Tyber Medical has received US Food and Drug Administration (FDA) clearance for BioTy, a modified surface treatment for use on their headless cannulated trauma screw system.
The BioTy surface treatment is a nano-scale technology which, according to a company release, features a unique proprietary process protected by a number of issued and pending patents. The technology modifies the surface characteristics of medical devices for advanced indications yet to be disclosed, but under development through the FDA review process.
This initial FDA clearance is the first step in a series of regulatory submissions that are expected to enable the company to add BioTy to current and future products in the Tyber Medical product portfolio, which includes a spacer for anterior cervical interbody fusion and an anterior cervical plate.
Tyber Medical, in collaboration with Northeastern University, is conducting a number of studies on BioTy to analyse cellular response with this technology. The company expects these results to support claims of a statistically significant decrease in bacterial adherence as compared to non-surface modified implants. “Based on initial results, we expect this technology to set the new market standard for orthopaedic implants and will be applicable across the entire market” says Rui Ferreira, vice president of R&D at Tyber Medical. “We believe this partnership and technology demonstrates that Tyber Medical and Northeastern University are committed to not only developing orthopaedic implants, but also scientific backed technologies that combine bioengineered surfaces and structural implants.”