Tivic Health Systems Rebrands to Valion Bio

Tivic Health Systems Inc. is changing its name to Valion Bio Inc. and its Nasdaq ticker symbol from TIVC to VBIO. The rebrand reflects the completion of a strategic transformation — the deliberate unwinding of a consumer medical device business and its replacement with a focused late-stage biopharmaceutical platform anchored by a government-priority asset with over 15 years and more than $140 million in cumulative development investment and supported by a wholly owned biomanufacturing subsidiary.

Valion Bio’s lead drug candidate, Entolimod, is a novel Toll-like receptor 5 (TLR5) agonist with a differentiated, dual-utility profile. As a medical countermeasure for Acute Radiation Syndrome (ARS), Entolimod has received FDA Fast Track and Orphan Drug designations and is being advanced under the FDA’s Animal Rule pathway, a regulatory framework that enables approval based on animal efficacy data when human trials are not feasible or ethical, substantially reducing clinical execution risk. The company is actively engaged with BARDA, DTRA, NIAID, and allied government agencies regarding Entolimod’s inclusion in the U.S. Strategic National Stockpile (SNS), where a procurement contract — if secured — would represent a non-dilutive, potentially nine-figure revenue event.

Critically, Entolimod’s mechanism, cytoprotection of bone marrow and gastrointestinal epithelial tissue through NF-κB signaling, positions it for parallel development in oncology supportive care. Valion Bio is targeting physician-sponsored clinical trials in chemotherapy-induced neutropenia in 2026, with Phase IIb readiness as the objective. Entolasta, a next-generation TLR5 agonist, provides additional pipeline depth and intellectual property extension across both indications.

“The Valion Bio name reflects the company we have become. We have a late-stage asset with validated biology, regulatory designations, a clear government procurement pathway, and a world-class manufacturing operation under one roof. This is a different company than the one that existed 18 months ago — and the new name should make that unmistakable to every investor, partner, and government stakeholder we engage,” said Michael K. Handley, CEO, Valion Bio.

Valion Bio is headquartered in San Antonio, Texas, close to the DoD biodefense ecosystem, including Brooke Army Medical Center. The company’s ARS countermeasure program sits at the intersection of several converging macro forces: a renewed federal focus on domestic biomanufacturing, accelerating global demand for national preparedness infrastructure following heightened nuclear threat awareness, and a bipartisan mandate to rebuild and modernize the Strategic National Stockpile. Allied government agencies are independently evaluating Entolimod for their own national stockpiling programs, creating a potential multi-jurisdictional procurement opportunity.