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<p>– <em>在 SLEEP 2026 的演示展示了使用个性化编程将非应答者转变为应答者的能力</em></p>
<p>伦敦 --（商业资讯）--LivaNova PLC（纳斯达克：LIVN），一家市场领先的医疗技术公司，今天宣布新的数据表明，在接受近端舌下神经刺激（pHGNS）治疗的中重度阻塞性睡眠呼吸暂停（OSA）患者中，使用其 PolySync™编程算法使累积的呼吸暂停 - 低通气指数（AHI）应答率提高至 84.5%。这些发现由主要作者、宾夕法尼亚大学佩雷尔曼医学院耳鼻喉科副教授、范德堡健康耳鼻喉科研究教授 Alan R. Schwartz 博士在 SLEEP 2026 上发表，这是第 40 届美国专业睡眠学会（APSS）年会。</p>
<p>这些结果建立在 LivaNova 之前报告的 OSPERY 随机对照试验（RCT）的结果基础上，该试验报告了在公司提供的 aura6000™系统下，经过 12 个月的 pHGNS 治疗后，应答者率为 65%。在 PolySync 子研究中，那些在 OSPERY 中经过一年个体接触刺激后未达到应答者标准的患者，接受了使用同时接触刺激的重新编程。这种方法将大多数患者转变为应答者，显著改善了 AHI 和氧饱和度指数（ODI）的结果，并将累积应答率提高至 84.5%。LivaNova 之前宣布，PolySync 将与其商业 pHGNS 产品一起提供，使得在治疗开始时能够整合先进的、针对患者的剂量调整。</p>
<p>“这些结果强调了我们基础治疗的强大以及通过创新进一步提升结果的机会，” LivaNova 首席创新官 Ahmet Tezel 博士表示。“OSPERY 展示了快速和持久的临床益处，而 PolySync 表明我们可以通过提高应答率和扩大 pHGNS 治疗的影响来有意义地建立在这一基础之上。这反映了我们持续致力于推进阻塞性睡眠呼吸暂停患者的个性化神经调节。”</p>
<p>PolySync 的发现扩展了 LivaNova 在阻塞性睡眠呼吸暂停（OSA）领域的 OSPREY 和 THN3 RCT 所建立的强大临床基础。正如之前报告的那样，OSPERY 在六个月时达到了其主要安全性和有效性终点，显示出 AHI 和 ODI 的显著降低，并在 12 个月的治疗中持续改善。完整数据集在《内科学年鉴》上发表，确认了在客观指标和患者报告结果（包括白天嗜睡和功能性生活质量）方面的临床意义和持续改善。</p>
<p>PolySync 建立在 LivaNova 差异化的 pHGNS 平台之上，该平台利用一个六接触电极，放置在近端舌下神经上，在任何神经分支之前，以便更广泛地接触气道肌肉并灵活优化治疗。通过实现同时接触刺激，PolySync 扩展了可能的刺激场的种类和数量，允许更广泛和更灵活地激活舌肌，并改善异质患者群体的治疗应答性。</p>
<p>“这些数据特别有意义，因为它们表明这种新颖的刺激范式可以进一步改善超出初始治疗应答所取得的结果，” Schwartz 说。“通过优化编程将非应答者转变为应答者的能力代表了治疗阻塞性睡眠呼吸暂停的重要进展。”</p>
<p>PolySync 编程耐受性良好，在子研究中未报告严重的治疗相关不良事件，也未报告与刺激或设备相关的不良事件。</p>
<p>“从强劲的 12 个月应答率到更高的累积结果的进展突显了该平台的临床潜力及其解决更广泛患者群体的能力，” LivaNova 全球商业化负责人 Lucile Blaise 表示。</p>
<p>除了 PolySync 子研究，LivaNova 还在 SLEEP 2026 上于周二展示了第二个科学海报。LivaNova 研究科学家 Rex Chin-Hao Chen 博士展示了支持 PolySync 中使用的同时接触刺激剂量合理性的计算模型。</p>
<p>在周三上午 10 点（东部时间），OSPERY 研究的首席研究员、加州大学圣地亚哥分校医学院教授、UC San Diego Health 的睡眠医学专家 Atul Malhotra 博士将在 SLEEP 2026 上展示一张海报，探讨 GLP-1 受体激动剂在 OSA 治疗方案中的整合。</p>
<p>Schwartz 和 Chen 的海报展示可以在这里查看。Malhotra 的海报将在他于 6 月 17 日的演讲结束后在同一网站上提供。</p>
<p>这些数据和展示共同突显了 LivaNova 在推进神经调节科学和扩大阻塞性睡眠呼吸暂停患者治疗选择方面的持续投资。</p>
<p>pHGNS 是一种 FDA 批准的治疗方法，旨在通过刺激舌肌来改善睡眠期间的气道通畅性，以防止上气道塌陷。LivaNova 的多接触架构支持更广泛的可编程配置，支持更精确、个性化的治疗。PolySync 编程的加入展示了先进算法如何进一步提升结果，并将治疗的益处扩展到更多患者。</p>
<p>在 3 月份获得 FDA 的预市场批准后，LivaNova 正在继续为其下一代 OSA 设备准备在 2026 年下半年向 FDA 提交的 PMA 补充申请。该设备旨在与磁共振成像（MRI）兼容，具备远程和安全的配置管理能力，以及持久的可充电电池技术（使用寿命可达 15 年）。</p>
<p>请访问我们新的 OSA 网站以了解更多信息。</p>
<p><strong>关于 LivaNova</strong></p>
<p>LivaNova PLC 是一家全球医疗技术公司，拥有近五十年的经验，致力于改变人们生活的轨迹。通过在特定神经和心脏疾病领域的创新医疗解决方案，LivaNova 努力点燃患者的转机。公司总部位于伦敦，拥有约 3300 名员工，业务遍及 100 多个国家，为全球患者、医疗专业人士和医疗系统提供服务。欲了解更多信息，请访问 www.livanova.com。</p>
<p><strong>安全港声明</strong></p>
<p>本新闻稿包含有关公司目标、信念、期望、战略、目标、计划、基本假设及其他不一定基于历史事实的 “前瞻性声明”。这些声明包括但不限于关于在科学会议上呈现的数据、对这些数据的解释及其潜在临床影响、aura6000 的性能和能力，以及公司下一代 OSA 设备的预期监管提交、批准和商业化。由于各种因素，包括公司最近的 10-K 表格年报第 1A 项中列出的因素，以及在 10-Q 季度报告和 8-K 当前报告中包含的任何风险因素，实际事件可能与我们前瞻性声明中所指示的情况有实质性差异。LivaNova 没有义务更新本新闻稿中包含的信息，以反映随后发生的事件或情况。</p>
<p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA2MTU1OTc0MjdyMQ?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://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA2MTU1OTc0MjdyMQ"/></p>
<p>在 businesswire.com 查看源版本：https://www.businesswire.com/news/home/20260615597427/en/</p>
