“Receiving FDA clearance is a pivotal milestone for our company and, more importantly, for patients seeking better options for kidney stone treatment,” Oren Levy, San Mateo, California–based SonoMotion’s co-founder and CEO, said in a news release yesterday.
“This 510(k) clearance represents a significant step toward commercialization, and we look forward to scaling manufacturing and making our non-invasive, anesthesia-free solutions available to patients and providers across the urology community. We are deeply grateful to the patients who participated in our studies, as well as the support from clinicians, investors, NASA, and the NIH.”
The news comes nine months after SonoMotion secured a $2.2 million NIH grant and successfully completed enrollment in a pivotal clinical trial for Break Wave.
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. According to the company, the procedure is completely non-invasive and requires no anesthesia. Patients are able to drive themselves to and from the procedure, and they can even eat and drink in the time leading up to the procedure.
Another SonoMotion system, Stone Clear, complements Break Wave because it helps clear the kidney of residual fragments post-lithotripsy. Stone Clear received FDA 510(k) de novo clearance in October 2024.
“Break Wave provides a new option for the safe and effective treatment of kidney stones that can be performed in nearly any healthcare setting and does not require a ureteral stent,” said Dr. Helena Chang of Kaiser Permanente.
“Patients with symptomatic obstructing ureteral stones can move immediately to treatment, saving weeks of pain and discomfort trying to pass a stone. Additionally, patients with asymptomatic kidney stones have an option to treat stones before they cause a painful event.”
