<p><strong>Peak Medical，ENvue 在英国的独家分销商，在报销决定后下达重大订单，预测 UroShield®套件的未来市场需求</strong></p>
<p>德克萨斯州泰勒，2025 年 12 月 18 日（GLOBE NEWSWIRE）-- ENvue Medical, Inc. <strong>（NASDAQ: FEED）（NASDAQ: NAOV）</strong>（“ENvue”，“ENvue Medical” 或 “公司”），是一家专注于非侵入性治疗系统的医疗技术公司，今天宣布 UroShield®套件已被纳入英国国家健康服务（NHS）药品清单第九部分，使其在英国范围内能够获得处方报销。</p>
<p>与这一报销里程碑同时，ENvue Medical 已从 Peak Medical 获得了一份初始采购订单，Peak Medical 是一家领先的英国分销商，专注于造口护理和泌尿科医疗设备，拥有广泛的医院和社区网络，反映出在 NHS 药品清单纳入后的早期商业需求。</p>
<p>NHS 药品清单第九部分建立了一条直接的、基于处方的报销途径，显著扩大了 UroShield®套件的可及性，该套件与 2023 年已纳入 NHS 药品清单第九部分的 UroShield®执行器一起使用，适用于社区和医院护理环境。长期尿管插入在英国很常见，已发表的研究表明，长期护理人群中导尿管的普遍率约为 6-7%，这一患者群体与导尿管相关尿路感染（CAUTIs）的风险增加相关。¹</p>
<p>UroShield®是一种非侵入性设备，旨在通过对导尿管施加低频超声能量来减少导尿管相关尿路感染（CAUTIs）和导尿管堵塞，帮助抑制生物膜的形成。CAUTIs 是全球最常见的设备相关医疗获得性感染之一。²,³</p>
<p>“这代表了 UroShield 的一个重要商业和报销转折点，” ENvue Medical 首席执行官 Doron Besser 博士表示。“药品清单的纳入消除了一个主要的报销障碍，使 NHS 处方能够规模化。初始采购订单为 2026 年提供了早期收入可见性，并且是我们在欧洲市场建立存在的第一步，在这些市场中，基于报销的准入模式和大量导尿患者群体可能支持未来的扩展。我们的团队将继续评估选择的欧洲国家的报销框架和市场准入途径，作为我们长期投资组合战略的一部分。”</p>
<p>Peak Medical 有限公司的董事总经理 Auriol Lawson 表示：“在确认 UroShield®套件这一关键报销里程碑后，我们很高兴与 ENvue Medical 合作。纳入 NHS 药品清单第九部分为英国患者打开了处方报销的通道，使我们能够推出解决我们医院和社区中导尿管相关尿路感染及其副作用重大挑战的领先技术。我们将继续致力于通过创新的非侵入性解决方案来支持英国的医疗系统，以改善患者的治疗效果，例如 UroShield®套件。”</p>
<p><strong>参考文献</strong></p>
<ol>
<li>Czwikla J 等。护理院居民中留置尿管的普遍率（Int J Nurs Stud. 2023）- NHS 护理院导尿管普遍率：英国约 6.9%，德国约 10.2%</li>
<li>Czwikla J, Schmiemann G, Hoffmann F。德国护理院中留置尿管的使用（BMC Urology,2024 年 6 月 14 日）- 德国导尿管普遍率 13.4%</li>
<li>CDC。导尿管相关尿路感染（CAUTI）基础知识（CDC.gov，更新于 2025 年 6 月 27 日）- CAUTIs 是最常见的医疗相关感染之一</li>
</ol>
<p><strong>关于 ENvue Medical, Inc.</strong></p>
<p>ENvue Medical, Inc.（NASDAQ: FEED）是一家医疗技术公司，致力于在临床和家庭护理环境中推进非侵入性和微创解决方案。公司总部位于德克萨斯州泰勒，在以色列特拉维夫和内舍尔设有研发中心，专注于两个不同的技术平台：</p>
<ul>
<li>基于声学的治疗技术，包括 PainShield®和 UroShield®，利用专有的低强度表面声波（SAW）技术。这些设备旨在用于家庭或护理环境，旨在治疗疼痛、减少细菌定植和破坏生物膜。</li>
</ul>
<ul>
<li>ENvue™导航平台，由 ENvue Medical Holdings, Corp.开发和运营，在伊利诺伊州阿灵顿高地和以色列特拉维夫设有办事处，是一种微创电磁导航系统，旨在帮助临床医生将喂养管放入胃肠道。已获得 FDA 510(k) 批准用于成人使用，ENvue 提供实时床边可视化管道移动，并支持在放置过程中进行知情决策。未来平台扩展可能包括儿科和血管通路应用。</li>
</ul>
<p>ENvue Medical 旨在推进非侵入性治疗和微创导航的标准，致力于患者安全、临床可用性和技术创新，覆盖多种医疗环境。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含 “前瞻性声明”。此类声明可能以 “打算”、“可能”、“将”、“计划”、“期望”、“预期”、“项目”、“预测”、“估计”、“旨在”、“相信”、“希望”、“潜在” 或类似词语开头。这些前瞻性声明包括但不限于：关于 ENvue Medical 平台的采用和实施、预期的商业扩展、增长、可扩展性以及 ENvue Medical 产品的实施、公司拟议的名称和符号变更、市场对公司技术的兴趣以及未来战略增长的预期。前瞻性声明并不保证未来的表现，基于某些假设，并受到各种已知和未知的风险和不确定性的影响，其中许多超出了公司的控制范围，无法预测或量化；因此，实际结果可能与这些前瞻性声明所表达或暗示的结果有实质性差异。这些风险和不确定性包括但不限于：(i) 市场对公司现有和新产品的接受度；(ii) 临床表现和运营结果；(iii) 产品实施中的延迟或复杂情况；(iv) 医疗器械行业的激烈竞争；(v) 产品责任或性能问题；(vi) 制造或供应链能力的限制；(vii) 报销限制；(viii) 知识产权保护；(ix) 美国及海外的医疗监管变化；以及 (x) 需要额外资本。关于公司及可能影响前瞻性声明实现的风险因素的更详细信息已在公司向证券交易委员会（“SEC”）提交的文件中列出，包括公司的 10-K 表格年度报告、10-Q 表格季度报告和 8-K 表格当前报告。投资者和证券持有人被敦促免费阅读这些文件，网址为：www.sec.gov。公司不承担因新信息、未来事件或其他原因而公开更新或修订其前瞻性声明的义务，除非法律要求。</p>
