SAN FRANCISCO - Tivic Health Systems Inc. (NASDAQ:TIVC), a health technology firm specializing in bioelectronic medicine, has received approval to move forward with a new phase of clinical research on its non-invasive cervical vagus nerve stimulation (ncVNS) technology. The Feinstein Institutes' Institutional Review Board has sanctioned the study, which aims to refine the device's performance by optimizing stimulation parameters.
The research, in collaboration with the Feinstein Institute of Bioelectronic Medicine, is a step towards personalizing treatment strategies and accelerating the development of Tivic Health's ncVNS-based products. The study will be led by Dr. Theodoros Zanos and Dr. Blake Gurfein, Tivic Health's Chief Scientific Officer.
Tivic Health previously completed a Phase 1 study on ncVNS, and the current study's findings will inform clinical trial designs for disease-specific validation expected next year. The company has also partnered with Fletcher Spaght to identify clinical applications with high unmet needs that could benefit from ncVNS.
CEO Jennifer Ernst expressed confidence that the integrated approach to clinical and product development will create significant revenue opportunities. Dr. Gurfein emphasized the importance of precision optimization in the development of non-invasive neurostimulation devices.
The global vagus nerve stimulation market is projected to grow substantially, reaching an estimated $21.3 billion by 2030, according to Polaris (NYSE:PII) Market Research. Tivic Health aims to capitalize on this growth by delivering personalized and effective non-invasive VNS treatments.
Tivic Health is known for its commercial product ClearUP, an FDA-approved bioelectronic device for sinus treatment, and seeks to establish itself as a leader in bioelectronic medicine by expanding its technology platforms to stimulate various nerve structures for treating chronic inflammatory conditions.
This news is based on a press release statement and includes forward-looking statements that involve risks and uncertainties. The company's continued progress in the ncVNS field and its potential market impact are subject to factors such as clinical trial outcomes and strategic partnerships.
In other recent news, Tivic Health Systems Inc. has announced a partnership with Fletcher Spaght, a healthcare growth strategy firm, to refine its commercial strategy for non-invasive cervical vagus nerve stimulation technology. The collaboration is expected to guide Tivic Health's market entry strategies and clinical study plans. Additionally, Tivic Health has expanded its equity incentive plan, increasing the number of shares authorized for issuance from 92,376 to 1,000,000.
The company has also ended its Fulfillment Services Agreement with ALOM Technologies Corporation, transitioning to alternative third-party logistics and storage services while developing in-house assembly and testing capabilities. Tivic Health has announced terms for a public offering aiming to raise approximately $4 million, which includes around 4.7 million shares of common stock, accompanied by Series A and Series B warrants for additional shares, each priced at $0.85.
Tivic Health has been granted three new patents by the United States Patent and Trademark Office and the European Patent Office, covering advancements in their microcurrent stimulation devices used for health treatments. However, Tivic Health received a non-compliance notice from the Nasdaq Stock Market LLC due to its common stock closing bid price falling below $1.00 per share for 33 consecutive business days. The company's stock remains listed on the Nasdaq Capital Market, and it has until December 26, 2024, to meet the minimum bid price requirement.
InvestingPro Insights
As Tivic Health Systems Inc. (NASDAQ:TIVC) forges ahead with its clinical research in the burgeoning field of bioelectronic medicine, investors and industry observers are closely monitoring the company's financial health and market performance. Tivic Health's strategic focus on non-invasive cervical vagus nerve stimulation (ncVNS) technology could play a pivotal role in tapping into the projected $21.3 billion vagus nerve stimulation market by 2030. However, a deeper look into the company's financial metrics and market behavior provides a nuanced picture of its current standing.
An InvestingPro Tip highlights that Tivic Health holds more cash than debt on its balance sheet, which is a positive indicator of the company's financial stability and its ability to fund ongoing research and development without excessive borrowing. Moreover, analysts anticipate sales growth in the current year, suggesting optimism regarding the company's revenue prospects as it advances its ncVNS technology.
From a market perspective, Tivic Health's stock has experienced significant volatility, a characteristic that investors should consider. The company's stock price movements have been quite volatile, and the stock has fared poorly over the last month, reflecting a potential risk for short-term investors. Additionally, the stock price has fallen significantly over the last year, which may present a buying opportunity for those who believe in the company's long-term potential.
InvestingPro Data for Tivic Health reveals a market capitalization of approximately $1.7 million, indicating its size within the industry. The company's revenue over the last twelve months as of Q2 2024 stands at $1.11 million, although it has experienced a revenue decline of 21.67% during the same period. These figures underscore the challenges Tivic Health faces in scaling its operations and the importance of its ongoing clinical research in potentially reversing this trend.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips on Tivic Health Systems Inc., providing deeper insights into the company's financial health and market performance. To explore these insights, visit: https://www.investing.com/pro/TIVC.
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