FREMONT, CA — November 18, 2025 — Leads & Copy — Tivic Health Systems, Inc. (NASDAQ:TIVC) has secured an exclusive Techwatch meeting with staff from the Biomedical Advanced Research and Development Authority (BARDA)’s Radiological and Nuclear Medical Countermeasures Program.
Tivic’s leadership team will present clinical data on Entolimod’s impact on radiation-induced injury and acute radiation syndrome (ARS). They will also discuss the progress of manufacturing readiness and preparations for a biologics license application (BLA).
The Techwatch format enables Tivic and BARDA staff to exchange technical information, establish program priorities, and discuss Entolimod’s development pathways for potential deployment in mass-casualty, stockpile, and field deployment scenarios.
This process allows BARDA to evaluate technology readiness, understand manufacturing and approval requirements, and identify potential pathways for funding and purchasing.
Jennifer Ernst, CEO of Tivic Health, stated that this interaction supports Tivic’s strategy to develop high-value therapeutic assets with potential government partnership or acquisition pathways. She added that their focus on radiation injury and host-directed countermeasures positions them well in a space with defined federal demand and long-term strategic relevance.
Entolimod, Tivic’s primary drug candidate, is a novel TLR5 agonist that triggers NF-kB signaling, activating anti-apoptotic and cell-protective mechanisms. Extensive trials, conducted under the FDA’s Animal Rule, have demonstrated that Entolimod for ARS leads to robust survival, enhanced GI tract recovery, and improved hematopoiesis in animal models when administered post-exposure to ionizing radiation.
Clinical studies indicate that Entolimod may serve as a radioprotective agent that can be used prophylactically (prior to exposure) to reduce damage. The FDA has granted Fast Track and Orphan Drug designations to Entolimod for ARS.
BARDA, a component of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), develops, procures, and stockpiles medical countermeasures. These include vaccines, drugs, and diagnostics that address chemical, biologic, radiologic, and nuclear public health threats.
Tivic Health Systems, Inc.’s mission focuses on harnessing the immune system to enhance clinical outcomes and save lives. Tivic’s biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age.
The company holds rights to Entolimod for treating neutropenia and Entolasta, an immunologically optimized variant of Entolimod for chronic applications. Tivic’s bioelectronic program is also developing a novel, non-invasive medical device targeting neural pathways implicated in many debilitating diseases.
Early trials of this device suggest it may regulate specific biologic responses, with the potential to deliver clinical outcomes similar to or better than surgically implanted devices. More information about Tivic can be found at https://ir.tivichealth.com.
Investor Contact: Hanover International, Inc., ir@tivichealth.com
Media Contact: Deanne Eagle or Laura Min Jackson, media@tivichealth.com
Source: Tivic Health Systems, Inc.
Source: Tivic Health Systems
