Tivic Health Systems Archives - Medical Design Sourcing

Tivic Health begins non-invasive, bioelectronic vagus nerve stimulation trial

Tivic Health (Nasdaq:TIVC) announced today that its funded study for vagus nerve stimulation received Institutional Review Board (IRB) approval.

San Francisco-based Tivic Health’s study takes place at the Feinstein Institutes for Medical Research. With IRB approval, the company can begin recruitment and enrollment for the study of its non-invasive bioelectronic nerve stimulation device. In collaboration with Tivic Health, the Feinstein Institutes initiated recruitment and completed the first patient enrollment. The study

An IRB, an FDA-registered group, reviews and monitors biomedical research involving human subjects. It can approve, require modifications to or disapprove research. An IRB serves an important role in protecting the rights and welfare of human research subjects, Tivic said in a news release.

The study utilizes a new neurostimulation approach with 20 individuals, plus data analysis and algorithm development. It may provide greater ta…

Tivic Health prices $1.4M common stock offering ahead of special stockholder meeting

Tivic Health (Nasdaq:TIVC) announced that it priced a public offering of common stock at $1.4 million.

San Francisco-based Tivic intends to offer 33.173 million shares of common stock at $0.041 per share. The company plans to use the net proceeds for working capital and general corporate purposes.

Tivic expects the offering to close on or about Aug. 9, subject to customary closing conditions, according to a news release. Maxim Group LLC serves as the sole placement agent for the offering on a reasonable best-efforts basis.

The closing of the offering may come just days before a vital special stockholders meeting for Tivic. Last week, CEO Jennifer Ernst issued a letter to investors updating them on the current situation at the bioelectronic medicine developer. Ernst’s letter stated that the company took several measures to fortify its position, including a workforce reduction and internal restructuring. The company did not disclose further details about t…

Tivic Health reduces workforce as it may face Nasdaq delisting

Tivic Health (Nasdaq:TIVC) CEO Jennifer Ernst issued a letter to investors updating them on the current situation at the bioelectronic medicine developer.

Ernst’s letter included the announcement that the company took several measures to fortify its position. That includes a reduction in force and internal restructuring. The company did not disclose further details about the reduction or restructuring.

San Francisco-based Tivic filed an SEC Form 8-K pertaining to a notice of delisting from the Nasdaq market. The company received notice in January that its closing price fell below $1 for 30 consecutive trading days. It received a six-month grace period to regain compliance.

Tivic recommended a reverse stock split to remedy the issue, but failed to pass the measure at its annual meeting of stockholders in June. The company set a special stockholder meeting for Aug. 11 and urged investors to vote in favor of a reverse split.

Ernst relayed her c…

Tivic Health prices $2.1M offering

Tivic Health (Nasdaq:TIVC) announced today that it priced its previously announced public offering of common stock at $2.1 million.

News of this offering follows the pricing of a $1.8 million offering of common stock last week.

San Francisco-based Tivic’s offer includes 51.25 million shares of common stock priced at 4¢ per share. The company expects proceeds to total $2.1 million before deducting fees and expenses. It earmarked proceeds for working capital and general corporate purposes.

Tivic expects the offering to close on or about July 19, subject to customary conditions. Maxim Group serves as the sole placement agent on a reasonable best-efforts basis for the offering.

Tivic develops bioelectronic medicine. Its offerings include a patented technology platform that leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Its non-invasive and targeted approach to treating inflammatory chronic health conditions ena…

Tivic Health prices $1.8M common stock offering

Tivic Health Systems (Nasdaq:TIVC) announced today that it priced an offering of its common stock worth approximately $1.8 million.

San Francisco-based Tivic priced the offering of 32.5 million shares of its common stock at $0.055 per share. The company intends to use the net proceeds for working capital and general corporate purposes.

Tivic said it expects to close the offering on or about July 11. It remains subject to the satisfaction of customary closing conditions.

Maxim Group LLC serves as the sole placement agent on a reasonable best-efforts basis for the offering.

Tivic develops bioelectronic medicine, including a patented technology platform that leverages stimulation on the trigeminal, sympathetic, and vagus nerve structures. Its non-invasive and targeted approach to treating inflammatory chronic health conditions enables drug-free solutions. The company said its offerings also feature high safety profiles, low risk and broad application…

Sinus pain is just the beginning for Tivic Health’s CEO

Tivic Health CEO Jennifer Ernst [Image courtesy of Tivic Health]

Tivic Health CEO Jennifer Ernst thinks the bioelectronic medicine space is ready to explode.

When serial inventor John Claude showed Jennifer Ernst an early prototype of what would become Tivic Health’s ClearUp device, she thought the 9-in.-long black wand looked like a rectal thermometer for a cow. But Claude said his wife agreed that running it over her face to deliver ultra-low current electrical waves cleared up sinus congestion.

Ernst — a Xerox veteran who went on to grow the U.S. business of flexible electronics company Thinfilm (now Ensurge Micropower) — was intrigued. It was her introduction to bioelectronic medicine. She compares the field to semiconductors, personal computers or online retail in their early days.

“This has all the markings of an industry that is going from the esoteric science to being ready to explode in the …

Tivic sinus pain relief device lands expanded indication for common cold, flu

(Image courtesy of Tivic Health)

Tivic Health Systems today said the FDA expanded the indication for use of its ClearUp Sinus Pain Relief to include congestion from allergies, the flu and the common cold.

The expanded indication is an addition to the device’s FDA clearance for treating allergy-related sinus pain caused by seasonal and year-round allergies.

ClearUp is a small handheld device that offers a non-invasive and drug-free treatment using gentle microcurrents to relieve sinus and nasal congestion and allergy-related sinus pain. It is available at major online retailers in the U.S.

“Bioelectronic devices stimulate the body to produce factors that it very tightly regulates. In the case of ClearUp, it stimulates the trigeminal nerve, which is responsible for sensing pain and pressure of the face, and also sympathetic fibers of the autonomic nervous system, which can induce vasoconstriction and reduced swelling,” chief medical offic…