Break Wave
Phase 3- Indications
- Kidney stones
Company intelligence / Profile preview
SonoMotion
San Mateo, California, United Statessonomotion.com ↗
- Ownership
- Private
- Development stage
- Commercial
01
Overview
SonoMotion’s Stone Clear™ device received FDA de novo clearance in October 2024 as the first and only noninvasive ultrasound device to facilitate passage of post-lithotripsy kidney stone fragments without anesthesia. Clinical data show a 70% reduction in relapse risk compared to observation. The Break Wave™ system, designed to fragment intact kidney stones using low-pressure ultrasound waves in awake patients without anesthesia, has completed pivotal clinical trials with results supporting an upcoming FDA 510(k) submission[2][3][4][6].
- Therapeutic areas
- Nephrology
- Modalities
- Device
- Industry
- Therapeutic Medical Devices
02
Drug pipeline
2 assets1 more asset in the full pipeline.
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Partnerships
Advance MedTech Holdings Pte. Ltd.University of Washington
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