Sonendo® Announces Health Canada Regulatory Approval for Next Generation GentleWave® G4 System
November 01 2022 - 7:00AM
Business Wire
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
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.
For more information about Sonendo and the GentleWave System,
please visit https://gentlewave.com/doctor/g4-system. To find a
GentleWave doctor in your area, please visit
https://gentlewave.com/.
About Sonendo
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.
For more information about Sonendo and the GentleWave System,
please visit https://gentlewave.com/doctor/g4-system. To find a
GentleWave doctor in your area, please visit
https://gentlewave.com/.
Forward Looking Statements
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221101005212/en/
Sarah Gallagher Crowe PR sgallagher@crowepr.com (224)
406-4709
Greg Chodaczek Gilmartin Group greg@gilmartinir.com or
ir@sonendo.com
Sonendo (NYSE:SONX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sonendo (NYSE:SONX)
Historical Stock Chart
From Apr 2023 to Apr 2024