SonoMotion's Break Wave Lithotripsy Device Meets Pivotal Trial Endpoints, Receives FDA Clearance
核心洞察
SonoMotion (搜索) announced that its Break Wave (搜索) Pivotal S.O.U.N.D Clinical Trial met co-primary efficacy and safety endpoints for non-invasive kidney stone treatment.
The Break Wave (搜索) device uses low pressure focused ultrasound to fragment kidney stones (搜索) without anesthesia or sedation, allowing patients to remain fully awake during treatment.
The company received FDA 510(k) clearance for a next-generation Break Wave (搜索) device featuring 31% smaller therapy probes and significantly reduced weight.
SonoMotion (搜索), a venture-backed medical device company, announced that its Break Wave (搜索) Pivotal S.O.U.N.D Clinical Trial has successfully met its co-primary efficacy and safety endpoints for treating kidney stones (搜索). The breakthrough represents a significant advancement in non-invasive lithotripsy technology, addressing a condition that affects one in 10 people in the U.S. and costs $10 billion annually.
Revolutionary Non-Invasive Technology
The Break Wave (搜索) device employs low pressure focused ultrasound to fragment kidney stones (搜索) by creating standing stress waves within the stone under real-time ultrasound image guidance. Unlike conventional lithotripsy procedures, the treatment is completely non-invasive and requires no anesthesia or sedation, allowing patients to remain fully awake throughout the procedure.
"The Break Wave (搜索) device represents the only anesthesia-free and ionizing radiation-free option to treat kidney stones (搜索) in a variety of healthcare settings, which means it can be delivered to patients where they need it," said Ryan Hsi, MD, Associate Professor of Urology at the University of California, Irvine. "Since it is non-invasive, it will allow patients to recover quickly and return to their busy lives."
The procedure's non-invasive nature enables patients to drive themselves to and from treatment and allows them to eat and drink prior to the procedure, eliminating many of the logistical challenges associated with traditional lithotripsy methods.
Clinical Impact and Market Significance
Kidney stones (搜索) present a substantial clinical burden, causing severe pain, impacting renal function, and reducing health-related quality of life. The condition often requires individuals and their caregivers to take time off school and work, with over 750,000 lithotripsy procedures performed annually in the United States.
Dr. Hsi emphasized the disruptive nature of kidney stones (搜索), stating, "Kidney stones are incredibly disruptive, causing severe pain, impacting renal function, reducing health-related quality of life, and often requiring individuals and their caregivers to take time off school and work."
FDA Clearance and Commercial Timeline
Following its original FDA clearance for Break Wave (搜索) in January 2026, SonoMotion (搜索) received additional FDA 510(k) clearance on May 1, 2026, for the next-generation Break Wave device. The newly cleared version features therapy probes with a 31% smaller footprint and significantly lighter weight, enhancing the device's portability and ease of use.
"Meeting our pivotal trial endpoints while receiving FDA clearance for a more compact device puts us in a strong position to bring Break Wave (搜索) to the millions of patients who suffer from kidney stones (搜索) each year," said Oren Levy, PhD, Co-Founder and Chief Executive Officer of SonoMotion (搜索). "We are proud of the team for continuously improving the technology, and are delighted to offer a truly non-invasive, anesthesia-free treatment that patients need and deserve."
Commercialization of the Break Wave (搜索) device is scheduled to begin in the second half of 2026.
Upcoming Clinical Presentation
The pivotal trial results will be presented by Dr. Ben Chew of the University of British Columbia during a plenary session at the 2026 American Urological Association (搜索) meeting in Washington DC on Saturday, May 16th at 11am ET. The presentation was selected as part of the practice-changing, paradigm-shifting clinical trials in urology program (P2s), which the AUA describes as "designed to showcase exceptional, groundbreaking studies that are expected to change the day-to-day practice of urology."
The Break Wave (搜索) device has the potential to become a first-line treatment option for kidney stones (搜索), offering treatment at any site of care and representing a paradigm shift in urological practice. SonoMotion (搜索) will showcase its solution at booth #1508 during the 2026 AUA meeting.