Tivic Health Reports 34% Revenue Decline and $5.66 Million Net Loss for Fiscal Year 2024

Tivic Health Systems, Inc. reported a significant decline in financial performance for the fiscal year ending December 31, 2024, with total revenue decreasing by 34% to $780,000, down from $1.18 million in 2023. This decline was primarily attributed to a 41% drop in unit sales, which fell to approximately 4,400 units from 7,400 units in the previous year. The company's net loss for the year was $5.66 million, a reduction from the $8.25 million loss reported in 2023, reflecting a decrease in operating expenses, which totaled $5.66 million compared to $8.53 million in the prior year.

In terms of operational changes, Tivic Health has made strategic moves to enhance its product offerings and market presence. The company entered into a significant licensing agreement with Statera Biopharma in February 2025, acquiring exclusive rights to the late-stage TLR5 agonist, Entolimod, aimed at treating acute radiation syndrome. This agreement also includes an option for additional indications, which could expand Tivic's product pipeline. Furthermore, the company appointed Michael Handley, former CEO of Statera, as Chief Operating Officer to lead the new biopharmaceutical division, indicating a shift towards integrating biopharmaceutical capabilities alongside its existing bioelectronic products.

Tivic Health's ClearUP device, which treats sinus pain and congestion, remains its primary commercial product. The device is sold through various online retailers and has been approved by the FDA for over-the-counter use. Despite the challenges in sales, the company has identified a substantial market opportunity, with estimates suggesting a potential $6 billion market for ClearUP under current FDA approvals, which could extend to $9.1 billion with additional indications. However, the company has reported that it has achieved less than 0.002% penetration in several identified addressable markets, indicating significant room for growth.

The company has also faced challenges related to its operational structure, including a material weakness in internal controls over financial reporting due to a small accounting team. As of December 31, 2024, Tivic Health had seven full-time employees and two contractors, reflecting a lean operational model aimed at reducing costs. The company anticipates needing additional capital to support its growth strategy, particularly in expanding its research and development efforts and addressing the integration of its newly licensed biopharmaceutical products.

Looking ahead, Tivic Health's management has expressed concerns about its ability to continue as a going concern, citing insufficient cash resources to meet anticipated needs over the next twelve months. The company plans to pursue additional financing options, including potential equity offerings, to support its operations and product development initiatives. The ongoing geopolitical tensions and economic uncertainties may further complicate these efforts, impacting the company's ability to raise capital and execute its strategic plans effectively.