SONOMOTION COMPLETES ENROLLMENT IN PIVOTAL CLINICAL TRIAL FOR BREAK WAVE™ SYSTEM AND SECURES $2.2 MILLION NIH GRANT

• Clinical data to support FDA 510(k) submission for the noninvasive Break Wave system
• Procedure is designed to fragment kidney stones using low pressure ultrasound waves in fully awake patients, without anesthesia, in the office or clinic
• Company secures a $2.2M Fastrack NIH SBIR grant to fund future Break Wave milestones

SAN MATEO, Calif., April 24, 2025 /PRNewswire/ -- SonoMotion, a medical device company developing noninvasive solutions for kidney stones, announced today it has been awarded a $2.2 million NIH grant and successfully completed patient enrollment in the SOUND Break Wave pivotal clinical trial. The SOUND trial is a 64-patient, prospective, multi-center, non-randomized study designed to evaluate 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 the planned Break Wave device FDA 510(k) submission. 

"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, was granted FDA 510(k) de novo clearance in October 2024.  The Stone Clear and Break Wave devices will operate on the same platform, providing a complete solution for the noninvasive treatment of kidney stones. Kidney stones affect one in 10 people in the U.S., costing $10 billion annually¹ and resulting in +750,000 annual procedures – typically requiring 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," commented Oren Levy, PhD, Co-Founder and CEO, SonoMotion. "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."

The SonoMotion solution will be featured at booth #1807 during the upcoming 2025 American Urological Association (AUA) meeting, April 26-29 in Las Vegas. 

ABOUT SONOMOTION
SonoMotion, a venture capital backed startup based in San Mateo, CA, is a clinical stage medical technology company developing next-generation, noninvasive solutions for the treatment of kidney stones.  The SonoMotion Break Wave device is an investigational device that is not approved for sale in the United States or elsewhere. To learn more, please visit www.sonomotion.com.

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

SOURCE SonoMotion, Inc.