Tivic Health Systems, Inc. (TIVC): History, Ownership, Mission, How It Works & Makes Money

When you look at Tivic Health Systems, Inc. (TIVC), do you see a consumer health tech company or a diversified biopharmaceutical player? The answer is both, but the company is in the middle of a dramatic transformation, shifting its focus away from the consumer device ClearUP, which drove Q3 2025 revenue of just $146,000, toward its late-stage clinical pipeline. This strategic pivot into immunotherapeutics-specifically the Entolimod drug candidate for acute radiation syndrome and its non-invasive vagus nerve stimulation (VNS) program-is the core of their new mission, aiming to treat disease by addressing both the body's biochemical and bioelectronic systems. Understanding this move is critical, especially as the company works to secure new financing and advance its clinical trials, which is where the real value story now lies.

Tivic Health Systems, Inc. (TIVC) History

You're looking for the foundational story of Tivic Health Systems, Inc. (TIVC), and what you need to understand is that the company has undergone a massive, deliberate transformation in 2025. It started as a consumer bioelectronic health-tech firm, but it's now pivoting hard to become a diversified immunotherapeutics company focused on biopharma and non-invasive neuromodulation. This shift is the single most important context for its current financial picture.

Given Company's Founding Timeline

Year established

Tivic Health Systems, Inc. was incorporated in 2016, aiming to develop bioelectronic medicine to treat chronic conditions.

Original location

The company was originally headquartered in Menlo Park, California, a classic Silicon Valley starting point. Its current operational address is in Fremont, California.

Founding team members

The company was co-founded by Jennifer Ernst, who serves as the Chief Executive Officer, and John Claude. Jennifer Ernst has been the consistent face of the company's strategic direction.

Initial capital/funding

The company raised a total of $8 million in its initial funding, with a Seed round closing in August 2019. This capital came from a consortium of investors, including Sand Hill Angels, Sierra Angels, and Astia Angels.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The most transformative moment for Tivic Health Systems, Inc. wasn't its IPO, but the strategic pivot in early 2025. This was a clear, high-risk, high-reward decision to move away from the competitive consumer health market and into the specialized, high-barrier biopharma space.

• The Biopharma Pipeline Acquisition: In February 2025, the company secured a worldwide exclusive license for Entolimod and its derivative, Entolasta. Entolimod is a late-stage Toll-like Receptor 5 (TLR5) agonist, a drug candidate for treating Acute Radiation Syndrome (ARS). This single move redefined the company overnight.
• Resource Reallocation: This shift meant drastically cutting advertising expenses for the consumer product, ClearUP, by 92% in Q1 2025 to free up capital for the new biopharma programs. This is why Q1 2025 revenue dropped to just $70,000 from $334,000 a year prior.
• Government Engagement: The company immediately engaged with the White House and the U.S. Food & Drug Administration (FDA) to explore potential military and defense applications for Entolimod, which is a critical step for a drug targeting ARS.
• Financing the Transformation: To fund this expensive pivot, the company secured new financing, including raising $1.4 million from a preferred equity purchase agreement by Q2 2025, plus an equity line of credit. Here's the quick math: at the end of Q3 2025, the company held $3.5 million in cash and equivalents, plus approximately $3.5 million in committed funding, which is defintely needed to advance a late-stage clinical program.

The company's focus is now firmly on advancing its clinical assets, including the non-invasive vagus nerve stimulation (ncVNS) program and the Entolimod program. To understand the future direction, you need to review the Mission Statement, Vision, & Core Values of Tivic Health Systems, Inc. (TIVC).

Tivic Health Systems, Inc. (TIVC) Ownership Structure

Tivic Health Systems, Inc. is a publicly traded entity, but its ownership structure is overwhelmingly dominated by insiders, which gives a small group of executives and directors significant control over strategic decisions.

This high insider ownership means the company's direction is defintely tied to the interests of its executive team and co-founder, John Claude, who is the single largest individual shareholder.

Tivic Health Systems, Inc.'s Current Status

Tivic Health Systems, Inc. (TIVC) is a publicly traded company, listed on the Nasdaq Capital Market (NasdaqCM). As of November 23, 2025, the company's market capitalization stands at approximately $2.91 million. The stock price was trading around $1.65 per share on November 21, 2025.

The company is currently undergoing a strategic transformation, shifting focus from its consumer health device, ClearUP, to its biopharma pipeline, which includes the late-stage drug candidate Entolimod™. This shift is reflected in its recent financials; the company reported Q3 2025 revenue of just $146,000 and a net loss of $2.6 million. Cash and equivalents were $3.5 million as of September 30, 2025. The company is a micro-cap stock, so liquidity can be a real issue.