<p><strong>LivaNova 投资者关系和媒体联系人</strong></p>
<p>+1 281-895-2382</p>
<p><strong>Briana Gotlin</strong></p>
<p>投资者关系副总裁</p>
<p>InvestorRelations@livanova.com</p>
<p><strong>Deanna Wilke</strong></p>
<p>企业传播副总裁</p>
<p>Corporate.Communications@livanova.com</p>
<p>来源：LivaNova PLC</p>

LIVN

<p>LivaNova 宣布，其 PolySync 编程算法使中度至重度阻塞性睡眠呼吸暂停（OSA）患者的累积反应率提高至 84.5%，这些患者接受了近端舌下神经刺激治疗。在 2026 年 SLEEP 大会上发布的数据表明，PolySync 通过同时接触刺激重新编程，将非反应者转变为反应者，与 OSPREY 试验中最初的 65% 反应者率相比，显著改善了 AHI 和氧气脱饱和结果</p>

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</div><p>– <em>Presentation at SLEEP 2026 illustrates ability to convert non-responders into responders using personalized programming</em></p>
<div class="lb-trans"><p>– <em>在 SLEEP 2026 的演示展示了使用个性化编程将非应答者转变为应答者的能力</em></p>
</div><p>LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced new data showing that use of its PolySync™ programming algorithm increased the cumulative apnea-hypopnea index (AHI) response rate to 84.5% in patients with moderate to severe Obstructive Sleep Apnea (OSA) when treated with proximal hypoglossal nerve stimulation (pHGNS). The findings were presented at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), by lead author Alan R. Schwartz, M.D., adjunct professor of otorhinolaryngology in the Perelman School of Medicine at the University of Pennsylvania and research professor of otolaryngology for Vanderbilt Health.</p>
<div class="lb-trans"><p>伦敦 --（商业资讯）--LivaNova PLC（纳斯达克：LIVN），一家市场领先的医疗技术公司，今天宣布新的数据表明，在接受近端舌下神经刺激（pHGNS）治疗的中重度阻塞性睡眠呼吸暂停（OSA）患者中，使用其 PolySync™编程算法使累积的呼吸暂停 - 低通气指数（AHI）应答率提高至 84.5%。这些发现由主要作者、宾夕法尼亚大学佩雷尔曼医学院耳鼻喉科副教授、范德堡健康耳鼻喉科研究教授 Alan R. Schwartz 博士在 SLEEP 2026 上发表，这是第 40 届美国专业睡眠学会（APSS）年会。</p>
</div><p>The results build on LivaNova’s previously reported outcomes from the OSPREY randomized controlled trial (RCT), which reported a 65% responder rate in the treatment arm after 12 months of pHGNS therapy delivered by the Company’s aura6000™ System. In the PolySync substudy, patients who did not meet responder criteria after one year of individual-contact stimulation in OSPREY underwent reprogramming using simultaneous-contact stimulation. This approach converted the majority of these patients into responders, significantly improving both AHI and oxygen desaturation index (ODI) outcomes and increasing the cumulative response rate to 84.5%. LivaNova previously announced that PolySync will be available with its commercial pHGNS product, enabling the integration of advanced, patient-specific titration at the onset of therapy.</p>
<div class="lb-trans"><p>这些结果建立在 LivaNova 之前报告的 OSPERY 随机对照试验（RCT）的结果基础上，该试验报告了在公司提供的 aura6000™系统下，经过 12 个月的 pHGNS 治疗后，应答者率为 65%。在 PolySync 子研究中，那些在 OSPERY 中经过一年个体接触刺激后未达到应答者标准的患者，接受了使用同时接触刺激的重新编程。这种方法将大多数患者转变为应答者，显著改善了 AHI 和氧饱和度指数（ODI）的结果，并将累积应答率提高至 84.5%。LivaNova 之前宣布，PolySync 将与其商业 pHGNS 产品一起提供，使得在治疗开始时能够整合先进的、针对患者的剂量调整。</p>
