First Subject Enrolled in Tivic Health’s Optimization Study for its Non-Invasive Vagus Nerve Stimulation Device
Tivic Health Systems (Nasdaq: TIVC) has enrolled its first subject in an optimization study for their non-invasive vagus nerve stimulation device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, aims to identify optimal device parameters for influencing autonomic nervous system function. Enrollment is expected to complete by early December.
The global vagus nerve stimulation market is projected to grow from $8.59 billion in 2021 to $21.3 billion in 2030, with a 10.6% CAGR. The peripheral nerve stimulation segment, Tivic's target market, is forecast to grow at 35% CAGR. The company has partnered with Fletcher Spaght Inc. to accelerate product development and commercial strategy based on their successful Phase 1 trial results.
Tivic Health Systems (Nasdaq: TIVC) ha arruolato il suo primo soggetto in uno studio di ottimizzazione per il loro dispositivo di stimolazione del nervo vago non invasivo. Lo studio, condotto dal The Feinstein Institute of Bioelectronic Medicine, mira a identificare i parametri ottimali del dispositivo per influenzare la funzione del sistema nervoso autonomo. Si prevede che l'arruolamento si completi entro l'inizio di dicembre.
Il mercato globale della stimolazione del nervo vago è previsto crescere da 8,59 miliardi di dollari nel 2021 a 21,3 miliardi di dollari nel 2030, con un CAGR del 10,6%. Il segmento della stimolazione dei nervi periferici, mercato target di Tivic, dovrebbe crescere con un CAGR del 35%. L'azienda ha stretto una partnership con Fletcher Spaght Inc. per accelerare lo sviluppo del prodotto e la strategia commerciale basata sui risultati dei loro riusciti trial di Fase 1.
Tivic Health Systems (Nasdaq: TIVC) ha inscrito a su primer sujeto en un estudio de optimización para su dispositivo de estimulación del nervio vago no invasivo. El estudio, realizado por The Feinstein Institute of Bioelectronic Medicine, tiene como objetivo identificar los parámetros óptimos del dispositivo para influir en la función del sistema nervioso autónomo. Se espera que la inscripción se complete a principios de diciembre.
Se proyecta que el mercado global de estimulación del nervio vago crecerá de 8.59 mil millones de dólares en 2021 a 21.3 mil millones de dólares en 2030, con un CAGR del 10.6%. Se pronostica que el segmento de estimulación de nervios periféricos, el mercado objetivo de Tivic, crecerá a un CAGR del 35%. La empresa se ha asociado con Fletcher Spaght Inc. para acelerar el desarrollo del producto y la estrategia comercial basada en los resultados exitosos de su ensayo de Fase 1.
티빅 헬스 시스템즈 (Nasdaq: TIVC)는 비침습적 미주신경 자극 장치에 대한 최적화 연구에 첫 번째 피험자를 등록했습니다. 이 연구는 파인스타인 생체 전자 의학 연구소에서 수행되며 자율 신경계 기능에 영향을 미치는 장치의 최적 매개변수를 식별하는 것을 목표로 합니다. 등록은 12월 초까지 완료될 것으로 예상됩니다.
전 세계 미주신경 자극 시장은 2021년 85억 9000만 달러에서 2030년 213억 달러로 성장할 것으로 예측되며, 연평균 성장률(CAGR)은 10.6%입니다. 티빅의 목표 시장인 말초신경 자극 세그먼트는 35% CAGR로 성장할 것으로 예상됩니다. 이 회사는 성공적인 1상 시험 결과를 바탕으로 제품 개발 및 상업 전략을 가속화하기 위해 플레처 스파그트 Inc.와 파트너십을 맺었습니다.
Tivic Health Systems (Nasdaq: TIVC) a inscrit son premier sujet dans une étude d'optimisation pour leur dispositif de stimulation du nerf vague non invasif. L'étude, menée par The Feinstein Institute of Bioelectronic Medicine, vise à identifier les paramètres optimaux du dispositif pour influencer la fonction du système nerveux autonome. L'inscription devrait être finalisée début décembre.
