Welcome to our dedicated page for Tivic Health Systems news (Ticker: TIVC), a resource for investors and traders seeking the latest updates and insights on Tivic Health Systems stock.
Tivic Health Systems Inc (TIVC) delivers innovative bioelectronic solutions through its non-invasive microcurrent therapies, most notably the ClearUP Sinus Relief device. This page provides direct access to all official corporate announcements, financial disclosures, and therapeutic development updates.
Investors and healthcare professionals will find chronologically organized press releases covering regulatory milestones, clinical study results, and partnership agreements. Our repository includes quarterly earnings reports, product launch details, and scientific validation updates – all essential for understanding TIVC's position in the health technology sector.
Key focus areas include advancements in bioelectronic treatment platforms, market expansion initiatives, and peer-reviewed research findings. Content is rigorously verified to ensure alignment with SEC filings and medical device regulations. Bookmark this page for efficient tracking of material developments affecting TIVC's therapeutic innovations and business trajectory.
Tivic (Nasdaq:TIVC) acquired cGMP manufacturing and development assets from Scorpius and launched Velocity Bioworks, a wholly owned CDMO subsidiary, to accelerate commercialization of Entolimod and serve third-party biotech customers. The company validated the Entolimod cell line at the site in Q3 and says the facility supports a BLA pathway.
Financing led by 3i, LP includes $16M debt for the asset purchase, up to $75M in preferred convertible equity (including an $18M near-term tranche), and an expected $50M equity line of credit affiliate facility.
Tivic Health (NASDAQ:TIVC) announced it secured an exclusive BARD A Techwatch meeting on November 18, 2025 to present clinical and manufacturing data for Entolimod for acute radiation syndrome (ARS).
The company said it will discuss Entolimod's animal-rule survival and organ-recovery data, manufacturing readiness, and preparations toward a biologics license application (BLA). Entolimod has FDA Fast Track and Orphan Drug designations and is being considered for mass-casualty stockpile and field deployment pathways that could lead to BARDA evaluation for funding or procurement.
Tivic Health (Nasdaq: TIVC) reported third quarter 2025 results on November 14, 2025 and outlined progress on its biologics transformation.
Key points: Revenue $146,000 vs $126,000 year-ago; gross loss $145,000 driven by a $230,000 inventory reserve; operating expenses $2.3M; net loss $2.6M. At September 30, 2025 cash and equivalents were $3.5M and the company reported no debt and approximately $3.5M in committed funding.
Corporate advances include transfer of two INDs for Entolimod, completion of cell line verification toward cGMP manufacturing, wind-down of the ClearUP consumer business, and $3.8M net proceeds from financing tranches in Q3.
Tivic Health (NASDAQ:TIVC) reported results from a collaborative clinical optimization study with The Feinstein Institutes showing personalization of non-invasive cervical vagus nerve stimulation (ncVNS) parameters strongly affected autonomic outcomes on November 13, 2025.
Key findings: personalizing stimulation frequency produced a 46% increase in heart rate variability (HRV) and was 8.9x more effective than a fixed frequency; optimal frequency varied between visits; electrode placement and configuration materially changed HRV; and 4 minutes of stimulation outperformed 20 minutes.
The study used healthy subjects and the company said the data may inform development for multiple patient populations.
Tivic Health (Nasdaq: TIVC) will report third quarter 2025 financial results on Friday, November 14, 2025 via a pre-recorded conference call and webcast.
The event is scheduled for 1:30 PM PT / 4:30 PM ET. Teleconference details: Toll Free 888-506-0062, International 973-528-0011, Participant Access Code 230582. A live webcast will be available at https://www.webcaster5.com/Webcast/Page/2865/53145.
Tivic Health (Nasdaq: TIVC) announced that CEO Jennifer Ernst will join a panel at the 8th Annual Northwell Health Innovation Constellation Forum on Thursday, Oct. 23 at 11:55 a.m. ET / 8:55 a.m. PT. The panel, titled "Building a Big Tent", will discuss advancing bioelectronic medicine by aligning stakeholders across healthcare, engaging first movers, and encouraging payor and pharma participation.
Panelists include Scott Gottlieb, MD and John M. O’Brien, PharmD, with Allysia Finley moderating. The session focuses on cross-sector collaboration to accelerate adoption and impact of bioelectronic therapies.
Tivic Health (Nasdaq: TIVC), a diversified immunotherapeutics company, announced that CEO Jennifer Ernst will present at the upcoming Emerging Growth virtual conference on September 25, 2025, at 11:25 AM ET.
The presentation will focus on Tivic's strategic transformation into the biopharmaceutical sector, highlighting their February 2025 acquisition of Statera Biopharma's TLR5 agonist portfolio. Ernst will discuss Entolimod, their lead candidate for Acute Radiation Syndrome (ARS), and their second indication for Neutropenia treatment. The company's approach combines biochemical and bioelectronic systems to address diseases.
Tivic Health Systems (Nasdaq: TIVC), an immunotherapeutics company, has achieved a significant milestone by completing the verification of its Entolimod™ cell line. This marks the first step towards establishing Current Good Manufacturing Practices (CGMP) for a future Biologics License Application (BLA).
In partnership with Scorpius Biomanufacturing, Tivic successfully produced new Entolimod proteins and confirmed through in vitro testing that the protein structure and yields are suitable for larger batch production. The verification process ensures that cell growth and protein expression processes maintain protein integrity without unwanted modifications that could affect functionality.
Tivic Health Systems (Nasdaq: TIVC) has acquired two investigational new drug applications (INDs) from Statera Biopharma for its lead candidate, Entolimod™. The first IND covers the treatment of acute radiation syndrome (ARS), including hematopoietic and gastrointestinal sub-syndromes. The second IND is for treating advanced cancers and related conditions.
The company plans to engage with the FDA regarding Entolimod's regulatory pathway and initiate clinical trials focusing on neutropenia, lymphocyte exhaustion, and cancer-related conditions. While Entolimod shows potential for anti-tumor activity, Tivic's immediate focus remains on developing it for acute radiation syndrome as the primary indication.
Tivic Health Systems (Nasdaq: TIVC) participated in the 2025 Military Health System Research Symposium (MHSRS) to advance discussions on Entolimod as a potential radiation countermeasure for military personnel. The company's President of Biopharma and COO, Michael Handley, engaged with key government agencies including BARDA, AFRRI, and MCDC to explore deployment pathways.
The symposium, held in Kissimmee, Florida from August 4-7, 2025, provided Tivic direct access to Department of Defense decision-makers and researchers. The discussions focused on Entolimod's potential to protect warfighters from radiation exposure, aligning with the participating agencies' missions in chemical, biological, radiological, and nuclear defense.
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