SonoMotion's Break Wave Lithotripsy Device Achieves Clinical Trial Milestones

Break Wave Device Meets Key Clinical Trial Benchmarks

In a groundbreaking development in urology, SonoMotion, a California-based medical device company, has announced that its Break Wave lithotripsy device has successfully met its pivotal trial's co-primary efficacy and safety endpoints. This announcement comes ahead of a key presentation scheduled at the upcoming American Urological Association (AUA) annual meeting on May 16, 2026, where the full trial results will be disclosed by Dr. Ben Chew of the University of British Columbia.

The Break Wave device stands out as it offers a non-invasive treatment method for kidney stones by utilizing low-pressure focused ultrasound technology. This innovative approach allows for the fragmentation of kidney stones without anesthesia, enabling patients to remain fully awake during the procedure. The ease of this treatment means that it can be performed at various healthcare settings, making it accessible to a wider range of patients.

Kidney stones are a common issue, affecting approximately one in ten people in the United States, leading to over 750,000 lithotripsy procedures annually, with an economic burden of around $10 billion. The results from the pivotal clinical trial highlight the need for effective and patient-friendly solutions in this domain.

Dr. Ryan Hsi, an Associate Professor of Urology at the University of California, Irvine, emphasizes the significant impact kidney stones have on patients' lives, noting the severe pain and associated lifestyle interruptions they cause. According to Dr. Hsi, the Break Wave device is revolutionary as it eliminates the need for anesthesia and ionizing radiation, facilitating a faster recovery for patients. As they do not require sedation, patients are also able to drive themselves home after the procedure, underscoring the convenience of this treatment.

Recently, the Break Wave device received FDA clearance, marking a pivotal moment in SonoMotion's journey. The approval allows the next-generation Break Wave device to enter the market in the latter half of 2026. This new version boasts improved therapy probes that are 31% smaller and considerably lighter than its predecessor.

Oren Levy, Co-Founder and CEO of SonoMotion, expressed pride in the team's accomplishment and highlighted the broader implications of this technology for patients. He noted that meeting clinical trial endpoints strengthens their position to bring the Break Wave treatment to millions of patients struggling with kidney stones, showcasing a significant enhancement in the quality of care.

The device will be on display at booth #1508 at the AUA meeting, where further details about its functionality and effectiveness will be available. With the continued advancement of non-invasive technologies, SonoMotion is well poised to change the landscape of kidney stone treatment, offering patients relief without the traditional burdens associated with surgical procedures.

As the medical community prepares for this new standard in kidney stone management, the anticipation builds for the future implications of the Break Wave device. For those affected by this common condition, it signifies hope for a less invasive, more effective treatment option.

For further information, visit SonoMotion’s official website.