Tivic Health Receives Approval from Institutional Review Board for ncVNS Optimization Study, Readies for Enrollment
Tivic Health Systems, Inc. (Nasdaq: TIVC) has received approval from The Feinstein Institutes' Institutional Review Board for its non-invasive cervical vagus nerve stimulation (ncVNS) optimization study. This clinical research collaboration aims to refine and optimize stimulation parameters for Tivic Health's ncVNS technology. The study will use physiological measurements to enhance device performance and refine specifications such as electrode positioning and electrical waveform parameters.
Key goals include optimizing treatment strategies and accelerating product development. The study, led by Dr. Theodoros Zanos and Dr. Blake Gurfein, will inform the selection of clinical populations and shape future trial designs. Tivic Health is taking an integrated approach to clinical, product development, and go-to-market planning for its medical-grade non-invasive VNS program, aiming to generate significant new revenue.
Tivic Health Systems, Inc. (Nasdaq: TIVC) ha ricevuto l'approvazione dal Comitato Etico delle Istituzioni Feinstein per il suo studio di ottimizzazione della stimolazione non invasiva del nervo vago cervicale (ncVNS). Questa collaborazione di ricerca clinica mira a perfezionare e ottimizzare i parametri di stimolazione per la tecnologia ncVNS di Tivic Health. Lo studio utilizzerà misurazioni fisiologiche per migliorare le prestazioni del dispositivo e affinare specifiche come il posizionamento degli elettrodi e i parametri dell'onda elettrica.
Gli obiettivi chiave includono l'ottimizzazione delle strategie di trattamento e l'accelerazione dello sviluppo del prodotto. Lo studio, guidato dal Dr. Theodoros Zanos e dal Dr. Blake Gurfein, informerà la selezione delle popolazioni cliniche e modellerà i futuri progetti sperimentali. Tivic Health sta adottando un approccio integrato allo sviluppo clinico, dello sviluppo del prodotto e alla pianificazione per il mercato per il suo programma di VNS non invasivo di grado medicale, con l'obiettivo di generare nuove entrate significative.
Tivic Health Systems, Inc. (Nasdaq: TIVC) ha recibido la aprobación de la Junta de Revisión Institucional de los Institutos Feinstein para su estudio de optimización de la estimulación no invasiva del nervio vago cervical (ncVNS). Esta colaboración de investigación clínica tiene como objetivo refinar y optimizar los parámetros de estimulación para la tecnología ncVNS de Tivic Health. El estudio utilizará mediciones fisiológicas para mejorar el rendimiento del dispositivo y refinar especificaciones como el posicionamiento de electrodos y los parámetros de la forma de onda eléctrica.
Los objetivos clave incluyen la optimización de estrategias de tratamiento y la aceleración del desarrollo del producto. El estudio, dirigido por el Dr. Theodoros Zanos y el Dr. Blake Gurfein, informará sobre la selección de poblaciones clínicas y moldeará futuros diseños de ensayos. Tivic Health está adoptando un enfoque integrado para el desarrollo clínico, el desarrollo del producto y la planificación de salida al mercado para su programa de VNS no invasivo de grado médico, con el objetivo de generar ingresos nuevos y significativos.
Tivic Health Systems, Inc. (Nasdaq: TIVC)는 Feinstein 연구소의 기관 윤리 검토 위원회로부터 비침습적 경추 미주신경 자극(ncVNS) 최적화 연구에 대한 승인을 받았습니다. 이 임상 연구 협력의 목표는 Tivic Health의 ncVNS 기술에 대한 자극 매개변수를 정제하고 최적화하는 것입니다. 본 연구는 생리학적 측정을 이용하여 장치 성능을 향상시키고 전극 위치 및 전기 파형 매개변수와 같은 사양을 정제할 것입니다.
주요 목표에는 치료 전략 최적화 및 제품 개발 가속화가 포함됩니다. 이 연구는 Dr. Theodoros Zanos와 Dr. Blake Gurfein이 주도하며, 임상 집단의 선택에 대한 정보를 제공하고 향후 시험 설계에 영향을 미칠 것입니다. Tivic Health는 의학 등급의 비침습적 VNS 프로그램을 위한 임상, 제품 개발 및 시장 진출 계획에 통합된 접근 방식을 취하고 있으며, 새로운 수익을 상당히 창출할 것을 목표로 하고 있습니다.
Tivic Health Systems, Inc. (Nasdaq: TIVC) a reçu l'approbation du Comité de révision institutionnelle des Instituts Feinstein pour son étude d'optimisation de la stimulation non invasive du nerf vague cervical (ncVNS). Cette collaboration de recherche clinique vise à affiner et à optimiser les paramètres de stimulation de la technologie ncVNS de Tivic Health. L'étude utilisera des mesures physiologiques pour améliorer les performances de l'appareil et affiner des spécifications telles que le positionnement des électrodes et les paramètres des formes d'onde électriques.
Les objectifs clés incluent l'optimisation des stratégies de traitement et l'accélération du développement des produits. L'étude, dirigée par Dr. Theodoros Zanos et Dr. Blake Gurfein, informera sur la sélection des populations cliniques et influencera les conceptions futures des essais. Tivic Health adopte une approche intégrée pour le développement clinique, le développement de produits et la planification de mise sur le marché pour son programme VNS non invasif de qualité médicale, visant à générer des revenus significatifs.
