Sonendo, Inc.

Sonendo, Inc. is a commercial-stage medical technology company focused on treating tooth decay. The company develops and manufactures the GentleWave® System, an innovative technology platform designed to clean and disinfect microscopic spaces within teeth without requiring the removal of tooth structure. The GentleWave System is a Class II device that has received 510(k) clearance from the United States Food and Drug Administration (FDA) for preparing, cleaning, and irrigating teeth indicated for root canal therapy (RCT). Sonendo's initial focus is on transforming RCT using the GentleWave System. The system's key components are a sophisticated, mobile console and pre-packaged, sterilized, single-use procedure instruments (PIs). It employs a proprietary mechanism of action combining procedure fluid optimization, broad-spectrum acoustic energy, and advanced fluid dynamics to reach microscopic spaces, dissolving and removing tissue and bacteria with minimal or no tooth structure removal. The GentleWave System offers clinical outcome benefits such as superior cleaning and disinfection, a less invasive procedure, high and rapid healing rates, and minimal to no post-operative pain. For dental practices and practitioners, benefits include more procedures completed in a single patient visit, a standardized protocol for efficiency and predictable outcomes, simple-to-use technology, low risk of cross-contamination, and practice differentiation. As of December 31, 2024, Sonendo held 141 issued patents and had 49 pending patent applications covering device, design, system, and method claims. The company's business previously operated through two segments: "Product" and "Software." The Product segment includes sales of the GentleWave System console and related accessories and instruments.