Tivic Health Partners with the Feinstein Institutes to Advance its Patent-pending, Non-Invasive Cervical Vagus Nerve Stimulation; Begins Optimization of ncVNS for use in Clinical Indications

Rhea-AI Summary

Tivic Health Systems (Nasdaq: TIVC) announced the initiation of the second phase of its clinical work to advance its non-invasive cervical vagus nerve stimulation (ncVNS). This phase involves a collaboration with The Feinstein Institutes for Medical Research at Northwell Health to optimize the ncVNS device for specific clinical indications. A 20-person clinical trial will be conducted, focusing on refining electrode positioning and key electrical waveform parameters. The first phase demonstrated significant changes in biomarkers for the brain, heart, and autonomic nervous system. This next phase aims to tailor the therapy to specific clinical indications and accelerate product development. VNS is a growing market within the $8.3 billion neurostimulation sector, with a projected CAGR of 12.2% from 2023 to 2032.

Positive

• Initiation of the second phase of clinical work to advance ncVNS.
• Collaboration with The Feinstein Institutes for Medical Research.
• Focus on optimizing device specifications for specific clinical indications.
• Clinical trial to involve 20 participants to refine electrode positioning and electrical waveform parameters.
• Significant changes in biomarkers for the brain, heart, and autonomic nervous system demonstrated in Phase 1.
• Potential clinical utility for patient populations, including epilepsy, PTSD, and ischemic stroke.
• VNS is a part of the growing $8.3 billion neurostimulation market, with a projected CAGR of 12.2% from 2023 to 2032.

Negative

• The necessity of a second phase suggests incomplete optimization in the first phase.
• Clinical trials involve only 20 participants, which may limit the generalizability of results.
• Potential risks and uncertainties associated with refining electrode positioning and electrical waveform parameters.
• Reliance on future successful outcomes of clinical trials for product development and market acceptance.
• No immediate financial benefits or revenue generation from the ongoing clinical trials.

Insights

Medical Research Analyst

Tivic Health's collaboration with the Feinstein Institutes to advance non-invasive cervical vagus nerve stimulation (ncVNS) is noteworthy. The ncVNS device aims at providing a non-surgical alternative to existing VNS treatments, which currently require implants. This could significantly expand the market for VNS therapies by making them more accessible and reducing associated risks.

The collaboration with Theodoros Zanos, Ph.D., a highly regarded figure in bioelectronic medicine, reinforces the legitimacy and potential of the technology. The Phase 2 trial will refine the device specifications, focusing on electrode positioning and electrical waveform parameters. If successful, this device could be tailored to treat a range of conditions such as epilepsy, PTSD and ischemic stroke, thereby positioning Tivic Health as a leader in the expanding $8.3 billion neurostimulation market.

Given the promising results from the initial study, this next phase could provide further validation and accelerate product development, eventually leading to regulatory approvals and commercialization. Nevertheless, investors should be aware that clinical trials are inherently risky and success is not guaranteed. If Phase 2 results are positive, the company could see substantial growth opportunities.

Financial Analyst

The collaboration with the Feinstein Institutes could prove to be a significant driver of Tivic Health's long-term growth. The neurostimulation market, with a CAGR of 12.2% through 2032, offers substantial growth opportunities. Successful optimization and commercialization of the ncVNS device could open new revenue streams and diversify Tivic Health's product portfolio.

It's important to consider the cost implications of ongoing clinical trials and R&D activities. While these investments are necessary for future growth, they could strain the company's finances in the short term. Investors should monitor Tivic’s financial health and funding strategies to ensure sustainability.

The partnership with a reputable institution like the Feinstein Institutes can enhance investor confidence and potentially bolster the stock's performance. However, successful commercialization depends on regulatory approvals, market acceptance and competitive dynamics within the rapidly evolving neurostimulation sector.

Market Research Analyst

The announcement highlights Tivic Health's focus on the rapidly expanding bioelectronic medicine market, particularly in neurostimulation. Given the projected market size and growth rate, the optimization of the non-invasive cervical vagus nerve stimulation (ncVNS) device can place Tivic in a strong competitive position. The market's growth is driven by the increasing prevalence of neurological disorders and the shift towards non-invasive treatment options.

Understanding the competitive landscape is essential. While Tivic’s technology offers a non-invasive alternative to traditional VNS devices, other companies are also exploring similar innovations. Tivic's ability to differentiate its product through efficacy, cost and ease of use will be critical in capturing market share.

Potential barriers include regulatory hurdles, market competition and the need for extensive clinical validation. However, positive results from the current and upcoming trials can significantly enhance Tivic's market positioning and drive adoption among healthcare providers and patients.

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today it has initiated the second phase of its clinical work to advance its novel non-invasive cervical vagus nerve stimulation (“ncVNS”). The company has entered into a collaboration agreement with The Feinstein Institutes for Medical Research at Northwell Health to optimize its ncVNS device therapy for use in specific clinical indications.