Tivic Health Systems, Inc. (Nasdaq: TIVC) hat die Genehmigung des Institutional Review Board der Feinstein Institute für seine nicht-invasive zervikale Vagusnervstimulation (ncVNS) Optimierungsstudie erhalten. Diese klinische Forschungskooperation zielt darauf ab, die Stimulationsparameter für die ncVNS-Technologie von Tivic Health zu verfeinern und zu optimieren. Die Studie wird physiologische Messungen verwenden, um die Geräteleistung zu verbessern und Spezifikationen wie Elektrodenplatzierung und elektrische Wellenformparameter zu verfeinern.
Die Hauptziele umfassen die Optimierung von Behandlungsstrategien und die Beschleunigung der Produktentwicklung. Die Studie, geleitet von Dr. Theodoros Zanos und Dr. Blake Gurfein, wird die Auswahl klinischer Populationen informieren und zukünftige Studienentwürfe gestalten. Tivic Health verfolgt einen integrierten Ansatz für klinische Entwicklung, Produktentwicklung und Markteinführungsplanung für sein nicht-invasives, medizinisch zugelassenes VNS-Programm, mit dem Ziel, erhebliche neue Einnahmen zu generieren.
- Approval received for ncVNS optimization study, advancing clinical research
- Collaboration with The Feinstein Institute of Bioelectronic Medicine, a leader in the field
- Potential to accelerate product development and personalize treatment strategies
- Integrated approach to clinical, product development, and go-to-market planning
- Global vagus nerve stimulation market projected to reach $21.3 billion by 2030 (CAGR 10.6%)
- None.
Insights
The approval from the Institutional Review Board for Tivic Health's ncVNS optimization study marks a significant step forward in the company's bioelectronic medicine development. This study, focusing on refining stimulation parameters and electrode positioning, is crucial for enhancing the efficacy of their non-invasive vagus nerve stimulation technology.
The collaboration with the prestigious Feinstein Institute and Dr. Zanos adds credibility and expertise to the research. The emphasis on personalization and optimization of treatment strategies aligns with the growing trend towards precision medicine, potentially giving Tivic a competitive edge in the rapidly expanding
However, investors should note that while this study is a positive step, it's still in the early stages of development. The success of the optimization study and subsequent clinical trials will be critical in determining the commercial viability of Tivic's ncVNS technology. The company's integrated approach to clinical, product development and market planning is promising, but execution will be key to translating this research into revenue-generating products.
Tivic Health's progress in ncVNS technology positions them well in the rapidly growing vagus nerve stimulation market. With a projected CAGR of
The collaboration with Fletcher Spaght to identify high-unmet clinical needs is a strategic move. This approach could help Tivic target niche markets where their technology can provide maximum value, potentially leading to faster market penetration and revenue generation. The company's focus on medical-grade, non-invasive VNS could be a key differentiator, especially if they can demonstrate superior efficacy and patient comfort compared to invasive alternatives.
While the news is promising, it's important to note that Tivic is still in the development phase. The timeline from optimization studies to marketable products can be lengthy in the medical device industry and regulatory hurdles remain. Investors should closely monitor the outcomes of this study and subsequent clinical trials to gauge the long-term potential of Tivic's technology.
This clinical research collaboration with Feinstein is designed to advance the development of Tivic Health’s ncVNS technology by refining and optimizing stimulation parameters. Physiological measurements will be used to enhance device performance and refine specifications such as electrode positioning and electrical waveform parameters. The data derived from the study will be used to inform the selection of clinical populations of interest and help shape the clinical study design for upcoming trials.
The company has previously announced the successful completion of its Phase 1 study on ncVNS. Key goals of the current study include:
- Optimizing Treatment Strategies: The research will provide critical data to advance both personalization of treatment and optimization of stimulation parameters.
- Accelerating Product Development: The optimized parameters will help accelerate development of Tivic Health’s product offerings based on ncVNS.
The company has also recently announced its collaboration with Fletcher Spaght, a leading healthcare growth strategy firm. Fletcher Spaght has begun substantiating clinical applications with high unmet needs that have potential to be addressed by Tivic Health’s patent-pending ncVNS system.
“We are taking an integrated approach to clinical, product development and go-to-market planning for our medical-grade non-invasive VNS program,” explained Jennifer Ernst, CEO of Tivic Health. “We believe this approach creates the best opportunities to generate significant new revenue based on this work.”
The optimization study will be conducted by The Feinstein Institute of Bioelectronic Medicine. It will be led by Dr. Theodoros Zanos, Ph.D., Associate Professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at The Feinstein Institutes at Northwell Health, in partnership with Dr. Blake Gurfein, Tivic Health’s Chief Scientific Officer.
“Precision optimization is an important but often overlooked step in non-invasive neurostimulation device development,” Dr. Gurfein commented. “I am pleased we are working with Dr. Zanos and other leaders in the field as we move from proof-of-concept to disease-specific validation in clinical trials anticipated next year.”
Polaris Market Research estimates the global vagus nerve stimulation market, valued at
About Tivic Health
Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms use stimulation of the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth
Forward-Looking Statements
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Media Contact:
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Investor Contact:
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Source: Tivic Health Systems, Inc.
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