<p><strong>投资者联系：</strong></p>
<p>KCSA 战略传播</p>
<p>Valter Pinto，董事总经理</p>
<p>电话：(212) 896-1254</p>
<p>Valter@KCSA.com</p>
<p>来源：ENvue Medical, Inc.</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZd05EWTNNQ00zTXpJNU1qQXpJekl4T0RjeU16TT0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZd05EWTNNQ00zTXpJNU1qQXpJekl4T0RjeU16TT0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ZGZhYjIxOTMtMDBjMi00NWU2LTllMTYtM2I3YmYzOGRkMmE5LTExOTg3ODYtMjAyNS0xMi0xOC1lbg==/tiny/ENvue-Medical-Inc-.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/ZGZhYjIxOTMtMDBjMi00NWU2LTllMTYtM2I3YmYzOGRkMmE5LTExOTg3ODYtMjAyNS0xMi0xOC1lbg==/tiny/ENvue-Medical-Inc-.png"/></p>

FEED

<p>ENvue Medical 的 UroShield® 套件已被纳入英国国家医疗服务体系（NHS）药品价格表第九部分，允许全国范围内的处方报销。随后，ENvue 在英国的分销商 Peak Medical 下了大额订单，显示出强劲的市场需求。UroShield® 套件通过使用低频超声能量帮助减少导尿管相关尿路感染（CAUTIs）。这一里程碑预计将推动 ENvue Medical 在英国及其他欧洲市场的商业扩展和收入增长</p>

<p><strong>Peak Medical, ENvue’s Exclusive Distributor in UK, Places Significant Order after Reimbursement Decision, Projecting Future Market Demand for UroShield® Kit</strong></p>
<div class="lb-trans"><p><strong>Peak Medical，ENvue 在英国的独家分销商，在报销决定后下达重大订单，预测 UroShield®套件的未来市场需求</strong></p>
</div><p>TYLER, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. <strong>(NASDAQ: FEED) (NASDAQ: NAOV)</strong> (“ENvue,” “ENvue Medical” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced that the UroShield® Kit has been added to the UK National Health Service (NHS) Drug Tariff Part IX, enabling nationwide prescription reimbursement across the UK.</p>
<div class="lb-trans"><p>德克萨斯州泰勒，2025 年 12 月 18 日（GLOBE NEWSWIRE）-- ENvue Medical, Inc. <strong>（NASDAQ: FEED）（NASDAQ: NAOV）</strong>（“ENvue”，“ENvue Medical” 或 “公司”），是一家专注于非侵入性治疗系统的医疗技术公司，今天宣布 UroShield®套件已被纳入英国国家健康服务（NHS）药品清单第九部分，使其在英国范围内能够获得处方报销。</p>
</div><p>In parallel with this reimbursement milestone, ENvue Medical has secured an initial purchase order from Peak Medical, a leading UK-based distributor specializing in stoma care and urology medical devices with a vast network of hospitals and community settings, reflecting early commercial demand following NHS Drug Tariff inclusion.</p>
<div class="lb-trans"><p>与这一报销里程碑同时，ENvue Medical 已从 Peak Medical 获得了一份初始采购订单，Peak Medical 是一家领先的英国分销商，专注于造口护理和泌尿科医疗设备，拥有广泛的医院和社区网络，反映出在 NHS 药品清单纳入后的早期商业需求。</p>
</div><p>The NHS Drug Tariff Part IX establishes a direct, prescription-based reimbursement pathway, significantly expanding access for the UroShield® Kit, which is used in conjunction with the UroShield® Actuator that was previously included in the NHS Drug Tariff Part IX in the UK in 2023, across community and hospital care settings. Long-term urinary catheterization is common in the UK, with published studies indicating catheter prevalence of approximately 6–7% in long-term care populations, a patient group associated with elevated risk of catheter-associated urinary tract infections (CAUTIs).¹</p>
