Science

SCIENCE

Bioelectronic Medicine

Bioelectronics is an emerging area of medicine. The human body is an electrochemical system, in which nerves carry electrical signals. Bioelectronic devices work by modulating the electrical activity in peripheral and central nerves in order to reduce symptoms and underlying causes of disease.

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Play Video

A New Wave Of Electronic Medicine

Tivic Health CEO discusses the future of bioelectronic medicine at CES 2020 Digital Health Summit.

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Our Approach: Non-invasive

Historically, bioelectronic medicine has relied on implanted devices. Tivic Health is focused, instead, on non-invasive approaches. Non-invasive therapies can be developed with less risk and delivered more quickly to the people who need them.

Key elements of our approach include:

Our First Product:
ClearUP® Sinus Pain Relief

Our first FDA-cleared product, ClearUP® Sinus Pain Relief (“ClearUP”), is a patented handheld device that uses gentle pulsed electron waves to relieve symptoms of sinus and nasal inflammation, which can be caused by allergies, sinus infections, cold and flu.

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Play Video

A New Wave Of Electronic Medicine

Tivic Health CEO discusses the future of bioelectronic medicine at CES 2020 Digital Health Summit.

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Clinical Research

FIRST TRIAL1:

Demonstrated rapid relief

How does
ClearUP work?

When a user glides ClearUP along the cheek, nose, and brow bone, ClearUP emits a pulsed electron wave.

This wave stimulates the nerves that pass through the sinus passages.

Vibration guides users to the optimal treatment points to relieve sinus pain and congestion.

Subjects using ClearUP reported significant improvements (compared to sham) in sinus pain and congestion 10 minutes after use.

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#p = 0.0074; *p = 0.0079; two-tailed unpaired t-test comparing Sham vs. ClearUP
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SECOND TRIAL2:

Long-term symptom relief with regular use

Subject used ClearUP at home for 4 weeks and experienced week-over-week improvements in sinus pain and congestion.

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#p < 0.01, *p < 0.0001; two-tailed paired t-test comparing pre-treatment vs. post-treatment
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Peer-Reviewed Publications

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1. Maul, X. A., Borchard, N. A., Hwang, P. H., & Nayak, J. V. (2019, April). Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial. In International forum of allergy & rhinology (Vol. 9, No. 4, pp. 352-356). Read Full Paper

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2. Goldsobel, A. B., Prabhakar, N., & Gurfein, B. T. (2019). Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectronic medicine, 5(1), 1-9. Read Full Paper

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The Physician's View

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Physicians share their viewpoints about ClearUP®

Subinoy Das, MD
CEO, US Institute for Advanced Sinus Care & Research

Alan Goldsobel, MD
Clinical Professor, University of California San Francisco, Allergy & Asthma Associates of Northern California,

Pipeline

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 still in early stages of development, and will require additional studies and regulatory clearances prior to bringing them to market. Each of these applications would involve regulation of pain and inflammation-related mediators like those seen in sinus and nasal inflammation.

Additional potential clinical applications of our technology focus on 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 euralgia; and acute conditions such as ear infections.

ClearUP Regulatory Clearances

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The information included on this site reflects Tivic Health research and development pipeline and is not intended for promotional purposes. There are significant risks and uncertainties in medical device research and development.

Clinical and regulatory hurdles may cause pipeline devices to be discontinued or delayed, or to fail to reach the market. There can be no guarantee that pipeline devices will receive regulatory clearances or that they will prove to be commercially successful. Tivic Health assumes no duty to update this information.

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