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Tivic Health Files Patent For Optimized Electrical Stimulation of the Vagus Nerve

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Tivic Health Systems (Nasdaq: TIVC) has filed Patent No. 63,492,402 with the U.S. Patent Office for a 'Method and Apparatus for Electrical Stimulation of the Vagus Nerve.' The patent aims to protect the company's technology for non-invasive cervical vagus nerve stimulation (VNS) device ahead of potential FDA approval and commercialization.

According to Blake Gurfein, Tivic Health's Chief Scientific Officer, research conducted at the Feinstein Institute demonstrated that personalizing stimulation parameters for each subject leads to significantly improved effects on autonomous nervous system measures compared to one-size-fits-all approaches. This customization capability is expected to enable more effective device therapies and create compelling use cases for targeted indications.

Tivic Health Systems (Nasdaq: TIVC) ha presentato il Brevetto n. 63.492.402 presso l'Ufficio Brevetti degli Stati Uniti per un 'Metodo e Apparecchiatura per la Stimolazione Elettrica del Nervo Vago.' Il brevetto mira a proteggere la tecnologia dell'azienda per un dispositivo di stimolazione non invasiva del nervo vago cervicale (VNS) in vista di una potenziale approvazione da parte della FDA e della commercializzazione.

Secondo Blake Gurfein, Direttore Scientifico di Tivic Health, la ricerca condotta presso l'Istituto Feinstein ha dimostrato che la personalizzazione dei parametri di stimolazione per ogni soggetto porta a effetti significativamente migliorati sulle misure del sistema nervoso autonomo rispetto agli approcci standardizzati. Questa capacità di personalizzazione dovrebbe consentire terapie più efficaci e creare casi d'uso interessanti per indicazioni mirate.

Tivic Health Systems (Nasdaq: TIVC) ha presentado la Patente No. 63,492,402 ante la Oficina de Patentes de EE. UU. para un 'Método y Aparato para la Estimulación Eléctrica del Nervio Vago.' La patente tiene como objetivo proteger la tecnología de la compañía para un dispositivo de estimulación no invasiva del nervio vago cervical (VNS) en previsión de una posible aprobación de la FDA y comercialización.

Según Blake Gurfein, Director Científico de Tivic Health, la investigación realizada en el Instituto Feinstein demostró que personalizar los parámetros de estimulación para cada sujeto conduce a efectos significativamente mejorados en las medidas del sistema nervioso autónomo en comparación con enfoques estándar. Esta capacidad de personalización se espera que permita terapias más efectivas y cree casos de uso atractivos para indicaciones específicas.

Tivic Health Systems (Nasdaq: TIVC)는 미국 특허청에 '미주 신경의 전기 자극을 위한 방법 및 장치'에 대한 특허 번호 63,492,402를 제출했습니다. 이 특허는 FDA 승인을 앞두고 회사의 비침습적 경부 미주 신경 자극(VNS) 장치 기술을 보호하는 것을 목표로 합니다.

Blake Gurfein Tivic Health의 최고 과학 책임자에 따르면, Feinstein 연구소에서 실시한 연구는 각 주제에 맞춰 자극 매개변수를 개인화하는 것이 일률적인 접근 방식에 비해 자율 신경계 측정에 상당히 개선된 효과를 가져온다는 것을 보여주었습니다. 이러한 개인화 기능은 보다 효과적인 장치 치료를 가능하게 하고 특정 적응증에 대한 매력적인 사용 사례를 창출할 것으로 기대됩니다.

Tivic Health Systems (Nasdaq: TIVC) a déposé le brevet n° 63.492.402 auprès de l'Office des brevets des États-Unis pour un 'Méthode et Appareil pour la Stimulation Électrique du Nerf Vague.' Le brevet vise à protéger la technologie de l'entreprise pour un dispositif de stimulation non invasive du nerf vague cervical (VNS) en prévision d'une éventuelle approbation par la FDA et de sa commercialisation.

