Tivic Secures Barda Meeting for Entolimod(TM) for Acute Radiation Syndrome
Tivic Health (NASDAQ:TIVC) announced it secured an exclusive BARD A Techwatch meeting on November 18, 2025 to present clinical and manufacturing data for Entolimod for acute radiation syndrome (ARS).
The company said it will discuss Entolimod's animal-rule survival and organ-recovery data, manufacturing readiness, and preparations toward a biologics license application (BLA). Entolimod has FDA Fast Track and Orphan Drug designations and is being considered for mass-casualty stockpile and field deployment pathways that could lead to BARDA evaluation for funding or procurement.
Tivic Health (NASDAQ:TIVC) ha annunciato di aver ottenuto un esclusivo incontro BARD A Techwatch il 18 novembre 2025 per presentare dati clinici e di produzione per Entolimod per la sindrome da radiazioni acute (ARS).
L'azienda ha detto che discuterà i dati di sopravvivenza e recupero degli organi secondo la regola animale, la prontezza della produzione e i preparativi verso una licenza biologica (BLA). Entolimod ha designazioni FDA Fast Track e Orphan Drug ed è considerato per percorsi di stoccaggio per disastri di massa e dispiegamento sul campo che potrebbero portare a una valutazione da parte di BARDA per finanziamento o approvvigionamento.
Tivic Health (NASDAQ:TIVC) anunció que obtuvo una exclusiva reunión BARD A Techwatch el 18 de noviembre de 2025 para presentar datos clínicos y de fabricación de Entolimod para el síndrome de irradiación aguda (ARS).
La empresa indicó que discutirá los datos de supervivencia según la regla animal y la recuperación de órganos de Entolimod, la preparación de la fabricación y los preparativos hacia una solicitud de licencia de biológicos (BLA). Entolimod cuenta con designaciones de la FDA Fast Track y Orphan Drug, y se está considerando para rutas de almacenamiento para catástrofes masivas y despliegue en campo que podrían llevar a una evaluación por BARDA para financiamiento o adquisición.
Tivic Health (NASDAQ:TIVC)는 2025년 11월 18일 ARS(acute radiation syndrome)를 위한 Entolimod의 임상 및 제조 데이터를 제시하기 위해 BARD A Techwatch 회의를 단독으로 확보했다고 발표했다.
회사는 Entolimod의 동물 규칙에 따른 생존 및 장기 회복 데이터, 제조 준비 상태, 생물의약품 라이선스 신청(BLA)에 대한 준비를 논의할 것이라고 말했다. Entolimod은 FDA의 패스트 트랙 및 Orphan Drug 지정을 받았으며 대량 재난 비축 및 현장 배치 경로를 위한 고려 대상이며 BARDA의 자금 지원 또는 조달 평가로 이어질 수 있다.
Tivic Health (NASDAQ:TIVC) a annoncé avoir obtenu un rendez-vous exclusif BARD A Techwatch meeting le 18 novembre 2025 pour présenter des données cliniques et de fabrication sur Entolimod pour le syndrome radiatif aigu (ARS).
L'entreprise a déclaré qu'elle discuterait des données de survie et de récupération d'organes selon la règle animale d'Entolimod, de la préparation à la fabrication et des préparatifs en vue d'une demande de licence biospharmaceutique (BLA). Entolimod bénéficie des désignations FDA Fast Track et Orphan Drug, et est envisagé pour des voies de stockage de masse et de déploiement sur le terrain susceptibles de mener à une évaluation par BARDA pour un financement ou un approvisionnement.
Tivic Health (NASDAQ:TIVC) gab bekannt, dass es ein exklusives BARD A Techwatch meeting am 18. November 2025 gesichert hat, um klinische und herstellungsbezogene Daten für Entolimod bei akuter Strahlenkrankheit (ARS) zu präsentieren.
Das Unternehmen sagte, es werde Entolimods Tierregeln-Überlebens- und Organ-Rückgewinnungsdaten, die Herstellungsvorbereitung und Vorbereitungen auf einen Biologics License Application (BLA) diskutieren. Entolimod hat FDA Fast Track- und Orphan Drug-Bezeichnungen und wird für Strategien zur Massengewinnung von Katastrophenreserven und Feldverteilung in Betracht gezogen, die zu einer BARDA-Bewertung für Finanzierung oder Beschaffung führen könnten.
Tivic Health (NASDAQ:TIVC) أعلنت أنها حصلت على اجتماع حصري BARD A Techwatch meeting في 18 نوفمبر 2025 لعرض بيانات سريرية وتصنيعية لـ Entolimod لاضطراب الإشعاع الحاد (ARS).
