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Sonendo® Announces Health Canada Regulatory Approval for Next Generation GentleWave® G4 System
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Sonendo has received Health Canada regulatory approval for its GentleWave G4 System, aimed at improving the treatment of tooth decay in Canada. This next-generation technology enhances user experience with a simplified workflow and advanced features, including battery backup and multi-operatory connectivity. A recent clinical trial showed that 99.5% of patients reported no pain during procedures using GentleWave Technology. This approval marks a significant expansion of Sonendo’s product offerings in Canada, reinforcing its commitment to endodontic practices.
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Received Health Canada approval for the GentleWave G4 System, expanding product offerings in Canada.
GentleWave G4 System enhances user experience with new features like battery backup and fluid reservoirs.
Clinical trial indicates 99.5% of patients experienced no pain during procedures, supporting product effectiveness.
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Health Canada Clearance Paves the Way for Latest Innovation from Sonendo in Canada, Designed for an Elevated User Experience, Improved Workflow and Optimized Practice Efficiency
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--
Sonendo, Inc. (NYSE: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that it has received Health Canada regulatory approval for commercial sales of its recently announced GentleWave G4 System, the next generation of its innovative technology platform designed to treat tooth decay. 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.
Health Canada regulatory clearance expands Sonendo’s suite of products available in Canada, allowing Sonendo to bring the GentleWave G4 System’s modern 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 recent 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.
“We are excited about introducing the GentleWave G4 System to our customers and the endodontic community in Canada,” said Michael Smith, chief commercial officer at Sonendo. “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."
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.
This press release contains "forward-looking statements" based on Sonendo's current expectations, forecasts and beliefs including statements related to the general release of the GentleWave G4 System. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Actual outcomes and results could differ materially due to a number of factors, including the ongoing uncertainty of the impact of the COVID-19 pandemic, as well as COVID recovery impact, on its business. These and other risks and uncertainties include those described more fully in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (the "SEC") on March 23, 2022, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2022 and June 30, 2022 filed with the SEC on May 10, 2022 and August 10, 2022, respectively, under the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," as well as any reports that Sonendo may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to Sonendo as of the date hereof. Sonendo undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing Sonendo's views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Sonendo. SONENDO, CLEANFLOW, GENTLEWAVE and ENDOCON are trademarks of Sonendo, Inc.
What is the significance of Sonendo receiving Health Canada approval for the GentleWave G4 System?
The approval allows Sonendo to commercialize the GentleWave G4 System in Canada, enhancing its product offerings and market reach.
What were the findings from the clinical trial related to the GentleWave Technology?
The clinical trial revealed that 99.5% of patients experienced no pain during the GentleWave Procedure, highlighting its effectiveness.
What improvements does the GentleWave G4 System offer over previous models?
The G4 System features a refined workflow, battery backup, high-capacity fluid reservoirs, and multi-operatory connectivity.
How does the GentleWave G4 System impact dental practices in Canada?
It optimizes practice efficiency by simplifying procedures, allowing up to six treatments before fluid refills, and enhancing overall patient experience.
