Tivic Health Systems, Inc..
TIVC.US | Manufacture of medical and dental instruments and supplies
Tivic Health Systems, Inc. is a bioelectronic medicine company focused on developing and commercializing non-invasive neuromodulation therapies. Their primary product, ClearUP, is a device designed to relieve sinus pain and congestion using microcurrent waveforms. The company focuses on developing a...Show More
Better Health for All
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Tivic Health's core business is entirely devoted to health improvement, with its portfolio delivering exceptional health benefits. Its primary product, ClearUP, is an FDA-cleared, drug-free device for sinus pain and congestion, with 74% of users experiencing relief after one treatment.
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The company is transitioning from consumer health tech to prescription-based therapeutics, including entolimod, which has Fast Track and Orphan Drug status for pediatric Acute Radiation Syndrome (ARS) and potential to treat radiation and chemotherapy side effects.
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The company plans to exit the consumer health tech business by year-end, indicating a complete transition to health-positive offerings.
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ClearUP has an adverse events rate of less than 1 per million users. However, the company's products are priced at an MSRP of $149, and 48% of allergy sufferers spend $100 or more annually on medication, suggesting the product is priced above cost.
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Entolimod has orphan drug status for pediatric ARS and is a military countermeasure, but there is no evidence of broader reach to vulnerable populations.
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Risk disclosures are mostly substantiated, but the absence of a healthcare professional in the direct-to-consumer purchasing process can compromise informed consent.
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Operating expenses increased to $2.0 million, up from $1.3 million, primarily from research and biologics investment, which represents a small portion of overall expenses.
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The company's focus on non-invasive, drug-free solutions like ClearUP and VNS devices demonstrates a strong emphasis on preventative health. The company's VNS device is being explored for post-COVID fatigue, indicating a moderate crisis response.
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VNS is an established treatment for depression, showing substantial mental health support.
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The company has completed an optimization study for its ncVNS device, but ethical standards for clinical trials are not fully detailed.
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Fair Money & Economic Opportunity
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No evidence available to assess Tivic Health Systems, Inc. on Fair Money & Economic Opportunity.
Fair Pay & Worker Respect
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Tivic Health Systems demonstrates strong employee satisfaction, with 81% of employees recommending working at the company based on 18 anonymous reviews.
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The company also offers mental health programs
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and provides raises for nurses.
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A comprehensive benefits package, including health coverage and wellness programs, is mentioned as being offered.
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Fair Trade & Ethical Sourcing
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No evidence available to assess Tivic Health Systems, Inc. on Fair Trade & Ethical Sourcing.
Honest & Fair Business
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Tivic Health Systems, Inc. has not been a party to any material legal proceedings, indicating no material ethics-related regulatory fines in the past three years.
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However, the company received a notice from Nasdaq in June 2024 for non-compliance with the minimum bid price requirement, which can be considered a warning letter.
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The company has a formal Whistleblower Complaint Policy, adopted in November 2021 and last updated in November 2023, which prohibits retaliation and outlines procedures for reporting concerns to the Audit and Risk Committee.
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However, there is no public information on training frequency or program effectiveness. The company has not had any financial restatements in the past five years.
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Regarding board independence, three directors (Dean Zikria, Sheryle Bolton, and Christina Valauri) are identified as independent, but the total percentage of independent directors on the board is not provided.
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The company's Code of Business Conduct and Ethics addresses anti-corruption, including compliance with the FCPA and prohibitions on illegal payments and gifts over $150.
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However, there is no evidence of training frequency or effectiveness metrics for this policy. The company holds ISO 13485 certification, re-certified in 2023, which validates internal processes for FDA compliance, indicating some third-party verification of operational standards.
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Kind to Animals
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No evidence available to assess Tivic Health Systems, Inc. on Kind to Animals.
No War, No Weapons
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Tivic Health Systems, Inc. develops products such as Entolimod, Entolasta, and ncVNS technology, which are medical treatments but are being discussed for potential military applications.
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In April 2025, the company held briefings with senior White House and FDA leadership to discuss expedited pathways and export support for these technologies for military use.
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This indicates that the company's technology is considered dual-use, with military applications being actively explored, even though its core business is bioelectronic medicine for civilian use.
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Planet-Friendly Business
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No specific, concrete data points related to planet-friendly business metrics were found for Tivic Health Systems, Inc. (TIVC.US) in the provided articles.
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While TIVC.US has engaged ALOM Technologies Corp. as its 3PL partner,
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the environmental performance data reported for ALOM (e.g., renewable energy use, net-zero targets, recycling efforts) is specific to ALOM's operations and is not explicitly stated to apply to TIVC.US's overall environmental footprint or strategy. and explicitly state that no sustainability data is available for TIVC.US.
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Respect for Cultures & Communities
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No evidence available to assess Tivic Health Systems, Inc. on Respect for Cultures & Communities.
Safe & Smart Tech
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Tivic Health Systems, Inc. holds ISO 13485 certification for medical device quality systems, which was recertified in 2023 and is valid until Q4 2026.
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The company's ClearUP device has received FDA Class II medical device clearance (510(k) number K182025, De Novo number DEN200006) and an EU CE Mark Certificate (CE 704687).
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The company is also engaged in ongoing efforts to comply with EU MDR 2017/745.
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Zero Waste & Sustainable Products
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No evidence available to assess Tivic Health Systems, Inc. on Zero Waste & Sustainable Products.