Tivic Health Systems, Inc.
Tivic Health Systems, Inc. is a commercial-phase health technology company developing and commercializing bioelectronic medicine to improve health, treat certain conditions and diseases, and make a meaningful difference in people’s lives.
Tivic believes consumers want more drug-free solutions, and is focusing on providing more non-invasive, drug free options directly to consumers. Tivic utilizes its patented technology and is in the process of building a pipeline of products across various treatment areas, beginning with sinus pain and congestion, with the goal of expanding its products and indications of use to address post-operative pain and migraine. Developing non-invasive products generally leads to shorter development timelines, lower risk, and broader applicability.
Nasdaq: TIVC
IR Website: https://tivichealth.com/investor/
Headquarters: Hayward, CA
Tivic’s first FDA approved, CE marked commercial product, ClearUP® Sinus Pain Relief (“ClearUP”), provides consumers with a new solution to treat sinus pain and congestion from nasal allergies, sinus infections, chronic sinusitis, colds, and flu. According to Mintel Group Ltd., as of 2019, treatments for these indications amounted to an approximately $9.9B market in the U.S., which market is currently dominated by pharmaceutical products.
Bioelectronic Medicine and Market
There are various themes that dominate today’s medical research market, including gene and cell therapy, gene slicing, and immuno-oncology, but there is an under-recognized approach that utilizes humans’ innate electrical systems to treat various conditions, also known as “Bioelectronic Medicine”. Bioelectronic medicine uses targeted electric signals to modulate neural circuits to diagnose and treat diseases. The bioelectronic medicine market is expected to grow at a compound annual growth rate (“CAGR”) of 7.9%, reaching a size of $36.79 billion by 2026, according to a Facts and Factors Market Research Report. In addition, an IDTechEx study reported there is a CAGR of 35% in the non-invasive space. The application of bioelectronic technology includes the use of pacemakers for abnormal heart rhythms, spinal cord stimulation, deep brain stimulation, and applications in the peripheral nervous system (“PNS”), including vagus nerve stimulation, sacral nerve stimulation, and others. Aside from cardiac rhythm management and central nervous system (“CNS”) applications, implantable bioelectronic devices are currently being tested for inflammatory diseases such as rheumatoid arthritis and Crohn’s disease.
Bioelectronic medicine holds certain compelling advantages over traditional drug-based interventions. Better diagnosis and prevention, precision targeting, tailored to the individual, real-time, continuous, and optimization are a few factors that support the case for the field’s growth potential for certain indications. Worldwide there are hundreds of clinical trials are now underway to investigate how harnessing the body’s peripheral wiring might help broadly in the treatment of acute and chronic diseases.
Tivic Technology and Pipeline
Drug-based treatment is pervasive in healthcare, given its long history and easy access. Even though drug-based treatment has its benefits, it can carry dangerous side effects for the human body and can also lead to habituation and, in certain cases, drug abuse. Cold, cough, and pain medications (Dextromethorphan, Pseudoephedrine, Acetaminophen) are available over the counter and are generally found to be misused. This has, in part, led to the need and preference for alternative treatment options, aiding the growth of bioelectronic medicine.
Tivic’s current product pipeline is centered around its proprietary technology. The core technology is a platform that the company intends to use as a base to develop medical devices for different indications, subject to regulatory approval. The technology combines various parameters that modulate the nerve signals to alleviate inflammation-driven symptoms like pain and congestion. The company believes that its platform allows for the extension of its core technology beyond the company’s current pipeline, providing broader market reach potential than targeting a single indication.
Product development activities are ongoing for two product candidates: (i) npdPP, a home-use device for treating postoperative pain after sinus surgery, and (ii) npdMI, a home-use device for treating migraine headaches. These product candidates are in the early stages of development and will require additional studies and regulatory clearances prior to bringing them to market. Each of these applications would involve the regulation of pain and inflammation-related mediators, similar to those seen in sinus and nasal inflammation.
Additional potential clinical applications of our technology focus on the stimulation of nerves of the face and head (trigeminal, vagus, facial). These include chronic quality-of-life conditions such as temporomandibular joint disorder and tinnitus; severe, life-altering conditions such as trigeminal neuralgia; and acute conditions such as ear infections.
ClearUP: A Unique Solution for an Age-Old Problem
Tivic’s first commercial product is ClearUP. ClearUP is an FDA approved, CE marked patented handheld device that uses a gentle electric pulse and frequency to relieve sinus pain and congestion, which are common symptoms of sinus and nasal inflammation. These symptoms are often associated with nasal allergies, sinus infections, chronic sinusitis, and cold and flu outbreaks, which, as of 2019, was an approximately $9.9 billion U.S. market, and is currently dominated by pharmaceutical products. ClearUP, a non-invasive bioelectronic therapy, can safely and comfortably deliver therapeutic benefits with no chemical side effects. ClearUP is a promising alternative to the drug-based treatments that currently dominate the underlying market.
ClearUP is a US FDA Class II and EU Class IIa medical device that has received three regulatory clearances: US FDA 510(k) number K182025, US FDA De Novo number DEN200006, and EU CE Mark Certificate number CE 704687. ClearUP is currently being sold directly to consumers and is available on amazon.com, bestbuy.com, walmart.com, fsastore.com, and tivichealth.com.