Tivic Health Systems, Inc.'s Ownership Breakdown

The ownership breakdown is highly concentrated, with insiders holding the vast majority of shares. This structure means that management and the board have a strong voting position, which can be a double-edged sword: alignment with long-term vision but less influence for external shareholders.

Here's the quick math on who controls the company, as of late 2025:

Tivic Health Systems, Inc.'s Leadership

The company is steered by a lean, experienced executive team focused on executing the biopharma transformation. Their experience spans both medical device commercialization and pharmaceutical development, which is critical for their new dual-platform strategy.

You can read more about their strategic direction and values here: Mission Statement, Vision, & Core Values of Tivic Health Systems, Inc. (TIVC).

The core executive leadership team as of November 2025 includes:

• Jennifer Ernst: Chief Executive Officer (CEO) & Founder. She has a strong background in business development from her two decades at Xerox PARC.
• Lisa Wolf: Chief Financial Officer (CFO). She brings over 30 years of financial leadership, including experience with Nasdaq-listed companies and the life sciences sector.
• Michael K. Handley: Chief Operating Officer (COO) and President of Biopharma. He joined in 2025 to lead the new biopharma division, having previously served as CEO of Statera Biopharma.

The appointment of Michael K. Handley in 2025 was a clear signal to the market about the seriousness of the shift toward drug development, particularly the Entolimod™ program.

Tivic Health Systems, Inc. (TIVC) Mission and Values

Tivic Health Systems' core purpose is to restore health by harnessing the body's own regulatory systems-the immune and autonomic nervous systems-through a dual approach of bioelectronic and biopharmaceutical therapies. This mission is currently driving a major strategic shift, moving resources to their late-stage drug candidate, Entolimod, which is focused on life-saving therapies like acute radiation syndrome, even as their consumer product revenue declined to just $70,000 in the first quarter of 2025.

Given Company's Core Purpose

You're looking at a company that's fundamentally trying to change how chronic and critical diseases are treated, moving beyond traditional pills and invasive procedures. Their commitment is to non-drug solutions and immunotherapeutics, which is a big, ambitious pivot. To be fair, this is a capital-intensive shift, and it's why their net loss for the first half of 2025 was $3.4 million, but it shows where their heart-and their future-lies.

• Patient-Centricity: Prioritizing patient well-being by developing clinically proven, non-invasive, and drug-free alternatives.
• Innovation: Fostering continuous improvement in both bioelectronic devices and biopharmaceutical compounds.
• Integrity: Maintaining the highest ethical standards in all clinical and business activities.
• Collaboration: Working closely with healthcare professionals and government entities, like engaging the White House and FDA on military applications for Entolimod in 2025.

Official mission statement

The mission of Tivic Health Systems, Inc. is to be a diversified therapeutics company dedicated to harnessing the power of the immune and autonomic nervous systems to combat disease and restore health. This means utilizing both bioelectronic medicine, like their non-invasive vagus nerve stimulation (ncVNS) program, and biologic medicines, such as the Toll-like Receptor 5 (TLR5) agonist Entolimod.

• Harness the immune and autonomic nervous systems to fight disease.
• Develop and commercialize non-drug bioelectronic and biologic solutions.
• Restore healthy function and reduce reliance on traditional pharmaceuticals.

Vision statement

The vision is clear: to be a leader in the bioelectronic medicine field, which is a space defintely poised for growth. They want to transform how chronic diseases are managed, so they are constantly advancing their technology and identifying new therapeutic areas. This focus is why they are now planning to exit the ClearUP business to focus on the late-stage pipeline.

• Be a leader in the bioelectronic medicine field.
• Transform the management of chronic diseases.
• Pioneer new bioelectronic technology and expand its applications.

Given Company slogan/tagline

While an explicit, short slogan isn't publicly emphasized, the company's actions in 2025 speak to a theme of 'Restoring Health Through Immunomodulation.' This is their focus, using the immune system to fight disease and improve health outcomes.

Here's the quick math: their shift from consumer health to late-stage drug development is a bet on this core idea, even as their total revenue for the last twelve months ending September 30, 2025, was only $482,000.

For a deeper dive into how this strategic transformation impacts their balance sheet, you should read Breaking Down Tivic Health Systems, Inc. (TIVC) Financial Health: Key Insights for Investors.

Tivic Health Systems, Inc. (TIVC) How It Works

Tivic Health Systems operates by developing a dual-platform approach to medicine, combining biopharmaceutical drug candidates with proprietary bioelectronic devices to modulate the body's immune and autonomic nervous systems and restore health. The company is strategically pivoting from its legacy consumer health device business to a therapeutics-focused model, concentrating on late-stage biologics and a next-generation non-invasive bioelectronic platform.

