Enrollment Complete in SonoMotion’s Break Wave Study

SonoMotion has been awarded a $2.2 million National Institutes of Health grant and completed patient enrollment in the SOUND Break Wave pivotal clinical trial.

The SOUND trial is a 64-patient, prospective, multi-center, non-randomized study evaluating the safety and effectiveness of the Break Wave system for fragmentation of stones in the kidney or ureter. The trial results will serve as the clinical basis for SonoMotion’s planned U.S. Food and Drug Administration (FDA) 510(k) submission for the Break Wave device. 

“Patients with obstructive kidney stones typically require treatment in a surgical suite under conscious sedation or general anesthesia,” said Dr. James Johannes, director at the Center of Endourology and Stone Disease, Lehigh Valley Health Network. “The Break Wave device provides patients with a noninvasive, anesthesia-free treatment option that can be performed at a variety of healthcare settings.  Break Wave has the potential to provide expedited stone treatment and faster convalescence allowing patients to return to their lives sooner than with traditional treatments.”   

Stone Clear, SonoMotion’s initial solution for facilitating clearance of post-lithotripsy residual fragments, has received FDA 510(k) de novo clearance.  The Stone Clear and Break Wave devices will operate on the same platform, providing a complete noninvasive kidney stone treatment solution. Kidney stones affect one in 10 people in the United States, costing $10 billion annually¹ and resulting in more than 750,000 annual procedures. These surgeries typically require anesthesia and a surgical suite.

“We are excited to receive the Fastrack SBIR grant from the NIH. This is a testament to our mission to fundamentally change how kidney stones are treated,” SonoMotion Co-Founder/CEO Oren Levy, Ph.D., stated. “SonoMotion’s platform has the potential to be a first-line treatment for kidney stones, offering a solution for patients who want to avoid anesthesia, without the wait time or cost associated with a surgical suite. Thank you to our investigators and research teams for helping us complete enrollment in our pivotal trial.”

A venture capital backed startup based in San Mateo, Calif., SonoMotion is a clinical stage medical technology company developing next-generation, noninvasive solutions for kidney stone treatment. The SonoMotion Break Wave device is an investigational device that is not approved for sale in the United States or elsewhere.

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