Mar 18 2010
Ondine Biopharma Corporation (the "Company" or "Ondine") (TSX:OBP)(AIM:OBP), a medical technology company developing photodisinfection-based products, announces that the U.S. Food and Drug Administration (FDA) has formally accepted for filing the Company's Pre-Market Approval (PMA) application for the Periowave™ Photodisinfection System for the treatment of chronic periodontitis in adults as an adjunct to standard methods of care.
Periowave™ Photodisinfection System
The FDA's action means that the PMA application is sufficiently complete and ready for substantive review.
"The acceptance of the PMA submission is a welcome step forward for Ondine and our business partner, Periowave Dental Technologies, Inc.," said Carolyn Cross, Chairman & CEO of Ondine. "One of Ondine's key priorities is to obtain regulatory clearance in the United States for the marketing of Periowave™, the first commercial application of the Company's photodisinfection technology."