Nevro Corp, a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of new data in the Journal of Pain Research demonstrating significant, durable pain relief and long-term and clinically meaningful reductions in hemoglobin A1c (HbA1c) and weight in study participants with painful diabetic neuropathy (PDN) and Type 2 diabetes who received 10 kHz high-frequency spinal cord stimulation (SCS) therapy.1.

Nevro Corp是一家全球医疗器械公司，正在为慢性疼痛的治疗提供全面的，改变生活的解决方案，今天宣布在《疼痛研究杂志》上发表新数据，证明显着，持久的疼痛缓解以及长期和临床上有意义的血红蛋白A1c（HbA1c）和体重降低接受10 kHz高频脊髓刺激（SCS）治疗的疼痛性糖尿病神经病变（PDN）和2型糖尿病患者的研究参与者。

Globally, the number of people with diabetes has quadrupled in the last two decades2, and PDN impacts up to 25% of all people with diabetes.3 PDN can have significant impacts on the quality of life for people living with this condition, with symptoms like numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.4 Patients typically manage PDN with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects.5 As a result, people with PDN suffer from significantly reduced health-related quality of life (HRQoL), impaired functionality and other comorbidities like sleep disorders, depression, and anxiety.6.

在全球范围内，糖尿病患者的数量在过去二十年中翻了两番2，PDN影响了所有糖尿病患者的25%。3 PDN可以对患有这种疾病的人的生活质量产生重大影响，症状包括麻木，刺痛/感觉异常，保护性感觉丧失，平衡受损以及对感觉刺激的反应降低。4患者通常使用口服止痛药治疗PDN，但这些药物的疗效相对较低，可能导致无法忍受的副作用。因此，PDN患者的健康相关生活质量（HRQoL）显着降低，功能受损以及其他合并症，如睡眠障碍，抑郁症等。和焦虑。

The analysis evaluated 144 patients with Type 2 diabetes and refractory PDN who received 10 kHz SCS therapy during the SENZA-PDN randomized controlled trial (RCT), the largest RCT to evaluate SCS to treat PDN. Changes in pain intensity, HbA1c, weight, and sleep were evaluated over 24 months, with participants stratified according to preimplantation HbA1c..

该分析评估了144名2型糖尿病和难治性PDN患者，他们在SENZA-PDN随机对照试验（RCT）期间接受了10 kHz SCS治疗，这是评估SCS治疗PDN的最大RCT。在24个月内评估疼痛强度，HbA1c，体重和睡眠的变化，参与者根据植入前HbA1c进行分层。。

At 24 months, the following benefits were noted1:

在24个月时，注意到以下好处1：

Significant, durable pain relief: Study participants had a mean pain reduction of 79.8% and the mean visual analog scale (VAS) score for lower limb pain decreased from 7.5 ± 0.1 cm at preimplantation to 1.5 ± 0.2 cm (p < 0.001).

显着，持久的疼痛缓解：研究参与者的平均疼痛减轻了79.8%，下肢疼痛的平均视觉模拟评分（VAS）评分从植入前的7.5±0.1 cm降至1.5±0.2 cm（p＜0.001）。

Clinically meaningful, statistically significant mean reductions in HbA1c: Participants with preimplantation HbA1c >7% and >8% achieved mean reductions of 0.5% (p = 0.031) and 1.1% (p = 0.004), respectively.

临床上有意义的，统计学上显着的HbA1c平均降低：植入前HbA1c>7%和>8%的参与者分别平均降低0.5%（p=0.031）和1.1%（p=0.004）。

Significant mean weight loss: Across all study participants, patients achieved a significant mean weight loss of 3.1 kg (p = 0.003). In participant subgroups with body mass indices (BMI) of ≥ 30 and ≥ 35 kg/m2, mean weight reductions were 4.1 kg (p = 0.001) and 5.4 kg (p = 0.005), respectively.

显着的平均体重减轻：在所有研究参与者中，患者的平均体重减轻了3.1公斤（p=0.003）。在体重指数（BMI）≥30和≥35 kg/m2的参与者亚组中，平均体重减轻分别为4.1 kg（p=0.001）和5.4 kg（p=0.005）。

Significant, durable reductions in pain interference with sleep: Study participants experienced a highly significant improvement in sleep quality, with pain and sleep questionnaire three-item (PSQ-3) scores decreasing by a mean of 65.2%, corresponding to a mean value of 1.9 ± 0.2 cm (p < 0.001).

疼痛对睡眠干扰的显着，持久的减少：研究参与者的睡眠质量有了非常显着的改善，疼痛和睡眠问卷三项（PSQ-3）评分平均下降了65.2%，相当于平均值1.9±0.2厘米（p<0.001）。

'People with PDN know that this condition can extend well beyond pain – impacting sleep, sensory functions, and overall quality of life,' said Dr. David Klonoff, Medical Director, Diabetes Research Institute at Mills-Peninsula Medical Center. 'This is the first study of SCS to demonstrate long-term, significant and clinically meaningful reductions in HbA1c and weight in people with PDN and Type 2 diabetes – suggesting possible metabolic benefits with 10 kHz SCS for these patients.'.

米尔斯半岛医学中心糖尿病研究所医学主任DavidKlonoff博士说，患有PDN的人知道这种情况可能远远超出疼痛的范围，影响睡眠、感觉功能和整体生活质量这是SCS的第一项研究，证明PDN和2型糖尿病患者的HbA1c和体重长期显着且具有临床意义的降低，这表明10 kHz SCS可能对这些患者产生代谢益处。”。

'The SENZA-PDN RCT has already demonstrated the significant pain relief benefit when using Nevro's HFX device for the millions of people suffering from PDN around the world,' said Dr. David Caraway, Nevro's Chief Medical Officer. 'Now, for the first time, we've observed secondary benefits like improved HbA1c and weight loss, which exhibit potentially disease-modifying effects for people with Type 2 diabetes.

