Nexalin Technology Completes Phase 1of its Innovative Virtual Clinic
Nexalin Technology (NXL) has completed Phase 1 of its proprietary virtual clinic, incorporating AI components for Electronic Data Capture (EDC) and Patient Monitoring System (PMS). The virtual platform is designed to enable clinical trials and treatments to be conducted remotely from patients' homes while providing real-time data to physicians.
The system will support Nexalin's Generation 3 Halo Device, a non-invasive headset that delivers 15mAmp deep frequency stimulation to treat mental health conditions including depression, insomnia, Alzheimer's disease, and addiction. The Halo device requires FDA clearance and physician prescription.
The EDC platform enables real-time data collection during trials through a smartphone application, while the PMS allows clinical teams to monitor patient progress and make treatment adjustments. The virtual clinic includes telemedicine features for direct patient-physician communication.
Nexalin Technology (NXL) ha completato la Fase 1 della sua clinica virtuale proprietaria, incorporando componenti AI per il Cattura dei Dati Elettronici (EDC) e il Sistema di Monitoraggio dei Pazienti (PMS). La piattaforma virtuale è progettata per consentire studi clinici e trattamenti da svolgersi a distanza, direttamente dalle case dei pazienti, fornendo al contempo dati in tempo reale ai medici.
Il sistema supporta il dispositivo Halo di Generazione 3 di Nexalin, un auricolare non invasivo che eroga stimolazione a bassa frequenza di 15mAmp per trattare disturbi mentali come depressione, insonnia, malattia di Alzheimer e dipendenza. Il dispositivo Halo richiede l'approvazione della FDA e una prescrizione medica.
La piattaforma EDC consente la raccolta dei dati in tempo reale durante gli studi tramite un'applicazione per smartphone, mentre il PMS permette ai team clinici di monitorare i progressi dei pazienti e apportare aggiustamenti al trattamento. La clinica virtuale include funzionalità di telemedicina per una comunicazione diretta tra paziente e medico.
Nexalin Technology (NXL) ha completado la Fase 1 de su clínica virtual propietaria, incorporando componentes de IA para la Captura Electrónica de Datos (EDC) y el Sistema de Monitoreo de Pacientes (PMS). La plataforma virtual está diseñada para permitir que los ensayos clínicos y tratamientos se realicen de forma remota desde los hogares de los pacientes, proporcionando datos en tiempo real a los médicos.
El sistema apoyará el Dispositivo Halo de Generación 3 de Nexalin, un auricular no invasivo que proporciona estimulación de frecuencia profunda de 15mAmp para tratar condiciones de salud mental, incluyendo depresión, insomnio, enfermedad de Alzheimer y adicción. El dispositivo Halo requiere la aprobación de la FDA y una receta médica.
La plataforma EDC permite la recolección de datos en tiempo real durante los ensayos a través de una aplicación para teléfonos inteligentes, mientras que el PMS permite a los equipos clínicos monitorear el progreso de los pacientes y hacer ajustes al tratamiento. La clínica virtual incluye características de telemedicina para la comunicación directa entre pacientes y médicos.
넥살린 테크놀로지(NXL)가 인공지능(AI) 구성 요소를 포함한 전자 데이터 수집(EDC) 및 환자 모니터링 시스템(PMS)으로 자신만의 가상 클리닉 1단계를 완료했습니다. 이 가상 플랫폼은 환자의 자택에서 원격으로 임상 시험과 치료가 이루어질 수 있도록 설계되었으며, 의사에게 실시간 데이터를 제공합니다.
이 시스템은 15mAmp의 깊은 주파수 자극을 제공하여 우울증, 불면증, 알츠하이머병 및 중독을 포함한 정신 건강 문제를 치료하는 비침습적인 헤드셋인 넥살린의 3세대 헤일로 장치를 지원합니다. 헤일로 장치는 FDA의 승인과 의사의 처방이 필요합니다.
EDC 플랫폼은 스마트폰 애플리케이션을 통해 시험 중 실시간 데이터 수집을 가능하게 하며, PMS는 임상 팀이 환자의 진행 상태를 모니터링하고 치료 조정을 할 수 있도록 합니다. 이 가상 클리닉은 환자와 의사가 직접 소통할 수 있는 원격의료 기능을 포함합니다.
