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Tivic Health Systems is like a:

• Therabody (maker of Theragun) for sinus and nasal inflammation.
• Philips Sonicare for sinus relief.

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• ClearUP: A bioelectronic medical device designed to provide non-invasive neuromodulation for the relief of sinus and nasal inflammation.

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Major Customers of Tivic Health Systems (TIVC)

Tivic Health Systems (TIVC) primarily sells its products directly to individual consumers through its own websites and via major online platforms. Additionally, it sells to online retailers who then resell to individuals. Given the nature of its product, ClearUP (a medical device for individual use), and the emphasis on direct-to-consumer channels, Tivic Health Systems primarily serves individual customers. The company targets the following categories of individual customers:

• Individuals experiencing sinus and nasal inflammation: This includes consumers suffering from chronic or acute conditions such as allergies, colds, or sinusitis, who are actively seeking relief for their symptoms.
• Health-conscious consumers seeking non-pharmacological and non-invasive treatment alternatives: These customers prefer drug-free solutions and holistic approaches to managing their health conditions, aligning with ClearUP's bioelectronic device nature.
• Consumers utilizing health savings accounts (HSAs) and flexible spending accounts (FSAs): As indicated by its presence on FSAStore.com, Tivic targets individuals who wish to use their pre-tax health funds for eligible medical devices.

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• Shenzhen Protronic Technology Co. Ltd.

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Michael K. Handley, Chief Executive Officer and President of Biopharma

Michael K. Handley was appointed CEO of Tivic Health Systems on March 4, 2026. He previously served as the company's Chief Operating Officer and President of Tivic Biopharma since February 18, 2025. Prior to joining Tivic Health, Mr. Handley served as President, Chief Executive Officer, and Chairman of Statera Biopharma, Inc. from July 2021 to February 2025. He was also the Chief Executive Officer and a director of Immune Therapeutics from July 2019 to March 2020. His career includes senior management roles at several life science companies, including Armis Biopharma, Spectranetics, Accelapure Corporation, Vessix Vascular, Inc. (which was acquired by Boston Scientific), and Acclarent (which was acquired by Johnson & Johnson). He has contributed to the U.S. approval and commercialization of seventeen products.

Lisa Wolf, Chief Financial Officer

Lisa Wolf was appointed permanent Chief Financial Officer of Tivic Health Systems on July 8, 2025, after serving as interim CFO since October 1, 2024. She possesses over 30 years of financial leadership experience in both public and private companies across diverse industries. Most recently, Ms. Wolf served as Vice President at Murdock Martell, a consulting firm. Earlier in her career, she was the Chief Accounting Officer of Nasdaq-listed Resonant, Inc., which was subsequently sold to Murata Electronics North America. She earned her CPA while working at Arthur Andersen.

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The key risks for Tivic Health Systems (TIVC) are primarily associated with its ongoing strategic transformation from a consumer health device company to a biopharmaceutical firm. These risks include:

1. Significant Financial Distress and Going Concern Uncertainty: Tivic Health Systems is currently unprofitable, exhibiting negative operating margins and is burning cash to fund its new biopharmaceutical pipeline. Its revenue from the legacy ClearUP product is minimal and intentionally decreasing as the company winds down this segment of its business. This strategic pivot introduces substantial financial and execution risks, and the company's ability to continue as a going concern has been a significant concern, highlighted by auditor reports.
2. High-Stakes Strategic Pivot to Biopharmaceutical Development: The company is undergoing a complete transformation, shifting its focus from a commercial-phase medical device company to a clinical-stage biopharma firm, primarily centered on the drug candidate Entolimod. This represents a "binary bet" on the success of their drug pipeline, and there is an anticipated significant revenue gap until their new biopharma product candidates achieve regulatory approvals and commercialization.
3. Potential NASDAQ Delisting: Given its financial challenges and weakened stock performance, Tivic Health Systems faces a potential NASDAQ delisting due to issues such as not meeting minimum bid price requirements.

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Tivic Health Systems (TIVC), a bioelectronic device company, has historically focused on its ClearUP product for sinus and nasal inflammation. However, the company is strategically shifting its focus from its ClearUP consumer business to biopharmaceuticals, including a vagus nerve stimulation (VNS) program and a late-stage Toll-like Receptor 5 (TLR5) agonist called Entolimod for acute radiation syndrome and advanced cancers.

