What is Tivic Health™?
Tivic Health Systems Inc (Tivic Health™) is a bioelectronic health-tech company dedicated to harnessing the science of neuromodulation for therapeutic benefit.
Who founded Tivic Health™?
Tivic Health™ was founded in 2016 by Jennifer Ernst and John Claude. Jennifer is a consummate hi-tech business developer with a history of developing markets from new technologies. During her 20 years at Xerox PARC, she held various go-to-market roles. At Thin Film Electronics, she launched and marketed multiple award-winning products. Jennifer earned her MBA from Santa Clara University. John Claude is a 30-year biomedical engineer and inventor of ClearUP™ Sinus Pain Relief. He has been behind numerous life-altering medical device innovations.
What products does Tivic Health™ offer?
Currently, Tivic Health™ is engaged in the FDA clearance process for ClearUP™ Sinus Pain Relief (ClearUP™). ClearUP™ uses microcurrent technology in a novel new way for the temporary relief of sinus pain caused by sinusitis, rhinosinusitis and allergic rhinitis.
Does Tivic Health™ have other products in development?
In addition to addressing sinus pain, we’re also exploring the impact of microcurrent for other indications. Future research may address additional diseases and conditions for people through easy-to-use, at-home products.
How many people suffer from sinus pain?
Chronic sinusitis is the most frequently reported respiratory condition in the United States with almost 34 million cases reported each year. According to Tivic Health’s market research, there are as many as 60 million sinus sufferers who are both diagnosed and self-diagnosed.
ClearUP™ Sinus Pain Relief
Who is ClearUP™ Sinus Pain Relief intended for?
ClearUP™ Sinus Pain Relief is designed for adults, 18 years or older, with frequent, moderate-to-severe sinus pain flare-ups.
What is ClearUP™ Sinus Pain Relief?
ClearUP™ Sinus Pain Relief (ClearUP™) is a new, non-invasive treatment to temporarily relieve sinus pain. ClearUP™ is a simple, and chemical-free handheld medical device that delivers targeted microcurrent waveforms (low-current electrical stimulation) to the trigeminal nerve.
How does ClearUP™ Sinus Pain Relief work?
ClearUP™ Sinus Pain Relief uses gentle microcurrent to stimulate the nerves underlying the cheek, nose and brow bone. The device detects the optimal treatment points and emits microcurrent waveforms demonstrated to relieve sinus pain.
How do I use ClearUP™ Sinus Pain Relief?
ClearUP™ Sinus Pain Relief (ClearUP™) works by gliding the device along the outer sinus passages at the designated areas along your cheek, nose and brow bone. To use ClearUP™, first turn the device on and select the intensity level you desire. Next, guide the ClearUP™ tip along your cheek, nose and under the brow bone. Stop when the device vibrates, indicating it has identified a treatment point. The device then transmits microcurrent to this point. After seven seconds ClearUP™ will stop vibrating, prompting you to resume gliding it along the designated areas. Continue this process around the cheek, nose and brow bone on both sides of the face for five minutes.
Is ClearUP™ Sinus Pain Relief cleared by the FDA?
Tivic Health™ is currently engaged with the FDA to receive clearance for ClearUP™ Sinus Pain Relief (ClearUP™). ClearUP™ is projected to be cleared by the FDA in 2019. This device is not currently for sale in the U.S.
Where can I purchase ClearUP™ Sinus Pain Relief?
Once FDA cleared, ClearUP™ Sinus Pain Relief will be available for purchase online via the Tivichealth.com site and potentially other health websites and health care channels. Please visit www.tivichealth.com for future information on where to purchase the product. Sign up for our mailing list to be the first to purchase the ClearUP™ device.
What is microcurrent?
Microcurrent is a low-current electrical stimulation about 1/1000 the level of traditional TENS therapy.
Is it safe?
Yes, ClearUp™ passed all required safety testing. Users should follow all instructions to ensure safety.
Is microcurrent technology new?
