VANCOUVER, Dec. 20 /CNW/ - Ondine Biopharma Corp. (TSX, AIM: OBP) reports
that the CDRH branch of the FDA has reviewed its submission for the
Periowave(TM) photodisinfection system. CDRH has classified the device as
Class III (Premarket Approval), an automatic designation since no
substantially equivalent system has been previously marketed. Final
determination of the regulatory pathway is subject to continued evaluation by
FDA of Ondine's submission as well as other information that may be required.
"Our FDA submission incorporates the results of many years of preclinical
and clinical development of Periowave(TM)", said Carolyn Cross, President and
CEO, Ondine Biopharma. "We believe that Periowave(TM) provides patients and
clinicians with a useful treatment modality in the fight against chronic adult
periodontal disease, especially important in this age of widespread antibiotic
resistance. While there can be no assurances with respect to timing and
outcome of the regulatory process, we certainly look forward to working with
the Agency through the review."
Periowave(TM) is a photodisinfection system commercialized by Ondine that
utilizes low-intensity lasers and microbiological stains to target and destroy
microbial pathogens and reduce the symptoms of disease. The photodisinfection
technology was 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 and the European Union for several intraoral indications.
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 Periodontal Disease
Periodontitis (gum disease) is a common human affliction, affecting one
third of all adults, and over half of the population over the age of 50.
Periodontitis results in gum tissue detachment, bleeding gums, oral malodour,
bone and tooth loss as well as other complications. The standard of care for
treating periodontal disease is Scaling and Root Planing ("SRP"), or gum
surgery, or both. SRP is the sub-gingival removal of plaque biofilm adhering
to the root surfaces. Periodontitis is associated with a host of other serious
conditions including heart disease, stroke, premature births and diabetes.
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. Photodynamic Disinfection (PDD) provides
broad-spectrum antimicrobial efficacy without encouraging the formation and
spread of antibiotic resistance. Ondine has developed Periowave(TM) for the
treatment of chronic periodontitis in adults, and is extending its platform
technology into other applications both within and outside the oral cavity.
The Company is headquartered in Vancouver, British Columbia, Canada, with a
research laboratory in Redmond, Washington, USA and an international office in
St Michael, Barbados. For additional information, please visit the Company's
website at: www.ondinebiopharma.com.
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
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,
firstname.lastname@example.org; Irma Gomez-Dib, Media & Investors Relations, FD
International, (212) 850-5761, Irma.email@example.com; Christina Bessant,
Investor Relations, The Equicom Group Inc., (416) 815-0700 ext. 269,
firstname.lastname@example.org; Canaccord Adams Ltd, Nominated Adviser & Broker,
Neil Johnson, Ryan Gaffney, +4420 7050 6500