Ablationssystem ist das dritte von der FDA genehmigte 510(k)-Gerät von NeuroOne und das erste mit einer therapeutischen Indikation. NeuroOne schätzt den aktuellen Markt für Gehirnablationen auf 100 Millionen Dollar weltweit mit erheblichem Wachstumspotenzial.
- Successful completion of 44 ablations in one patient using OneRF™ Ablation System
- Patient reportedly seizure-free with improved mood and memory two months post-procedure
- Positive feedback from lead neurosurgeon Dr. Michael Staudt
- OneRF™ Ablation System is NeuroOne's third FDA 510(k)-cleared device
- Brain ablation market estimated at $100M worldwide with potential for multifold growth
- None.
Insights
The successful completion of 44 ablations using NeuroOne's OneRF™ Ablation System marks a significant advancement in epilepsy treatment. This case demonstrates the system's capability to perform a high number of precise ablations, far exceeding typical clinical scenarios. The patient's reported seizure freedom and improvements in mood and memory two months post-procedure are promising early indicators of the treatment's efficacy.
However, it's important to note that long-term outcomes are yet to be evaluated. The medical community will closely monitor this case for sustained benefits and potential side effects. If the positive results persist, it could potentially reshape treatment protocols for drug-resistant epilepsy, offering a less invasive alternative to traditional surgery. This breakthrough could significantly impact NeuroOne's market position in the rapidly growing
NeuroOne's breakthrough case with the OneRF™ Ablation System could be a game-changer for the company's financial outlook. With an estimated brain ablation market of
Investors should note that NeuroOne now has a full line of FDA-cleared devices, including diagnostic and therapeutic options. This comprehensive portfolio could lead to higher revenue streams and improved profit margins. However, it's important to consider that widespread adoption and revenue growth may take time and the company may face competition in this rapidly evolving market. Long-term clinical data will be important for sustained market penetration and financial success.
The OneRF™ Ablation System's performance in this case showcases impressive technological capabilities. Completing 44 ablations through just six implanted electrodes over two days demonstrates the system's precision, efficiency and safety features. The ability to perform bedside ablations guided by sEEG recordings indicates a high level of integration between diagnostic and therapeutic functionalities.
This technology represents a significant leap in minimally invasive neurosurgical techniques. The system's versatility in addressing various neurological disorders could lead to expanded applications beyond epilepsy treatment. However, as with any medical technology, long-term reliability and consistency across multiple cases will be critical. Future developments may focus on further miniaturization, increased automation and enhanced real-time imaging integration to improve targeting accuracy and patient outcomes.
Forty-four ablations performed successfully in one patient
Patient currently reportedly seizure free with improvements in mood and memory
EDEN PRAIRIE, Minn., Sept. 10, 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 in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient.
In mid-July, led by Dr. Michael Staudt, Neurosurgeon, a patient benefitted from forty-four ablations through six different implanted OneRF electrodes over a two-day period. These ablations were performed based on guidance provided by the sEEG recordings that confirmed the focal epileptic zone in the patient. The ablation sessions were performed at the patient’s bedside and were well-tolerated by the patient. Immediate and short-term clinical evaluation suggests a positive outcome of the ablation procedure. At two months follow-up, the patient is seizure-free with self-reported improvements in mood and memory. Long term outcomes will be evaluated over time.
Dr. Staudt commented “We are very pleased with how NeuroOne’s OneRF system performed in this case, and we look forward to adopting this capability in our clinical practice. We think many patients could benefit from this technology in the near future.”
“We are extremely pleased that the OneRF system had a positive impact for the patient. This case was unique in that it far exceeded the range of ablations found in clinical literature. It was exciting to see the system safely perform forty-four ablations and yield a positive outcome to date. We appreciate Dr. Staudt and his staff’s support during the case and look forward to future cases,” said Dave Rosa, CEO of NeuroOne.
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
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.
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FAQ
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