Tivic Health Approved for ncVNS Study, Aiming to Enhance Treatment Options
Tivic Health's Milestone: IRB Approval for ncVNS Study
Tivic Health® Systems, Inc. (NASDAQ: TIVC), a pioneering health tech company, is thrilled to announce its recent approval from The Feinstein Institutes’ Institutional Review Board. This approval marks a significant step in the advancement of its innovative non-invasive cervical vagus nerve stimulation (ncVNS) technology. The upcoming study is geared towards refining and optimizing the treatment parameters associated with ncVNS, a technique that holds promise for various health conditions.
Enhancing ncVNS Technology Through Clinical Research
The clinical research collaboration with The Feinstein Institutes aims to harness physiological measurements that will improve device performance significantly. By focusing on stimulation parameters, the study will refine critical specifications like electrode positioning and electrical waveform characteristics. This data will not only aid in determining appropriate clinical populations but also assist in shaping an effective design for subsequent clinical trials.
Goals of the Optimization Study
This comprehensive optimization study will work towards achieving two key objectives:
- Optimizing Treatment Strategies: By providing essential data, the study aims to advance personalized treatment strategies and optimization of stimulation parameters.
- Accelerating Product Development: The refined parameters will hasten the development of Tivic Health's product offerings based on the ncVNS technology, ultimately enhancing speed to market.
Strategic Collaborations and Their Importance
Tivic Health has also recently engaged in a collaboration with Fletcher Spaght, a renowned healthcare growth strategy firm. This partnership is tasked with exploring high unmet medical needs that could potentially be addressed through Tivic Health’s patent-pending ncVNS system. Such collaborations not only broaden the scope of potential applications but also enhance the company’s strategy for clinical relevance.
Leadership Insights
Jennifer Ernst, the CEO of Tivic Health, emphasized the integrated approach the company is adopting towards clinical product development and go-to-market strategies. She stated, "We are taking an integrated approach to clinical, product development and go-to-market planning for our medical-grade non-invasive VNS program. We believe this approach creates the best opportunities to generate significant new revenue based on this work." This sentiment underscores the company’s commitment to innovation and market leadership.
The Research Team and Their Focus Areas
The study will be facilitated by The Feinstein Institute of Bioelectronic Medicine, under the leadership of Dr. Theodoros Zanos, Ph.D., who serves as an Associate Professor there. He will collaborate closely with Dr. Blake Gurfein, Tivic Health’s Chief Scientific Officer, whose guidance in the project is invaluable. Dr. Gurfein remarked, "Precision optimization is an important but often overlooked step in non-invasive neurostimulation device development." This collaboration aims to transition from proof-of-concept to disease-specific validation in clinical trials anticipated in the upcoming year.
Market Insights on Vagus Nerve Stimulation
The global vagus nerve stimulation market is projected to grow from an estimated $8.59 billion in 2021 to $21.3 billion by 2030, demonstrating a compound annual growth rate (CAGR) of 10.6% during the forecast period. Tivic Health is strategically positioning itself to be a market leader by offering enhanced, personalized, and effective treatment solutions through its non-invasive VNS technology.
About Tivic Health
Tivic Health is at the forefront of health tech innovation, specializing in the domain of bioelectronic medicine. Their technology utilizes stimulation techniques targeting the trigeminal, sympathetic, and vagus nerve structures to provide therapeutic solutions for chronic health conditions without the need for pharmaceuticals. The company’s first commercial product, ClearUP, is an FDA-approved handheld device designed to alleviate sinus pressure and has received numerous accolades. ClearUP is clinically validated and available through various online retail platforms and distributors.
Frequently Asked Questions
What is ncVNS?
ncVNS stands for non-invasive cervical vagus nerve stimulation, a technique aimed at enhancing health outcomes by targeting specific nerve structures.
Who is leading the ncVNS optimization study?
The study is being led by Dr. Theodoros Zanos and Dr. Blake Gurfein, both of whom have extensive experience in neurostimulation research.
Why is Tivic Health focusing on optimizing treatment parameters?
Optimizing treatment parameters is essential for personalizing care paths for patients and increasing the effectiveness of the ncVNS technology.
What market opportunity is there for Tivic Health?
The vagus nerve stimulation market is expected to grow significantly, presenting a substantial opportunity for Tivic Health to expand its product offerings and market presence.
What products does Tivic Health offer?
Tivic Health offers a range of bioelectronic medicine products, with ClearUP being its flagship device for treating sinus issues.
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