Tivic Health's Vagus Nerve Stimulation: A Promising Path to Growth

Tivic Health Systems, Inc. (Nasdaq: TIVC), a health tech company specializing in bioelectronic medicine, recently released its annual CEO letter to shareholders, highlighting key developments in 2024 and outlining expectations for 2025. The letter emphasized the company's strategic pivot towards Vagus Nerve Stimulation (VNS), a transformative technology with significant market potential.

VNS has emerged as a powerful tool in medicine, primarily through surgically implanted simulators. The global VNS market is projected to reach $21 billion in the next five years, growing at a CAGR of 10.6%. Implanted stimulators have been approved for or are nearing approval for treating depression, epilepsy, chronic stroke rehabilitation, and rheumatoid arthritis in the US and additional conditions overseas. Tivic Health aims to capitalize on this momentum by focusing on non-invasive stimulation approaches.

Tivic's non-invasive cervical approach to VNS (ncVNS) offers a less capital-intensive pathway to market while generating similar biological and clinically meaningful effects. The company's non-invasive VNS system has shown best-in-industry effects on outcomes like heart rate variability and achieved comparable or superior results when compared to invasive implants.

In May 2024, Tivic completed a pilot study with Feinstein Institute of Bioelectronic Medicine, demonstrating that its ncVNS approach was able to drive clinically meaningful changes in brain, cardiac, and nervous system activity, consistent with vagus nerve engagement. The company is now underway with a second collaborative study to further optimize ncVNS parameters and their impact on vagus nerve activation.

Tivic's investment in research and development for VNS has significantly contributed to its intellectual property portfolio and market opportunities. As of 2024, the company holds 16 issued patents and 10 pending patents across the U.S., Europe, India, and China, protecting its innovations globally. The company's non-invasive cervical approach to VNS has identified targeted market opportunities exceeding $30 billion, demonstrating the potential of its R&D efforts to drive growth and value.



The collaboration with Feinstein Institute of Bioelectronic Medicine has enhanced Tivic Health's clinical validation and credibility in the VNS market. The pilot study with Feinstein demonstrated the effectiveness of Tivic's ncVNS approach, increasing confidence in the technology's potential to achieve comparable or superior results to invasive implants. The collaboration with a leading bioelectronic medicine institute adds credibility to Tivic's development program, positioning its non-invasive solution as a potentially disruptive alternative to surgical implants.



Tivic Health's strategic focus on optimizing ClearUP business cash flow and regaining Nasdaq compliance has contributed to its financial stability and growth. In 2024, the company achieved a gross margin of over 65% in direct-to-consumer channels, up from 28% in 2023, demonstrating effective cost management during the transition phase. This improvement, coupled with a 30% reduction in net operating loss, indicates a successful optimization of ClearUP's business cash flow. Additionally, Tivic's efforts to regain Nasdaq compliance, including a reverse stock split and appeals, have maintained the company's listing status, ensuring continued access to capital markets for growth and investment opportunities.

In conclusion, Tivic Health's investment in Vagus Nerve Stimulation represents a strategic move into a high-growth market with significant potential. The company's non-invasive cervical approach to VNS, combined with its robust intellectual property portfolio and collaboration with Feinstein Institute, positions Tivic Health as a strong contender in the bioelectronic medicine space. As the company continues to optimize its ncVNS device parameters and improve its financial performance, investors can expect Tivic Health to play a growing role in the future of healthcare.