New Aevo System™ (2019) Receives Medical Device License in Canada
Posted on June 26, 2019
The Aevo System™ facilitates faster tooth movement and decreases orthodontically induced tooth root
resorption during orthodontic treatment.
EDMONTON, Alberta, Canada, June 26th, 2019 —SmileSonica Inc., global leader in non-invasive therapeutic ultrasound dental solutions, announced their new Aevo System™ (2019) has received its medical device license from Health Canada as a class II medical device. The Aevo System™ was developed to meet both patients’ and dental professionals’ main orthodontic challenge of accelerating orthodontic treatment safely. Canada joins a list of 35 countries in which the Aevo System™ is now commercially available.
“When we launched our first Aevo System™ in 2016 in Canada, we were warmly welcomed by the dental community. The practicing professionals and patients were instrumental is providing feedback that has been incorporated in our new Aevo System™ (2019). We thank our participating clinics and patients for all their support.” says Darryl Lesiuk, VP Corporate Development at SmileSonica Inc.
The Aevo System™ results from private clinics show an average increase of 54.8% in faster tooth movement when using wire braces and change of trays every 3-4 days when using clear aligners. This out performs the average increase of 29% results of our original clinical trial. Equally important, Aevo System™ (2019) continues to decrease orthodontically induced tooth root resorption.
“We have learned a lot from our customers and patients. We are proud of our Team and their ability to turn these learnings into the commercially available new Aevo System™ (2019). We are excited to introduce our new system in Canada.” says Cristian Scurtescu, Founder and CEO of SmileSonica Inc.
SmileSonica Inc., based in Edmonton, Alberta, Canada has grown to a global company and is ISO 13485 and MDSAP certified to design, manufacture, and distribute ultrasound therapy devices and accessories for use in dentistry. The SmileSonica Team includes Engineering, Quality & Regulatory, Manufacturing and Sales. Currently selling in Canada, Europe and Australia, SmileSonica continues to receive clinic and patient support, which has resulted in the company’s success. For more information, visit www.smilesonica.com.
Aevo System™: In a recent study, over 89% of orthodontic patients surveyed wished they could reduce the length of their orthodontic treatment. The Aevo System™ is clinically proven to enhance the physiological processes associated with orthodontic treatment. Licensed Indication for Use: “Regular use of the Aevo System™ during orthodontic treatment will facilitate faster tooth movement and decrease orthodontically induced tooth root resorption.” The Aevo System™ provides low-intensity pulsed ultrasound (LIPUS) to a patient’s dental area for 20 minutes per day for the duration of the orthodontic treatment. Complementary to orthodontic braces (including wire braces and clear aligners), the Aevo System™ is battery powered, wireless, wearable, and intended for home use or on-the-go. For more information, visit www.aevosystem.com.
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If you would like more information about this topic, please contact Darryl Lesiuk at 587-758-8433 or darryl.lesiuk@smilesonica.com.