Neuspera® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved its integrated sacral neuromodulation (iSNM) system for the treatment of urinary urge incontinence (UUI).

Neuspera® Medical, Inc.，神经调节未来综合技术的领先开发者，今天宣布美国食品药品监督管理局（FDA）已批准其用于治疗尿急失禁（UUI）的综合骶神经调节（iSNM）系统。

Neuspera's iSNM system offers patients with UUI an alternative to traditional SNM. UUI is a major component of overactive bladder, a condition that affects approximately 1 in 5 women in the U.S. UUI has a major impact on quality of life, driving the demand for more effective and patient-friendly treatment options. .

Neuspera的iSNM系统为患有UUI的患者提供了传统SNM的替代方案。UUI是膀胱过度活动症的主要组成部分，这种疾病影响着美国大约五分之一的女性。UUI对生活质量有重大影响，推动了对更有效且更友好的治疗方案的需求。

Six-month pivotal trial data showed the Neuspera iSNM device delivers efficacy comparable to established SNM therapies, while eliminating the discomfort, surgical risks, and cosmetic concerns of implanted batteries.

六个月的关键试验数据显示，Neuspera的iSNM装置在疗效上与现有的SNM疗法相当，同时消除了植入电池带来的不适、手术风险和美观方面的顾虑。

The Phase II pivotal clinical study of 128 patients implanted with Neuspera's iSNM therapy found:

Neuspera的iSNM疗法植入128名患者的II期关键临床研究发现：

84.2% of patients had a 50% or greater reduction in urgent leaks

84.2%的患者紧急漏尿减少了50%或更多

– on par with reported rates in recent SNM studies

– 与近期SNM研究中报告的比率相当

84% of patients who responded to treatment were classified as 'super responders,'

84%的治疗有效的患者被归类为“超级反应者”，

meaning they experienced more than a

这意味着他们经历了更多的

75% reduction in UUI symptoms

UUI症状减少75%

42% of patients who responded were completely 'dry,' with 100% reduction in UUI symptoms

42% 的患者完全“干爽”，UUI 症状减少了 100%

3.5x clinically significant improvement in quality of life

生活质量显著提高了3.5倍

with a reduction in voids and urgent episodes

随着空隙和紧急情况的减少

'FDA approval of Neuspera's iSNM system represents a major advancement for millions of patients with UUI,' said Dr.

“Neuspera的iSNM系统获得FDA批准，这代表了数百万UUI患者的重大进步，”博士表示。

Howard Goldman

霍华德·戈德曼

, vice-chairman of Urology at the Cleveland Clinic. 'For too long, patients have had to weigh the benefits of SNM therapy against real concerns about complications related to implanted batteries and the need for surgeries to replace it. Neuspera's integrated system provides symptom relief without these additional burdens.'.

克利夫兰诊所泌尿科副主任。“长期以来，患者不得不权衡SNM疗法的益处与对植入电池相关并发症的真实担忧以及更换手术的必要性。Neuspera的集成系统提供了症状缓解，且没有这些额外负担。”

How Neuspera's Integrated iSNM Therapy Works

Neuspera的集成iSNM疗法如何工作

Neuspera's integrated Sacral Neuromodulation (iSNM) system offers all the capabilities of traditional SNM in a highly advanced form factor. A smart, miniaturized neurostimulator is implanted near the sacral nerve, and therapy is activated using an external disc worn against the lower back for approximately two hours daily.

Neuspera的集成骶神经调节（iSNM）系统以高度先进的形式提供了传统SNM的所有功能。一个智能的小型神经刺激器被植入靠近骶神经的位置，治疗通过佩戴在下背部的外部磁盘激活，每天大约使用两个小时。

When not in use, the therapy disc charges wirelessly, like a smartphone. This intelligent system supports complex neuromodulation therapy delivery while eliminating complications related to implanted batteries, addressing common patient concerns without compromising performance..

当不使用时，治疗盘像智能手机一样进行无线充电。这一智能系统支持复杂的神经调节治疗传递，同时消除了与植入电池相关的并发症，在不影响性能的情况下解决了常见的患者顾虑。

'Neuspera is setting a new standard in UUI therapy with the first integrated SNM system,' said

“Neuspera凭借首个集成的SNM系统，正在为UUI治疗设立新的标准，”

Dave Van Meter

戴夫·范·米特

, CEO of Neuspera. 'Our mission is to remove barriers to care with a smart, patient-centered solution that truly improves quality of life for the millions impacted by UUI. This FDA approval is a proud and meaningful moment for the entire Neuspera team and our clinical partners, whose passion and dedication made it possible.'.

Neuspera首席执行官表示：“我们的使命是通过一种智能的、以患者为中心的解决方案来消除护理障碍，这一方案真正改善了受UUI影响的数百万人的生活质量。此次FDA批准对于整个Neuspera团队以及我们的临床合作伙伴来说，是一个值得骄傲且意义重大的时刻，正是他们的热情和奉献使之成为可能。”

About Neuspera Medical

关于Neuspera Medical

Neuspera Medical, Inc. is a leader in advanced, directionally adaptive energy systems that power tiny medical implants deep within the body. The company is introducing a new class of neurostimulation technology, starting with the first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence (UUI), approved by the FDA in .

Neuspera Medical, Inc. 是一家领先的公司，专注于先进的、方向自适应的能量系统，为深入人体内部的微型医疗植入物提供动力。该公司正在推出一类新的神经刺激技术，首先推出了用于治疗急迫性尿失禁 (UUI) 的首个集成骶神经调节 (iSNM) 系统，并已获得 FDA 批准。