Bioelectronics
We are investing in one of the most promising and emerging areas of science: bioelectronic medicine to effect immune system regulation. Specifically, Tivic is studying the science of non-invasive, cervical vagus nerve stimulation, or ncVNS.
The first of Tivic’s trials for its non-invasive device shows promising signals for the potential to regulate specific biologic responses potentially leading to modulating the immune system. These modulatory effects on the immune system could be implicated in many cardiac, neurologic and autoimmune conditions.
Vagus Nerve Stimulation: Tivic Health’s Next-Generation Treatment Paradigm
At Tivic Health we are working to treat some of today’s most prevalent inflammatory and neurological diseases through bioelectronic medicine, specifically, the stimulation of the body’s vagus nerve — the command-and-control center of the body.
The Function and Benefits of Stimulating the Vagus Nerve
The vagus nerve is one of the most critical nerves in the body, connecting the brain to many vital organs, including the heart, lungs, and digestive tract. The word “vagus” means wandering in Latin, which is appropriate as it is the longest of the cranial nerves. Although it is often referred to as singular, it’s actually a pair of nerves that emerge from the right and left side of the brainstem and carry signals from the brain to the rest of the body and vice versa using both afferent sensory fibers relaying information to the brain and efferent nerves relaying information to the organ.
The vagus nerve is responsible for balancing many of the body’s essential functions, including digestion, breathing, and heart rate. It also plays a crucial role in controlling the parasympathetic nervous system, which is responsible for calming the body and reducing stress levels. The nerve helps to regulate the release of hormones and cytokines, which are involved in the body’s immune response. It also helps to regulate inflammation and can modulate the release of neurotransmitters such as dopamine and serotonin, which are involved in mood regulation.
The afferent section is responsible for carrying sensory information from the peripheral organs and tissues to the central nervous system. This section of the nerve contains specialized nerve fibers that detect and transmit information about various physiological parameters, including blood pressure, heart rate, respiration, and digestion.
The efferent section is responsible for carrying motor information from the central nervous system to the peripheral organs and tissues. It is also responsible for regulating various involuntary muscles, including the muscles of the digestive system, the respiratory system, and the cardiovascular system. It helps to regulate blood pressure, heart rate, and respiratory rate, ensuring that the body functions efficiently.
Benefits of Stimulating the Vagus Nerve
VNS is a therapeutic approach that involves the use of electrical impulses delivered to the vagus nerve to treat a variety of medical conditions. While the exact mechanism of action is not completely understood, it is believed that VNS has the ability to modulate the activity of the nervous system, leading to improvements in symptoms.
VNS can be achieved through both invasive and non-invasive stimulation.
Invasive VNS: Invasive VNS involves the surgical implantation of a device that delivers electrical impulses to the vagus nerve. The device is typically implanted in the chest and is connected to the nerve via a wire that runs under the skin. Invasive VNS has been approved by the FDA for the treatment of several medical conditions.
Examples of the applications that invasive VNS is already approved for by the U.S. Food & Drug Administration include: Epilepsy, where the delivery of electrical impulses to the vagus nerve has been shown to reduce the frequency and intensity of seizures by modulating the activity of the brain, depression, where Invasive VNS has been shown to be effective in improving the symptoms of treatment-resistant depression by increasing the activity of the neurotransmitter serotonin, a chemical that plays a role in regulating mood. And, rheumatoid arthritis, where studies have shown that VNS can reduce inflammation and pain in the joints, and increase the production of regulatory T cells, which can help to control the immune response and prevent inflammation.
Non-invasive VNS: Non-invasive VNS involves the use of external devices to stimulate the vagus nerve, without the need for surgical implantation. Non-invasive VNS typically delivers electrical signals that penetrate the skin and underlying soft tissues to reach the vagus nerve directly.
In particular, non-invasive VNS has been proven to safely and effectively stimulate the vagus nerve to treat migraines where the placement of electrodes on the skin over the vagus nerve in the neck shows treatment can be effective in reducing the frequency and severity of migraines in some patients.
VNS is a promising therapeutic approach for several medical conditions. With further research and development, VNS has the potential to not only revolutionize the treatment of many conditions but also to improve the lives of millions of people.
Tivic believes its VNS studies will form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs. The non-invasive nature of Tivic’s vagus nerve stimulation studies may also offer the potential of delivering clinical outcomes similar to or better than those of surgically implanted devices, without the risks or side effects of more invasive VNS treatments.
Preliminary studies demonstrate key biometric changes widely accepted as clinical surrogates indicated vagus nerve stimulation, including:
- sustained pupil constriction
- significant ECG (electrocardiogram) changes in heart rate and EEG (electroencephalograph), indicating positive changes in gamma and theta brainwaves
Research Insights & Articles
Tivic VNS Optimization Study
Tivic has already confirmed the effectiveness of its non-invasive cervical vagus nerve stimulation (ncVNS) platform. Data show Tivic’s platform induces responses in the autonomic, cardiac, and central nervous systems. A current trial, which is being conducted by The Feinstein Institute of Bioelectronic Medicine is now underway to identify device parameters that optimally influence autonomic nervous system (ANS) function, including the frequency and the duration of potential treatments. Tivic Health plans to use these results to prioritize clinical indications it will carry forward into further testing and commercial development.
Tivic Health Study Demonstrated Clinically Effective Biological Changes in Response to Cervical Vagus Nerve Stimulation
Tivic Health’s pilot research study validated its novel and proprietary approach to ncVNS using objective measures of the autonomic nervous system, cardiac function, and brain activity. The strength of the data suggest Tivic’s differentiated approach to ncVNS may yield superior clinical outcomes when compared to the current status quo in vagus nerve stimulation.
Shubham Debnath.1, 2, Fylaktis Fylaktou1, 2, Todd J. Levy1, 2, Blake T. Gurfein3, Theodoros P. Zanos1, 2
1 Institute of Bioelectronic Medicine, Feinstein Institutes for Medical Research, 350 Community
Dr, Manhasset, NY, 11030
2Institute of Health System Science, Feinstein Institutes for Medical Research, 350 Community Dr., Manhasset, NY 11030
3Tivic Health Systems, Inc., Fremont, CA 94025