Sonomotion

What Sonomotion does

SonoMotion is a privately-held medical device company founded in 2014 and headquartered in San Mateo, California, that develops non-invasive, ultrasound-based systems for treating kidney stone disease. The company's core technology is Burst Wave Lithotripsy (BWL), a low-pressure focused ultrasound platform derived from an exclusive license to the University of Washington's IP portfolio, supported by over 60 peer-reviewed publications. Its two FDA-cleared products are Break Wave, a lithotripsy system that fragments kidney stones in fully awake patients with little to no anesthesia in an office setting, and Stone Clear, a therapy that repositions post-lithotripsy residual fragments within a 15-minute office procedure to enable natural passage. Both products are positioned as alternatives to traditional shock wave lithotripsy that requires anesthesia, operating room access, and specialized equipment.

The company is at a commercialization inflection point. FDA de-novo clearance for Stone Clear was secured in November 2024, FDA 510(k) clearance for Break Wave was secured in January 2026, and a next-generation Break Wave device with a 31% smaller probe footprint received 510(k) clearance in May 2026, with commercial launch planned for H2 2026. The SOUND pivotal trial met co-primary efficacy and safety endpoints across ten clinical sites in the US and Canada, including University of Washington, UBC, UCSD, Cleveland Clinic, and Chesapeake Urology. SonoMotion has raised over $38M in equity from Advanced MedTech Holdings, UWH LLC, MedVenture Partners, BioVentures, and Lyndon Rive, plus $8M in non-dilutive NIH and NASA grants, and operates with a 1-10 person team leveraging a strategic OEM and co-development partnership with GE Healthcare for ultrasound platform integration.

SonoMotion's go-to-market is direct enterprise field sales to urologists, urology practices, hospitals, and ambulatory surgical centers, supplemented by presence at major urology conferences (AUA, EAU). Revenue mechanics will be hardware sales of the Break Wave and Stone Clear devices to healthcare providers under negotiated procurement contracts, with potential downstream procedure and consumable revenue once installed. Pricing is not publicly disclosed. The company targets the US kidney stone treatment market where approximately 1 in 10 Americans are affected and over 750,000 lithotripsy procedures are performed annually at a cost of roughly $10 billion in healthcare spending.

Name

Sonomotion

Legal name

SonoMotion

Website

https://sonomotion.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

SonoMotion is a privately-held medical device company developing non-invasive, ultrasound-based systems for kidney stone fragmentation and fragment repositioning. It serves urologists and hospitals with FDA-cleared Break Wave and Stone Clear devices targeting the US lithotripsy market.

Ownership category

akta.pro rank

Product category

Urology Medical Devices

NAICS

Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Kidney Stone Management & Lithotripsy Devices (HLAHAKAI)

akta.pro secondary industries

Endourology & Minimally Invasive Urologic Surgery (HLAKAOAF), Urolithiasis / Kidney Stone Centers (HLAKAOAG)

Keywords

• Kidney stone treatment
• Non-invasive lithotripsy
• Ultrasound medical devices
• Urology medical devices
• Stone fragmentation systems

Headquarters

HQ city

South San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Medical Device Sales: SonoMotion generates revenue through the sale of its Break Wave and Stone Clear medical devices to healthcare providers, hospitals, and urology practices. The company commercialized Break Wave in the second half of 2026 following FDA 510(k) clearances.
2. Procedure/Consumable Revenue: Potential revenue from procedure-related consumables and services as the devices are adopted in clinical settings for kidney stone treatment.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

SonoMotion develops and commercializes non-invasive ultrasound-based medical devices for kidney stone treatment. Its two FDA-cleared products, Break Wave™ (low-pressure focused ultrasound lithotripsy to fragment stones) and Stone Clear™ (ultrasonic propulsion to reposition residual fragments), enable treatment on fully awake patients in office settings without anesthesia or ureteral stents.