Le marché mondial de la stimulation du nerf vague devrait passer de 8,59 milliards de dollars en 2021 à 21,3 milliards de dollars en 2030, avec un taux de croissance annuel composé (CAGR) de 10,6 %. Le segment de la stimulation des nerfs périphériques, le marché ciblé de Tivic, devrait croître à un CAGR de 35 %. L'entreprise a établi un partenariat avec Fletcher Spaght Inc. pour accélérer le développement des produits et la stratégie commerciale basée sur les résultats réussis de leur essai de phase 1.
Tivic Health Systems (Nasdaq: TIVC) hat sein erstes Subjekt in einer Optimierungsstudie für ihr nicht-invasives Vagusnervstimulationsgerät eingeschrieben. Die Studie, die vom Feinstein Institute of Bioelectronic Medicine durchgeführt wird, zielt darauf ab, optimale Geräteparameter zu identifizieren, um die Funktion des autonomen Nervensystems zu beeinflussen. Die Einschreibung soll bis Anfang Dezember abgeschlossen sein.
Der globale Markt für Vagusnervstimulation wird voraussichtlich von 8,59 Milliarden Dollar im Jahr 2021 auf 21,3 Milliarden Dollar im Jahr 2030 wachsen, mit einer jährlichen Wachstumsrate (CAGR) von 10,6%. Der Bereich der peripheren Nervenstimulation, der Zielmarkt von Tivic, wird mit einer CAGR von 35% prognostiziert. Das Unternehmen hat sich mit Fletcher Spaght Inc. zusammengeschlossen, um die Produktentwicklung und die kommerzielle Strategie basierend auf den erfolgreichen Ergebnissen ihrer Phase-1-Studie zu beschleunigen.
- Strong market growth potential with VNS market projected to reach $21.3B by 2030
- Company's target segment (peripheral nerve stimulation) expected to grow at 35% CAGR
- Successful completion of Phase 1 trial
- Strategic partnership with Fletcher Spaght Inc. for development and commercial strategy
- Product still in early development phase requiring FDA approval
- Faces competition from existing surgical implant solutions
Insights
The enrollment of the first subject in Tivic Health's optimization study marks a important step in developing their non-invasive vagus nerve stimulation (ncVNS) technology. The study's focus on parameter optimization is essential for advancing toward FDA approval and could significantly impact the company's commercial potential in the
The collaboration with The Feinstein Institute and Fletcher Spaght demonstrates a strategic approach to clinical development. However, while the market opportunity is substantial, with projected
The study, being run by The Feinstein Institute of Bioelectronic Medicine, will identify device parameters, including frequency and duration of treatment, that optimally influence autonomic nervous system (ANS) function. The results will be used to inform clinical indication priority and commercial development. Enrollment is expected to be complete by early December.
“The effectiveness of Tivic’s non-invasive cervical vagus stimulation (ncVNS), which influences autonomic function, has already been established, demonstrating large ANS responses impacting cardiovascular and central nervous system activity,” stated Tivic Health Chief Scientific Officer Blake Gurfein. “The data from this study will advance our technology toward potential FDA approval for non-invasive treatment of large market indications, where current treatments are invasive, inadequate, or both.”
Market Opportunity
Polaris Market Research estimates the global vagus nerve stimulation (VNS) market will grow from
The vagus nerve is the longest autonomic nerve in the body and regulates many organ systems associated with chronic disease. VNS is approved by the US Food & Drug Administration for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.
Tivic previously announced it has engaged Fletcher Spaght, Inc. (FSI), a leading healthcare growth strategy firm, to accelerate its product development and commercial strategy. FSI has conducted a comprehensive market assessment of Tivic Health’s ncVNS technology drawing from clinical outcomes from Tivic Health’s successful Phase 1 trial, which it announced in May. FSI, in conjunction with Tivic Health’s scientific and clinical leadership, will help drive the company’s clinical strategy and product development in 2025 and beyond.
About Tivic Health
Tivic Health (http://tivichealth.com) is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s patented technology platform leverages stimulation on 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. Tivic Health, with collaborators including The Feinstein Institute for Bioelectronic Medicine is developing new VNS devices that will more precisely target and modulate vagus nerve activity to deliver better clinical outcomes, with non-invasive or minimally invasive devices.
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 assumption 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. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, 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.
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Media Contact:
Morgan Luke
Morgan.Luke@tivichealth.com
Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
FAQ
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