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.

NARRATIVE One in 11 Americans will have kidney stones in their lifetime. Most of the $10B annual cost of this disease is incurred by visits to the emergency department, surgery, and unplanned post-surgery events. The proposed work has the goal of commercializing Break Wave, a promising new technology that offers an office-based and anesthesia-free method to fragment stones that has the potential to reduce complications and costs associated with current stone management.