The San Mateo, California-based company enrolled 64 patients in its prospective, multi-center, non-randomized SOUND Break Wave trial. SOUND evaluates the safety and effectiveness of the Break Wave system for fragmentation stones in the kidney or ureter. The company plans to use results to serve as the clinical basis for its planned FDA 510(k) submission.
Dr. James Johannes serves as director at the Center of Endourology and Stone Disease, Lehigh Valley Health Network. Johannes said in a news release that Break Wave provides non-invasive, anesthesia-free treatment options. They can also 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,” Johannes said.
SonoMotion already received FDA 510(k) de novo clearance for its Stone Clear solution last fall. Break Wave operates on the same platform, providing a complete solution for the noninvasive treatment of kidney stones.
“We are excited to receive the Fastrack SBIR grant from the NIH,” said Oren Levy, co-founder and CEO, SonoMotion. “This is a testament to our mission to fundamentally change how kidney stones are treated. 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.”
