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

Break Wave 的商业准备就绪 - 基于 SonoMotion Office 的碎石解决方案

• 批准号: 10385222
• 负责人: Oren Levy
• 金额: $ 40万
• 依托单位: SONOMOTION, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385222
• 关键词: Accident and Emergency department; Acoustics; Acute; Adoption; Adverse event; Affect; Algorithms; American; Americas; Anesthesia procedures; Animals; Biological Assay; Canada; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Computer Models; Cost of Illness; Data; Device Designs; Devices; Diabetes Mellitus; Disease; Dose; Effectiveness; Event; Extracorporeal Shockwave Lithotripsy; Family suidae; Fluoroscopy; Fracture; Goals; Grant; Healthcare; Histologic; Human; Hypertension; In Vitro; Injury; Injury to Kidney; Intervention; Kidney; Kidney Calculi; Laser Lithotripsy; Lithotripsy; Methods; Minor; Obesity; Operative Surgical Procedures; Outcome; Patients; Physiologic pulse; Population; Prevalence; Procedures; Readiness; Risk; Safety; Scheme; Shock; Stents; Stress; System; Technology; Temperature; Testing; Therapeutic; Time; Ultrasonography; Ureteroscopy; Urologic Diseases; Urology; Vision; Visit; Waxes; Width; Work; base; care burden; commercialization; cost; design; efficacious treatment; first-in-human; human subject; imaging system; lens; new technology; novel; porcine model; pressure; simulation; standard of care

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.

意义：需要对肾结石进行安全有效的基于办公室的岩石疗法治疗。肾结石很常见；它们影响了近10％的美国人口，并且患病率与高血压，糖尿病和肥胖症等疾病并行同行。肾结石也是美国最昂贵的泌尿科疾病之一。美国的医疗保健负担每年超过100亿美元。这笔成本的很大一部分是由于大约一百万个手术干预措施和计划外术后事件的20-40％。这包括常见的非侵入性手术干预措施（SWL）和输尿管镜激光岩石疗法（URS），这是一种常见的内窥镜检查。两者都有重大不良事件的5％或更高的风险，在美国，这两种程序均在手术套件中进行，并在患者麻醉的情况下进行。技术：Sonomotion正在开发Break Wavetm，这是一种基于办公室的，无创和麻醉的肾脏和输尿管石的无碎石疗法，以重新定义数百万人的护理标准。 Break Wave采用了一种新型技术，该技术使用了超声波的多周期，低振幅脉冲而不是冲击波来诱导石材断裂。这种方法有可能降低受伤的风险和程序并发症的速度，并显着降低程序时间和成本。此外，低振幅脉冲将排除对麻醉的需求，提供基于办公室的治疗方法。这也可能提供有吸引力的替代障碍石的主动监视。初步数据：体外研究表明，Break Wave技术能够将大多数常见的人类石材类型分解为始终是1-2 mm的碎片。在猪模型中进行的临床模拟表明，破坏石头所需的超声剂量低于诱导肾脏损伤所需的水平。临床研究表明，该技术在人类中安全有效。具体目的：当前项目中包含的具体目的集中在商业化和广泛采用市场所需的活动上，包括后期设备的设计以及由台式和临床研究所告知的后期设备设计和程序调整。