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SAN FRANCISCO, CA, JANUARY 3, 2019 - Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). ClearUP is an over-the-counter (OTC) device that provides consumers with a simple, non-invasive and drug-free option to relieve sinus pain caused by various environmental allergies such as dust, mold, pollens and pet dander.

ClearUP uses gentle microcurrent waveforms to provide sinus pain relief to the 40 to 60 million Americans who suffer from allergic rhinitis. Its state-of-the-art technology measures the user’s unique skin properties to target the optimal treatment points. A small, handheld device, ClearUP easily glides along the outside of the nasal passages -- the cheek, nose and brow bone -- to deliver low current electrical waveforms that stimulate the nerves under the skin to help relieve sinus pain. ClearUP will be available over-the-counter without a prescription by mid-2019.

As part of its FDA submission, Tivic Health conducted a double-blind, randomized control trial with 71 patients with sinus pain, to evaluate the effect of microcurrent waveforms on sinus pain. In this pivotal trial, it was demonstrated that after one treatment with ClearUP, three out of four users achieved sinus pain relief (74 percent). In addition, 82 percent of those who used ClearUP preferred it over their current treatment(s). The results of this trial, conducted in May 2018 at a top-tier U.S. research science center, were presented at the American Rhinologic Society Annual Meeting in October 2018.

“In line with our corporate vision to create accessible, cutting-edge solutions for chronic conditions, we are very pleased to bring to market a next generation microcurrent device that will help transform treatment for the common allergy sufferer," said Jennifer Ernst, CEO of Tivic Health. “ClearUP’s FDA clearance marks a major milestone for Tivic Health and puts us on the map as an innovative leader in the field of bioelectronics and neuromodulation.”

"For the many patients suffering from allergy-related sinus pain, we now have an effective treatment option that does not involve pills, a spray or nasal flush, surgery or opioids. ClearUP is an important new option that is drug-free, side-effect free and non-invasive,” added Subinoy Das, MD, FACS, FARS, Chief Executive Officer and Medical Director for the U.S. Institute for Advanced Sinus Care and Research; and a member of Tivic Health's Medical Advisory Board.

Sinus sufferers are concerned about taking sinus medicine and its side effects. The company's earlier third-party research with 600 sinus pain sufferers revealed that 95 percent wanted to decrease the amount of medicines they were taking and 91 percent were concerned about side effects from their current treatments.

ClearUP’s one-button control is easy-to-use and offers three intensity levels to personalize treatment to best suit the needs of the individual. ClearUP is intended for adults only, 18+ years of age, and can be used whenever needed, up to four times a day. Each treatment session takes five minutes. ClearUP is reusable and rechargeable, and can be used at work, home or while traveling.

About Bioelectronic Technology

Bioelectronics, a $6.2 billion industry, combines biology and electrical engineering. Devices work by modulating electrical activity in peripheral and central nerves to mitigate symptoms and/or underlying causes of disease. It is being studied to treat a range of diseases including rheumatoid arthritis, drug resistant epilepsy and alcoholism. The most common bioelectronics device is the pacemaker, first introduced in 1958. In September 2018, bioelectronics was named as one of the top ten disruptive technologies by the World Economic Forum.

About Tivic Health Systems Inc.

Tivic Health Systems Inc. (Tivic Health™) is a bioelectronic device company dedicated to developing microcurrent therapy solutions for chronic diseases and conditions. Tivic Health’s first product, ClearUP™ Sinus Pain Relief, targets sinus pain associated with allergic rhinitis. Founded in 2016, Tivic Health is part of a $6.2B global neuromodulation industry. The team is dedicated to harnessing the power of neuromodulation for home use products, empowering people to improve their health and quality of life. For more information, visit www.tivichealth.com and follow us on Twitter at @TivicHealth and on Facebook at www.facebook.com/TivicHealth.

Media Contacts

Cheryl Delgreco
cdelgreco@msipr.com
617-723-4004

Gina Cella
gcella@cellapr.com
857-239-9198 ...Read More

CLEARUP TREATS COMMON SINUS PAIN FROM ALLERGIC RHINITIS AT CES 2019, EUREKA PARK, BOOTH 53355

Las Vegas, December 17, 2019 – Tivic Health™, a bioelectronic device company, will introduce ClearUP™ Sinus Pain Relief – the first bioelectronic treatment for sinus pain at CES 2019. ClearUP is a handheld device that offers a new way to manage sinus pain for the more than 40 million Americans who suffer from allergic rhinitis.

ClearUP Sinus Pain Relief is not a pill, spray or nasal flush – it’s a small, handheld device used exclusively on the outside of the sinus passages. As the user glides ClearUp along their cheek nose and brow bone, it locates areas of skin where tiny electrical waveforms can pass easily. This low-current electrical stimulation, called microcurrent, stimulates the nerves under the skin to relieve sinus pain.

“ClearUP is a groundbreaking device that was successfully tested this fall at a top- tier U.S. science research center in a double-blind randomized control trial. After just one treatment, three out of four allergic rhinitis users achieved sinus pain relief,” said Jennifer Ernst, CEO of Tivic Health. “ClearUP is taking the power of bioelectronic technology and providing consumers with a simple, non-invasive option to relieve sinus pain for the millions who suffer from various allergies.”

“It’s very exciting to have this whole new form of treatment using extremely safe neuromodulation (microcurrent) as a way to address the needs of the patient,” Dr. Alan Goldsobel, an allergist at Allergy and Asthma Associates of Northern California.

ClearUP Facts

  • Clinically proven to be safe and effective
  • FDA cleared
  • Easy one-button control
  • Three intensity levels for user customization
  • Light and vibration system helps users target treatment points
  • Quick five-minute treatment
  • Portable for home, work, travel
  • Non-invasive, no chemicals or side effects
  • Rechargeable and reusable
  • Price is $149
  • Available mid 2019

Tivic Health plans to sell ClearUP Sinus Pain Relief in the summer of 2019 at www.tivichealth.com.

About Bioelectronics

In September 2018, the World Economic Forum named bioelectronics or electroceuticals as one of the top 10 disruptive technologies poised to change medical treatment. A $6.2 billion industry, bioelectronic medicine is the convergence of biology and electrical engineering. Devices work by modulating the electrical activity in peripheral and central nerves in order to mitigate both symptoms and underlying causes of diseases.

About Tivic Health Systems Inc

Tivic Health is a bioelectrical device company dedicate to developing microcurrent therapy solutions for chronic diseases and conditions. The company is harnessing the power of bioelectronic medicine and neuromodulation into home-use products that empower people to improve their health and quality of life. www.tivichealth.com @tivichealth

Forward Looking Statement

This release contains forward-looking statements that are based on the current expectations and beliefs of Tivic Health Systems Inc. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including product launch and timing.

Media Contact

Cheryl Delgreco
Media Strategies
617-429-6749
cdelgreco@msipr.com ...Read More

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