What's Happening?
SonoMotion, a medical device company based in San Mateo, California, has announced that its Break Wave Pivotal S.O.U.N.D Clinical Trial has successfully met its co-primary efficacy and safety endpoints. The Break Wave device is a non-invasive solution
for treating kidney stones, utilizing low-pressure focused ultrasound to fragment stones without the need for anesthesia or ionizing radiation. This development is significant as it offers a new treatment option that can be administered in various healthcare settings, allowing patients to recover quickly and return to their daily activities. The device has received FDA clearance, and commercialization is expected to begin in the latter half of 2026.
Why It's Important?
The Break Wave device represents a significant advancement in the treatment of kidney stones, which affect one in ten people in the U.S. and result in substantial healthcare costs. By providing a non-invasive, anesthesia-free treatment option, the device could reduce the need for more invasive procedures and associated recovery times, thereby improving patient quality of life and reducing healthcare costs. The successful trial results and FDA clearance position SonoMotion to address a large market need, potentially benefiting millions of patients annually.
What's Next?
The full results of the pivotal trial will be presented at the American Urological Association annual meeting, highlighting the device's potential to change urological practice. With FDA clearance secured, SonoMotion plans to begin commercialization in the second half of 2026, focusing on expanding access to this innovative treatment. The company will likely engage with healthcare providers to integrate the Break Wave device into clinical practice, potentially influencing treatment protocols for kidney stones.