ClearUP’s clinical trials demonstrated the product is an efficacious drug-free alternative for sinus pain and congestion with no chemical side effects. In a 71-person randomized controlled study conducted by a third-party academic research center, greater than 95% of the users reported that the device was easy to use, and 82% preferred ClearUP® over existing treatments.
ClearUP applies a gentle electric pulse to help reduce inflammation and pain. Subtle microcurrents are emitted from the tip of the unit directly to the sinus nerve fibers below the skin. ClearUP works with your body’s natural electricity and is clinically proven and FDA approved to be safe and effective for the treatment of sinus pain and moderate to severe congestion. ClearUP treats sinus pain associated with allergic rhinitis and moderate to severe congestion caused by environmental flare-ups, colds, and flu.
Key selling attributes of ClearUP:
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100% drug-free
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No chemical side effects
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A short, 5-minute treatment cycle provides up to 6 hours of relief
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FDA approved
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1-year warranty
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88% saw a reduction in congestion
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74% experienced immediate relief
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Proudly made in California
Investor Presentation
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Management Overview
Jennifer Ernst
Chief Executive Officer & Co-Founder
Jennifer is a co-founder and has served as our Chief Executive Officer and as a Director. She served as the CEO and Chief Strategy Officer of the U.S. subsidiary of Thin Film Electronics ASA. She worked for Xerox PARC for over 20 years, where she held multiple go-to-market roles, including as the Director of Business Development. Ms. Ernst previously served as a director of FlexTech Alliance, the U.S. national consortium for flexible and printed electronics, for three years, including one year as the Chair. Jennifer earned her Master of Business Administration degree from Santa Clara University.
She has also been featured in Inc., The HealthCare Technology Report, and Thrive Global as a female leader who is shaking up things in the industry.
Veronica Cai
Chief Financial Officer
Veronica is a strategic and collaborative executive with two and a half decades of finance and accounting experience, specializing in scaling finance organizations in early development stage to post commercial, large international corporations and IPOs. She has held various senior financial executive roles in both publicly listed and private-equity backed companies in the medical technology and life sciences industries, assisting with the navigation through transitions between the different phases of business and fundraising efforts. Prior to joining the Company, Veronica was the Vice President of Accounting & Finance at RefleXion Medical, the Principal Accounting Officer and Corporate Controller at Catalyst Biosciences, the Assistant Controller at Zogenix, an Inspections Specialist at the Public Company Accounting Board (PCAOB), and a Senior Manager at Ernst & Young.
Blake Gurfein, PhD
Chief Scientific Officer
Blake leads Tivic Health’s clinical and scientific research. In addition to his full-time role at Tivic Health, he is also an Adjunct Assistant Professor of Medicine at UCSF. Blake is an expert in neuromodulation device development and has served as a research executive and consultant for medical device and pharma companies including Rio Grande Neurosciences and EMD Serono/Pfizer. Blake’s prior research in neuroscience and immunology has been funded by the National Institutes of Health and philanthropic donors, yielding high-impact journal publications.
Ph.D., Neuroscience, Icahn School of Medicine at Mount Sinai; Sc.B., Neuroscience, Brown University.
Ryan Sabia
Chief Operating Officer
Ryan serves as Chief Operating Officer with 18 years of experience in global supply chain, systems infrastructure, and sales operations in industries that range from automotive, medical supply, and consumer electronics. Ryan served as Global Director of Strategic Operations for Mars, Inc., General Manager of Operations for Medelita, LLC, a medical apparel and manufacturing company. Prior to that, he worked as Senior Director of Operations for Pinpoint Resources Group, a software technology consulting company and as Hedge Fund Financial Reporting Analyst for J.P. Morgan. He is is seasoned in environments that range from Fortune 500 companies (J.P. Morgan, BestBuy, and Toyota) to bootstrap startups, while specializing in scaling for global omnichannel logistics and e-commerce marketplaces.
Sanjay Ahuja
Senior Vice President, of Regulatory Affairs
Sanjay is a hands-on technologist and strategist implementing and enhancing regulatory affairs, and quality systems for medical devices, diagnostic systems, biologics, evidence-based pharma, and combination products. He has been a lead regulatory and quality liaison responsible for developing and implementing key quality and regulatory functional strategies including obtaining complex approvals and clearances from the US FDA and international agencies. He has harmonized key quality & regulatory strategies and processes and has worked for several industry leaders in the past including Corning, Johnson and Johnson, and Thermo Fisher. Sanjay is certified as a Six SIgma Blackbelt and earned his Ph.D. in Materials Science from the University of Alabama.
Chandrasekhar Durisety, PhD
Vice President, Engineering and Manufacturing
Chandrasekhar is in charge of product development, supply chain, procurement, manufacturing as well as identifying, building and optimizing partnerships with vendors related to product design and production. Since joining Tivic Health as the 1st full-time employee, Chandrasekhar has played an important role in the product development and manufacturing. Prior to Tivic Health, Chandrasekhar worked as Director of Field Applications Engineering at Thinfilm Electronics Inc. and built field teams across APAC, EMEA and North America. He holds a Bachelor’s degree in Instrumentation from Birla Institute of Technology & Science (BITS, Pilani) , Master’s and Doctoral degree in Electrical Engineering from University of Tennessee, Knoxville.
Risks & Disclosures
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