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

意义：需要一种安全有效的基于诊所的肾结石碎石治疗。肾结石是常见的;它们影响近10%的美国人口，并且患病率继续与诸如高血压、糖尿病和肥胖症的疾病平行地增长。肾结石也是美国最昂贵的泌尿系统疾病之一;美国每年的医疗负担超过100亿美元。这一成本的很大一部分是由于大约100万次手术干预和20-40%的计划外术后事件。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。两者都有5%或更高的重大不良事件风险，并且在美国，两种手术都是在患者麻醉的手术室内进行的。工艺流程：SonoMotion正在开发Break WaveTM，这是一种基于办公室的非侵入性和无麻醉的肾结石和输尿管结石碎石解决方案，可以重新定义数百万人的护理标准。Break Wave采用了一种新技术，该技术使用多周期、低振幅的超声波脉冲而不是冲击波来诱导结石破裂。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，低幅度脉冲将排除麻醉的需要，提供基于办公室的治疗方法。这也可能提供一个有吸引力的替代方案，以主动监视阻塞的石头。初步数据：体外研究表明，Break Wave技术能够将大多数常见的人体结石类型破碎成大小一致的1-2 mm碎片。在猪模型中进行的临床模拟表明，破碎结石所需的超声剂量低于诱导肾损伤所需的水平。临床研究表明，该技术对人类安全有效。具体目标：当前项目中包含的具体目标侧重于商业化和广泛市场采用所需的活动，包括实验室和临床研究所告知的后期器械设计和程序调整。

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.