Product overview

SonoMotion is developing a noninvasive platform designed to fragment and reposition kidney stones at any clinical setting on fully awake patients. The company has two innovative products: Break Wave (for fragmenting kidney stones using low-pressure ultrasound waves with little to no anesthesia) and Stone Clear (for repositioning residual fragments to help patients pass stones naturally). Both products enable treatment outside traditional surgical settings.

Differentiator

Problem solved

Functional benefit

Brands

• Break Wave: Low-pressure focused ultrasound therapy system designed to fragment kidney stones on fully awake patients with little to no anesthesia in an office setting
• Stone Clear

Products and services

• Break Wave Break Wave is a non-invasive lithotripsy device that uses low-pressure focused ultrasound waves to fragment kidney stones in fully awake patients with little to no anesthesia in an office setting. It is sold to urologists, hospitals, and ambulatory surgical centers for the treatment of kidney stones.
• Stone Clear Stone Clear is an ultrasonic propulsion therapy device designed to reposition post-lithotripsy residual fragments within a 15-minute office procedure on fully awake patients, helping them pass their stones naturally. It is sold to urologists and urology practices as a complement to lithotripsy.

Quantifiable outcome

• Non-invasive kidney stone fragmentation without anesthesia or ureteral stents
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• GE HealthcarecoreTechnology or Integration · 31 October 2017Established strategic partnership with definitive OEM agreement and co-development agreement for ultrasound technology integration. Expanded relationship in 2019 with updated OEM agreement. GE Healthcare provides ultrasound platform expertise and potential market access.
• University of WashingtoncoreStrategic or Co-development Partner · 11 January 2015Exclusive license to extensive IP portfolio related to Break Wave and Stone Clear technologies. Core technology source providing foundational ultrasound lithotripsy innovations and ongoing clinical trial collaboration (10 trial sites).

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Peers

• Siemens Healthineers (Lithotripsy):
• Boston Scientific (Urology/Pelvic Health):

Broad incumbents

• Shockwave Medical (Johnson & Johnson): Developer of intravascular lithotripsy (IVL) using acoustic pulse technology for vascular applications; acquired by J&J. Comparable as another company commercializing acoustic/ultrasound-based therapy technology in clinical settings.
• Karl Storz (Endourology): Leading manufacturer of endoscopes and instruments for endourology, including ureteroscopy systems used for kidney stone removal. Broad incumbent competing against SonoMotion in the kidney stone treatment market.
• Cook Medical (Urology): Manufacturer of urological devices including stone management products such as ureteral stents, baskets, and extraction devices used in kidney stone procedures. Broad incumbent offering adjacent products in the same clinical workflow.
• Becton Dickinson (BD) Urology: Major medical device company with a urology portfolio including stone management products (acquired with C.R. Bard). Broad incumbent competing for kidney stone treatment market share through ureteral stents, baskets, and drainage products.
• Olympus (Medical Systems): Major manufacturer of urological endoscopy and lithotripsy equipment including ureteroscopes and laser fibers. A broad incumbent competing in the kidney stone management space with flexible ureteroscopy-based solutions.

Direct peers

• EDAP TMS: Developer and manufacturer of focused ultrasound and shock wave lithotripsy devices for urology, including the Sonolith and Renew systems. Directly competes with SonoMotion in non-invasive kidney stone fragmentation with its lithotripsy product line.
• Dornier MedTech: Established manufacturer of shock wave lithotripsy (SWL) systems for kidney stone treatment. Directly competes with SonoMotion's Break Wave in the lithotripsy category, though using a different modality (focused shock waves vs. focused ultrasound) that requires anesthesia and OR settings.

Emerging players

• HistoSonics: Emerging medical device company using focused ultrasound (histotripsy) for non-invasive tissue destruction. Comparable as a similarly-stage company commercializing a novel focused-ultrasound therapeutic modality in a clinical setting.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds4 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sonomotion