- Tivic Health (TIVC, Financial) secures positive interest from White House and FDA for military applications of its product candidates.
- Discussions included potential expedited FDA approval pathways for Entolimod™ and Entolasta™, plus breakthrough designations for ncVNS technology.
- Tivic’s TLR5 program receives significant funding from government agencies for developing treatments against acute radiation syndrome.
Tivic Health Systems, Inc. (TIVC), a therapeutics company based in Fremont, California, announced successful briefings with senior leadership at both the White House and FDA regarding the potential military and defense applications of its product candidates. These meetings took place in Washington, D.C., on April 17th, and focused on Tivic's TLR5 biologic program and its non-invasive cervical vagus nerve stimulation (ncVNS) technology.
Tivic discussed its lead product candidate, Entolimod™, designed to treat acute radiation syndrome (ARS), which has garnered significant interest from agencies such as BARDA, NASA, and the Department of Defense. These agencies have notably funded the TLR5 program, which Tivic believes fills a critical gap in protection against ionizing radiation damage.
In its meeting with the FDA, Tivic explored expedited approval pathways for Entolimod™ and its second-generation product, Entolasta™, alongside Tivic's ncVNS technology. The discussions included potential breakthrough device designations aimed at treating neurologic disorders relevant to military personnel, such as PTSD.
Tivic CEO Jennifer Ernst emphasized the importance of these discussions for advancing treatments that could protect military and first responder communities. COO Michael Handley highlighted the unique protective attributes of Entolimod's single-dose application for gastrointestinal and hemopoietic cell protection.
