<p>与放射性和核医学对策项目的会议</p>
<p>加利福尼亚州弗里蒙特 / ACCESS Newswire /2025 年 11 月 18 日/ Tivic Health® Systems, Inc.是一家处于后期阶段的治疗公司，今天宣布已与生物医学高级研究与开发局（BARDA）的放射性和核医学对策项目工作人员达成独家技术观察会议。</p>
<p>Tivic 的领导层将展示 Entolimod 对辐射引起的损伤和急性辐射综合症（ARS）的临床数据，以及其在制造准备方面的进展和为生物制品许可申请（BLA）所做的准备。</p>
<p>技术观察格式允许 Tivic 和 BARDA 工作人员交换技术信息，确定项目优先级，并讨论 Entolimod 在大规模伤亡、储备和现场部署情况下的潜在开发路径。该过程使 BARDA 能够评估技术准备情况，了解制造和批准要求，并识别潜在的资金和采购路径。</p>
<p>Tivic Health 首席执行官 Jennifer Ernst 表示：“这种互动支持 Tivic 的战略，旨在开发具有潜在政府合作或收购路径的高价值治疗资产。我们相信，我们对辐射损伤和宿主导向对策的关注使我们在具有明确联邦需求和长期战略相关性的领域中处于良好位置。”</p>
<p>Entolimod 是 Tivic 的主要药物候选者，是一种新型的 TLR5 激动剂，能够触发 NF-kB 信号通路，激活抗凋亡和细胞保护机制。根据 FDA 的动物规则，Entolimod 用于 ARS 已进行了广泛的试验，并在动物模型中显示出强大的生存率、增强的胃肠道恢复和改善的造血功能，尤其是在暴露于电离辐射后给药时。临床研究还表明，Entolimod 可能作为一种放射保护剂，能够在暴露前（预防性）使用以减少损伤。Entolimod 用于 ARS 已获得 FDA 的快速通道和孤儿药物认证。</p>
<p><strong>关于 BARDA 的更多信息</strong></p>
<p>BARDA 是战略准备与响应管理局（ASPR）的一部分，隶属于美国卫生与公众服务部（HHS），负责开发、采购和储备医疗对策，包括应对化学、生物、放射和核公共卫生威胁的疫苗、药物和诊断工具。</p>
<p><strong>关于 Tivic Health Systems, Inc.</strong></p>
<p>Tivic 的使命是利用免疫系统改善临床结果并拯救生命。</p>
<p><strong>Tivic 的生物制品化合物</strong> 激活一种先天免疫通路，以防止骨髓和受辐射和年龄影响的各系统上皮组织中的细胞死亡。该公司的主要药物候选者 Entolimod™用于急性辐射综合症，是一种新型的 TLR5 激动剂，已获得快速通道和孤儿药物认证，并处于后期开发阶段。该公司还拥有 Entolimod 用于治疗中性粒细胞减少症的权利，以及 Entolasta，这是一种针对慢性应用的免疫优化变体。</p>
<p><strong>Tivic 的生物电子项目</strong> 正在开发一种新型的非侵入性医疗设备，旨在针对许多常见和严重疾病中涉及的神经通路。早期试验显示出积极信号，表明 Tivic 的方法可能调节特定的生物反应，公司相信其早期阶段的迷走神经刺激设备有潜力提供与外科植入设备相似或更好的临床结果。要了解更多关于 Tivic 的信息，请访问：https://ir.tivichealth.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿可能包含 “前瞻性声明”，这些声明面临重大风险和不确定性。本新闻稿中包含的所有声明，除了历史事实的陈述外，均为前瞻性声明。本新闻稿中的前瞻性声明可以通过使用诸如 “预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“打算”、“寻求”、“可能”、“计划”、“潜在”、“预测”、“项目”、“目标”、“旨在”、“应该”、“将”、“会” 或这些词的否定形式或其他类似表达来识别，尽管并非所有前瞻性声明都包含这些词。前瞻性声明基于 Tivic Health Systems Inc.当前的预期，并且受到固有的不确定性、风险和假设的影响，这些因素难以预测。此外，某些前瞻性声明基于对未来事件的假设，这些假设可能并不准确，包括与 FDA、BARDA 及其他监管机构的互动和指导；公司与其合作伙伴关系的变化；临床试验和研究结果的时间和成功；未能获得 FDA 或类似的许可或批准以及不符合 FDA 或类似法规；公司未来对其 ncVNS 治疗、Entolimod 和 Entolasta 的开发；公司商业战略的变化；监管要求和批准路径；公司未来成功商业化其产品候选的能力；公司及其产品候选未来可能获得的潜在机会；公司对额外营运资金的需求及其在需要时获得资金的能力；公司持续经营的能力；公司维持其纳斯达克上市的能力；以及关税、通货膨胀、法律、监管、政治和经济风险的变化。实际结果可能因各种因素与任何前瞻性声明中包含的内容有实质性差异。因此，您被警告不要对这些前瞻性声明过度依赖。有关与公司相关的风险和不确定性的讨论，以及其他重要因素，请参见 Tivic Health 向 SEC 提交的文件，包括其截至 2024 年 12 月 31 日的年度报告（Form 10-K），该报告于 2025 年 3 月 21 日提交给 SEC，标题为 “风险因素”，以及公司随后向 SEC 提交的文件。本新闻稿中包含的前瞻性声明截至本日期，Tivic Health Systems, Inc.不承担更新该信息的义务，除非适用法律要求。</p>
<p>要了解更多关于 Tivic 的信息，请访问：https://ir.tivichealth.com</p>
<p>投资者联系：</p>
<p>Hanover International, Inc.</p>
<p>ir@tivichealth.com</p>
<p>媒体联系：</p>
<p>Deanne Eagle 或 Laura Min Jackson</p>
<p>media@tivichealth.com</p>
<p><strong>来源：</strong> Tivic Health Systems</p>
<p>查看 ACCESS Newswire 上的原始新闻稿</p>

TIVC

