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Bio2 Technologies Enrolls First Vitrium Patient in Cervical Spine Fusion Trial -

Bio2 Technologies enrolled the first patient in the randomized, multi-center, non-inferiority Investigational Device Exemption clinical trial of the Vitrium cervical interbody device. The 168-patient study will compare Vitrium to allograft in spinal fusion. The company received FDA approval for the trial in 4Q18 after pre-clinical studies demonstrated that Vitrium implants are substituted with newly-regenerated bone while exhibiting sufficient strength for use in load-bearing reconstructive surgeries. Vitrium is a proprietary structural and resorbable orthobiomaterial that uses the patient's own regenerative process to achieve fusion without metal or plastic left behind. (Bio2 Technologies, 8/5/19)