SonoMotion Nabs FDA De Novo Clearance for Stone Clear Device

The U.S. Food and Drug Administration (FDA) has granted de novo clearance to SonoMotion’s Stone Clear device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments. Stone Clear reportedly is the first and only device that delivers ultrasound pulses externally to move and facilitate the passage of residual fragments without surgery and in the clinic setting.

“Patients with post-lithotripsy residual fragments are more likely to have complications, emergency department visits, or repeat procedures, yet they have no reliable non-invasive option aside from passive observation,” said James E. Lingeman, M.D., clinical professor of Urology, Indiana University School of Medicine. “The Stone Clear device provides patients with a non-invasive option to reduce their residual fragment stone burden in the clinic environment while being fully awake.”

Kidney stones affect one in 10 people in the United States, costing $10 billion annually.¹ The Stone Clear device is part of a platform designed to treat kidney stones without requiring anesthesia and in any health care settings where a patient with a kidney stone may present themselves, including the doctor’s office and emergency departments.

Ultrasound propulsion in patients with post-lithotripsy residual fragments reduced the risk of relapse by 70% compared to standard-of-care observation.² Results from the randomized controlled clinical trial with up to five-year follow-up were published in the December 2024 issue of the Journal of Urology.

SonoMotion’s second solution, called Break Wave, will operate on the same platform and will use focused ultrasound to non-invasively fragment kidney stones in the upper urinary tract without anesthesia and in a clinic setting. Break Wave is currently undergoing clinical trials in the United States and Canada.

“SonoMotion’s goal is to fundamentally change how kidney stones are treated, and securing FDA clearance for Stone Clear is a major milestone towards this goal,” SonoMotion Co-Founder/CEO Oren Levy, Ph.D., said. “SonoMotion’s technologies have the potential to be a first-line treatment for kidney stones, offering a solution for patients who want to avoid anesthesia, minimize wait times for surgery without the need for urinary stenting—a procedure often more painful than the kidney stone itself.”

A VC-backed startup based in San Mateo, Calif., SonoMotion is a clinical stage medical technology company developing next-generation non-invasive solutions for kidney stone treatment. The SonoMotion Break Wave device is an investigational product not approved for sale anywhere in the world.

References
¹ Litwin MS, CS S. NIH Publication No. 12-7865.
² Sorensen MD et al. Randomized Controlled Trial of Ultrasonic Propulsion–Facilitated Clearance of Residual Kidney Stone Fragments vs Observation. Journal of Urology. 2024 Dec 1;212(6):811–20.