FDA issues de novo clearance SonoMotion’s Stone Clear device, for kidney stone treatment

Stone Clear

Credit: SonoMotion, Inc.

SonoMotion Inc., a venture-backed medical device company focused on non-invasive kidney stone treatments, announced Nov. 13 it has received de novo clearance from the U.S. Food and Drug Administration for its Stone Clear device.

The approval marks the first device cleared by the FDA that uses external ultrasound pulses to help move and facilitate passage of post-lithotripsy kidney stone fragments without surgery.

“SonoMotion’s goal is to fundamentally change how kidney stones are treated, and securing FDA clearance for Stone Clear is a major milestone toward this goal,” said Oren Levy, Ph.D., co-founder and chief executive officer of SonoMotion, in the statement. “Our technologies have the potential to be a first-line treatment for kidney stones, offering patients an option to avoid anesthesia and reduce wait times for surgery.”

Kidney stones affect one in 10 people in the United States, leading to an estimated $10 billion in annual health care costs, according to the company. Stones can be treated with various methods, including lithotripsy, which breaks them into smaller pieces. However, residual fragments can remain and result in complications, such as emergency department visits or repeat procedures.

Stone Clear is part of a platform designed to move and facilitate the passage of stone fragments without anesthesia in a range of health care settings, including outpatient offices and emergency departments. According to the company, ultrasound propulsion in patients with post-lithotripsy residual fragments reduced the risk of relapse by 70% compared to standard observation. Results from the randomized controlled clinical trial, which included up to five years of follow-up, will be published in the December 2024 issue of the Journal of Urology.

"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, MD, Clinical Professor of Urology, Indiana University School of Medicine, in a company news release. "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."

SonoMotion is also developing Break Wave, a second solution that uses focused ultrasound to fragment stones in the upper urinary tract without anesthesia. Break Wave is undergoing clinical trials in the United States and Canada.