Enrollment Complete in Tivic Health Optimization Study for its Non-Invasive Vagus Nerve Stimulation Device
Tivic Health Systems (Nasdaq: TIVC) has completed enrollment in its optimization study for a non-invasive vagus nerve stimulation (VNS) device at The Feinstein Institute of Bioelectronic Medicine. The study aims to identify optimal device parameters affecting autonomic nervous system function. Expected completion is in early Q1 2025. The global VNS market is projected to grow from $8.59 billion in 2021 to $21.3 billion in 2030, with peripheral nerve stimulation segment growing at 35% CAGR. The company has engaged Fletcher Spaght Inc. to accelerate product development and commercial strategy following successful Phase 1 trial results.
Tivic Health Systems (Nasdaq: TIVC) ha completato l'arruolamento nel suo studio di ottimizzazione per un dispositivo di stimolazione del nervo vago non invasivo (VNS) presso il Feinstein Institute of Bioelectronic Medicine. Lo studio ha l'obiettivo di identificare i parametri ottimali del dispositivo che influiscono sul funzionamento del sistema nervoso autonomo. Il completamento è previsto all'inizio del primo trimestre del 2025. Si prevede che il mercato globale della VNS crescerà da 8,59 miliardi di dollari nel 2021 a 21,3 miliardi di dollari nel 2030, con il segmento della stimolazione nervosa periferica in crescita con un CAGR del 35%. L'azienda ha coinvolto Fletcher Spaght Inc. per accelerare lo sviluppo del prodotto e la strategia commerciale in seguito ai risultati positivi della fase 1 del trial.
Tivic Health Systems (Nasdaq: TIVC) ha completado la inscripción en su estudio de optimización para un dispositivo de estimulación del nervio vago no invasivo (VNS) en el Feinstein Institute of Bioelectronic Medicine. El estudio tiene como objetivo identificar los parámetros óptimos del dispositivo que afectan el funcionamiento del sistema nervioso autónomo. Se espera que se complete a principios del primer trimestre de 2025. Se proyecta que el mercado global de VNS crezca de 8,59 mil millones de dólares en 2021 a 21,3 mil millones de dólares en 2030, con el segmento de estimulación del nervio periférico creciendo a una tasa de crecimiento anual compuesta (CAGR) del 35%. La empresa ha contratado a Fletcher Spaght Inc. para acelerar el desarrollo del producto y la estrategia comercial tras los exitosos resultados de la fase 1 del ensayo.
티빅 헬스 시스템즈 (Nasdaq: TIVC)는 페인스타인 생체전자의학 연구소에서 비침습적 미주신경 자극(VNS) 장치에 대한 최적화 연구의 등록을 완료했습니다. 이 연구는 자율신경계 기능에 영향을 미치는 최적의 장치 매개변수를 식별하는 것을 목표로 합니다. 예상 완료 시기는 2025년 1분기 초입니다. 글로벌 VNS 시장은 2021년 85억 9천만 달러에서 2030년 213억 달러로 성장할 것으로 예상되며, 말초신경 자극 부문은 연평균 35%의 성장률을 기록할 것입니다. 이 회사는 성공적인 1단계 시험 결과에 따라 제품 개발 및 상업 전략을 가속화하기 위해 플레처 스팍 인크(Fletcher Spaght Inc.)를 고용했습니다.
Tivic Health Systems (Nasdaq: TIVC) a terminé l'inscription dans son étude d'optimisation pour un dispositif de stimulation non invasive du nerf vague (VNS) au Feinstein Institute of Bioelectronic Medicine. L'étude vise à identifier les paramètres optimaux du dispositif affectant le fonctionnement du système nerveux autonome. L'achèvement est prévu pour le début du premier trimestre 2025. Le marché mondial de la VNS devrait passer de 8,59 milliards de dollars en 2021 à 21,3 milliards de dollars en 2030, le segment de la stimulation nerveuse périphérique croissant à un taux de croissance annuel composé (CAGR) de 35 %. L'entreprise a engagé Fletcher Spaght Inc. pour accélérer le développement du produit et la stratégie commerciale suite aux résultats positifs des essais de phase 1.
Tivic Health Systems (Nasdaq: TIVC) hat die Einschreibung in seine Optimierungsstudie für ein nicht-invasives Stimulationsgerät des Vagusnervs (VNS) am Feinstein Institute of Bioelectronic Medicine abgeschlossen. Die Studie zielt darauf ab, die optimalen Geräteparameter zu identifizieren, die die Funktion des autonomen Nervensystems beeinflussen. Der Abschluss wird zu Beginn des ersten Quartals 2025 erwartet. Der globale VNS-Markt wird voraussichtlich von 8,59 Milliarden US-Dollar im Jahr 2021 auf 21,3 Milliarden US-Dollar im Jahr 2030 wachsen, wobei der Bereich der peripheren Nervenstimulation mit einer durchschnittlichen jährlichen Wachstumsrate (CAGR) von 35 % wächst. Das Unternehmen hat Fletcher Spaght Inc. beauftragt, die Produktentwicklung und die kommerzielle Strategie nach den erfolgreichen Ergebnissen der Phase-1-Studie zu beschleunigen.
- Completed enrollment in optimization study for VNS device
- Operating in a growing market projected to reach $21.3B by 2030
- Peripheral nerve stimulation segment growing at 35% CAGR
- Successful Phase 1 trial completed
- Product still requires FDA approval
- Study results not expected until Q1 2025
- Facing competition from established invasive VNS technologies
Insights
The completion of enrollment in Tivic Health's optimization study marks a significant milestone in developing their non-invasive vagus nerve stimulation device. The study's focus on identifying optimal device parameters for autonomic nervous system function is important for two reasons: First, it addresses the key limitation of current non-invasive VNS approaches that show variable responses and second, it positions Tivic to potentially bridge the gap between invasive and non-invasive treatments.
The
The study is being conducted by The Feinstein Institute of Bioelectronic Medicine. The objective of the study is to identify device parameters that optimally influence autonomic nervous system (ANS) function. These include the frequency and the duration of potential treatments. Tivic Health plans to use these results to prioritize clinical indications that the company expects to carry forward into further testing and commercial development. The trial is expected to be completed in early first quarter 2025.
“Already we have established that our non-invasive cervical vagus stimulation device has shown large, rapid effects in clinically important biological measures,” stated Tivic Health Chief Scientific Officer Blake Gurfein. “This study is the next step in moving us closer to potential FDA approval of a non-invasive treatment for clinical indications that are inadequately addressed by the current treatment options.”
“While implanted VNS technologies have proven their clinical efficacy and commercial viability, they are not always appropriate for certain clinical scenarios,” stated Jennifer Ernst, CEO of Tivic Health Systems. “Early non-invasive VNS approaches have resulted in variable responses and modest efficacy. In contrast, we anticipate this study will allow us to optimize our novel approach to treating diseases with unmet needs and capitalize on the gap between invasive and non-invasive VNS treatments,” concluded Ernst.
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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