Here are three points:
1. BioTy is a modified surface treatment and this initial FDA clearance is the first step in a series of regulatory submissions that will enable the Tyber Medical to add BioTy to current and future products.
2. Tyber Medical, in collaboration with Northeastern University in Boston, is conducting multiple studies on BioTy to analyze cellular response with this technology.
3. Tyber Medical has also expanded its exclusive licensing agreement with Northeastern University. The company also expects the results of the studies to support claims of a statistically significant decrease in bacterial adherence as compared to non-surface modified implants.
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