</div><p>“These results underscore the strength of our underlying therapy and the opportunity to further enhance outcomes through innovation,” said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. “OSPREY demonstrated rapid and durable clinical benefit, and PolySync shows that we can meaningfully build on that foundation by improving response rates and expanding the impact of pHGNS therapy. This reflects our ongoing commitment to advancing personalized neuromodulation for patients with Obstructive Sleep Apnea.”</p>
<div class="lb-trans"><p>“这些结果强调了我们基础治疗的强大以及通过创新进一步提升结果的机会，” LivaNova 首席创新官 Ahmet Tezel 博士表示。“OSPERY 展示了快速和持久的临床益处，而 PolySync 表明我们可以通过提高应答率和扩大 pHGNS 治疗的影响来有意义地建立在这一基础之上。这反映了我们持续致力于推进阻塞性睡眠呼吸暂停患者的个性化神经调节。”</p>
</div><p>The PolySync findings extend the strong clinical foundation established by LivaNova’s OSPREY and THN3 RCTs, the first RCTs in hypoglossal nerve stimulation (HGNS). As previously reported, OSPREY met its primary safety and efficacy endpoints at six months, demonstrating significant reductions in AHI and ODI, with continued improvements through 12 months of therapy. The full dataset, published in <em>Annals of Internal Medicine</em>, confirmed clinically meaningful and sustained improvements across both objective measures and patient-reported outcomes, including daytime sleepiness and functional quality of life.</p>
<div class="lb-trans"><p>PolySync 的发现扩展了 LivaNova 在阻塞性睡眠呼吸暂停（OSA）领域的 OSPREY 和 THN3 RCT 所建立的强大临床基础。正如之前报告的那样，OSPERY 在六个月时达到了其主要安全性和有效性终点，显示出 AHI 和 ODI 的显著降低，并在 12 个月的治疗中持续改善。完整数据集在《内科学年鉴》上发表，确认了在客观指标和患者报告结果（包括白天嗜睡和功能性生活质量）方面的临床意义和持续改善。</p>
</div><p>PolySync builds on LivaNova’s differentiated pHGNS platform, which utilizes a six-contact electrode positioned on the proximal hypoglossal nerve, prior to any nerve branching, to enable broader access to airway muscles and flexible therapy optimization. By enabling simultaneous-contact stimulation, PolySync expands the variety and number of possible stimulation fields, allowing for broader and more flexible activation of lingual muscles and improved treatment responsiveness across a heterogeneous patient population.</p>
<div class="lb-trans"><p>PolySync 建立在 LivaNova 差异化的 pHGNS 平台之上，该平台利用一个六接触电极，放置在近端舌下神经上，在任何神经分支之前，以便更广泛地接触气道肌肉并灵活优化治疗。通过实现同时接触刺激，PolySync 扩展了可能的刺激场的种类和数量，允许更广泛和更灵活地激活舌肌，并改善异质患者群体的治疗应答性。</p>
</div><p>“These data are particularly meaningful because they demonstrate that this novel stimulation paradigm can further improve outcomes beyond that achieved with the initial response to therapy,” Schwartz said. “The ability to convert non-responders into responders through optimized programming represents an important advancement in treating Obstructive Sleep Apnea.”</p>
<div class="lb-trans"><p>“这些数据特别有意义，因为它们表明这种新颖的刺激范式可以进一步改善超出初始治疗应答所取得的结果，” Schwartz 说。“通过优化编程将非应答者转变为应答者的能力代表了治疗阻塞性睡眠呼吸暂停的重要进展。”</p>
</div><p>PolySync programming was well tolerated, with no serious treatment-emergent adverse events and no stimulation- or device-related adverse events reported in the substudy.</p>
<div class="lb-trans"><p>PolySync 编程耐受性良好，在子研究中未报告严重的治疗相关不良事件，也未报告与刺激或设备相关的不良事件。</p>
</div><p>“The progression from strong 12-month response rates to even higher cumulative outcomes highlights the clinical potential of this platform and its ability to address a broader patient population,” said Lucile Blaise, Global Head of Commercialization, OSA, at LivaNova.</p>
