Ondine Submits 510(k) Application to FDA for Periowave(TM) Gum Disease Treatment System



    VANCOUVER, Oct. 1 /CNW/ - Ondine Biopharma Corporation (TSX: OBP; AIM:
OBP), a medical technology company developing photodisinfection-based
products, announces that it has filed a 510(k) submission to the Food and Drug
Administration (FDA) seeking clearance to market the Periowave(TM)
Photodisinfection System in the U.S. for the treatment of gum diseases.
    Periowave(TM) is a non-antibiotic disinfection system comprising a
low-intensity diode laser and photodisinfection solution provided in one-time
use disposable treatment packs. The photosensitizing solution is topically
applied to the treatment site and preferentially stains pathogenic microbes
present at the site. Once activated by the Periowave(TM) laser, the sensitizer
rapidly destroys the pathogens as well as pathogen-associated virulence
factors. The photodisinfection process does not encourage the development of
antibiotic resistance.
    "This 510(k) submission represents a major milestone for Ondine," said
Carolyn Cross, President & CEO of Ondine. "Our submission incorporates the
results of many years of preclinical and clinical development. We are proud of
the dedicated team of people who have helped to bring the Periowave(TM) system
to market in Canada and the European Union, and we look forward to bringing to
U.S. patients the same technology for reduction of infection and inflammation
associated with periodontal diseases. We believe that Periowave(TM) has the
potential to provide clinicians with an important approach to the treatment of
this widespread, chronic condition."

    About Periowave(TM)

    Periowave(TM) is a photodisinfection system developed by Ondine that
utilizes low-intensity lasers and wavelength-specific, light-activated
photosensitive compounds to specifically target and destroy microbial
pathogens and reduce the symptoms of disease. The Photodynamic Disinfection
technologies were developed by Professor Michael Wilson and colleagues at the
Eastman Dental Institute, University College London, and licensed to Ondine by
UCL Business plc, University College London. Periowave(TM) is currently
approved in Canada for the treatment of periodontitis, gingivitis,
peri-implantitis, peri-mucositis and in endodontics, and for nasal
decolonization of pathogenic bacteria such as methicillin-resistant
Staphylococcus aureus (MRSA). The Periowave(TM) system is also approved in the
European Union for adult periodontitis, endodontics, peri-implantitis and
nasal decolonization of MRSA. Additional information about Periowave(TM) is
available at www.periowave.com.

    For more information about the FDA & the submission review process,
please visit the FDA website at: www.fda.gov.

    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 creating 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 headquartered in Vancouver, British
Columbia, Canada, with a research 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 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; Christina Bessant, Investor Relations, The Equicom
Group Inc., (416) 815-0700 ext. 269, cbessant@equicomgroup.com; Irma
Gomez-Dib, Media Relations, Financial Dynamics, (212) 850-5761,
Irma.gomez.dib@fd.com; Nominated Adviser, Neil Johnson, Ryan Gaffney Canaccord
Adams Ltd, +44(0)20 7050 6500

Organization Profile

ONDINE BIOPHARMA CORPORATION

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