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Atrix (US) completes pivotal guided tissue regeneration (GTR) trial

Atrix (US) says it has completed the clinical phase of its guided tissue regeneration (GTR) pivotal study. The Atrisorb GTR barrier is a biodegradable device for gum surgery. The company plans to file a 510(k) with the FDA in the fourth quarter of 1995 and expects to launch Atrisorb in Europe in early 1996. Atrix management believes that up to half of the 10 million gum surgeries performed worldwide each year could use GTR. Currently only about a third of the procedures employ regeneration devices.

Atrix (US) says it has completed the clinical phase of its guided tissue regeneration (GTR) pivotal study. The Atrisorb GTR barrier is a biodegradable device for gum surgery. The company plans to file a 510(k) with the FDA in the fourth quarter of 1995 and expects to launch Atrisorb in Europe in early 1996. Atrix management believes that up to half of the 10 million gum surgeries performed worldwide each year could use GTR. Currently only about a third of the procedures employ regeneration devices.

The company has completed patient enrolment for Phase III trials of a second dental product, Atrigel, a drug delivery compound...

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