Ondine Biopharma Receives CE Mark Approval for PERIOWAVE
Ondine Biopharma Corporation announced CE Mark approval for its proprietary Periowave(TM) Photodynamic disinfection (PDD) System for the treatment of periodontal diseases. This regulatory milestone clears the way for Ondine to begin preparations for marketing its laser-based antimicrobial system throughout the EU as well as selected countries throughout the world.
"CE Mark approval permits us to expand our market reach beyond Canada, where Periowave(TM) is currently being sold," said Carolyn Cross, President and CEO of Ondine Biopharma. "The CE Mark also indicates that we have met the essential health, safety and environmental protection requirements detailed in the European Directives covering medical devices." Periowave(TM) is a Photodynamic Disinfection system that utilizes low-intensity lasers and wavelength-specific, light-activated compounds to specifically target and destroy microbial pathogens and reduce the symptoms of disease. The compounds are generally topically applied and one or more lasers are used to activate the compounds and complete the disinfection. The Photodynamic Disinfection technologies were developed by Professor Michael Wilson and colleagues at the Eastman Dental Institute, University College London, and licensed to Ondine by UCL Biomedica PLC, University College London.
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