Tivic Health Systems , Inc. (NASDAQ:TIVC) stock surged over 200% following the company’s announcement of positive interest from the White House and the FDA in its product candidates for military and defense applications. The significant move comes after Tivic Health provided briefings to senior leadership in Washington, D.C. on April 17th, highlighting the potential of its biologic and bioelectronic therapies.
During the briefings, Tivic Health discussed its TLR5 program, including the lead product candidate Entolimod™, which has previously received substantial funding from U.S. Government agencies for development. The company’s educational briefing to the White House focused on the need for advanced treatments for acute radiation syndrome and the potential improvements in treating radiation damage through the TLR5 pathway. The meeting with FDA senior leadership explored expedited pathways to approval for Entolimod and Entolasta™, another TLR5 agonist, as well as export opportunities.
Additionally, Tivic Health presented its non-invasive cervical vagus nerve stimulation (ncVNS) technology, which is being developed to treat inflammatory, cardiac, and neurologic disorders. The ncVNS program, with ongoing clinical studies, received positive feedback on expedited pathways such as breakthrough device designations.
Jennifer Ernst, CEO of Tivic, expressed gratitude for the opportunity to discuss the clinical pipeline’s importance in potentially protecting and healing military personnel, first responders, and citizens. She anticipates ongoing discussions as the company’s medical programs progress toward potential FDA approval. Michael Handley, COO and President of Tivic Biopharma, also commented on the potential of Entolimod to treat exposure to ionizing radiation and the interest in the ncVNS program’s indications for the veteran population.
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