<div class="lb-trans"><p>NHS 药品清单第九部分建立了一条直接的、基于处方的报销途径，显著扩大了 UroShield®套件的可及性，该套件与 2023 年已纳入 NHS 药品清单第九部分的 UroShield®执行器一起使用，适用于社区和医院护理环境。长期尿管插入在英国很常见，已发表的研究表明，长期护理人群中导尿管的普遍率约为 6-7%，这一患者群体与导尿管相关尿路感染（CAUTIs）的风险增加相关。¹</p>
</div><p>UroShield® is a non-invasive device designed to reduce catheter-associated urinary tract infections (CAUTIs) and catheter blockages by applying low-frequency ultrasonic energy to the catheter, helping to inhibit biofilm formation. CAUTIs are among the most common device-associated healthcare-acquired infections globally.²,³</p>
<div class="lb-trans"><p>UroShield®是一种非侵入性设备，旨在通过对导尿管施加低频超声能量来减少导尿管相关尿路感染（CAUTIs）和导尿管堵塞，帮助抑制生物膜的形成。CAUTIs 是全球最常见的设备相关医疗获得性感染之一。²,³</p>
</div><p>“This represents a meaningful commercial and reimbursement inflection point for UroShield,” said Doron Besser, MD, Chief Executive Officer of ENvue Medical. “Drug Tariff inclusion removes a major reimbursement barrier and enables scalable NHS prescribing. The initial purchase order provides early revenue visibility heading into 2026 and is a first step in establishing our presence in European markets where reimbursement-driven access models and large catheterized patient populations may support future expansion. Our team will continue to assess reimbursement frameworks and market access pathways in select European countries as part of our longer-term portfolio strategy.”</p>
<div class="lb-trans"><p>“这代表了 UroShield 的一个重要商业和报销转折点，” ENvue Medical 首席执行官 Doron Besser 博士表示。“药品清单的纳入消除了一个主要的报销障碍，使 NHS 处方能够规模化。初始采购订单为 2026 年提供了早期收入可见性，并且是我们在欧洲市场建立存在的第一步，在这些市场中，基于报销的准入模式和大量导尿患者群体可能支持未来的扩展。我们的团队将继续评估选择的欧洲国家的报销框架和市场准入途径，作为我们长期投资组合战略的一部分。”</p>
</div><p>Auriol Lawson, Managing Director of Peak Medical Ltd., said, “We are excited to partner with ENvue Medical after confirmation of this critically important reimbursement milestone for the UroShield® Kit. The addition to the NHS Drug Tariff Part IX opens up prescription reimbursement access for patients across the UK and allows us to bring to market leading technology that addresses significant challenges of catheter-associated urinary tract infections and side effects in our hospitals and communities. We remain committed to supporting our healthcare system in the UK with innovative, non-invasive solutions to improve patient outcomes such as the UroShield® Kit.”</p>
<div class="lb-trans"><p>Peak Medical 有限公司的董事总经理 Auriol Lawson 表示：“在确认 UroShield®套件这一关键报销里程碑后，我们很高兴与 ENvue Medical 合作。纳入 NHS 药品清单第九部分为英国患者打开了处方报销的通道，使我们能够推出解决我们医院和社区中导尿管相关尿路感染及其副作用重大挑战的领先技术。我们将继续致力于通过创新的非侵入性解决方案来支持英国的医疗系统，以改善患者的治疗效果，例如 UroShield®套件。”</p>
</div><p><strong>References</strong></p>
<div class="lb-trans"><p><strong>参考文献</strong></p>
</div><ol>
