LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced the preliminary results for the unipolar patient cohort of the RECOVER clinical study, assessing the use of VNS Therapy™ in treatment-resistant depression. The study did not meet its primary endpoint (PE) for the unipolar cohort; however, statistical significance was achieved in select secondary endpoints..

伦敦--（商业新闻短讯）--市场领先的医疗技术公司LivaNova PLC（纳斯达克：LIVN）今天宣布了RECOVER临床研究单极患者队列的初步结果，评估了VNS Therapy™在难治性抑郁症中的应用。该研究未达到单极队列的主要终点（PE）；然而，在选定的次要终点中取得了统计学意义。。

The PE measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort with a predetermined p-value of p<0.023. Over the course of 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline.

PE测量了单极患者队列中主动和假VNS治疗对蒙哥马利-Åsberg抑郁评定量表（MADRS）反应率的差异，预定p值为p<0.023。在12个月的过程中，积极治疗组显示出与治疗组基线相比具有统计学意义和临床意义的改善。

Due to a strong response in the sham group, which was unforeseen in the study design, statistical separation between the treatment and sham arms for the PE was not achieved by the end of the study. Despite this, the totality of data supports a meaningful treatment effect for those who received active VNS Therapy particularly given that the RECOVER unipolar patient population has a significant unmet need after having failed numerous other treatment modalities..

由于假手术组的反应强烈，这在研究设计中是不可预见的，因此在研究结束时，PE治疗组和假手术组之间的统计分离没有实现。尽管如此，总体数据支持那些接受积极VNS治疗的患者的有意义的治疗效果，特别是考虑到恢复单极患者群体在许多其他治疗方式失败后仍有大量未满足的需求。。

“We would like to thank the patients and physicians who participated in RECOVER to date, as well as the U.S. Centers for Medicare and Medicaid Services, who we partnered with to design this study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “Despite not achieving statistical significance for the primary endpoint for the unipolar cohort in the RECOVER study, the effect of active VNS Therapy was within our expectations and resulted in clinically meaningful benefits in select secondary endpoints.

LivaNova首席执行官弗拉基米尔·马卡萨里亚（VladimirMakatsaria）表示：“我们要感谢迄今为止参与RECOVER的患者和医生，以及我们合作设计这项研究的美国医疗保险和医疗补助服务中心。”。“尽管在RECOVER研究中单极队列的主要终点没有达到统计学意义，但主动VNS治疗的效果在我们的预期范围内，并在选定的次要终点产生了临床上有意义的益处。

We are conducting an in-depth analysis of the data with key stakeholders and will determine the path forward in the coming weeks.'.

我们正在与主要利益相关者对数据进行深入分析，并将在未来几周内确定前进的道路。”。

The Company expects to publish the unipolar cohort data, including details on the PE and secondary endpoints, in peer-reviewed journals in the fourth quarter of 2024. Importantly, no safety issues were reported.

该公司预计将于2024年第四季度在同行评审期刊上发布单极队列数据，包括PE和次要终点的详细信息。重要的是，没有报告安全问题。

“I am encouraged by the clinically meaningful outcomes for the RECOVER unipolar patient population that is markedly treatment resistant,” said Dr. Charles R. Conway, Director of the Washington University in St. Louis Resistant Mood Disorders Center and Principal Investigator for RECOVER. “As we have previously published, the unipolar patients who entered the RECOVER study were of a greater severity than we had anticipated in the study design and have very few treatment options remaining.

华盛顿大学圣路易斯抵抗情绪障碍中心主任兼RECOVER首席研究员查尔斯·康韦（CharlesR.Conway）博士说：“对于恢复单极患者群体的临床意义重大的结果，我感到鼓舞。”。“正如我们之前发表的那样，进入RECOVER研究的单极患者的严重程度比我们在研究设计中预期的要高，并且剩下的治疗选择很少。

We now have a large body of data to evaluate, and I look forward to better understanding it in totality.”.

