SONOMOTION BREAK WAVE™ LITHOTRIPSY DEVICE MEETS PIVOTAL TRIAL PRIMARY ENDPOINTS

May 14, 2026 |

3 min read

Full trial results to be presented at the American Urological Association (AUA) annual meeting on May 16, 2026
The Break Wave device non-invasively fragments stones in the kidney or ureter on fully awake patients, without anesthesia, and at any site of care – with the potential to become a first-line treatment option
SonoMotion received FDA clearance for the next-generation Break Wave device, with commercialization beginning in the second half of 2026
Kidney stones affect one in 10 people in the U.S., costing $10 billion annually and resulting in over 750,000 lithotripsy procedures per year¹

SAN MATEO, Calif., May 14, 2026 /PRNewswire/ -- SonoMotion, a venture-backed medical device company developing non-invasive solutions for kidney stones, announced today that the Break Wave Pivotal S.O.U.N.D Clinical Trial has met its co-primary efficacy and safety endpoints.

The pivotal trial results will be presented on behalf of the trial investigators by Dr. Ben Chew of the University of British Columbia during a plenary session at the 2026 AUA meeting in Washington DC on Saturday, May 16th at 11am ET. The presentation was one of the few studies selected to be part of the practice-changing, paradigm-shifting clinical trials in urology program (P2s). The AUA describes the P2s program as being "designed to showcase exceptional, groundbreaking studies that are expected to change the day-to-day practice of urology."

Break Wave uses low pressure focused ultrasound to fragment kidney stones by creating standing stress waves within the stone under real-time ultrasound image guidance. The procedure is completely non-invasive and requires no anesthesia or sedation, allowing patients to drive themselves to and from the procedure and eat and drink prior to the procedure.

"Kidney stones are incredibly disruptive, causing severe pain, impacting renal function, reducing health-related quality of life, and often requiring individuals and their caregivers to take time off school and work," said Ryan Hsi, MD, Associate Professor of Urology at the University of California, Irvine. "The Break Wave device represents the only anesthesia-free and ionizing radiation-free option to treat kidney stones in a variety of healthcare settings, which means it can be delivered to patients where they need it. Since it is non-invasive, it will allow patients to recover quickly and return to their busy lives."

On the heels of its original FDA clearance for Break Wave in January 2026, SonoMotion also announced that it received FDA 510(k) clearance on May 1, 2026, for the next-generation Break Wave device. The newly cleared version features therapy probes with a 31% smaller footprint and significantly lighter weight. Commercialization will begin in the second half of 2026.

"Meeting our pivotal trial endpoints while receiving FDA clearance for a more compact device puts us in a strong position to bring Break Wave to the millions of patients who suffer from kidney stones each year," said Oren Levy, PhD, Co-Founder and Chief Executive Officer of SonoMotion. "We are proud of the team for continuously improving the technology, and are delighted to offer a truly non-invasive, anesthesia-free treatment that patients need and deserve."

The SonoMotion solution will be featured at booth #1508 during the 2026 AUA meeting.

ABOUT SONOMOTION

SonoMotion, a venture capital backed startup based in San Mateo, CA, is a commercial medical technology company developing next-generation, noninvasive solutions for the treatment of kidney stones. To learn more, please visit www.sonomotion.com.

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