NeuroOne Successfully Completes Feasibility Study With Its OneRF Ablation System
NeuroOne Successfully Completes Feasibility Study With Its OneRF Ablation System
Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, MN
動物研究在明尼蘇達州羅切斯特的梅奧診所的傑米·範·貢佩爾博士的指導下完成
Company on track to submit OneRF 510(k) application to the FDA in the second quarter of calendar year 2023
公司有望在2023日曆年的第二季度向美國食品藥品管理局提交OneRF 510 (k) 申請
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.
明尼蘇達州伊甸草原，2022 年 12 月 6 日 /PRNewswire/ — 專注於改善神經系統疾病患者的外科治療選擇和療效的醫療技術公司 NeuroOne 醫療技術公司（納斯達克股票代碼：NMTC）（NeuroOne 或公司）今天宣佈，它已成功完成了其 OneRF 消融系統的可行性研究，該開發技術利用現有的植入式 seeG 診斷電極治療腦組織有區別的。
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.
該研究在動物模型中評估了該公司的新射頻消融系統。該研究使用了NeuroOne獲得美國食品藥品管理局批准的SeeG電極與專有的射頻發生器和獨特的溫度控制配件相結合，用於監測和維持消融術的溫度。這允許臨床醫生設置每次消融的溫度和時間。Van Gompel 博士和他的團隊植入了五個 seeG 電極，進行了電生理記錄，然後使用不同的溫度和時間設置完成了總共十次射頻消融術。所有消融均通過核磁共振成像掃描得到證實。
"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.
“這項技術有可能代表該領域的重大改進，因爲它是已知的第一個在整個消融過程中根據溫度監測和調整設置的Seeg制導射頻系統。添加此功能可能會提高程序的安全性。我們對OneRF消融系統的持續進展感到非常興奮，並相信如果成功，它可能會對爲這些手術設定新的黃金標準產生重大影響。我們期待美國食品藥品管理局在2023年第二個日曆季度提交該設備。” NeuroOne首席執行官戴夫·羅莎說。
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 $500 million and $6 billion.
正如先前報道的那樣，NeuroOne還在推進一系列治療電極技術，用於DBS（深部腦刺激）的慢性刺激和脊髓刺激治療慢性背部疼痛。這些治療電極技術代表着價值在5億至60億美元之間的潛在市場。
譯文內容由第三人軟體翻譯。