CEO Letter to Shareholders Issued by Tivic Health
Tivic Health (Nasdaq: TIVC) released its annual CEO letter highlighting key developments in 2024 and outlook for 2025. The company improved its commercial business with ClearUP 2.0 launch, achieving 4.4-star customer reviews and establishing >65% gross margins in direct-to-consumer channels, up from 28% in 2023.
The company is focusing on Vagus Nerve Stimulation (VNS), with their non-invasive cervical approach (ncVNS) showing promising results in pilot studies with Feinstein Institute. The VNS market is forecasted to reach $21B in five years with 10.6% CAGR. Tivic has identified >$30B market opportunities for their ncVNS approach and holds 16 issued patents and 10 pending patents across multiple countries.
For 2025, Tivic plans to advance disease-specific clinical trials, improve ClearUP business cash flow, and work towards regaining Nasdaq compliance.
Tivic Health (Nasdaq: TIVC) ha pubblicato la sua lettera annuale del CEO evidenziando i principali sviluppi del 2024 e le prospettive per il 2025. L'azienda ha migliorato il suo business commerciale con il lancio di ClearUP 2.0, ottenendo recensioni da 4,4 stelle da parte dei clienti e stabilendo margini lordi superiori al 65% nei canali diretti al consumatore, rispetto al 28% del 2023.
L'azienda si sta concentrando sulla Stimolazione del Nervo Vago (VNS), con il loro approccio cervicale non invasivo (ncVNS) che mostra risultati promettenti negli studi pilota condotti con l'Istituto Feinstein. Si prevede che il mercato della VNS raggiunga i 21 miliardi di dollari in cinque anni con un CAGR del 10,6%. Tivic ha identificato opportunità di mercato superiori a 30 miliardi di dollari per il loro approccio ncVNS e detiene 16 brevetti concessi e 10 brevetti in attesa in vari paesi.
Per il 2025, Tivic prevede di avanzare con studi clinici specifici per malattie, migliorare il flusso di cassa del business ClearUP e lavorare per riequilibrare la conformità con il Nasdaq.
Tivic Health (Nasdaq: TIVC) publicó su carta anual del CEO destacando los desarrollos clave en 2024 y las perspectivas para 2025. La compañía mejoró su negocio comercial con el lanzamiento de ClearUP 2.0, logrando reseñas de 4.4 estrellas de los clientes y estableciendo márgenes brutos superiores al 65% en los canales directos al consumidor, frente al 28% en 2023.
La empresa se está enfocando en la Estimulación del Nervio Vago (VNS), con su enfoque cervical no invasivo (ncVNS) mostrando resultados prometedores en estudios piloto con el Instituto Feinstein. Se prevé que el mercado de VNS alcance los 21 mil millones de dólares en cinco años con una CAGR del 10.6%. Tivic ha identificado oportunidades de mercado superiores a los 30 mil millones de dólares para su enfoque ncVNS y posee 16 patentes concedidas y 10 patentes pendientes en varios países.
Para 2025, Tivic planea avanzar en ensayos clínicos específicos de enfermedades, mejorar el flujo de caja del negocio ClearUP y trabajar para recuperar el cumplimiento con el Nasdaq.
티빅 헬스(Tivic Health) (Nasdaq: TIVC)은 2024년 주요 발전 사항과 2025년 전망을 강조하는 연례 CEO 편지를 발표했습니다. 이 회사는 ClearUP 2.0 출시를 통해 상업 비즈니스를 개선했으며, 고객 리뷰에서 4.4성급 평가를 얻고 소비자 직접 판매 채널에서 65% 이상의 총 마진을 설정했습니다. 이는 2023년의 28%에서 증가한 수치입니다.
회사는 미주신경 자극(VNS)에 집중하고 있으며 비침습적 경부 접근법인 ncVNS가 파인슈타인 연구소와의 파일럿 연구에서 유망한 결과를 보이고 있습니다. VNS 시장은 향후 5년 내에 210억 달러에 이를 것으로 예상되며, 연평균 성장률(CAGR)은 10.6%로 나타났습니다. 티빅은 ncVNS 접근 방식에 대해 300억 달러가 넘는 시장 기회를 확인했으며, 여러 국가에서 16개의 특허가 승인되고 10개의 특허가 대기 중입니다.
