Tivic Health Systems Inc Stock Price, News & Analysis

Tivic Health Systems (Nasdaq: TIVC) has appointed Michael K. Handley as President of Tivic Biopharma and Chief Operating Officer. Handley, former CEO of Statera Biopharma, will lead the company's newly formed biopharma division and oversee the development of Entolimod™, a recently licensed late-stage product candidate.

Throughout his career, Handley has contributed to the global commercialization of 17 drugs and devices generating approximately $7 billion in annual sales. His responsibilities will include building the biopharma team, advancing Entolimod through manufacturing validation, regulatory approval, and commercialization.

As part of his employment agreement, Tivic granted Handley 600,000 restricted stock units (RSUs) as an inducement award. The RSUs will vest over four years, with 25% vesting after one year and the remainder vesting in 12 quarterly installments, subject to continuous service.

Tivic Health Systems (NASDAQ: TIVC) has acquired worldwide exclusive license rights from Statera Biopharma for Entolimod™, a late-stage TLR5 agonist targeting acute radiation syndrome (ARS). The agreement includes an exclusive option for five additional indications for Entolimod and its derivative, Entalasta™.

This strategic move transforms Tivic from a single-product, direct-to-consumer company into a diversified therapeutics company. Entolimod has received FDA Fast Track and Orphan Drug designation for ARS treatment and has undergone over forty animal and human trials with $140 million in prior investment.

The global ARS market is valued at $5.2 billion in 2024, with a projected 5% annual growth rate through 2031. The acquisition positions Tivic to address immune and autonomic dysregulation through both neural and molecular pathways, with potential FDA approval within 24 months.

Tivic Health (Nasdaq: TIVC) released its annual CEO letter highlighting key developments in 2024 and outlook for 2025. The company improved its commercial business with ClearUP 2.0 launch, achieving 4.4-star customer reviews and establishing >65% gross margins in direct-to-consumer channels, up from 28% in 2023.

The company is focusing on Vagus Nerve Stimulation (VNS), with their non-invasive cervical approach (ncVNS) showing promising results in pilot studies with Feinstein Institute. The VNS market is forecasted to reach $21B in five years with 10.6% CAGR. Tivic has identified >$30B market opportunities for their ncVNS approach and holds 16 issued patents and 10 pending patents across multiple countries.

For 2025, Tivic plans to advance disease-specific clinical trials, improve ClearUP business cash flow, and work towards regaining Nasdaq compliance.

Tivic Health Systems (Nasdaq: TIVC) reported Q3 2024 financial results, highlighting progress in three strategic areas. The company completed a supply chain redesign for its ClearUP product line, achieving 70% gross margins. Revenue was $126,000 for Q3 and $600,000 for nine months, down 27% from 2023. The company reported a Q3 net loss of $1.4 million, improved from $1.8 million in 2023.

Tivic advanced its non-invasive vagus nerve stimulation (VNS) development, completing Phase 1a optimization study enrollment. The company partnered with Fletcher Spaght to accelerate commercial strategy and appointed Lisa Wolf as interim CFO. Cash position stood at $2.2 million, with additional $775,000 raised through stock sales in October-November 2024.

Tivic Health Systems (Nasdaq: TIVC) has completed enrollment in its optimization study for a non-invasive vagus nerve stimulation (VNS) device at The Feinstein Institute of Bioelectronic Medicine. The study aims to identify optimal device parameters affecting autonomic nervous system function. Expected completion is in early Q1 2025. The global VNS market is projected to grow from $8.59 billion in 2021 to $21.3 billion in 2030, with peripheral nerve stimulation segment growing at 35% CAGR. The company has engaged Fletcher Spaght Inc. to accelerate product development and commercial strategy following successful Phase 1 trial results.

Tivic Health Systems (Nasdaq: TIVC) has validated two European Patent Office patents in Great Britain, Germany, and France. The patents cover methods for identifying treatment points and dynamically personalizing stimulation in their sinus treatment device, ClearUP. EP3615133 protects device methods for identifying treatment points and triggering treatment modes, while EP3615134 covers methods for dynamically adjusting stimulation voltage during treatment. These validations are part of Tivic's international portfolio of 16 issued and 10 pending patents across the U.S., Europe, India, and China.

Tivic Health Systems (Nasdaq: TIVC), a bioelectronic medicine health tech company, has announced it will release its third quarter 2024 financial results on Thursday, November 14 after market close. The company will host a pre-recorded conference call and webcast at 1:30 p.m. PST / 4:30 p.m. EST. Shareholders and interested parties can participate via phone or webcast, with questions to be submitted to ir@tivichealth.com by November 11.

Tivic Health Systems (Nasdaq: TIVC) has enrolled its first subject in an optimization study for their non-invasive vagus nerve stimulation device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, aims to identify optimal device parameters for influencing autonomic nervous system function. Enrollment is expected to complete by early December.

The global vagus nerve stimulation market is projected to grow from $8.59 billion in 2021 to $21.3 billion in 2030, with a 10.6% CAGR. The peripheral nerve stimulation segment, Tivic's target market, is forecast to grow at 35% CAGR. The company has partnered with Fletcher Spaght Inc. to accelerate product development and commercial strategy based on their successful Phase 1 trial results.

Tivic Health Systems (Nasdaq: TIVC) announced CEO Jennifer Ernst will present at BioFuture 2024 in New York, October 28-30. The presentation, scheduled for October 29 at 2:30 p.m. EDT, will showcase the company's advancements in bioelectronic medicine and recent data on vagus nerve stimulation.

The conference features prominent speakers including Dr. Kevin Tracey from The Feinstein Institutes for Medical Research, Tivic's clinical partners. The event will explore how vagus nerve stimulation is transforming treatments for conditions like rheumatoid arthritis, Crohn's disease, cancer, diabetes, and mental health. One-on-one meetings with investors are available through the BioFuture Showcase Partnering Platform, with a virtual component following November 5-7.