Tivic Health and Feinstein Institute Present New Data Showing Personalized Vagus Nerve Stimulation Method Optimizes Impact on Autonomic Nervous System
Tivic Health (Nasdaq: TIVC) has announced new data demonstrating the effectiveness of their personalized non-invasive vagus nerve stimulation (ncVNS) method in optimizing autonomic nervous system activity. The findings were presented at the Sixth Bioelectronic Medicine Summit in collaboration with The Feinstein Institute of Medicine.
Key results from the study showed that:
- No single stimulation frequency had a universal effect, emphasizing the need for personalized approaches
- In 60% of participants, raw Heart Rate Variability (HRV) nearly doubled following ncVNS stimulation
- Normalized HRV increased 2.67x post-stimulation, indicating enhanced parasympathetic activity
The company believes these results support their strategy to develop personalized neuromodulation devices for treating inflammatory, cardiac, and neurologic disorders as alternatives to invasive surgeries and pharmaceuticals.
Tivic Health (Nasdaq: TIVC) ha annunciato nuovi dati che dimostrano l'efficacia del loro metodo di stimolazione del nervo vago non invasiva personalizzata (ncVNS) nell'ottimizzazione dell'attività del sistema nervoso autonomo. I risultati sono stati presentati al Sesto Summit sulla Medicina Bioelettronica in collaborazione con il Feinstein Institute of Medicine.
I risultati chiave dello studio hanno mostrato che:
- Nessuna singola frequenza di stimolazione ha avuto un effetto universale, sottolineando la necessità di approcci personalizzati
- Nel 60% dei partecipanti, la Variabilità della Frequenza Cardiaca (HRV) grezza è quasi raddoppiata dopo la stimolazione ncVNS
- La HRV normalizzata è aumentata di 2,67 volte dopo la stimolazione, indicando un'attività parasimpatica migliorata
L'azienda crede che questi risultati supportino la loro strategia di sviluppare dispositivi di neuromodulazione personalizzati per il trattamento di disturbi infiammatori, cardiaci e neurologici come alternative a interventi chirurgici invasivi e farmaci.
Tivic Health (Nasdaq: TIVC) ha anunciado nuevos datos que demuestran la efectividad de su método de estimulación del nervio vago no invasiva personalizada (ncVNS) para optimizar la actividad del sistema nervioso autónomo. Los hallazgos se presentaron en la Sexta Cumbre de Medicina Bioelectrónica en colaboración con el Feinstein Institute of Medicine.
Los resultados clave del estudio mostraron que:
- No hubo una frecuencia de estimulación única que tuviera un efecto universal, enfatizando la necesidad de enfoques personalizados
- En el 60% de los participantes, la Variabilidad de la Frecuencia Cardíaca (HRV) cruda casi se duplicó tras la estimulación ncVNS
- La HRV normalizada aumentó 2,67 veces después de la estimulación, indicando una actividad parasimpática mejorada
La empresa cree que estos resultados respaldan su estrategia de desarrollar dispositivos de neuromodulación personalizados para tratar trastornos inflamatorios, cardíacos y neurológicos como alternativas a cirugías invasivas y fármacos.
티빅 헬스 (Nasdaq: TIVC)는 개인화된 비침습적 미주신경 자극(ncVNS) 방법이 자율신경계 활동을 최적화하는 데 효과적이라는 새로운 데이터를 발표했습니다. 이 결과는 파인스타인 의학 연구소와 협력하여 제6회 생체전자 의학 정상 회의에서 발표되었습니다.
연구의 주요 결과는 다음과 같습니다:
- 단일 자극 주파수는 보편적인 효과가 없으며, 개인화된 접근 방식의 필요성을 강조했습니다
- 참여자의 60%에서 원시 심박수 변동성(HRV)은 ncVNS 자극 후 거의 두 배로 증가했습니다
- 정상화된 HRV는 자극 후 2.67배 증가하여 부교감 신경 활동이 향상되었음을 나타냅니다
회사는 이러한 결과가 침습적 수술 및 약물의 대안으로서 염증성, 심장 및 신경 장애를 치료하기 위한 개인화된 신경 조절 장치를 개발하는 전략을 지원한다고 믿고 있습니다.