Addressable Markets for Tivic Health Systems' Products and Services:

For Sinus and Nasal Inflammation (ClearUP - historical primary product):

• The global sinusitis treatment market was valued at approximately USD 2.40 billion in 2024 and is projected to reach around USD 4.22 billion by 2034.
• The global allergic rhinitis drugs market size was valued at USD 13.7 billion in 2024 and is estimated to grow to USD 19.9 billion by 2034. Other estimates place the global allergic rhinitis market at USD 12.24 billion in 2024, expected to grow to USD 16.97 billion by 2033.
• The global sinus dilation devices market size was valued at USD 2.74 billion in 2022 and is expected to reach USD 3.8 billion by 2027. North America accounts for over 40% of the revenue in the sinus dilation devices market.

For Non-Invasive Neuromodulation (Vagus Nerve Stimulation - emerging focus):

• The global neuromodulation devices market was valued at USD 5.82 billion in 2024 and is projected to reach USD 12.15 billion by 2033. The non-invasive segment is anticipated to hold the largest share of this market. North America is identified as the largest market for neuromodulation.
• More specifically, the non-invasive neurostimulation devices market is estimated to be valued at USD 1.45 billion in 2025 and is expected to reach USD 3.15 billion by 2032.

For TLR5 Agonists (Entolimod - emerging focus for acute radiation syndrome and advanced cancers):

• Addressable market sizes specifically for TLR5 agonists or Entolimod for acute radiation syndrome (ARS) and advanced cancers were not explicitly provided in the available information.

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For Tivic Health Systems (NASDAQ: TIVC), the expected drivers of future revenue growth over the next 2-3 years are primarily centered on its strategic pivot to a biopharmaceutical company, moving away from its consumer health device business.

1. Commercialization and Government Stockpiling of Entolimod: A significant driver of future revenue is the potential commercialization and government stockpiling of Entolimod, Tivic Health's lead drug candidate. Entolimod is a late-stage TLR5 agonist in late Phase III development for acute radiation syndromes. The company is actively engaged in discussions with government agencies, such as BARDA, regarding potential stockpiling, which could represent a substantial revenue stream.

2. Expansion of TLR5 Agonist Pipeline: Beyond acute radiation syndrome, Tivic Health's broader TLR5 agonist portfolio, including Entolasta for chronic radiation syndromes, aims to address a wider range of indications. This pipeline expansion into oncology-related conditions, such as neutropenia (a debilitating side effect of radiation treatments), and other immune system disorders, offers multiple future revenue opportunities through new drug development and commercialization.

3. Biomanufacturing and Contract Development/Manufacturing Organization (CDMO) Services: Tivic Health has vertically integrated Velocity Bioworks, a contract development and manufacturing organization. This provides in-house manufacturing capabilities for its own drug candidates and also opens up a new revenue stream by offering biomanufacturing services to other biotech companies. This strategy is expected to reduce outsourcing delays and costs while generating additional income.

4. Development and Commercialization of Next-Generation Vagus Nerve Stimulation (VNS) Devices: While the direct-to-consumer ClearUP product is being wound down, Tivic Health plans to increase its research and development investments in its vagus nerve platform and clinical applications. The company is exploring alternative commercial opportunities for next-generation VNS devices intended for chronic conditions, suggesting a potential for new product launches in the medical device sector with a focus on therapeutic applications beyond its initial consumer offering.

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Capital Allocation Decisions (Last 3-5 Years)

Share Issuance

• Tivic Health Systems completed an initial public offering (IPO) on November 11, 2021, raising $16 million by issuing 3,000,000 shares at a price range of $5.00-$6.00 per share.
• The company conducted a public offering reported on August 14, 2025, which raised gross proceeds of approximately $4.0 million, with net proceeds around $3.3 million.
• Shareholders experienced substantial dilution over the past year (as of Q3 2025), with the total shares outstanding growing by 353.5%.

Inbound Investments

• In the third quarter of 2025, Tivic Health Systems closed tranches of a preferred equity purchase agreement, securing $3.8 million in net proceeds.
• The company has a $25 million equity line of credit (ELOC) in place, with approximately $3.5 million remaining available under a preferred equity agreement as of September 30, 2025, earmarked for advancing its biologics pipeline.

Outbound Investments

• In February 2025, Tivic Health Systems licensed the late-stage TLR5 agonist Entolimod, which has Fast Track and Orphan Drug designations.
• The company acquired biomanufacturing assets, used to form Velocity Bioworks, for approximately $16 million. This acquisition was part of a strategic shift to become a vertically integrated biopharmaceutical company.

Capital Expenditures

• Tivic Health Systems invested $10,000 in capital expenditures during Q3 2025, primarily for funding long-term assets and infrastructure.
• The acquisition of biomanufacturing assets for approximately $16 million in early 2026 represents a significant capital expense to enable cost savings for its Contract Development and Manufacturing Organization (CDMO) operations.