Nexalin Technology (NXL) a complété la Phase 1 de sa clinique virtuelle propriétaire, intégrant des composants d'IA pour la Capture Électronique de Données (EDC) et le Système de Suivi des Patients (PMS). La plateforme virtuelle est conçue pour permettre la réalisation d'essais cliniques et de traitements à distance, depuis le domicile des patients, tout en fournissant des données en temps réel aux médecins.
Le système prendra en charge le Dispositif Halo de Génération 3 de Nexalin, un casque non invasif qui délivre une stimulation à basse fréquence de 15mAmp pour traiter des troubles mentaux tels que la dépression, l'insomnie, la maladie d'Alzheimer et la dépendance. Le dispositif Halo nécessite l'approbation de la FDA et une prescription médicale.
La plateforme EDC permet la collecte de données en temps réel pendant les essais via une application pour smartphone, tandis que le PMS permet aux équipes cliniques de suivre les progrès des patients et d'apporter des ajustements au traitement. La clinique virtuelle comprend des fonctionnalités de télémédecine pour une communication directe entre le patient et le médecin.
Nexalin Technology (NXL) hat Phase 1 seiner eigenen virtuellen Klinik abgeschlossen, die KI-Komponenten für die elektronische Datenerfassung (EDC) und das Patientenüberwachungssystem (PMS) integriert. Die virtuelle Plattform ist darauf ausgelegt, klinische Studien und Behandlungen aus den Wohnungen der Patienten heraus durchzuführen, während sie den Ärzten Echtzeitdaten bereitstellt.
Das System unterstützt Nexalins Generation 3 Halo-Gerät, ein nicht-invasives Headset, das 15mAmp tiefe Frequenzstimulation abgibt, um psychische Erkrankungen wie Depressionen, Schlaflosigkeit, Alzheimer und Sucht zu behandeln. Das Halo-Gerät erfordert eine Genehmigung der FDA und eine ärztliche Verschreibung.
Die EDC-Plattform ermöglicht die Erfassung von Echtzeitdaten während der Studien über eine Smartphone-Anwendung, während das PMS den klinischen Teams ermöglicht, den Fortschritt der Patienten zu überwachen und Anpassungen bei der Behandlung vorzunehmen. Die virtuelle Klinik beinhaltet Telemedizin-Funktionen für die direkte Kommunikation zwischen Patienten und Ärzten.
- Development of AI-based virtual clinic platform completed Phase 1
- Platform enables remote treatment delivery and monitoring, expanding market reach
- Integration of real-time data collection and analysis capabilities
- Clinical data supports safety and efficacy of 15mAmp waveform treatment
- FDA clearance still required for Gen-3 Halo Device
- Product requires prescription and physician monitoring, limiting accessibility
Insights
The launch of Nexalin's virtual clinic Phase 1 represents a strategic pivot in mental health treatment delivery, integrating AI-driven monitoring with their 15mAmp DIFS technology. The Gen-3 Halo headset's at-home treatment model, combined with real-time data monitoring, could significantly reduce treatment barriers and improve patient compliance. However, several critical challenges remain unaddressed: FDA clearance timeline uncertainties, reimbursement pathways and clinical validation of the virtual monitoring system's efficacy compared to in-clinic treatments.
The EDC platform's integration with smartphone applications for real-time data collection positions Nexalin to potentially accelerate their clinical trial processes and reduce operational costs. Yet, the success heavily depends on the robustness of their AI algorithms and the system's ability to maintain consistent data quality across home environments. The
The implementation of AI-driven EDC and PMS systems marks a significant technological advancement in remote patient monitoring for neurostimulation devices. The cloud-based architecture enabling real-time data collection and analysis could provide valuable insights into treatment efficacy and patient compliance patterns. However, the platform's success will largely depend on its ability to handle complex data security requirements for medical information and maintain reliable connectivity for continuous monitoring.
The partnership with Trial-Track for custom development indicates a focused approach to creating specialized monitoring solutions, but the technical complexity of integrating AI-based monitoring with medical device data streams presents substantial execution risks. The telemedicine feature adds another layer of complexity to the system architecture, requiring robust fail-safes and backup protocols to ensure uninterrupted patient care.
AI Components for Electronic Data Capture and Patient Monitoring to be Integrated into Phase 2
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.
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.
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 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.
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.”
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.”
About Nexalin Technology, Inc.
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: https://nexalin.com/.
Forward-looking statements
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.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
FAQ
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