1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
TIVC
Event Date
2021-11-11
Sector
Health Care
Subsector
Health Care Equipment & Supplies
Offer Range
$5.00-$5.00
Shares Offered
3M
Shares Outstanding Pre-IPO
2.88M
2.88M
$27.2M
104.2%
Implied Upside vs Midpoint
Description
Tivic Health Systems, Inc. is a commercial-phase bioelectronic medicine company focused on inflammation. Our first product, ClearUP® Sinus Relief (“ClearUP”), is a patented handheld device that uses ultra-low current electrical waves to relieve symptoms of sinus and nasal inflammation. ClearUP is a US FDA Class II and EU Class IIa medical device that has received three regulatory clearances: (US FDA 510(k) number K182025, US FDA De Novo number DEN200006 and EU CE Mark Certificate number CE 704687). ClearUP consistently gets high ratings from consumers across multiple sales platforms. McKinsey & Co estimates that bioelectronic medicine “represents a multibillion dollar opportunity even with modest penetration.” Bioelectronic medicine treats disease and conditions by modulating the electrical signals carried along various nerve pathways. The field grew out of the multi-billion-dollar neuromodulation industry and relied, historically, on implantable devices (e.g. pacemakers, spinal implants, deep brain stimulators). We have shown that ClearUP, a non-invasive bioelectronic therapy, can safely and comfortably deliver therapeutic benefits with a favorable safety profile. We have brought bioelectronic medicine to the home treatment market for nasal allergies, sinus infections, chronic sinusitis, cold and flu. ClearUP is sold through major on-line retail channels, with over 500 4- and 5-star reviews. amazon.com Walmart Best Walgreens Tivic Health® Buy 388 Reviews 65 Reviews 25 Reviews 7 Reviews 242 Reviews This $9.9 billion U.S. market is dominated by pharmaceuticals. However, through a market research study commissioned by the Company, in which 600 individuals who reported ongoing sinus conditions were electronically surveyed, we discovered that: · 70% of sufferers are not completely satisfied with current over the counter treatment options; · 90% are interested in treatments that reduce use of medications; and · 66% are concerned about side effects. We conducted two published clinical studies with leading research institutions. The first clinical study was a randomized controlled double-blind trial conducted by the Standard University Sinus Center consisting of 71 subjects suffering from sinus pain and congestion, each of whom used either ClearUP or a sham device. The second clinical study was a 30-person study on the use of ClearUP over a period of four weeks conducted by the Allergy and Asthma Associates of Santa Clara Valley Research Center. These studies demonstrated that ClearUP is highly effective at relieving sinus pain from allergic rhinitis and moderate to severe congestion with no substantive side effects. ClearUP has received customer validation with over 500 4- and 5-star reviews across multiple sales platforms. We are currently preparing a second-generation version of ClearUP (“ClearUP Gen 2”) for market. Covered by the same patents, our ClearUP Gen 2 version of ClearUP is designed to lower cost for high-volume manufacturing and distribution. Based on our analysis of regulatory guidance and approval by our designated EU Notified Body (an organization designated by an EU member state to assess the conformity of certain products prior to their release in the EU market), we have determined that ClearUP Gen 2 is covered by the same regulatory clearances as ClearUP, and therefore will not require separate approvals from the U.S. Food and Drug Administration (“FDA”) prior to commercialization. However, it is possible the FDA could determine that ClearUP Gen 2 is not covered by the same regulatory clearances as our existing ClearUP device. If the FDA were to make such a determination, we could be forced to cease distribution of ClearUP Gen 2 until we obtain regulatory clearance or approval, and we could be subject to additional enforcement action by the FDA. --- We were incorporated on September 22, 2016, as a California corporation. Effective as of June 7, 2021, we reincorporated as a Delaware corporation. Our principal executive office is located in Newark, California at 39899 Balentine Drive, Suite 200, Newark, California 94560. Our telephone number is (888) 276-6888 and our corporate website is www.tivichealth.com.
Tivic Health Systems, Inc. annual income statement and balance sheet, FY 2022 to FY 2025, as reported in SEC filings.
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | $1.8M | — | — | — |
| Gross profit | $299K | — | — | — |
| Operating income | ($10.1M) | — | ($4.5M) | ($7.9M) |
| Net income | ($10.1M) | — | ($5.7M) | ($8.9M) |
| Metric | FY 2022 | FY 2023 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $5.9M | — | $2.8M | $31.6M |
| Total liabilities | $2.2M | — | $272K | $7.4M |
| Total equity | $3.6M | $3.6M | $2.5M | $16.8M |
| Cash & equivalents | $3.5M | — | $2.0M | $12.6M |