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Problem Tech Solves
Tech Brief
Tivic Health sits in the newest area of medicine called “bioelectronic medicine” which has emerged as an alternative to pharmaceutical drugs by providing non-invasive, over-the-counter healthtech devices to treat diseases and chronic conditions, enhance wellness, and improve lives. Bioelectronic devices and therapies use modulating electrical signals carried along the body’s various nerve pathways and work with the body’s neural circuits to restore healthy function. With Tivic Health’s first product, ClearUP, the company has built consumer awareness by bringing bioelectronic medicine to the home treatment market. ClearUP treats sinus pain and congestion from seasonal allergies, colds and flu. The device works with your body’s natural electricity to symptoms associated with inflammation by targeting the sinus nerve fibers below the skin. As consumer awareness grows, bioelectronic medicine will become increasingly prevalent as a mainstream approach to treatment. And consumer demand for non-pharmaceutical treatments for sinus conditions continues to grow. Bioelectronic devices are providing consumers with new options to improve their quality of life with drug-free treatments and offer significant cost-saving opportunities to healthcare systems. Tivic Health seeks to become a leader in non-invasive bioelectronic medicine. By leveraging its core technology and extending the market reach Tivic Health plans to build a portfolio of bioelectronic solutions. The team is committed to developing new therapies for patients suffering from chronic illnesses and is on a trajectory to have a significant positive impact on medicine.
Tech Differentiators
Bioelectronic devices stimulate the body to produce factors that the body naturally tightly regulates. Tivic has created a non-invasive bioelectronic platform offering effective therapeutic solutions with high safety profiles, low risk, and broad application. ClearUP stimulates the trigeminal nerve, which is responsible for sensing pain and pressure of the face, and sympathetic fibers of the autonomic nervous system, which can induce vasoconstriction and reduced swelling. Modulation of these pathways provides rapid relief of sinus pain and congestion without the side effects that often come with drugs used for these symptoms. For the large number of patients affected by sinus pain and congestion, ClearUP is a game-changing product that improves their health and quality of life. Working through the pandemic Tivic saw consumers are highly interested in products to help them better manage their health and wellness. Tivic has taken a sophisticated technology and delivered it via ClearUP, an effective over-the-counter device that is accessible and affordable to consumers to treat sinus pain associated with allergic rhinitis and moderate to severe congestion caused by environmental flare-ups, colds, and flu. Tivic’s clinical trials and product reviews demonstrate consumers are actively looking for non-pharmaceutical methods to treat illnesses. This strong consumer trend for home-use solutions sold over the counter was picked up by retailers who are looking for innovative home health care products to meet the needs of customers.
Validation
ClearUP underwent two clinical studies demonstrating safety and efficacy in treating sinus pain and congestion. A randomized placebo-controlled double-blinded trial at Stanford University Sinus Center included 71 subjects suffering facial pain attributed to sinus pain and congestion. Greater than 95% of the users reported that the device was easy to use, and 82% preferred ClearUP over existing treatments. In a clinical study by Allergy and Asthma Associates, San Jose, 30 subjects with moderate facial pain attributed to sinonasal disease used ClearUP for five minutes a day and treated themselves at home one-to-four times daily for four weeks. The device was found effective for 88% of the users after four weeks of administration and was found to be safe with minor side effects that resolved without intervention. Published Bioelectronic Medicine. https://tivichealth.com/wp-content/uploads/2019/12/Bioelectronic-Medicine-Paper-Nov-2019.pdf Tivic recently concluded a pilot study, evaluating a new device to treat pain after functional endoscopic sinus surgery. Conducted with the U.S. Institute for Advanced Sinus Care and Research in Cleveland the study was successfully completed by nine out of ten individuals who reported a decrease in the numeric rating scale for pain and opioid medication intake. Earlier this year Tivic announced a clinical study investigating the extension of the company’s bioelectronic platform, offering a potentially new alternative to opioids for post-operative care following sinus surgeries. This 60-person double-blind, randomized controlled trial is being conducted with a leading international hospital and investigates the extensibility of Tivic’s platform as a specialized treatment for pain following functional endoscopic sinus surgery.
