Sonendo, Inc. is a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. The company has developed and manufactures the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without removing tooth structure. The GentleWave System is a Class II device with FDA 510(k) clearance for preparing, cleaning, and…
Sonendo, Inc. is a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. The company has developed and manufactures the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without removing tooth structure. The GentleWave System is a Class II device with FDA 510(k) clearance for preparing, cleaning, and irrigating teeth indicated for root canal therapy.
Sonendo generates revenue primarily from the sale of the GentleWave System console and related single-use procedure instruments (PIs), which are sterilized, disposable consumables required for each procedure. The company also offers ancillary products such as SoundSeal and its branded EDTA solution, which are used during the GentleWave Procedure to enhance sealing and disinfection. Revenue is driven by sales to dental practitioners in the United States and Canada, including endodontists and general dentists performing root canal treatments.
The company operates through the following segments: Product and Software.
- Product: This segment includes the sales of the GentleWave System console and related accessories and instruments. The GentleWave G4 console is the current generation device designed for optimized performance and simplified workflow. The CleanFlow Procedure Instrument is the company's sterilized, single-use PI that works with all GentleWave systems. Ancillary products such as SoundSeal and Sonendo-branded EDTA are also part of this segment.
- Software: This segment, which was divested in March 2024, included the sales of traditional software licenses for practice management software to enable an integrated digital office for endodontists. The software was offered through the company's wholly-owned subsidiary, TDO Software, Inc. (TDO), before its divestiture. The segment generated revenue from licensing its practice management software to dental practices.
Sonendo operates in the dental technology market, specifically targeting the root canal therapy segment within the broader endodontics industry. The company competes against conventional root canal treatment methods and established dental device manufacturers such as Dentsply Sirona, Envista, and Henry Schein. Its competitive advantages include the proprietary mechanism of action of the GentleWave System, which combines fluid optimization, broad-spectrum acoustic energy, and advanced fluid dynamics to clean root canals more effectively than traditional instrumentation. The system is supported by a strong intellectual property portfolio, including 141 issued patents and 49 pending patent applications as of December 31, 2024, and is differentiated by its ability to preserve tooth structure, reduce post-operative pain, and improve procedure efficiency.
Sonendo's customer base consists primarily of dental practitioners in the United States and Canada, including endodontists and general dentists who perform a high volume of root canal procedures. The company estimates that approximately 5,000 endodontists and 176,000 general dentists exist in this market, with a subset of about 50,000 general dentists performing most of their root canal treatments in-house rather than referring to specialists. These customers represent the core audience for the GentleWave System's commercial strategy.