Tivic Health Systems, Inc. operates as a bio-electronic health-tech company, which develops micro current therapy solutions for chronic diseases and conditions. The company was founded by Jennifer Ernst and John Claude on September 22, 2016 and is headquartered in Fremont, CA.
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- Tivic Health Systems acquired strategic manufacturing and development assets from Scorpius Holdings to establish Velocity Bioworks, a wholly owned CDMO subsidiary focused on biologics production. - The acquisition secures US-based cGMP manufacturing capabilities for Entolimod, Tivic's lead drug candidate for acute radiation syndrome that holds Fast Track and Orphan Drug designations. - The transaction is backed by a $90M+ financing package led by 3i, LP, including $16M in debt financing for asset acquisition and up to $75M in preferred convertible equity for commercialization efforts. - Velocity Bioworks will provide contract development and manufacturing services to both Tivic and third-party biotech companies, creating additional near-term revenue opportunities for the company.
- Tivic Health Systems has secured an exclusive Techwatch meeting with BARDA's Radiological and Nuclear Medical Countermeasures Program to present clinical data on Entolimod for acute radiation syndrome. - Entolimod, a novel TLR5 agonist, has demonstrated robust survival benefits and enhanced recovery in animal models when administered after radiation exposure, with FDA Fast Track and Orphan Drug designations. - The meeting will focus on development pathways for potential mass-casualty deployment and government stockpiling, supporting Tivic's strategy for federal partnership or acquisition opportunities. - Clinical studies suggest Entolimod may also serve as a prophylactic radioprotective agent to reduce radiation damage when administered prior to exposure.
- Tivic Health received two investigational new drug applications from Statera Biopharma for its lead candidate Entolimod, covering acute radiation syndrome and advanced cancer treatments. - The INDs enable Tivic to formally engage with the FDA regarding Entolimod's regulatory pathway and pursue clinical trials in neutropenia and lymphocyte exhaustion. - Entolimod is a novel TLR5 agonist that has demonstrated robust survival benefits in animal models and received Fast Track designation for acute radiation syndrome treatment. - The company maintains near-term focus on acute radiation syndrome while exploring Entolimod's anti-tumor activity potential in advanced cancer applications.
- Tivic Health engaged with key US Government agencies including BARDA, AFRRI, and MCDC at the 2025 Military Health System Research Symposium to discuss Entolimod's potential as a military radiation countermeasure. - Entolimod, a novel TLR5 agonist with FDA Fast Track designation, is designed to prevent cell death in bone marrow and epithelial tissues impacted by radiation exposure. - The company's dual platform approach combines biopharmaceutical compounds that activate innate immune pathways with bioelectronic systems targeting neural pathways for various diseases. - These discussions represent a significant step toward potential military deployment of Entolimod to protect warfighters from radiation exposure in combat situations.
- Tivic Health has demonstrated that personalizing non-invasive vagus nerve stimulation parameters significantly enhances autonomic nervous system response, with heart rate variability nearly doubling in 60% of study participants. - The company has filed a new patent (No. 63,801,058) to protect its personalized VNS technology, which aims to deliver more consistent therapeutic effects compared to current treatment options. - Tivic's approach represents a potential breakthrough in bioelectronic medicine, offering a non-invasive alternative for treating inflammatory, cardiac, and neurologic disorders where immune system dysregulation is a factor.
- Tivic Health Systems has secured exclusive global rights to Entolimod, a Phase III TLR5 agonist from Statera Biopharma, for treating acute radiation syndrome. - The FDA-designated Fast Track and Orphan Drug candidate has undergone 40 animal and human trials, positioning it for potential market entry within 24 months. - The acquisition includes an exclusive option for five additional indications of Entolimod and its derivative Entalasta, marking Tivic's strategic expansion into diversified therapeutics.
- Tivic Health has finished enrolling participants in a study to optimize its non-invasive vagus nerve stimulation (VNS) device for various clinical applications. - The study, conducted at the Feinstein Institute of Bioelectronic Medicine, aims to identify device parameters that optimally influence autonomic nervous system (ANS) function. - Tivic Health anticipates that the trial results will help prioritize clinical indications for further testing and commercial development, with completion expected in early 2025. - The company's CEO, Jennifer Ernst, noted the limitations of implanted VNS technologies, suggesting non-invasive options may be more suitable for certain patients.
- Tivic Health has finished enrolling participants in a study evaluating its non-invasive vagus nerve stimulation (VNS) system. - The Feinstein Institute is conducting the trial to optimize device parameters like frequency and duration for influencing the autonomic nervous system. - Tivic Health intends to use the study results to prioritize clinical indications for further development and expects trial completion in early 2025. - The company aims to address unmet needs with a novel non-invasive VNS approach, bridging the gap between invasive and less effective non-invasive treatments.
- Tivic Health's pilot study demonstrated significant physiological responses to their non-invasive cervical vagus nerve stimulation (ncVNS) technology, including a 97% increase in heart rate variability, a key indicator of vagus nerve activity. - The 20-person clinical trial, conducted with the Feinstein Institutes for Medical Research, showed measurable effects on brain activity with a 24% increase in frontal theta power and 66% reduction in frontal gamma power, consistent with reduced anxiety. - Researchers believe the technology may have clinical applications for conditions including epilepsy, post-traumatic stress disorder, and ischemic stroke, potentially offering non-surgical alternatives in the growing $8.3B neurostimulation market.
