Health Canada Approves Sonendo’s Next-Gen GentleWave G4 System

Sonendo Inc. has received Health Canada regulatory approval for the GentleWave G4 System, the next generation version of its tooth decay treatment platform. With Sonendo’s patented technology at its core, the GentleWave G4 System is designed for an optimized doctor and patient experience with a refined, simplified workflow—all while delivering the enhanced level of clean that is only available with GentleWave Technology.

“We are excited about introducing the GentleWave G4 System to our customers and the endodontic community in Canada,” Chief Commercial Officer Michael Smith said. “We believe the GentleWave G4 System offers endodontic practices and their patients an elevated experience that also reinforces our commitment to commercial support and expansion in Canada.”
 
Health Canada regulatory clearance expands Sonendo’s suite of products available in Canada, allowing Sonendo to bring the GentleWave G4 System’s design to the market, including an intuitive, user-friendly interface, battery backup and high-capacity fluid reservoirs, and multi-operatory connectivity.
 
The approval for sale of the GentleWave G4 System follows the launch of the CleanFlow procedure instrument in Canada. According to a recent clinical trial, 99.5% of patients experienced no pain during the GentleWave Procedure with the addition of CleanFlow Technology.
 
The GentleWave G4 System was created with future software adaptations and evolving features in mind. An intuitive, user-friendly interface provides step-by-step guidance for practitioners and auditory cues that improve procedure awareness, reducing the need to look away from the patient during treatment. Battery backup and high-capacity fluid reservoirs decrease downtime between treatments and allow up to six procedures before refilling fluids. The system also allows multi-operatory connectivity, which means doctors can monitor multiple systems across their office, leading to improved workflow efficiency.
 
Sonendo is a commercial-stage medical technology company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. Sonendo developed and manufactured the GentleWave System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without the need to remove tooth structure. The system utilizes a proprietary mechanism of action, which combines procedure fluid optimization, broad-spectrum acoustic energy, and advanced fluid dynamics, to debride and disinfect deep regions of the complex root canal system in a less invasive procedure that preserves tooth structure. The clinical benefits of the GentleWave System when compared to conventional methods of root canal therapy include improved clinical outcomes, such as superior cleaning that is independent of root canal complexity and tooth anatomy, high and rapid rates of healing and minimal to no post-operative pain. In addition, the GentleWave System can improve the workflow and economics of dental practices and offers patients an effective, less invasive, and less painful alternative to traditional root canal therapy.
 
Sonendo is also the parent company of TDO Software, Inc., the developer of widely used endodontic practice management software solutions, designed to simplify practice workflow. TDO Software integrates practice management, imaging, referral reporting and CBCT imaging, and offers built-in communication with the GentleWave System.