# First-In-Human Feasibility Trial of Break Wave - The Office-Based Lithotripsy Solution

> **NIH NIH R44** · SONOMOTION, INC. · 2021 · $969,606

## Abstract

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
most costly 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 an office-based,
non-invasive, and anesthesia free stone lithotripsy solution for kidney and ureteral stones to redefine the
standard of care for millions of people. Break WaveTM (i.e. BWL) is a novel method of stone fragmentation 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 fragmenting most common human stones into fragment sizes that are
consistently less than 1 mm. Clinical simulation conducted in a porcine model indicates the pressure levels
required to break stones are below the pressure levels required to induce renal injury. Specific Aims: Aim 1 is
a 30-patient, prospective, open-label, multi-center, single-arm First-In-Human feasibility clinical trial to assess
the safety and effectiveness of Break Wave. Subjects presenting with upper urinary tract stones will be recruited
as an alternative to SWL. Effectiveness is to be determined by stone passage, post-treatment low dose CT
imaging, and the need for secondary procedures; safety is to be evaluated through the documented occurrences
of adverse events, post-procedural imaging, unplanned physician/ED visits. Procedural tolerance and
effectiveness will also be evaluated at multiple pressure levels and at reduced to no anesthesia. The trial will be
conducted across 4 centers to derive a broad range of feedback across multiple well-established urologists.
Throughout the trial, SonoMotion will identify device design and procedural adjustments to improve safety and
effectiveness, and implement those changes in Aim 2. Aim 2 will...

## Key facts

- **NIH application ID:** 10133627
- **Project number:** 5R44DK109779-06
- **Recipient organization:** SONOMOTION, INC.
- **Principal Investigator:** Oren Levy
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $969,606
- **Award type:** 5
- **Project period:** 2016-05-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10133627

## Citation

> US National Institutes of Health, RePORTER application 10133627, First-In-Human Feasibility Trial of Break Wave - The Office-Based Lithotripsy Solution (5R44DK109779-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10133627. Licensed CC0.

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