Given Company's Product/Service Portfolio

Given Company's Operational Framework

The operational framework is undergoing a significant transformation, shifting capital and resources away from consumer sales toward high-value research and development (R&D) in biopharmaceuticals. This is a critical pivot, so the current operational focus is heavily weighted toward clinical and manufacturing milestones for the drug pipeline.

• Biologics Development: The core process is advancing Entolimod and Entolasta through regulatory and manufacturing readiness. This includes completing cell line verification and initiating the current Good Manufacturing Practice (cGMP) manufacturing validation process, a key step before a Biologics License Application (BLA).
• Clinical Pipeline Management: Tivic Health Systems manages two transferred INDs for Entolimod, which allows the company to move directly into Phase 2 clinical studies for neutropenia and advanced cancer indications, bypassing earlier trial phases.
• Financial Resource Allocation: The company is intentionally reducing advertising expenses for ClearUP, which contributed to a decline in revenue to $302,000 for the first nine months of 2025, to focus capital on the Entolimod program. Operating expenses for the nine-month period of 2025 were $5.9 million, reflecting increased R&D investment in the biologics program.
• Bioelectronic R&D: Continued R&D on the ncVNS device, including the recently completed Optimization Study, to support future commercialization and licensing opportunities for its patent-pending technology.

The near-term runway is tight; cash and equivalents were $3.5 million at September 30, 2025, with a net loss of $2.6 million for Q3 2025. Exploring Tivic Health Systems, Inc. (TIVC) Investor Profile: Who's Buying and Why?

Given Company's Strategic Advantages

The company's strategic advantages lie in the late-stage nature of its acquired assets and its unique dual-platform approach, which positions it at the intersection of bioelectronics and biopharma.

• De-Risked Asset Portfolio: Entolimod is described as a late-stage, highly de-risked drug candidate, which means it has existing human safety data and regulatory progress, allowing for a faster path to Phase 2 trials via the transferred INDs.
• Novel Mechanism of Action (Entolimod): As a Toll-like Receptor 5 (TLR5) agonist, Entolimod has a novel mechanism that can potentially treat radiation-caused damage to the gastrointestinal (GI) tract for Acute Radiation Syndrome (ARS), a capability not offered by currently stockpiled G-CSF drugs. This is a defintely compelling differentiator for government contracts.
• Military/Government Focus: The company is actively engaging with the White House and the U.S. Food & Drug Administration (FDA) to position Entolimod as a potential military countermeasure drug for ARS, which represents a significant non-dilutive commercial opportunity.
• Bioelectronic IP: The patent-pending ncVNS technology, which demonstrated enhanced autonomic effects through personalized stimulation, provides a second, distinct intellectual property (IP) stream for future licensing or development in chronic disease management.

Tivic Health Systems, Inc. (TIVC) How It Makes Money

Tivic Health Systems, Inc. currently generates revenue primarily through the sale of its non-invasive consumer medical device, ClearUP, but this is a rapidly winding down operation as the company executes a major strategic pivot to become a diversified immunotherapeutics company. The future business model, which currently generates zero revenue, is centered on developing and commercializing a biopharma pipeline, specifically the drug candidate Entolimod for acute radiation syndrome (ARS) and other indications, plus a prescription non-invasive vagus nerve stimulation (ncVNS) device program.

Tivic Health Systems, Inc.'s Revenue Breakdown

The company's revenue profile as of late 2025 is an anomaly, reflecting a deliberate exit from its consumer business to focus capital on its clinical pipeline. For the third quarter of 2025, reported revenue totaled only $146,000. This makes the breakdown simple, but the trend is the critical factor for investors to understand.

Here's the quick math: nearly all of the $146,000 in Q3 2025 revenue came from the ClearUP device. The company intentionally discontinued all advertising and marketing for the consumer product on October 1, 2025, meaning this stream is defintely drying up. You should expect minimal to no revenue from this segment moving forward until the new pipeline products gain regulatory approval.

Business Economics

The economics of Tivic Health Systems, Inc. are currently defined by a high-margin legacy product being phased out and a high-cost, zero-revenue clinical development pipeline being scaled up. This transition means the current financial statements reflect a research-and-development (R&D) engine, not a commercial one.

