Ondine 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.
    "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."

    About Ondine Biopharma Corporation

    Ondine is developing non-antibiotic therapies for the treatment of a
broad spectrum of bacterial, fungal and viral infections. The Company is
focused on developing and commercializing leading edge products utilizing its
patented light-activated technology. Photodisinfection provides broad-spectrum
antimicrobial efficacy without encouraging the formation and spread of
antibiotic resistance. The Company is based in Vancouver, British Columbia,
Canada, with a research and development laboratory in Bothell, Washington,
USA, and an international office in St. Michael, Barbados. For additional
information, please visit the Company's website at: www.ondinebiopharma.com.

    Forward-Looking Statements:

    Certain statements contained in this release containing words like
"believe", "intend", "may", "expect" and other similar expressions, are
forward-looking statements that involve a number of risks and uncertainties.
Factors that could cause actual results to differ materially from those
projected in the Company's forward-looking statements include the following:
market acceptance of our technologies and products; our ability to obtain
financing; our financial and technical resources relative to those of our
competitors; our ability to keep up with rapid technological change;
government regulation of our technologies; our ability to enforce our
intellectual property rights and protect our proprietary technologies; the
ability to obtain and develop partnership opportunities; the timing of
commercial product launches; the ability to achieve key technical milestones
in key products and other risk factors identified from time to time in the
Company's public filings.

    
    The TSX Exchange has not reviewed and does not accept responsibility for
    the adequacy or accuracy of this release.
    





For further information:

For further information: Carolyn Cross, President and Chief Executive
Officer, Ondine Biopharma Corporation, (604) 669-0555,
ccross@ondinebiopharma.com; Adam Peeler, Investor Relations, The Equicom Group
Inc., (416) 815-0700 ext. 225, apeeler@equicomgroup.com; Canaccord Adams Ltd,
Nominated Adviser & Broker, Neil Johnson, Ryan Gaffney, +4420 7050 6500

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ONDINE BIOPHARMA CORPORATION

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