Bio2 Technologies, a privately held orthopaedics company, has announced that it received US Food and Drug Administration (FDA) approval to begin enrolment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion device. Vitrium will be evaluated as a structural device that facilitates bone remodelling 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. Composed entirely of bioactive glass, Vitrium represents an innovative approach on a well-studied osteostimulative mechanism of action with a long track record of safe clinical use.
The randomised, controlled, non-inferiority pivotal study will capture safety and effectiveness data with a twelve-month end point. Vitrium is currently in commercial use under 510(k) clearances as a bone graft substitute. “Our positive ovine study results presented at last year’s North American Spine Society, showing Vitrium’s safe resorption/bone formation profile, stimulation of new bone formation, and strength to share/bear physiologic loads—all ideal characteristics of an interbody fusion device, gave us the confidence and enthusiasm to proceed with the IDE study,” noted Janet Krevolin, Bio2’s chief operating officer.
“Spine implant manufacturers are incorporating incremental improvements to PEEK and Titanium interbody devices in an attempt to achieve better bony integration. Vitrium offers the ideal clinical paradigm, achieving fusion exclusively with the patient’s own newly regenerated bone, with no foreign material remaining in the fusion mass. This natural, self-healing process resonates with spine surgeons, and I believe it will for their patients as well,” stated Paul Nichols, president and CEO of Bio2 Technologies.