我们现在有大量的数据需要评估，我期待着从整体上更好地理解它。”。

The bipolar patient cohort continues for RECOVER and LivaNova will continue its discussions with the U.S. Centers for Medicare and Medicaid Services (CMS) regarding reconsideration of coverage for VNS Therapy for treatment-resistant depression.

躁郁症患者队列继续恢复，利瓦诺娃将继续与美国医疗保险和医疗补助服务中心（CMS）讨论重新考虑VNS治疗难治性抑郁症的覆盖范围。

About RECOVER

关于恢复

LivaNova’s VNS Therapy has been approved for the treatment of depression since earning CE Mark in 2001 and 510(k) from the U.S. Food and Drug Administration in 2005. RECOVER – which stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy™ System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression – is a clinical study initiated in September 2019 as part of a Coverage with Evidence Development framework per the U.S.

自2001年获得CE评分和2005年获得美国食品和药物管理局510（k）评分以来，利瓦诺娃的VNS疗法已被批准用于治疗抑郁症。RECOVER是一项前瞻性、多中心、随机对照盲法试验，证明了VNS Therapy™系统作为辅助治疗与无刺激控制在难治性抑郁症患者中的安全性和有效性，是2019年9月启动的一项临床研究，是美国证据开发框架覆盖范围的一部分。

Centers for Medicare and Medicaid (CMS) National Coverage Determination process..

医疗保险和医疗补助中心（CMS）全国覆盖率确定过程。。

The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life.

RECOVER是同类研究中规模最大的随机临床研究，它正在检查多达1000名18岁或18岁以上的单极或双相抑郁症患者，这些患者很难治疗。这项双盲随机对照研究正在评估VNS治疗如何缓解患者的抑郁症状并改善生活质量。

It is being carried out at up to 100 leading hospitals and medical centers across the United States. For more information on the RECOVER clinical study, please visit www.RECOVERVNS.com..

它正在美国多达100家领先的医院和医疗中心进行。有关RECOVER临床研究的更多信息，请访问www.RECOVERVNS.com。。

About VNS Therapy for Depression

关于VNS治疗抑郁症

The VNS Therapy™ System, Symmetry™, is FDA approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

VNS Therapy™系统Symmetry™已获得FDA批准，并在美国用于对18岁或以上经历严重抑郁发作且对四种或四种以上足够抗抑郁药治疗没有足够反应的患者进行慢性或复发性抑郁症的辅助长期治疗。

Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and are less noticeable over time. Safety information is available here..

常见的副作用是声音嘶哑、呼吸急促、喉咙痛和咳嗽。副作用通常发生在刺激期间，随着时间的推移不太明显。此处提供安全信息。。

About LivaNova

关于LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide.

利瓦诺娃股份有限公司是一家全球医疗技术公司，拥有近50年的经验，并坚持不懈地致力于通过医疗技术为患者及其家人提供希望，在特定的神经和心脏疾病中提供改变生活的解决方案。利瓦诺瓦总部位于伦敦，拥有约2900名员工，在全球100多个国家拥有分支机构，服务于患者、医疗保健专业人员和医疗保健系统。

For more information, please visit www.livanova.com..

欲了解更多信息，请访问www.livanova.com。。

Safe Harbor Statement

安全港声明

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 progress relating to the RECOVER study and the VNS Therapy System, Symmetry.

本新闻稿包含有关公司目标、信念、期望、战略、目标、计划、基本假设和其他不一定基于历史事实的陈述的“前瞻性陈述”。这些声明包括但不限于有关RECOVER研究和VNS治疗系统Symmetry进展的声明。

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.

由于各种因素的影响，实际事件可能与我们的前瞻性声明中指出的事件存在重大差异，包括公司最新年度报告表10-K第1A项中列出的因素，以及表10-Q季度报告和表8-K当前报告中包含的任何风险因素。

LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances..

利瓦诺娃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。。