Tivic Health will conduct a second 20-person clinical trial in collaboration with Theodoros Zanos, Ph.D., Associate Professor in the Institute of Bioelectronic Medicine and Head of the Neural and Data Science Lab at the Feinstein Institutes. Physiological measurements will be used to identify optimal device specifications, including refining electrode positioning and key electrical waveform parameters utilized in its successful Phase 1 study.

“Our recently released ncVNS results demonstrated a large clinically important change in biomarkers for the brain, heart, and autonomic nervous system,” says Blake Gurfein, Ph.D., Chief Scientific Officer of Tivic Health. “This next phase of the research will build upon those results to tailor the therapy to specific clinical indications and accelerate our product development.”

Through its successful Phase 1 study, Tivic Health demonstrated a novel ncVNS approach that management believes could have clinical utility in several patient populations, including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.

Background:

VNS is a growing market that is part of the $8.3B neurostimulation market, which has a projected CAGR of 12.2% from 2023 through 2032, according to Global Market Insights. The vagus nerve is the longest autonomic nerve in the body. The vagus nerve regulates many organ systems associated with chronic disease, and thus modulating activity in this nerve pathway is of significant interest in the medical industry. VNS is currently indicated for treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation, and it is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants.

Tivic Health, with collaborators such as The Feinstein Institute for Bioelectronic Medicine, hopes to lead the way to meaningful improvement in how VNS devices can more precisely target and modulate vagus nerve activity to achieve intended biological and clinical outcomes, with non-invasive or minimally invasive devices.

Previously, the company has announced:

• May 2024: Tivic Health Announces Successful Completion of Non-Invasive Vagus Nerve Stimulation Study (VNS); Demonstrates Clinically Effective Biological Changes in the Autonomic, Cardiac, and Central Nervous Systems
• January 2024: Tivic Health Announces Enrollment Complete for Study of Novel Non- Invasive Bioelectronic Approach to Vagus Nerve Stimulation
• August 2023: Tivic Health Funded Study Begins Enrollment for Novel Non-Invasive Bioelectronic Approach to Vagus Nerve Stimulation
• April 2023: Tivic Expands Bioeletronic Portfolio: Files Patent Application for New Approach to Non-Invasive Vagus Nerve Stimulation

About Tivic Health

Tivic Health is a commercial health tech company advancing the field of bioelectronic medicine. Tivic Health’s patented technology platform leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Tivic Health’s non-invasive and targeted approach to the treatment of inflammatory chronic health conditions gives consumers and providers drug-free therapeutic solutions with high safety profiles, low risk, and broad applications. Tivic Health’s first commercial product ClearUP is an FDA approved, award-winning, handheld bioelectronic sinus device. ClearUP is clinically proven, doctor-recommended, and is available through online retailers and commercial distributors. For more information visit http://tivichealth.com @TivicHealth

Forward-Looking Statements

This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: statements regarding the future development and/or effectiveness of ncVNS treatment; Tivic Health’s ability to develop and commercialize products arising out of the ncVNS treatment; Tivic Health’s plans to seek regulatory approval for such clinical products; Tivic Health’s plans for developing an ncVNS treatment, including in the epilepsy, post-traumatic stress disorder, and/or ischemic stroke space; expected clinical utility, including which patient populations may be pursued; market and other conditions; supply chain constraints; macroeconomic factors, including inflation; and unexpected costs, charges or expenses that reduce Tivic Health’s capital resources. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Tivic Health’s actual results to differ from those contained in the forward-looking statements, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”; as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522711437/en/

Media:

Morgan Luke

Morgan.Luke@tivichealth.com

Investor:

Hanover International, Inc.

ir@tivichealth.com

Source: Tivic Health Systems, Inc.

FAQ

What is Tivic Health's recent announcement about?

Tivic Health announced the initiation of the second phase of its clinical work to advance its non-invasive cervical vagus nerve stimulation (ncVNS).

Who is Tivic Health collaborating with for the ncVNS optimization?

Tivic Health is collaborating with The Feinstein Institutes for Medical Research at Northwell Health for the ncVNS optimization.

What is the focus of Tivic Health's second clinical trial phase for ncVNS?

The focus is on refining electrode positioning and key electrical waveform parameters used in the ncVNS device.

How many participants are involved in Tivic Health's second ncVNS clinical trial?

The second ncVNS clinical trial will involve 20 participants.

What were the results of Tivic Health's Phase 1 ncVNS study?

The Phase 1 study demonstrated significant changes in biomarkers for the brain, heart, and autonomic nervous system.

What is the projected market size for neurostimulation?

The neurostimulation market is projected to be $8.3 billion with a CAGR of 12.2% from 2023 to 2032.