<li>Czwikla J, et al. Prevalence of indwelling urinary catheters in nursing home residents (Int J Nurs Stud. 2023) - NHS nursing home catheter prevalence: UK ~6.9%, Germany ~10.2%</li>
<li>Czwikla J, Schmiemann G, Hoffmann F. Use of indwelling urinary catheters in German nursing homes (BMC Urology, 14 Jun 2024) - German catheter prevalence 13.4%</li>
<li>CDC. Catheter-associated urinary tract infection (CAUTI) basics (CDC.gov, updated June 27, 2025) - CAUTIs are one of the most common healthcare-associated infections</li>
</ol>
<div class="lb-trans"><ol>
<li>Czwikla J 等。护理院居民中留置尿管的普遍率（Int J Nurs Stud. 2023）- NHS 护理院导尿管普遍率：英国约 6.9%，德国约 10.2%</li>
<li>Czwikla J, Schmiemann G, Hoffmann F。德国护理院中留置尿管的使用（BMC Urology,2024 年 6 月 14 日）- 德国导尿管普遍率 13.4%</li>
<li>CDC。导尿管相关尿路感染（CAUTI）基础知识（CDC.gov，更新于 2025 年 6 月 27 日）- CAUTIs 是最常见的医疗相关感染之一</li>
</ol>
</div><p><strong>About ENvue Medical, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 ENvue Medical, Inc.</strong></p>
</div><p>ENvue Medical, Inc. (NASDAQ: FEED) is a medical technology company advancing both non-invasive and minimally invasive solutions across clinical and home care settings. Headquartered in Tyler, Texas, with research and development in Tel-Aviv and Nesher, Israel, the Company focuses on two distinct technology platforms:</p>
<div class="lb-trans"><p>ENvue Medical, Inc.（NASDAQ: FEED）是一家医疗技术公司，致力于在临床和家庭护理环境中推进非侵入性和微创解决方案。公司总部位于德克萨斯州泰勒，在以色列特拉维夫和内舍尔设有研发中心，专注于两个不同的技术平台：</p>
</div><ul>
<li>Acoustic-based therapeutic technologies, including PainShield® and UroShield®, which utilize proprietary low-intensity surface acoustic wave (SAW) technology. These devices are intended for use in home or care settings and are designed to treat pain, reduce bacterial colonization, and disrupt biofilms.</li>
</ul>
<div class="lb-trans"><ul>
<li>基于声学的治疗技术，包括 PainShield®和 UroShield®，利用专有的低强度表面声波（SAW）技术。这些设备旨在用于家庭或护理环境，旨在治疗疼痛、减少细菌定植和破坏生物膜。</li>
</ul>
</div><ul>
<li>ENvue™ Navigation Platform, developed and operated by ENvue Medical Holdings, Corp., with offices in Arlington Heights, Illinois, and Tel-Aviv, Israel, is a minimally invasive electromagnetic navigation system intended to assist clinicians in placing feeding tubes into the gastrointestinal tract. FDA 510(k) cleared for adult use, ENvue provides real-time bedside visualization of tube movement and supports informed decision-making during the placement procedure. Future platform expansion may include pediatric and vascular access applications.</li>
</ul>
<div class="lb-trans"><ul>
<li>ENvue™导航平台，由 ENvue Medical Holdings, Corp.开发和运营，在伊利诺伊州阿灵顿高地和以色列特拉维夫设有办事处，是一种微创电磁导航系统，旨在帮助临床医生将喂养管放入胃肠道。已获得 FDA 510(k) 批准用于成人使用，ENvue 提供实时床边可视化管道移动，并支持在放置过程中进行知情决策。未来平台扩展可能包括儿科和血管通路应用。</li>
</ul>
