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：需要一种安全有效的诊室碎石术治疗肾结石。肾结石很常见；它们影响着近 10% 的美国人口，并且患病率与高血压、糖尿病和肥胖等疾病同时持续增长。肾结石也是美国最昂贵的泌尿系统疾病之一。美国每年的医疗保健负担超过100亿美元。该成本的很大一部分是由于约 100 万次手术干预和 20-40% 的计划外术后事件发生率。这包括体外冲击波碎石术（SWL）（一种常见的无创外科手术）和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，这两种手术都是在患者麻醉的情况下在手术室中进行的。技术：SonoMotion 正在开发 Break WaveTM，这是一种基于办公室的、非侵入性、免麻醉的肾和输尿管结石碎石解决方案，旨在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受伤风险和手术并发症的发生率，并显着降低手术时间和成本。此外，低振幅脉冲将不需要麻醉，从而提供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，Break Wave 技术能够将最常见的人类结石类型破碎成尺寸一致为 1-2 毫米的碎片。在猪模型中进行的临床模拟表明，碎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，包括根据实验室和临床研究提供的后期设备设计和程序调整。