Microcurrent has been used for decades by health care providers in implantable devices such as deep brain stimulators, pacemakers, and spinal cord stimulators. ClearUP™ Sinus Pain Relief is the first treatment to use microcurrent to relieve sinus pain.
How often can I use ClearUP™ Sinus Pain Relief?
You can use ClearUP™ Sinus Pain Relief any time you suffer sinus pain.
How long does a ClearUP™ Sinus Pain Relief treatment take?
Treatment is quick and easy. Each treatment with ClearUP™ Sinus Pain Relief takes approximately five minutes to complete.
Is ClearUP™ Sinus Pain Relief easy to use?
ClearUP™ Sinus Pain Relief (ClearUP™) is an easy to use, small, portable device. ClearUP™ has a simple design with one button to control both the ON and OFF function as well as three intensity levels. The unit guides the user to the optimal points of treatment.
What makes ClearUP™ Sinus Pain Relief different from other treatments?
Sinus pain is a symptom that is frustrating for sinus sufferers and physicians alike because there are no good treatments and the source of pain is not fully understood. Available treatments for sinus congestion and inflammation do not directly impact pain for most sufferers. ClearUP™ Sinus Pain Relief (ClearUP™) is different from other sinus treatments because it is specifically designed to treat sinus pain. ClearUP™ empowers people to control their sinus pain symptoms effectively and directly, without the use of a pill or spray.
Does ClearUP™ have a battery and will I need to replace it?
ClearUP™ Sinus Pain Relief is powered by a lithium battery, which is rechargeable using the accompanying USB charger (Do not replace the battery).
Is ClearUP™ Sinus Pain Relief rechargeable?
ClearUP™ Sinus Pain Relief (ClearUP™) is rechargeable. The unit should be charged prior to first use and as necessary thereafter. ClearUP™ will be disabled while it is charging.
How will I know if ClearUP™ Sinus Pain Relief needs to be charged?
If ClearUP™ Sinus Pain Relief needs to be charged, a light located on the front bottom of the device will blink slowly.
Is ClearUP™ Sinus Pain Relief Reusable?
ClearUP™ Sinus Pain Relief (ClearUP™) “is a high quality, durable medical device designed to be reusable. Between uses, disinfect ClearUP™ with alcohol wipes to keep tip surface clean.
Does ClearUP™ Sinus Pain Relief have wires, cables or electrodes like TENS devices?
No. Unlike TENS units, ClearUP™ Sinus Pain Relief (ClearUP™) is wireless and does not require extra electrode pad usage or purchases. ClearUP™ does not require additional accessories.
When will ClearUP™ Sinus Pain Relief be available?
ClearUP™ Sinus Pain Relief is expected to receive clearance from the FDA in 2019.
How much does ClearUP™ Sinus Pain Relief cost?
ClearUP™ Sinus Pain Relief will retail for under $200.00.
Is ClearUP™ Sinus Pain Relief covered by my insurance?
Currently, ClearUP™ Sinus Pain Relief (ClearUP™) is not covered by insurance providers. Tivic Health™ will be working with insurance providers to determine if ClearUP™ will be covered under insurance in the future.
Is ClearUP™ Sinus Pain Relief clinically proven?
Stanford Medical Center (Stanford Sinus Center) conducted a double-blind, randomized, placebo-controlled trial to measure the benefits of ClearUP™ Sinus Pain Relief (ClearUP™) on sinus pain. The trial was successful and met its predetermined endpoint. The results will be presented at the 2018 American Rhinologic Society (ARS) Annual Meeting.
When will the clinical trial results be available?
Stanford Medical Center will present the data gathered from the clinical trial during a podium presentation at the 2018 American Rhinologic Society (ARS) Annual Meeting in Atlanta, Oct. 5-6. Results of the clinical trial will be available at tivichealth.com following the presentation. Feel free to sign up for our blog to read about the data once it’s available.
Is ClearUP™ Sinus Pain Relief cleared by the FDA?
ClearUPTM is currently under review by the FDA and projected to be cleared in 2019. This device is not currently for sale in the U.S.