Ondine Biopharma Corporation Announces FDA Confirmation of Regulatory Pathway for Periowave(TM)

VANCOUVER, Aug. 27 /CNW/ - Ondine Biopharma Corporation (TSX: OBP; AIM: OBP), a medical technology company developing photodisinfection-based products, today announced it has received confirmation from the U.S. Food & Drug Administration (FDA) that the Company's Periowave(TM) Photodisinfection System will be evaluated as a Class III medical device under premarket approval (PMA) regulations. Having received clarification of the regulatory pathway, the Company intends to submit its existing clinical trial data as part of its PMA application to the FDA.