Tivic Health (Nasdaq: TIVC) a annoncé de nouvelles données démontrant l'efficacité de sa méthode de stimulation du nerf vague non invasive personnalisée (ncVNS) pour optimiser l'activité du système nerveux autonome. Les résultats ont été présentés lors du Sixième Sommet sur la Médecine Bioélectronique en collaboration avec le Feinstein Institute of Medicine.
Les résultats clés de l'étude ont montré que:
- Aucune fréquence de stimulation unique n'avait d'effet universel, soulignant la nécessité d'approches personnalisées
- Chez 60 % des participants, la Variabilité de la Fréquence Cardiaque (HRV) brute a presque doublé après la stimulation ncVNS
- La HRV normalisée a augmenté de 2,67 fois après la stimulation, indiquant une activité parasympathique améliorée
L'entreprise pense que ces résultats soutiennent sa stratégie de développement de dispositifs de neuromodulation personnalisés pour traiter des troubles inflammatoires, cardiaques et neurologiques comme alternatives aux chirurgies invasives et aux médicaments.
Tivic Health (Nasdaq: TIVC) hat neue Daten veröffentlicht, die die Wirksamkeit ihrer personalisierten nicht-invasiven Vagusnervstimulation (ncVNS) Methode zur Optimierung der Aktivität des autonomen Nervensystems zeigen. Die Ergebnisse wurden beim Sechsten Gipfel für Bioelektronische Medizin in Zusammenarbeit mit dem Feinstein Institute of Medicine präsentiert.
Die wichtigsten Ergebnisse der Studie zeigten, dass:
- Keine einzelne Stimulationsfrequenz eine universelle Wirkung hatte, was die Notwendigkeit personalisierter Ansätze betont
- Bei 60 % der Teilnehmer verdoppelte sich die rohe Herzfrequenzvariabilität (HRV) nahezu nach der ncVNS-Stimulation
- Die normalisierte HRV stieg nach der Stimulation um das 2,67-fache, was auf eine verbesserte parasympathische Aktivität hinweist
Das Unternehmen ist der Ansicht, dass diese Ergebnisse ihre Strategie unterstützen, personalisierte Neuromodulationsgeräte zur Behandlung von entzündlichen, kardialen und neurologischen Erkrankungen als Alternativen zu invasiven Operationen und Arzneimitteln zu entwickeln.
- Clinical data shows effectiveness of personalized ncVNS technology
- 60% response rate with doubled HRV in successful cases
- 2.67x increase in normalized HRV post-stimulation
- Pending patents strengthen IP position
- 40% of participants showed no significant response to treatment
- Technology still in development phase, not yet commercialized
Insights
Tivic Health's latest data demonstrates meaningful progress in their development of personalized non-invasive vagus nerve stimulation (ncVNS) technology. Working with the renowned Feinstein Institute, their research showed that personalizing stimulation frequencies significantly enhanced the effect on heart rate variability (HRV), a key marker of autonomic nervous system function.
The data revealed two particularly noteworthy findings: First, no single stimulation frequency universally worked for all subjects, confirming the need for personalized approaches. Second, in
This personalization approach represents a potential breakthrough for bioelectronic medicine. The vagus nerve serves as a critical communication pathway between brain and body, regulating various inflammatory, cardiac, and neurological functions. Finding the "right frequency" for each individual could dramatically improve therapeutic outcomes compared to standardized approaches.
From a development perspective, these early-stage results support Tivic's strategic direction in creating patient-specific therapies. Their non-invasive approach aims to avoid the surgical complications of implanted VNS devices while potentially matching their efficacy through personalization. The pending patent protection further strengthens their intellectual property position in this emerging field.
