Nexalin Technology Completes Phase 1of Its Innovative Virtual Clinic
Nexalin Technology Completes Phase 1of Its Innovative Virtual Clinic
AI Components for Electronic Data Capture and Patient Monitoring to be Integrated into Phase 2
用於電子數據採集和患者監測的AI元件將被集成到第二階段中
HOUSTON, TX, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the "Company" or "Nexalin") the leader in Deep Intracranial Frequency Stimulation (DIFS) of the brain, is pleased to announce the launch of Phase 1 of its proprietary virtual clinic. The virtual clinic will utilize artificial intelligence (AI) and Nexalin's new Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS). This AI ecosystem is designed to allow the entire clinical trial process—and ultimately the treatment experience—to be conducted virtually in the privacy of patients' homes while providing physicians with real-time digital data related to the patient's treatment experience. This innovative AI platform is being designed to manage Nexalin's virtual clinic and clinical research capabilities, as well as streamline the patient experience for its Generation 3 Halo Device.
德克薩斯州休斯頓,2024年12月23日(全球新聞稿)——Nexalin科技公司(納斯達克:NXL;NXLIW)(以下簡稱"公司"或"Nexalin")是腦深層頻率刺激(DIFS)領域的領導者,欣然宣佈其專有虛擬診所的第一階段啓動。該虛擬診所將利用人工智能(AI)和Nexalin的新電子數據採集(EDC)平台及患者監測系統(PMS)。該AI生態系統旨在使整個臨牀試驗過程——最終治療體驗——能夠在患者家中的隱私中進行,同時向醫生提供與患者治療體驗相關的實時數字數據。這個創新的AI平台旨在管理Nexalin的虛擬診所和臨牀研究能力,同時簡化其第三代光環設備的患者體驗。
Recently, Nexalin announced its plan to transition its groundbreaking brain-stimulation technology from traditional mental health clinics into patients' homes with the Gen-3 Halo headset. The Halo headset administers Nexalin's 15mAmp deep frequency stimulation to the brain. The entire treatment process is non-invasive and undetectable to the patient. Clinical data supports the safety and efficacy of Nexalin's advanced 15mAmp waveform for addressing mental health challenges, including depression, insomnia, Alzheimer's disease, addiction, and other conditions. The Halo headset requires FDA clearance as a medical device, along with a prescription and monitoring by a physician. Halo is designed to be used in the privacy of a patient's home, in an AI-based virtual setting while supervised by a licensed physician.
最近,Nexalin宣佈計劃將其開創性的腦刺激技術從傳統心理健康診所轉移到患者家中,使用第三代光環耳機。光環耳機向大腦施加Nexalin的15mAmp深頻刺激。整個治療過程是非侵入式的,並且對患者不可檢測。臨牀數據支持Nexalin的先進15mAmp波形在應對心理健康問題(包括抑鬱症、失眠、阿爾茨海默病、上癮及其他疾病)方面的安全性和有效性。光環耳機需要FDA批准作爲醫療設備,並需醫生處方與監測。光環旨在在患者家中的隱私環境中使用,在AI基礎的虛擬場景中由持證醫生監督。
Phase 1 of Nexalin's virtual clinic also introduces the proprietary Electronic Data Capture (EDC) platform, which enables efficient real-time data acquisition and analysis during clinical trials. Integrated with a patient-friendly smartphone application, the AI-based system will allow users to initiate treatment sessions virtually. Treatment data is automatically and securely uploaded to the cloud, ensuring compliance with diverse study protocols and providing actionable insights.
Nexalin虛擬診所的第一階段還引入了專有的電子數據採集(EDC)平台,該平台能夠在臨牀試驗中實現高效的實時數據採集和分析。與用戶友好的智能手機應用程序集成後,該基於AI的系統將允許用戶虛擬啓動治療會話。治療數據會自動且安全地上傳到雲端,確保遵循多樣的研究協議並提供可操作的見解。
Nexalin will also configure its AI platform to include a Patient Monitoring System (PMS) to enhance the treatment experience. Through its interactive smartphone application, clinical teams can monitor patient progress, analyze adherence to treatment protocols, and make real-time adjustments as necessary. The virtual clinic will also include a built-in telemedicine feature, enabling direct communication between patients and Nexalin's Brain-Health clinical team, ensuring personalized care and support throughout the treatment process.
