Orthopedics company Bio2 Technologies has received FDA approval to begin enrollment in an IDE clinical study to evaluate its Vitrium bioactive glass as a cervical interbody fusion device. 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 bone conductivity. Vitrium represents an innovative approach to a well-studied osteostimulative mechanism of action with a long track record of safe clinical use, according to the Woburn, Mass. company.
The randomized, controlled, non-inferiority pivotal study will capture safety and effectiveness data with a 12-month endpoint. Vitrium is currently in commercial use under 510(k) clearances as a bone graft substitute.
The results of the company’s study on sheep, presented at last year’s North American Spine Society, showed that Vitrium has a 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, according to Bio2 Technologies COO Janet Krevolin.
“Spine implant manufacturers are incorporating incremental improvements to PEEK and titanium interbody devices in an attempt to achieve better bony integration,” added president & CEO Paul Nichols in a prepared statement. “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.”