<div class="lb-trans"><p>“从强劲的 12 个月应答率到更高的累积结果的进展突显了该平台的临床潜力及其解决更广泛患者群体的能力，” LivaNova 全球商业化负责人 Lucile Blaise 表示。</p>
</div><p>In addition to the PolySync substudy, LivaNova presented a second scientific poster Tuesday at SLEEP 2026 relating to PolySync. Rex Chin-Hao Chen, Ph.D., a LivaNova research scientist, presented computational modeling supporting the dosing rationale for the simultaneous-contact stimulation used in PolySync.</p>
<div class="lb-trans"><p>除了 PolySync 子研究，LivaNova 还在 SLEEP 2026 上于周二展示了第二个科学海报。LivaNova 研究科学家 Rex Chin-Hao Chen 博士展示了支持 PolySync 中使用的同时接触刺激剂量合理性的计算模型。</p>
</div><p>On Wednesday at 10 a.m. EDT, Atul Malhotra, M.D., lead investigator for the OSPREY study, professor of medicine at University of California San Diego School of Medicine, and sleep medicine specialist at UC San Diego Health, will present a poster at SLEEP 2026 examining the integration of GLP-1 receptor agonists into treatment protocols for OSA.</p>
<div class="lb-trans"><p>在周三上午 10 点（东部时间），OSPERY 研究的首席研究员、加州大学圣地亚哥分校医学院教授、UC San Diego Health 的睡眠医学专家 Atul Malhotra 博士将在 SLEEP 2026 上展示一张海报，探讨 GLP-1 受体激动剂在 OSA 治疗方案中的整合。</p>
</div><p>The poster presentations by Schwartz and Chen can be viewed here. Malhotra’s poster will be available at the same site upon conclusion of his presentation on June 17.</p>
<div class="lb-trans"><p>Schwartz 和 Chen 的海报展示可以在这里查看。Malhotra 的海报将在他于 6 月 17 日的演讲结束后在同一网站上提供。</p>
</div><p>Together, these data and presentations highlight LivaNova’s continued investment in advancing neuromodulation science and expanding treatment options for the large and growing population of patients with OSA.</p>
<div class="lb-trans"><p>这些数据和展示共同突显了 LivaNova 在推进神经调节科学和扩大阻塞性睡眠呼吸暂停患者治疗选择方面的持续投资。</p>
</div><p>pHGNS is an FDA-approved therapy designed to improve airway patency during sleep by stimulating tongue muscles to prevent upper airway collapse. LivaNova’s multi-contact architecture enables a broad range of programmable configurations, supporting more precise, individualized therapy. The addition of PolySync programming demonstrates how advanced algorithms can further enhance outcomes and extend the benefits of therapy to more patients.</p>
<div class="lb-trans"><p>pHGNS 是一种 FDA 批准的治疗方法，旨在通过刺激舌肌来改善睡眠期间的气道通畅性，以防止上气道塌陷。LivaNova 的多接触架构支持更广泛的可编程配置，支持更精确、个性化的治疗。PolySync 编程的加入展示了先进算法如何进一步提升结果，并将治疗的益处扩展到更多患者。</p>
</div><p>Building upon the FDA premarket approval received in March for aura6000, LivaNova is continuing to prepare its next-generation OSA device for a PMA supplement application to the FDA in the second half of 2026. This device is being designed for compatibility with magnetic resonance imaging (MRI), remote and secure configuration management capabilities, and long-lasting, rechargeable battery technology (up to 15 years).</p>
<div class="lb-trans"><p>在 3 月份获得 FDA 的预市场批准后，LivaNova 正在继续为其下一代 OSA 设备准备在 2026 年下半年向 FDA 提交的 PMA 补充申请。该设备旨在与磁共振成像（MRI）兼容，具备远程和安全的配置管理能力，以及持久的可充电电池技术（使用寿命可达 15 年）。</p>