<p>Tivic Health Systems 已与 BARDA 的放射性和核医学对策项目达成了一次技术观察会议，以讨论用于急性辐射综合症的 Entolimod。会议将涵盖临床数据、生产准备情况以及生物制品许可申请。Entolimod 是一种 TLR5 激动剂，在试验中显示出良好的结果，并获得了 FDA 的快速通道和孤儿药资格。这次互动与 Tivic 的战略相一致，旨在开发具有高价值的治疗资产，并寻求潜在的政府合作伙伴关系</p>

<p>Meeting with Radiological and Nuclear Medical Countermeasures Program</p>
<div class="lb-trans"><p>与放射性和核医学对策项目的会议</p>
</div><p>FREMONT, CA / ACCESS Newswire / November 18, 2025 / Tivic Health® Systems, Inc. , 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.</p>
<div class="lb-trans"><p>加利福尼亚州弗里蒙特 / ACCESS Newswire /2025 年 11 月 18 日/ Tivic Health® Systems, Inc.是一家处于后期阶段的治疗公司，今天宣布已与生物医学高级研究与开发局（BARDA）的放射性和核医学对策项目工作人员达成独家技术观察会议。</p>
</div><p>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.</p>
<div class="lb-trans"><p>Tivic 的领导层将展示 Entolimod 对辐射引起的损伤和急性辐射综合症（ARS）的临床数据，以及其在制造准备方面的进展和为生物制品许可申请（BLA）所做的准备。</p>
</div><p>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.</p>
<div class="lb-trans"><p>技术观察格式允许 Tivic 和 BARDA 工作人员交换技术信息，确定项目优先级，并讨论 Entolimod 在大规模伤亡、储备和现场部署情况下的潜在开发路径。该过程使 BARDA 能够评估技术准备情况，了解制造和批准要求，并识别潜在的资金和采购路径。</p>
</div><p>&#34;This interaction supports Tivic's strategy to develop high-value therapeutic assets with potential government partnership or acquisition pathways,&#34; said Jennifer Ernst, CEO of Tivic Health. &#34;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.&#34;</p>
<div class="lb-trans"><p>Tivic Health 首席执行官 Jennifer Ernst 表示：“这种互动支持 Tivic 的战略，旨在开发具有潜在政府合作或收购路径的高价值治疗资产。我们相信，我们对辐射损伤和宿主导向对策的关注使我们在具有明确联邦需求和长期战略相关性的领域中处于良好位置。”</p>
</div><p>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.</p>
<div class="lb-trans"><p>Entolimod 是 Tivic 的主要药物候选者，是一种新型的 TLR5 激动剂，能够触发 NF-kB 信号通路，激活抗凋亡和细胞保护机制。根据 FDA 的动物规则，Entolimod 用于 ARS 已进行了广泛的试验，并在动物模型中显示出强大的生存率、增强的胃肠道恢复和改善的造血功能，尤其是在暴露于电离辐射后给药时。临床研究还表明，Entolimod 可能作为一种放射保护剂，能够在暴露前（预防性）使用以减少损伤。Entolimod 用于 ARS 已获得 FDA 的快速通道和孤儿药物认证。</p>
</div><p><strong>More About BARDA</strong></p>
<div class="lb-trans"><p><strong>关于 BARDA 的更多信息</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>BARDA 是战略准备与响应管理局（ASPR）的一部分，隶属于美国卫生与公众服务部（HHS），负责开发、采购和储备医疗对策，包括应对化学、生物、放射和核公共卫生威胁的疫苗、药物和诊断工具。</p>
</div><p><strong>About Tivic Health Systems, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Tivic Health Systems, Inc.</strong></p>
</div><p>Tivic's mission is to harness the immune system to improve clinical outcomes and save lives.</p>
<div class="lb-trans"><p>Tivic 的使命是利用免疫系统改善临床结果并拯救生命。</p>
</div><p><strong>Tivic</strong>' <strong>s biologics compounds</strong> 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.</p>
<div class="lb-trans"><p><strong>Tivic 的生物制品化合物</strong> 激活一种先天免疫通路，以防止骨髓和受辐射和年龄影响的各系统上皮组织中的细胞死亡。该公司的主要药物候选者 Entolimod™用于急性辐射综合症，是一种新型的 TLR5 激动剂，已获得快速通道和孤儿药物认证，并处于后期开发阶段。该公司还拥有 Entolimod 用于治疗中性粒细胞减少症的权利，以及 Entolasta，这是一种针对慢性应用的免疫优化变体。</p>
</div><p><strong>Tivic</strong>' <strong>s bioelectronic program</strong> 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.</p>
