SonoMotion’s Break Wave Lithotripsy Device Meets its Clinical Trial Goals

SonoMotion said its Break Wave pivotal S.O.U.N.D clinical trial has met its co-primary efficacy and safety endpoints. 

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 before the procedure.

Kidney stones affect one in 10 people in the United States, costing $10 billion annually and resulting in more than 750,000 lithotripsy procedures per year.¹

“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, M.D., 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.”

The U.S. Food and Drug Administration cleared SonoMotion’s original and next-generation Break Wave devices. The latest version features therapy probes with a 31% smaller footprint and a significantly lighter weight.

“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,” SonoMotion Co-Founder/CEO Oren Levy, Ph.D., stated. “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.”

A venture capital-backed startup based in San Mateo, Calif., SonoMotion is a commercial medical technology company developing next-generation, noninvasive solutions for kidney stone treatment. 

Reference
¹ Litwin MS, CS S. NIH Publication No. 12-7865.