SonoMotion

SonoMotion operates in a focused segment of urology medical devices rather than competing across a broad surgical portfolio. Its differentiation is the combination of low-pressure ultrasound lithotripsy and stone-fragment repositioning, addressing both stone fragmentation and residual-fragment clearance. Break Wave is designed for treatment in fully awake patients, typically in an office setting with little to no anesthesia, while Stone Clear is intended to help patients pass residual fragments after lithotripsy. This creates a care model that could reduce procedural complexity relative to treatments requiring operating-room infrastructure or general anesthesia. The company’s market position is strengthened by Break Wave’s FDA 510(k) clearance on Jan 21, 2026 and its pivotal-trial primary-endpoint milestone on May 14, 2026. However, the available company profile does not provide a verified competitor list, comparative clinical outcomes, commercial revenue, installed-base data, or confirmed adoption metrics.

SonoMotion’s trajectory shows a progression from early device development to regulatory and commercialization readiness. Founded in 2014, the company raised a $4.5 million venture round in 2017, followed by a $10 million Series B in 2019 and a $12.4 million Series C in 2022. A $2.2 million National Institutes of Health grant announced on Feb 28, 2025 added non-dilutive support for Break Wave development and brought structured cumulative funding to $29.1 million. Product development has advanced in parallel: Stone Clear received FDA 510(k) de novo clearance in October 2024, while Break Wave completed pivotal-trial enrollment in April 2025 and reported primary-endpoint success in May 2026. FDA 510(k) clearance for Break Wave on Jan 21, 2026 marked the clearest inflection point, shifting the company from primarily clinical development toward commercialization. The stated plan to introduce a next-generation Break Wave device with smaller, lighter probes in the second half of 2026 indicates continued product iteration. With only two featured current positions and an employee band of 1–10, execution capacity and scaling remain key unknowns.