Sonomotion

High-Level Overview

SonoMotion is a clinical-stage medical device company developing noninvasive ultrasound-based treatments for kidney stones, primarily Break Wave™ for fragmenting stones and Stone Clear™ for repositioning fragments.[1][2][5][6] It serves urologists, hospitals, and patients seeking office-based procedures without anesthesia, addressing the limitations of invasive lithotripsy by enabling faster, lower-cost treatments with quicker recovery.[1][5][6] The company has raised $36.3M total, including a recent $2.2M NIH grant, completed pivotal trial enrollment, and holds FDA Breakthrough Device Designation, signaling strong growth momentum toward commercialization.[1][2][5]

Origin Story

Founded in 2014 in San Mateo, California, by Oren Levy, PhD (Co-Founder and CEO), SonoMotion emerged from research into ultrasound applications for stone management, aiming for handheld, office-based systems to target, detach, break, and expel kidney stones.[1][2][6] Early demonstrations included stone repositioning in humans and fragmentation in porcine models using a 350-kHz probe.[2] Pivotal moments include FDA Breakthrough Device Designation for Break Wave™ in 2022, a $10M Series B in prior years, and a $12.4M Series C co-led by Advanced MedTech Holdings and Lyndon Rive, followed by completing enrollment in the 64-patient SOUND pivotal trial and securing a $2.2M NIH Fastrack SBIR grant as of April 2025.[1][2][4][5]

Core Differentiators

• Noninvasive ultrasound platform: Uses low-pressure waves (e.g., max 2.5 MPa for repositioning, 7 MPa for breaking) to fragment and reposition stones in awake patients, avoiding anesthesia, surgical suites, and long wait times.[1][2][5][6]
• Office-based accessibility: Handheld system enables procedures in clinics, reducing costs and enabling faster convalescence compared to traditional lithotripsy.[1][5][6]
• Clinical validation and regulatory progress: FDA Breakthrough Designation accelerates reviews; pivotal SOUND trial data supports upcoming 510(k) submission; over 60 peer-reviewed publications.[2][5][6]
• Proven efficacy in trials: Fragments stones in kidney/ureter; repositions fragments post-lithotripsy for natural clearance, demonstrated in human and animal models.[1][2]

Role in the Broader Tech Landscape

SonoMotion rides the trend toward minimally invasive, patient-centric medtech in urology, where kidney stones affect over 3 million Americans annually, driving 750,000+ procedures amid rising demand for outpatient solutions.[5][6] Timing aligns with FDA's Breakthrough pathway and NIH funding for innovative SBIR projects, accelerating market entry amid labor shortages and cost pressures on hospitals.[2][5] Favorable market forces include global urology growth (e.g., Advanced MedTech's portfolio) and investor interest from medtech VCs, positioning SonoMotion to disrupt a market dominated by invasive ESWL or ureteroscopy by enabling first-line, anesthesia-free treatments.[2][4] It influences the ecosystem by advancing ultrasound tech, potentially reducing procedure burdens and inspiring similar point-of-care innovations.

Quick Take & Future Outlook

SonoMotion is poised for FDA clearance via 510(k) post-SOUND trial data, with NIH funding fueling commercialization of Break Wave™ as a potential first-line therapy.[1][5] Upcoming milestones include AUA 2025 showcase and Series C deployment for scaling, amid trends like AI-enhanced imaging and expanded outpatient medtech.[5][6] Its influence may evolve by setting standards for noninvasive stone management, expanding to global markets via partners like Advanced MedTech, and capturing share in a high-volume disease area—transforming kidney stone care from hospital ordeals to routine clinic visits.