2025년을 위해 티빅은 질병별 임상 시험을 진행하고, ClearUP 비즈니스의 현금 흐름을 개선하며, 나스닥 규정 준수를 회복하기 위해 노력할 계획입니다.
Tivic Health (Nasdaq: TIVC) a publié sa lettre annuelle du PDG mettant en avant les développements clés de 2024 et les perspectives pour 2025. L'entreprise a amélioré son activité commerciale avec le lancement de ClearUP 2.0, obtenant des avis de clients à 4,4 étoiles et établissant des marges brutes supérieures à 65 % dans les canaux de vente directe aux consommateurs, contre 28 % en 2023.
L'entreprise se concentre sur la Stimulation du Nerve Vague (VNS), avec son approche cervicale non invasive (ncVNS) montrant des résultats prometteurs dans des études pilotes avec l'Institut Feinstein. Le marché de la VNS devrait atteindre 21 milliards de dollars dans cinq ans avec un taux de croissance annuel composé (CAGR) de 10,6 %. Tivic a identifié des opportunités de marché de plus de 30 milliards de dollars pour son approche ncVNS et détient 16 brevets délivrés et 10 brevets en attente dans plusieurs pays.
Pour 2025, Tivic prévoit de faire avancer les essais cliniques spécifiques aux maladies, d'améliorer le flux de trésorerie de l'activité ClearUP et de travailler à la restauration de la conformité avec le Nasdaq.
Tivic Health (Nasdaq: TIVC) hat seinen jährlichen CEO-Brief veröffentlicht, in dem wichtige Entwicklungen für 2024 und Ausblicke für 2025 hervorgehoben werden. Das Unternehmen hat sein Geschäft mit der Einführung von ClearUP 2.0 verbessert, Kundenbewertungen von 4,4 Sternen erreicht und in den Direktvertriebs-Kanälen Bruttomargen von über 65 % erzielt, verglichen mit 28 % im Jahr 2023.
Das Unternehmen konzentriert sich auf die Stimulation des Vagusnervs (VNS), wobei ihr nicht-invasiver zervikaler Ansatz (ncVNS) in Pilotstudien mit dem Feinstein-Institut vielversprechende Ergebnisse zeigt. Der VNS-Markt wird voraussichtlich in fünf Jahren 21 Milliarden Dollar erreichen, mit einer jährlichen Wachstumsrate (CAGR) von 10,6 %. Tivic hat Marktchancen von über 30 Milliarden Dollar für seinen ncVNS-Ansatz identifiziert und hält 16 erteilte Patente sowie 10 anhängige Patente in mehreren Ländern.
Für 2025 plant Tivic, krankheitsspezifische klinische Studien voranzutreiben, den Cashflow des ClearUP-Geschäfts zu verbessern und die Einhaltung der Nasdaq-Vorgaben wiederherzustellen.
- Gross margin increased to >65% from 28% in 2023 for D2C channels
- Customer reviews improved to 4.4 Stars
- Reduced net operating loss by >30%
- Expanded partnerships with McKesson and Cardinal Health
- Portfolio of 16 issued and 10 pending patents across multiple countries
- Successful pilot study results for ncVNS technology
- Needs to regain Nasdaq listing compliance
- Technical issues surfaced in ClearUP product in late 2023
Insights
Provides updates on vagus nerve stimulation (VNS) program and expectations for 2025
Dear Fellow Shareholders:
As we conclude 2024 and look forward to 2025, I’d like to take this opportunity to recap some of the important developments this year and share some of our expectations for 2025.
Improvements in Commercial Business:
- We launched ClearUP 2.0, resulting in improved customer experience and correcting technical issues that had surfaced in late 2023.
- We saw go-to-market partnerships with McKesson and Cardinal Health accelerating dramatically in the second half of the year.
- Improvements in both customer engagement and the product itself drove customer reviews to 4.4 Stars and significantly reduced defect-related returns.
- We continued optimizing our marketing mix to improve marketing effectiveness and reach.
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We restructured our supply chain establishing a recurring gross margin greater than
65% in our direct-to-consumer (D2C) channels, which makes up the bulk of our business. A marked change from the less than28% aggregate gross margin we reported in 2023.