وقالت الشركة إنها ستناقش بيانات البقاء على قيد الحياة وفق قاعدة الحيوان واستعادة الأعضاء، والاستعدادات التصنيعية، والتحضيرات نحو طلب ترخيص بيولوجي (BLA). Entolimod لديه تصنيفات FDA Fast Track وOrphan Drug وهي قيد النظر لمسارات التخزين لكوارث كبرى ونشر ميداني قد يقود إلى تقييم BARDA للتمويل أو الشراء.
- BARDA Techwatch meeting secured on November 18, 2025
- Fast Track and Orphan Drug designations from FDA
- Animal-rule data showing robust survival and improved GI and hematopoiesis
- No BLA submitted yet; only preparations underway
- BARDA Techwatch meeting is non-binding and does not guarantee funding or procurement
Insights
BARDA Techwatch meeting signals potential pathway to federal funding and stockpile consideration for Entolimod.
Tivic gains a formal technical exchange with BARDA staff to present clinical efficacy, manufacturing readiness and BLA preparation as part of a Techwatch review on
The meeting mechanism lets BARDA evaluate technology and manufacturing readiness and explore funding or procurement options; this aligns the program with defined federal acquisition and stockpile processes and could shorten technical review cycles if data meet BARDA criteria.
Key dependencies and risks include demonstration of sufficient evidence under the FDA Animal Rule, clear manufacturing scale-up plans, and successful BLA preparations; each is stated as a discussion topic during the Techwatch and will materially affect BARDA interest.
Watch for concrete follow-ups: BARDA feedback on manufacturing gaps, any indication of pathway to procurement or advanced development funding, and formal milestones tied to the BLA process over the next 6–18 months.
Meeting with Radiological and Nuclear Medical Countermeasures Program
FREMONT, CA / ACCESS Newswire / November 18, 2025 / Tivic Health® Systems, Inc. (NASDAQ:TIVC), a late-stage therapeutics company, today announced it has secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA)'s Radiological and Nuclear Medical Countermeasures Program staff.
Tivic leadership will be presenting clinical data on Entolimod's effects on radiation-induced injury and acute radiation syndrome (ARS), its progress on manufacturing readiness and the preparations it has been making for a biologics license application, or BLA.
The Techwatch format allows Tivic and BARDA staff to exchange technical information, establish program priorities, and discuss development pathways for Entolimod to potentially be deployed in mass-casualty, stockpile, and field deployment situations. The process enables BARDA to evaluate technology readiness, understand manufacturing and approval requirements, and identify potential pathways to funding and purchasing.
"This interaction supports Tivic's strategy to develop high-value therapeutic assets with potential government partnership or acquisition pathways," said Jennifer Ernst, CEO of Tivic Health. "We believe our focus on radiation injury and host-directed countermeasures positions us well in a space with defined federal demand and long-term strategic relevance."
Entolimod, Tivic's lead drug candidate, is a novel TLR5 agonist that triggers NF-kB signaling, activating anti-apoptotic and cell protective mechanisms. Under the FDA's Animal Rule, Entolimod for ARS has been the subject of extensive trials and has demonstrated robust survival, enhanced GI tract recovery and improved hematopoiesis in animal models when administered after exposure to ionizing radiation. Clinical studies also suggest Entolimod may serve as a radioprotective agent that can be used prophylactically (prior to exposure) to reduce damage. Entolimod for ARS has been granted Fast Track and Orphan Drug designations by the FDA.
More About BARDA
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) and operates within the U.S. Department of Health and Human Services (HHS) agency to develop, procure, and stockpile medical countermeasures, including vaccines, drugs and diagnostics that address chemical, biologic, radiologic, and nuclear public health threats.
About Tivic Health Systems, Inc.
Tivic's mission is to harness the immune system to improve 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's lead drug candidate, Entolimod™ for acute radiation syndrome, is a novel TLR5 agonist that has been granted Fast Track and Orphan Drug designations and is in late-stage development. The company also holds rights to Entolimod for the treatment of neutropenia and to Entolasta, an immunologically optimized variant of Entolimod for chronic applications.
Tivic's bioelectronic program has been developing a novel, non-invasive medical device designed to target the neural pathways implicated in many prevalent and debilitating diseases. Early trials show promising signals that Tivic's approach may regulate specific biologic responses, and the company believes its early-stage vagus nerve stimulation device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted devices. To learn more about Tivic, visit: https://ir.tivichealth.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of interactions with and guidance from the FDA, BARDA, and other regulatory authorities; changes to the company's relationship with its partners; timing and success of clinical trials and study results; the failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company's business strategy; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; the potential opportunities that may be available to the company and its product candidates in the future; the company's need for, and ability to secure when needed, additional working capital; the company's ability to continue as a going concern; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors," as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law.
To learn more about Tivic, visit: 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
View the original press release on ACCESS Newswire
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