• Pricing Strategy (ClearUP): The consumer device was sold directly to consumers and through resellers, with the Q3 2025 revenue increase attributed to reduced selling prices to push through remaining inventory before the exit.
• Gross Margin Paradox: The reported gross profit for Q3 2025 was a gross loss of $145,000. This was solely due to a $230,000 inventory reserve and write-down related to the consumer business wind-down. What this estimate hides is that the underlying product margin, excluding this one-time charge, was actually a healthy 42%, up from 35% in the year-ago quarter.
• Future Economics: The long-term economic model shifts to biopharma, which involves massive upfront R&D and clinical trial costs, but promises blockbuster potential upon approval. Entolimod, for example, is being positioned as a medical countermeasure for acute radiation syndrome (ARS), which could lead to large-scale government contracts for military stockpiling-a very different, high-value, non-dilutive revenue stream compared to a consumer device.

The company's capital allocation is now almost entirely focused on advancing Entolimod toward a Biologics License Application (BLA) and developing the non-invasive vagus nerve stimulation (ncVNS) prescription device.

Tivic Health Systems, Inc.'s Financial Performance

The third quarter of 2025 clearly illustrates the financial strain of this pivot, showing a widening net loss but also a strengthened balance sheet to fund the new strategy. The company is operating in a capital-intensive pre-commercial phase.

• Net Loss: The net loss for Q3 2025 was $2.6 million, a significant widening from the $1.4 million loss in the prior-year quarter. For the first nine months of 2025, the net loss totaled $6.03 million.
• Operating Expenses (OpEx): Operating expenses jumped to $2.3 million in Q3 2025, up from $1.5 million a year ago. This increase is a direct result of adding the biopharma business in February 2025 and increasing R&D investment.
• Liquidity and Runway: As of September 30, 2025, the company reported $3.5 million in cash and cash equivalents. Plus, they have approximately $3.5 million remaining in committed funding from a preferred equity purchase agreement, giving them a limited runway to hit critical manufacturing and clinical milestones.
• Balance Sheet Health: Critically, Tivic Health Systems, Inc. maintains no debt on its balance sheet, which provides flexibility as they seek additional non-dilutive funding, such as potential government contracts for Entolimod.

The financial health of the company is currently less about revenue growth and more about efficient capital deployment to reach regulatory milestones. You can dive deeper into the implications of this financial shift in Breaking Down Tivic Health Systems, Inc. (TIVC) Financial Health: Key Insights for Investors.

Tivic Health Systems, Inc. (TIVC) Market Position & Future Outlook

Tivic Health Systems, Inc. is executing a high-stakes pivot from a niche consumer healthtech company to a diversified immunotherapeutics firm, a strategic shift that positions its future entirely on the success of its pre-commercial biopharma and bioelectronic pipeline. The company is trading its small, but established, ClearUP revenue stream for a shot at the high-value, high-risk markets of Acute Radiation Syndrome (ARS) and non-invasive vagus nerve stimulation (ncVNS).

The company's financial performance reflects this transition, with revenue (net of returns) for the first nine months of 2025 totaling just $302,000 as resources were redirected, resulting in a net loss of $6.0 million for the same period. This is a classic biotech move: sacrificing near-term consumer sales for potential blockbuster therapeutic development. Exploring Tivic Health Systems, Inc. (TIVC) Investor Profile: Who's Buying and Why?

Competitive Landscape

The competitive assessment must focus on Tivic Health Systems, Inc.'s new target markets, as the ClearUP consumer business is being wound down by the end of 2025. The company's future hinges on its proprietary TLR5 agonist, Entolimod, and its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) device.

Here's the quick math: Tivic Health Systems, Inc. is pre-commercial in its new focus areas, so its current market share in the global VNS market, valued at up to $667.4 million in 2025, is defintely negligible. Its core advantage is its unique dual approach: using bioelectronic devices (ncVNS) and biopharmaceuticals (Entolimod) to target the immune system.

Opportunities & Challenges

The company's strategic transformation opens the door to high-value markets but introduces significant execution and financial risks.

Industry Position

Tivic Health Systems, Inc. is no longer a consumer device company; it's an early-stage biopharma player with a unique bioelectronic component. The company's industry standing is defined by its pipeline potential, not current sales.

• Biopharma: Entolimod's Fast Track designation for ARS and interest from government agencies position it as a serious contender in the niche but high-value medical countermeasure space. This is a critical national security market.
• Bioelectronics: The ncVNS device places Tivic Health Systems, Inc. in the rapidly growing non-invasive VNS segment, which is expected to see the fastest growth within the overall VNS market. The total VNS market is projected to be worth up to $667.4 million in 2025.
• Financial Standing: The company is a micro-cap with a market capitalization of only $3.8 million as of November 2025, and a consensus analyst rating of Sell. This indicates a highly speculative position, dependent entirely on clinical and regulatory milestones for its new pipeline.

The company's trajectory is binary: either the biopharma assets generate a major partnership or government contract, or the company faces severe liquidity issues despite having no debt on its balance sheet.