Tigran Hands In FDA Application Concerning Sales In the US
Tigran has 16 April 2009 handed in an FDA application (510 (K)) concerning sales of titanium granules for dental bone regrowth in the USA. Approval is expected in 2010.
- USA is a very important market for dental products. An FDA-approval opens up great possibilities for Tigran, says Björn Sellert, CEO of Tigran Technologies.
Tigran's bone regeneration material is used within a number of application areas, such as peri-implantitis. Peri-implantitis is an inflammation followed by bone resorption around a dental implant and occurs in over 16 % of implants1. During 2009 about 10 million implants were placed on a world basis2, and the number of implant treatment grows about16-18 % annually3. As many as 50 % of all implant treatments in the USA must commence with a bone regeneration treatment4.
- With a population of 300 million, USA is an important future market. When visiting American Academy of Osseointegration's annual congress in February our method of rebuilding jawbone attracted great interest. Strategic evaluation of distribution alternatives for the American market is in progress, finishes Björn Sellert.