Nexalin還將配置其AI平台,包括一個患者監測系統(PMS),以增強治療體驗。通過其互動智能手機應用程序,臨牀團隊可以監測患者的進展,分析治療協議的遵循情況,並根據需要進行實時調整。虛擬診所還將包括一個內置的遠程醫療功能,允許患者與Nexalin的腦健康臨牀團隊直接溝通,確保在整個治療過程中提供個性化的關懷和支持。
Both the EDC and PMS systems were custom-developed by Trial-Track to Nexalin's specifications. Reynold Yordy, CTO of Trial-Track, expressed his enthusiasm, "We are thrilled to collaborate with Nexalin, a company leading the way in AI-based neurostimulation technology. We are confident that Phase 1 of Nexalin's virtual clinic, incorporating the EDC and PMS, will greatly enhance the clinical trial experience for patients and set a new standard of care for individuals struggling with mental health challenges."
EDC和PMS系統均是由Trial-Track按照Nexalin的規格定製開發的。Trial-Track的首席技術官Reynold Yordy表示:"我們很高興能與Nexalin合作,Nexalin是一家在基於AI的神經刺激技術方面處於領先地位的公司。我們相信,Nexalin虛擬診所的第一階段,結合EDC和PMS,將極大提升患者的臨牀試驗體驗,併爲面臨心理健康挑戰的個人樹立新的護理標準。"
Mark White, CEO of Nexalin, remarked, "This AI platform is a major milestone for Nexalin as we continue to innovate and improve the treatment experience for patients. Our partnership with Trial-Track has allowed us to leverage their technical expertise to create tools that support our Generation 3 Halo Device and virtual, AI-based clinic while driving efficiency in our future clinical trials. This combination of the Gen-3 Halo Device, EDC platform, and PMS represents a significant advancement in our commitment to improving patient outcomes."
Nexalin的首席執行官Mark White表示:"這個AI平台對於Nexalin來說是一個重大的里程碑,因爲我們持續創新並改善患者的治療體驗。我們與Trial-Track的合作使我們能夠利用他們的技術專長,創建支持我們第3代Halo設備和虛擬的基於AI的診所的工具,同時提高我們未來臨牀試驗的效率。這種第3代Halo設備、EDC平台和PMS的結合,體現了我們改善患者結果的承諾的顯著進展。"
About Nexalin Technology, Inc.
關於Nexalin科技有限公司。
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin's products are non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: .
Nexalin設計和開發創新的神經刺激產品,獨特地幫助應對全球心理健康流行病。Nexalin的所有產品均爲非侵入性,且對人體不可察覺,旨在爲精神健康問題患者提供緩解。Nexalin利用生物電子醫療技術來治療心理健康問題。Nexalin相信其神經刺激醫療設備可以深入滲透與心理健康障礙相關的中腦深層結構。Nexalin認爲,其下一代設備中更深層的波形將產生增強的患者反應,而不會有任何不良副作用。Nexalin Gen-2 15毫安神經刺激設備已在中國、巴西和阿曼獲得批准。關於公司的更多信息可在以下網站找到:.
Forward-looking statements
前瞻性聲明
This press release contains statements that constitute "forward-looking statements," These statements relate to future events or Nexalin's future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management "believes", "expects", "anticipates", "plans", "intends" and similar expressions) should be considered forward-looking statements that involve risks and uncertainties which could cause actual events or Nexalin's actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2023, and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC's website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
本新聞稿包含構成「前瞻性陳述」的聲明,這些聲明與未來事件或Nexalin的未來財務表現有關。任何提及期待、預測或其他對未來事件或情況的描述,或不是歷史事實的陳述(包括但不限於Nexalin或其管理層「相信」、「期望」、「預期」、「計劃」、「打算」等類似表達的聲明)都應視爲前瞻性陳述,這些內容涉及可能導致實際事件或Nexalin的實際結果與前瞻性陳述所示存在重大差異的風險和不確定性。前瞻性陳述受到多種條件的約束,這些條件中有許多超出了公司的控制範圍,包括在公司截至2023年12月31日的10-K報告風險因素部分列出的因素,以及其他向證券交易委員會提交的文件。這些文件的副本可在SEC網站www.sec.gov上獲取。此類前瞻性陳述是在本日期發佈的,可能會隨着時間的推移而過時。此類前瞻性陳述是在本日期發佈的,可能會隨着時間的推移而過時。公司不承擔更新這些聲明的義務,以反映發佈日期之後的修訂或變化,除非法律要求。
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
聯繫:
Crescendo Communications, LLC
電話: (212) 671-1020
電子郵件: NXL@crescendo-ir.com