Research & Development
Bio2 Technologies Inc wins US FDA approval to evaluate Vitrium as a cervical interbody fusion device under IDE clinical study
14 November 2018 -

Orthopedics company Bio2 Technologies Inc revealed on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) to commence enrollment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion device to achieve better bony integration.

The company said Vitrium will be evaluated as a structural device that facilitates bone remodeling via a gradual conversion from Vitrium to the patient's own bone. A proprietary process is used to produce Vitrium's structure and porosity, enabling exceptional bone conductivity.

This randomised, controlled, non-inferiority pivotal study will capture safety and effectiveness data of Vitrium with a 12 month end point, added the company.

Composed entirely of bioactive glass, Vitrium, a structurally stable, fully resorbable autogenic-biomatrix, represents an innovative approach on a well-studied osteostimulative mechanism of action with a long track record of safe clinical use.

Currently, Vitrium is in commercial use under 510(k) clearances as a bone graft substitute, concluded the company.

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