“SENZA-PDN随机对照试验已经证明，当使用Nevro的HFX设备治疗全世界数百万患有PDN的人时，可以显着缓解疼痛，”Nevro的首席医疗官David Caraway博士说现在，我们首次观察到次要益处，如改善HbA1c和减肥，这对2型糖尿病患者具有潜在的疾病缓解作用。

I'm grateful for the dedication of the clinical investigators who supported this latest analysis and the broader SENZA-PDN RCT as we continue gathering data to support market access for more patients.'.

我感谢临床研究人员的奉献，他们支持这项最新分析和更广泛的SENZA-PDN RCT，因为我们继续收集数据，以支持更多患者的市场准入。”。

The 24-month data from the SENZA-PDN RCT were originally published in Diabetes Research and Clinical Practice in 2023. These data showed that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and improvements in HRQoL, neurological function, and sleep at 24 months post-implantation..

SENZA-PDN RCT的24个月数据最初于2023年发表在《糖尿病研究与临床实践》上。这些数据表明，与单独使用CMM相比，接受高频10 kHz SCS植入物和常规医疗管理（CMM）的患者在植入后24个月经历了持久的疼痛缓解和HRQoL，神经功能和睡眠的改善。。

To learn more about Nevro's 10 kHz Therapy™ for PDN, visit www.nevro.com.

要了解更多有关Nevro针对PDN的10 kHz Therapy™的信息，请访问www.Nevro.com。

References

参考文献

Nevro's high-frequency, 10 kHz spinal cord stimulation (SCS) device has not been approved or evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of HbA1c and/or weight loss.

Nevro的高频10 kHz脊髓刺激（SCS）装置尚未获得美国食品和药物管理局（FDA）的批准或评估，用于治疗HbA1c和/或减肥。

World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871

。（2016年）《全球糖尿病报告》。。https://apps.who.int/iris/handle/10665/204871

Shillo P, et al. Painful and Painless Diabetic Neuropathies: What Is the Difference? Curr Diab Rep. 2019 May 7;19(6):32. doi: 10.1007/s11892-019-1150-5. PMID: 31065863; PMCID: PMC6505492.

疼痛性和无痛性糖尿病神经病变：有什么区别？Curr Diab Rep.2019年5月7日；19（6）：32。doi:10.1007/s11892-019-1150-5。PMID:31065863；PMCID:PMC6505492。

Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022.

Pop Busui R，Ang L，Boulton AJM，Feldman EL，Marcus RL，Mizokami Stout K等。疼痛性糖尿病周围神经病变的诊断和治疗。阿灵顿（VA）：美国糖尿病协会；2022

Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083.

Yang，M.，Qian，C.，＆Liu，Y.（2015）。美国糖尿病周围神经性疼痛的次优治疗。疼痛医学（马萨诸塞州马尔登），16（11），2075-2083。

Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes research and clinical practice, 109(2), 215–225.

。欧洲痛苦的糖尿病周围神经病变的人文和经济负担：文献综述。糖尿病研究与临床实践，109（2），215-225。

Internet Posting of Information

网上发布信息

Nevro routinely posts information that may be important to investors in the 'Investors' section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

Nevro定期在其网站www.Nevro.com的“投资者”部分发布对投资者可能重要的信息。公司鼓励投资者和潜在投资者定期咨询Nevro网站，以获取有关Nevro的重要信息。

About Nevro

关于Nevro

Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 115,000 patients globally.

Nevro总部位于加利福尼亚州红木市，是一家全球医疗器械公司，专注于提供全面的改变生活的解决方案，继续为慢性疼痛治疗中持久的患者结果设定标准。。

Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy..

。。

Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ('SI joint') pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients..

Nevro最近为患有慢性骶髂关节（“SI关节”）疼痛的患者增加了一种微创治疗选择，现在在SI关节融合领域提供了最全面的产品组合，旨在满足医生的偏好和不同的患者需求，以改善患者的预后和生活质量。。

Senza®, Senza II®, Senza Omnia™, and HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with Nevrocloud™ insights for enhanced patient and practice management..

Senza®、Senza II®、Senza Omnia™和HFX iQ是唯一提供Nevro专有10 kHz治疗的SCS系统。Nevro独特的支持服务为每位患者在整个止痛过程中提供HFX Coach™服务，并为每位医生提供Nevrocloud™见解，以增强患者和实践管理。。

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX AdaptivAI, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp.

SENZA、SENZA II、SENZA OMNIA、OMNIA、HF10、HF10徽标、10 kHz治疗、HFX、HFX徽标、HFX iQ、HFX iQ徽标、HFX算法、HFX CONNECT、HFX CONNECT徽标、HFX ACCESS、HFX ACCESS徽标、HFX COACH、HFX COACH徽标、Nevrocloud、RELIEF MULTIPLIED、HFX AdaptivAI、X徽标、NEVRO和NEVRO徽标是NEVRO Corp的商标或注册商标。

Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents. Bluetooth® and the Bluetooth symbol are registered trademarks of their respective owners..

涵盖Senza HFX iQ和其他Nevro产品的专利在Nevro.com/Patents上列出。Bluetooth®和Bluetooth符号是其各自所有者的注册商标。。

To learn more about Nevro, connect with us on LinkedIn, X, Facebook, and Instagram.

要了解更多关于Nevro的信息，请通过LinkedIn、X、Facebook和Instagram与我们联系。

Investors and Media:

投资者和媒体：

Angie McCabe

安吉·麦凯布

Vice President, Investor Relations & Corporate Communications

投资者关系与企业传播副总裁

[email protected]

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Source: nevro.com

来源：nevro.com