</div><p>ENvue Medical aims to advance standards in non-invasive therapy and minimally invasive navigation, with a commitment to patient safety, clinical usability, and technology innovation across a range of healthcare environments.</p>
<div class="lb-trans"><p>ENvue Medical 旨在推进非侵入性治疗和微创导航的标准，致力于患者安全、临床可用性和技术创新，覆盖多种医疗环境。</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 contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. These forward-looking statements include, but are not limited to: statements regarding the adoption and implementation of ENvue Medical’s platforms, anticipated commercial expansion, growth, scalability, and implementation of ENvue Medical’s products, the Company’s proposed name and symbol change, market interest in the Company’s technology, and future expectations for strategic growth. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: (i) market acceptance of the Company’s existing and new products; (ii) clinical performance and operational outcomes; (iii) delays or complications in product implementation; (iv) intense competition in the medical device industry; (v) product liability or performance issues; (vi) limitations in manufacturing or supply chain capabilities; (vii) reimbursement limitations; (viii) intellectual property protection; (ix) healthcare regulatory changes in the U.S. and abroad; and (x) the need for additional capital. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Investors and security holders are urged to read these documents free of charge at: www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.</p>
<div class="lb-trans"><p>本新闻稿包含 “前瞻性声明”。此类声明可能以 “打算”、“可能”、“将”、“计划”、“期望”、“预期”、“项目”、“预测”、“估计”、“旨在”、“相信”、“希望”、“潜在” 或类似词语开头。这些前瞻性声明包括但不限于：关于 ENvue Medical 平台的采用和实施、预期的商业扩展、增长、可扩展性以及 ENvue Medical 产品的实施、公司拟议的名称和符号变更、市场对公司技术的兴趣以及未来战略增长的预期。前瞻性声明并不保证未来的表现，基于某些假设，并受到各种已知和未知的风险和不确定性的影响，其中许多超出了公司的控制范围，无法预测或量化；因此，实际结果可能与这些前瞻性声明所表达或暗示的结果有实质性差异。这些风险和不确定性包括但不限于：(i) 市场对公司现有和新产品的接受度；(ii) 临床表现和运营结果；(iii) 产品实施中的延迟或复杂情况；(iv) 医疗器械行业的激烈竞争；(v) 产品责任或性能问题；(vi) 制造或供应链能力的限制；(vii) 报销限制；(viii) 知识产权保护；(ix) 美国及海外的医疗监管变化；以及 (x) 需要额外资本。关于公司及可能影响前瞻性声明实现的风险因素的更详细信息已在公司向证券交易委员会（“SEC”）提交的文件中列出，包括公司的 10-K 表格年度报告、10-Q 表格季度报告和 8-K 表格当前报告。投资者和证券持有人被敦促免费阅读这些文件，网址为：www.sec.gov。公司不承担因新信息、未来事件或其他原因而公开更新或修订其前瞻性声明的义务，除非法律要求。</p>
</div><p><strong>Investor Contact:</strong></p>
<div class="lb-trans"><p><strong>投资者联系：</strong></p>
</div><p>KCSA Strategic Communications</p>
<div class="lb-trans"><p>KCSA 战略传播</p>
</div><p>Valter Pinto, Managing Director</p>
<div class="lb-trans"><p>Valter Pinto，董事总经理</p>
</div><p>PH: (212) 896-1254</p>
<div class="lb-trans"><p>电话：(212) 896-1254</p>
</div><p>Valter@KCSA.com</p>
<div class="lb-trans"><p>Valter@KCSA.com</p>
</div><p>SOURCE: ENvue Medical, Inc.</p>
<div class="lb-trans"><p>来源：ENvue Medical, Inc.</p>
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ENvue Medical，前身为 NanoVibronix，其 UroShield®套件在英国获得报销 | NAOV 股票新闻