Specialists in Medical Device Development and Manufacturing

Periowave
Ondine's proprietary treatment, PERIOWAVE?, uses a novel non-antibiotic approach for treating the underlying infection responsible for periodontal disease.


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PERIOWAVE™ From Ondine Biopharma Corporation


Ondine's proprietary treatment, PERIOWAVE™, uses a novel non-antibiotic approach for treating the underlying infection responsible for periodontal disease.

After routine scaling, the dentist will apply the compound directly into the periodontal pockets and around the gum line of affected teeth. The compound quickly penetrates the plaque preferentially binding to multiple structural components in bacteria, including their toxic secretions. Laser light is then applied directly to the affected sites using a fibre optic probe. A powerful free-radical reaction destroys the targeted bacteria and the associated toxins such as collagenase. The procedure is expected to take under 20 minutes to complete for the entire mouth. Little or no pain will be involved, a significant advantage over current traditional treatments. Additionally, treatments will generally be administered by hygienists.

Customer Quote

"The Starfish Team was excellent to work with - very professional and flexible in meeting our company's specific requirements. The Starfish Project Manager took an active role in managing the transition from our engineering team to their manufacturing group and helped keep us on track to deadlines and deliverables."

The background

Ondine approached StarFish in the fall of 2004 inquiring about the costs of manufacturing their pre-production medical device. At the time Ondine, who was not ISO certified, required a partner with full certification who had the knowledge to become the responsible manufacture and the expertise to submit for a Health Canada license on their behalf.

Challenges

  • Quickly ramping up a manufacturing process for the device in a manner that would be compliant with the National and International medical device regulatory bodies (ISO 13485 and also regulatory bodies for different markets).
  • Obtaining Health Canada certification and manufacturing the devices in a timeframe that would allow Ondine to meet their milestones. 
  • Developing the manufacturing systems at StarFish that would allow for a smooth transfer of Responsible Manufacturing to Ondine when Ondine was ready to move to full scale production.

Approach

  • StarFish regulatory and optics experts worked with the Ondine engineering team to finalize the details on the device design.
  • The operations team at StarFish worked with the Ondine engineering team to transfer the responsible manufacturing of the device to StarFish.
  • A Health Canada expert at StarFish was assigned to the Ondine project to move the product and the processes forward as quickly as possible.

Result

  • QA systems, manufacturing systems, and ISO 13485 were achieved.
  • Pre-production units were certified and delivered.
  • Ondine successfully received Health Canada status in November 2005 and since has formally introduced product to market.

www.ondinebiopharma.com/
StarFish Product Engineering Inc. #5-555 Ardersier Rd., Victoria, BC, Canada V8Z 1C8 Tel:250-388-3537 Fax:250-483-1975