</div><p>Please visit our new OSA website to learn more.</p>
<div class="lb-trans"><p>请访问我们新的 OSA 网站以了解更多信息。</p>
</div><p><strong>About LivaNova</strong></p>
<div class="lb-trans"><p><strong>关于 LivaNova</strong></p>
</div><p>LivaNova PLC is a global medical technology company built on nearly five decades of experience and a vision to change the trajectory of lives for a new day. Through ingenious medical solutions in select neurological and cardiac conditions, LivaNova strives to ignite patient turnarounds. Headquartered in London, with approximately 3,300 employees and a presence in more than 100 countries, LivaNova serves patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com.</p>
<div class="lb-trans"><p>LivaNova PLC 是一家全球医疗技术公司，拥有近五十年的经验，致力于改变人们生活的轨迹。通过在特定神经和心脏疾病领域的创新医疗解决方案，LivaNova 努力点燃患者的转机。公司总部位于伦敦，拥有约 3300 名员工，业务遍及 100 多个国家，为全球患者、医疗专业人士和医疗系统提供服务。欲了解更多信息，请访问 www.livanova.com。</p>
</div><p><strong>Safe Harbor Statement</strong></p>
<div class="lb-trans"><p><strong>安全港声明</strong></p>
</div><p>This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding data presented at scientific meetings, the interpretation and potential clinical impact of such data, the performance and capabilities of the aura6000, and anticipated regulatory submissions, approvals, and commercialization of the Company’s next-generation OSA device. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.</p>
<div class="lb-trans"><p>本新闻稿包含有关公司目标、信念、期望、战略、目标、计划、基本假设及其他不一定基于历史事实的 “前瞻性声明”。这些声明包括但不限于关于在科学会议上呈现的数据、对这些数据的解释及其潜在临床影响、aura6000 的性能和能力，以及公司下一代 OSA 设备的预期监管提交、批准和商业化。由于各种因素，包括公司最近的 10-K 表格年报第 1A 项中列出的因素，以及在 10-Q 季度报告和 8-K 当前报告中包含的任何风险因素，实际事件可能与我们前瞻性声明中所指示的情况有实质性差异。LivaNova 没有义务更新本新闻稿中包含的信息，以反映随后发生的事件或情况。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA2MTU1OTc0MjdyMQ" alt="" original-src="https://cts.businesswire.com/ct/CT?id=bwnews&amp;sty=20260615597427r1&amp;sid=acqr8&amp;distro=nx&amp;lang=en"/></p>
<p>View source version on businesswire.com: https://www.businesswire.com/news/home/20260615597427/en/</p>
<div class="lb-trans"><p>在 businesswire.com 查看源版本：https://www.businesswire.com/news/home/20260615597427/en/</p>
</div><p><strong>LivaNova Investor Relations and Media Contacts</strong></p>
<div class="lb-trans"><p><strong>LivaNova 投资者关系和媒体联系人</strong></p>
</div><p>+1 281-895-2382</p>
<div class="lb-trans"><p>+1 281-895-2382</p>
</div><p><strong>Briana Gotlin</strong></p>
<div class="lb-trans"><p><strong>Briana Gotlin</strong></p>
</div><p>VP, Investor Relations</p>
<div class="lb-trans"><p>投资者关系副总裁</p>
</div><p>InvestorRelations@livanova.com</p>
<div class="lb-trans"><p>InvestorRelations@livanova.com</p>
</div><p><strong>Deanna Wilke</strong></p>
<div class="lb-trans"><p><strong>Deanna Wilke</strong></p>
</div><p>VP, Corporate Communications</p>
<div class="lb-trans"><p>企业传播副总裁</p>
</div><p>Corporate.Communications@livanova.com</p>
<div class="lb-trans"><p>Corporate.Communications@livanova.com</p>
</div><p>Source: LivaNova PLC</p>
<div class="lb-trans"><p>来源：LivaNova PLC</p>
</div>

LivaNova 在 OSPREY 研究中展示了通过 PolySync 编程治疗阻塞性睡眠呼吸暂停的 84.5% 累积响应率 | LIVN 股票新闻