Commercial readiness of Break Wave - The SonoMotion Office-Based Lithotripsy Solution

意义：需要一种安全有效的办公室碎石治疗肾结石。肾结石很常见；它们影响着近10%的美国人口，其患病率与高血压、糖尿病和肥胖等疾病同步增长。肾结石也是美国最昂贵的泌尿系统疾病之一；美国的医疗负担每年超过100亿美元。这一费用的很大一部分是由于大约100万次手术干预和20-40%的意外术后事件。这包括体外冲击波碎石术（SWL），一种常见的非侵入性手术干预，以及输尿管镜激光碎石术（URS），一种常见的内窥镜手术。这两种手术都有5%或更高的严重不良事件的风险，在美国，这两种手术都是在病人麻醉的情况下在手术室内进行的。技术：SonoMotion正在开发Break WaveTM，这是一种基于办公室的、无创的、无麻醉的肾结石和输尿管结石碎石解决方案，将重新定义数百万人的护理标准。Break Wave采用了一种新颖的技术，使用多周期、低振幅的超声脉冲而不是冲击波来诱导结石骨折。这种方法有可能降低损伤的风险和手术并发症的发生率，并显著降低手术时间和成本。此外，低振幅脉冲将排除麻醉的需要，提供一种基于办公室的治疗方法。这也可能为主动监视障碍物提供一种有吸引力的替代方案。初步数据：体外研究表明，破波技术能够将大多数常见的人类结石类型破碎成1-2毫米大小的碎片。在猪模型中进行的临床模拟表明，破石所需的超声剂量低于引起肾损伤所需的剂量。临床研究表明该技术对人体安全有效。具体目标：当前项目的具体目标集中在商业化和广泛市场采用所需的活动上，包括后期设备设计和根据实验和临床研究进行的程序调整。

Significance: There is a need for a safe and effective office-based lithotripsy treatment for kidney stones. Kidney stones are common; they affect nearly 10% of the US population and the prevalence continues to grow in parallel with diseases such as high blood pressure, diabetes, and obesity. Kidney stones are also one of the costliest urologic diseases in America; the health care burden in the US exceeds $10 billion annually. A substantial portion of this cost is due to the approximately one million surgical interventions and 20-40% rate of unplanned post-surgical events. This includes extracorporeal shock wave lithotripsy (SWL), a common noninvasive surgical intervention, and ureteroscopy laser lithotripsy (URS), a common endoscopic procedure. Both have a 5% or greater risk of significant adverse events and, in the US, both procedures are conducted within a surgical suite with the patient anesthetized. Technology: SonoMotion is developing Break WaveTM, an office-based, non-invasive, and anesthesia free lithotripsy solution for kidney and ureteral stones to redefine the standard of care for millions of people. Break Wave employs a novel technology that uses multi-cycle, low-amplitude pulses of ultrasound rather than shock waves to induce stone fracture. This approach has the potential to reduce the risk of injury and the rate of procedural complications, as well as significantly lower procedural time and cost. Furthermore, the low amplitude pulses will preclude the need for anesthesia, providing an office-based treatment method. This could also potentially provide an attractive alternative to active surveillance of an obstructing stone. Preliminary Data: In vitro studies have shown the Break Wave technology is capable of breaking most common human stone types into fragment that are consistently 1-2 mm in size. Clinical simulation conducted in a porcine model indicates the ultrasound dose required to break stones is below the level required to induce renal injury. Clinical studies show the technology safe and effective in humans. Specific Aim: The specific aim included in the current project are focused on activities required for commercialization and widespread market adoption, including late-stage device design and procedural adjustments as informed by bench top and clinical studies.