This data represents a significant validation point for Tivic's technology platform and strategic direction in non-invasive neuromodulation. The collaboration with Feinstein Institute, a leader in bioelectronic medicine, adds substantial credibility to these findings.
The personalization aspect is particularly compelling from a market perspective. By demonstrating that optimizing stimulation parameters for individual patients significantly increases efficacy, Tivic is addressing a fundamental limitation of current neuromodulation approaches. This could potentially create both clinical and commercial advantages in a field that has historically struggled with variable patient responses.
The
For context, the global neurostimulation devices market is substantial, with particular growth in non-invasive segments as both patients and providers seek alternatives to surgical implants and pharmaceuticals. Tivic's approach targets multiple high-value indications across inflammatory, cardiac, and neurologic conditions where current treatment options often carry significant side effects or efficacy.
While this research remains pre-clinical and several development stages from commercialization, it demonstrates that Tivic's platform has potential applications beyond its current product offerings, potentially expanding its addressable market and creating multiple pathways for future revenue growth.
Advances Tivic’s Development of Non-Invasive VNS Devices Aimed at Treating Inflammatory, Cardiac and Neurologic Disorders
The data were presented in a poster presentation, titled, “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation,” at the Sixth Bioelectronic Medicine Summit, March 4 & 5. The findings were based on Tivic’s collaboration with The Feinstein Institute of Medicine, one of the global scientific leaders in bioelectronic medicine.
“These promising findings reinforce Tivic’s premise that non-invasive bioelectronic devices can effectively treat inflammatory, cardiac and neurologic disorders without invasive surgeries or pharmaceuticals - both of which carry burdensome side effects,” said Jennifer Ernst, CEO of Tivic Health. “With these new data secured with pending patents, we believe that we have demonstrated the potential for developing personalized, scalable bioelectronic therapies to treat patients in need.”
Tivic Health’s poster presentation, titled, “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation,” highlighted a novel ncVNS approach and its ability to modulate autonomic nervous system (ANS) function and brain activity. Key results included:
-
Personalized stimulation approach for optimal autonomic modulation:
- No single stimulation frequency had a universally dominant effect on HRV, highlighting the need for personalized neuromodulation strategies.
- Choosing the optimal ncVNS stimulation frequency for each study subject resulted in a meaningful increase in effect size of HRV change, paving the way for patient-specific therapy.
-
Significant increase in heart rate variability (HRV), indicating enhanced parasympathetic activity:
-
In
60% of participants (responders), raw HRV nearly doubled on average following ncVNS stimulation. - Normalized HRV increased 2.67x post-stimulation, suggesting a strong activation of vagal tone and improved autonomic balance.
-
In
The data presented resulted from Tivic’s ongoing collaboration with the Feinstein Institute of Bioelectronic Medicine to advance high-precision vagus nerve stimulation in a non-invasive form factor.
About The Bioelectronic Medicine (BEM) Summit
The BEM Summit is a premier gathering of industry leaders, researchers, and clinicians exploring cutting-edge neurotechnologies and neuromodulation therapies. Hosted by the Feinstein Institutes for Medical Research, the event brings together experts in bioelectronic medicine, autonomic neuroscience, and inflammation research to discuss the latest advancements in the field.
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’s bioelectronic division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. Tivic Health’s biopharma division’s lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™.
Tivic Health already has an FDA-approved over-the-counter device, ClearUP™ that treats 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, including as a result of changes to the company’s relationship with the Feinstein Institute, future development of the company’s ncVNS treatment, changes to the company’s business strategy, clinical trial and study results, consummation of any strategic transactions, the company’s need for, and ability to secure when needed, additional working capital, and the company’s ability to maintain its Nasdaq listing. 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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Investor Contact:
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Source: Tivic Health Systems, Inc.
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