Selon Blake Gurfein, Directeur Scientifique de Tivic Health, des recherches menées à l'Institut Feinstein ont démontré que la personnalisation des paramètres de stimulation pour chaque sujet entraîne des effets significativement améliorés sur les mesures du système nerveux autonome par rapport aux approches standardisées. Cette capacité de personnalisation devrait permettre des thérapies plus efficaces et créer des cas d'utilisation convaincants pour des indications ciblées.

Tivic Health Systems (Nasdaq: TIVC) hat beim US-Patentamt das Patent Nr. 63.492.402 für ein 'Verfahren und Gerät zur elektrischen Stimulation des Vagusnervs' eingereicht. Das Patent zielt darauf ab, die Technologie des Unternehmens für ein nicht-invasives Gerät zur Stimulation des zervikalen Vagusnervs (VNS) vor einer möglichen FDA-Zulassung und Vermarktung zu schützen.

Laut Blake Gurfein, dem Chief Scientific Officer von Tivic Health, hat eine am Feinstein Institute durchgeführte Forschung gezeigt, dass die Personalisierung der Stimulationsparameter für jedes Subjekt zu signifikant verbesserten Effekten auf die Messungen des autonomen Nervensystems im Vergleich zu standardisierten Ansätzen führt. Diese Anpassungsfähigkeit wird voraussichtlich effektivere Geräte-Therapien ermöglichen und überzeugende Anwendungsfälle für gezielte Indikationen schaffen.

Positive
  • Patent filing strengthens intellectual property protection
  • Technology demonstrates superior efficacy through personalization
  • Advancing toward FDA approval and commercialization
Negative
  • FDA approval still pending
  • Commercialization timeline uncertain

- Patent based on state-of-the-art science of vagus nerve stimulation approach shows greater effect from personalization of treatment -

FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health, announced today that it has filed a new patent application with the U.S. Patent Office. Patent No. 63,492,402, entitled “Method and Apparatus for Electrical Stimulation of the Vagus Nerve,” expands the claims and protection around the technology in advance of potential U.S. Food & Drug Administration approval and commercialization of Tivic’s non-invasive cervical vagus nerve stimulation (VNS) device.

“This patent for our VNS technology builds upon the findings from our sponsored research at the Feinstein Institute, which has demonstrated that tailoring key stimulation parameters to each study subject results in a meaningfully improved effect on measures of the autonomous nervous system,” said Blake Gurfein, Tivic Health Chief Scientific Officer. “When compared with other technologies that apply the same stimulation approach to all patients, we believe this improvement will enable Tivic Health to develop more effective device therapies, which will be a key differentiator and create compelling use cases for the indications we plan to target.”

About Tivic Health Systems, Inc.

Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health takes a multi-pronged approach to treating the root causes of diseases caused by immune dysregulation and dysautonomia. The combination of bioelectronic and biologic medicines allow Tivic to target disorders and disease via both neural pathways and molecular approaches.

Tivic Health’s first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development of ncVNS treatment, Tivic Health’s ability to commercialize products arising out of the ncVNS treatment, Tivic Health’s plans to seek regulatory approval for such clinical products and Tivic Health’s continued focus on developing ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; unexpected costs, charges or expenses that reduce Tivic Health’s capital resources; and Tivic Health’s ability to maintain its Nasdaq listing. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health’s actual results to differ from those contained in the forward-looking statements, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

Investor Contact:

Hanover International, Inc.

ir@tivichealth.com

Source: Tivic Health Systems, Inc.

FAQ

What is the new patent filed by Tivic Health (TIVC) for vagus nerve stimulation?

Patent No. 63,492,402 covers the method and apparatus for electrical stimulation of the vagus nerve, focusing on personalized stimulation parameters for improved effectiveness.

How does Tivic Health's VNS technology differ from existing solutions?

Tivic's technology tailors stimulation parameters to individual patients, showing improved effects on autonomous nervous system measures compared to standard one-size-fits-all approaches.

What are the potential benefits of Tivic Health's (TIVC) personalized VNS approach?

The personalized approach has demonstrated meaningfully improved effects on autonomous nervous system measures, potentially leading to more effective device therapies.

What stage is Tivic Health's (TIVC) VNS device in the development process?

The device is awaiting potential FDA approval, with the company securing patent protection ahead of planned commercialization.

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