Bio2 Technologies received FDA approval to begin enrolling patients in an investigational device exemption clinical study to evaluate Vitrium as a cervical interbody fusion device.
Here are three insights:
1. The company will evaluate Vitrium as a structural device that facilitates bone remodeling through a gradual conversion from the device to the patient's own bone.
2. Vitrium is composed of bioactive glass.
3. The randomized, controlled, non-inferiority pivotal study will evaluate Vitrium's safety and effectiveness with a twelve-month endpoint. Vitrium is currently in commercial use under 510(k) clearance as a bone graft substitute.
"Spine implant manufacturers are incorporating incremental improvements to PEEK and titanium interbody devices in an attempt to achieve better bony integration," said Bio2 Technologies CEO Paul Nichols. "Vitrium offers the ideal clinical paradigm, achieving fusion exclusively with the patient's own newly regenerated bone, with no foreign material remaining the fusion mass."