Tivic’s Future is in Vagus Nerve Stimulation (VNS)
While we continue to improve the performance of our commercial business, some of the most important news this year pertains to our focused entry into Vagus Nerve Stimulation (VNS).
VNS has been steadily emerging as a transformative technology in medicine, mostly based on surgically implanted simulators. Polaris Research forecasts that the VNS market will be worth
Our strategy is to build on this momentum, focusing on achieving the same or better results using non-invasive stimulation approaches. Our non-invasive cervical approach to VNS (ncVNS) offers a less capital-intensive pathway to market while generating similar biological and clinically meaningful effects. In fact, our non-invasive VNS system has shown best-in-industry effects on outcomes like heart rate variability and achieved “comparable-to” or “better-than” results when compared to invasive implants.
In May 2024, we completed a pilot study with Feinstein Institute of Bioelectronic Medicine and demonstrated that our ncVNS approach was able to drive clinically meaningful changes in brain, cardiac, and nervous system activity, consistent with vagus nerve engagement.
We are now underway with our second collaborative study that is designed to further optimize ncVNS parameters and their impact on vagus nerve activation. This includes electrode positioning, frequency, and amplitude of stimulation. Results thus far have been positive, increasing confidence as we plan to move into clinical trials with the target populations of medical interest in 2025.
These investments to tune the device specifications have both yielded meaningful improvements in efficacy markers and created new intellectual property (IP) that we are protecting on a global scale. The study has been fully enrolled and data from the study will be announced following study completion next year.
In parallel with our clinical work, we have worked with seasoned advisors to aggressively evaluate the VNS landscape. This in-depth analysis has involved both primary and secondary research and uncovered targeted opportunities for our ncVNS approach exceeding
Today, Tivic has a robust
We are confident that our investment in research and development, combined with a deep understanding of the regulatory processes, commercial drivers and medical needs, will serve us well as we transform Tivic to drive greater degrees of success.
Equally as important, we are seeing positive trends in the industry as a whole. Industry awareness of VNS and the accompanying insurance coverage continues to improve. We expect that patient demand for these drug-free therapeutics, supported by appropriate financial access, will accelerate as information about VNS makes its way into mainstream media. VNS and bioelectronic medicine more broadly are expected to play a growing role in the future of healthcare.
Looking back at 2024:
- We announced best-of-breed results in a field new to Tivic Health.
- We demonstrated clinically meaningful benefits from innovations in non-invasive VNS that parallel or exceed those of approved implanted devices, based on key biometric markers.
- We expanded our partnership with Feinstein Institute of Bioelectronic Medicine, one of the preeminent academic institutes in the field.
- We filed new intellectual property and received our first international patents.
Company Priorities for 2025
Looking at both the improvements in the base business and the advances we made with vagus nerve stimulation (VNS), we have a lot to be proud of in 2024.
I am even more pleased we accomplished all of this while slashing our net operating loss by more than
As we look to 2025,
- We are exploring new opportunities to increase cash flow generated by the ClearUP business.
- We look forward to completing the current work with Feinstein Institute of Bioelectronic Medicine.
- We are charting disease-specific clinical trials, moving the company closer to securing regulatory approvals for what we expect will be life-changing treatments for patients in need.
- We look forward to talking in more detail about the specific target indications as we advance into the next stage of clinical trial work in 2025.
We anticipate that the advancement of our clinical programs for ncVNS will be key to increasing long-term shareholder value. In addition, the board and I continue to evaluate a range of options to maximize shareholder returns, including taking the necessary steps to ensure we regain Nasdaq listing compliance.
I would like to recognize the exceptional efforts of the lean and dedicated Tivic Health team. I thank them for their relentless drive and hard work. Together, with our investors, collaborators, and supporters, we are striving to build a company that can transform the future of medicine and make a lasting, positive impact on the lives of people around the world.
We are excited about the opportunities that lie ahead, and we look forward to continuing this journey with all of you in 2025.
Sincerely,
Jennifer Ernst
Chief Executive Officer
About Tivic Health
Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s technology platforms leverage 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 ClearUPTM is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUPTM 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
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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Investor Contact:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
FAQ
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