Health Canada Clears Fotona Dynamis for Stress Urinary Incontinence (SUI) and Vulvovaginal Atrophy (VVA) / Genitourinary Syndrome of Menopause (GSM)

LJUBLJANA,Slovenia,Aug. 27,2019 -- In an industry first achievement,Fotona's Dynamis Laser System received clearance by Health Canada,Canada's Food and Drugs Act and Regulations Agency,to treat stress urinary incontinence (SUI) and vulvovaginal atrophy (VVA) / genitourinary syndrome of menopause (GSM). Treatment for these conditions can be achieved by using the proprietary Fotona SMOOTH® Er:YAG modality and robotic G-Runner and G-set handpieces and speculums,which were specially designed for ease of use and precision during intravaginal treatments. After extensive review of detailed documentation and published studies performed with Fotona's Dynamis laser system,clearance was granted by Health Canada,further validating Fotona's commitment to evidence-based medicine.

The patented Fotona SMOOTH® technology holds a very unique position in the market,making it a leading solution for providers and patients. Unlike competing laser technologies,Fotona SMOOTH® is completely non-ablative and combines an additional superficial heat-shocking mechanism of tissue regeneration with a unique self-regulating safety feature. These dual-tissue regeneration characteristics of Fotona SMOOTH® are believed to be responsible for the reported extraordinary safety and efficacy of Fotona's Er:YAG lasers when used for thermotherapy of the vaginal wall to alleviate symptoms of stress urinary incontinence and genitourinary syndrome of menopause.

Combining two complementary wavelengths,1064nm and 2940nm,with Fotona's proprietary pulse characteristics,the Dynamis PRO is a multi-purpose system that is capable of performing a wide range of applications,not only in gynecology but also in surgery and aesthetics. The robotic G-Runner enables revolutionary intravaginal treatments with ease and precision. This innovative technology is why providers choose Fotona to achieve optimal outcomes for their patients and further establish their practices as best-in-class.

This clearance is yet another achievement for Fotona,marking the first of its kind in the laser industry. Known globally for its continuous dedication to developing industry-leading technology,Fotona has earned its place as the gold standard in laser technology for health providers and patients around the world.

ABOUT FOTONA

Fotona (www.fotona.com) has sold over 30,000 lasers around the world,with direct sales in the U.S. and distribution in over 60 countries. Fotona produces award-winning lasers in dentistry,aesthetics,dermatology,gynecology & other medical fields. Fotona has one of the most highly educated workforces in the industry,with an exceptionally high number of PhDs specializing in laser and medical technology. Strong R&D capabilities have always been a key competitive advantage of the company,resulting in many patented solutions,including the Optoflex® articulated arm,Quantum Square Pulse and Variable Square Pulse technologies,Fotona SMOOTH®mode,Vacuum Cell technology,and more.

The company manufactures all of its laser systems in-house,ensuring that each system is of the highest quality,reliability,ease-of-use and durability,in compliance with all applicable international standards. When you choose Fotona,you choose a company that aims to continuously Choose Perfection to meet the needs of a highly demanding marketplace.

CONTACT:

Ladislav Grad

info@fotona.com

(+386)-1-5009-100