Ondine Announces FDA Confirmation Of Regulatory Pathway For Periowave
Vancouver - Ondine Biopharma Corporation, a medical technology company developing photodisinfection-based products, recently announced it has received confirmation from the U.S. Food & Drug Administration (FDA) that the Company's Periowave 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.
"The confirmation of the medical device regulatory pathway from the FDA is a significant milestone toward obtaining approval to market Periowave in the U.S.," said Carolyn Cross, President and CEO of Ondine Biopharma Corporation. "As stated in our December 20, 2007 press release, this regulatory designation recognizes the novel nature of the Periowave(TM) Photodynamic Disinfection system. With more than 20,000 patients treated in Canada and the EU, we are very pleased with the enthusiastic response from the clinical community in these markets and the increasing acceptance of this anti-bacterial technology. Once approved, we expect that the PMA will provide competitive barriers that will offer strategic benefits to Ondine in both the dental and medical markets."
SOURCE: Ondine Biopharma Corporation