<div class="lb-trans"><p><strong>Tivic 的生物电子项目</strong> 正在开发一种新型的非侵入性医疗设备，旨在针对许多常见和严重疾病中涉及的神经通路。早期试验显示出积极信号，表明 Tivic 的方法可能调节特定的生物反应，公司相信其早期阶段的迷走神经刺激设备有潜力提供与外科植入设备相似或更好的临床结果。要了解更多关于 Tivic 的信息，请访问：https://ir.tivichealth.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release may contain &#34;forward-looking statements&#34; 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 &#34;anticipate,&#34; &#34;believe,&#34; &#34;contemplate,&#34; &#34;could,&#34; &#34;estimate,&#34; &#34;expect,&#34; &#34;intend,&#34; &#34;seek,&#34; &#34;may,&#34; &#34;might,&#34; &#34;plan,&#34; &#34;potential,&#34; &#34;predict,&#34; &#34;project,&#34; &#34;target,&#34; &#34;aim,&#34; &#34;should,&#34; &#34;will,&#34; &#34;would,&#34; 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 &#34;Risk Factors,&#34; 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.</p>
<div class="lb-trans"><p>本新闻稿可能包含 “前瞻性声明”，这些声明面临重大风险和不确定性。本新闻稿中包含的所有声明，除了历史事实的陈述外，均为前瞻性声明。本新闻稿中的前瞻性声明可以通过使用诸如 “预期”、“相信”、“考虑”、“可能”、“估计”、“期望”、“打算”、“寻求”、“可能”、“计划”、“潜在”、“预测”、“项目”、“目标”、“旨在”、“应该”、“将”、“会” 或这些词的否定形式或其他类似表达来识别，尽管并非所有前瞻性声明都包含这些词。前瞻性声明基于 Tivic Health Systems Inc.当前的预期，并且受到固有的不确定性、风险和假设的影响，这些因素难以预测。此外，某些前瞻性声明基于对未来事件的假设，这些假设可能并不准确，包括与 FDA、BARDA 及其他监管机构的互动和指导；公司与其合作伙伴关系的变化；临床试验和研究结果的时间和成功；未能获得 FDA 或类似的许可或批准以及不符合 FDA 或类似法规；公司未来对其 ncVNS 治疗、Entolimod 和 Entolasta 的开发；公司商业战略的变化；监管要求和批准路径；公司未来成功商业化其产品候选的能力；公司及其产品候选未来可能获得的潜在机会；公司对额外营运资金的需求及其在需要时获得资金的能力；公司持续经营的能力；公司维持其纳斯达克上市的能力；以及关税、通货膨胀、法律、监管、政治和经济风险的变化。实际结果可能因各种因素与任何前瞻性声明中包含的内容有实质性差异。因此，您被警告不要对这些前瞻性声明过度依赖。有关与公司相关的风险和不确定性的讨论，以及其他重要因素，请参见 Tivic Health 向 SEC 提交的文件，包括其截至 2024 年 12 月 31 日的年度报告（Form 10-K），该报告于 2025 年 3 月 21 日提交给 SEC，标题为 “风险因素”，以及公司随后向 SEC 提交的文件。本新闻稿中包含的前瞻性声明截至本日期，Tivic Health Systems, Inc.不承担更新该信息的义务，除非适用法律要求。</p>
</div><p>To learn more about Tivic, visit: https://ir.tivichealth.com</p>
<div class="lb-trans"><p>要了解更多关于 Tivic 的信息，请访问：https://ir.tivichealth.com</p>
</div><p>Investor Contact:</p>
<div class="lb-trans"><p>投资者联系：</p>
</div><p>Hanover International, Inc.</p>
<div class="lb-trans"><p>Hanover International, Inc.</p>
</div><p>ir@tivichealth.com</p>
<div class="lb-trans"><p>ir@tivichealth.com</p>
</div><p>Media Contact:</p>
<div class="lb-trans"><p>媒体联系：</p>
</div><p>Deanne Eagle or Laura Min Jackson</p>
<div class="lb-trans"><p>Deanne Eagle 或 Laura Min Jackson</p>
</div><p>media@tivichealth.com</p>
<div class="lb-trans"><p>media@tivichealth.com</p>
</div><p><strong>SOURCE:</strong> Tivic Health Systems</p>
<div class="lb-trans"><p><strong>来源：</strong> Tivic Health Systems</p>
</div><p>View the original press release on ACCESS Newswire</p>
<div class="lb-trans"><p>查看 ACCESS Newswire 上的原始新闻稿</p>
</div>

Tivic 为 Entolimod(TM) 用于急性辐射综合症争取到 Barda 会议