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.
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."