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 bioactive glass 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.
Tom Cha, M.D., Principal Investigator of the Bio2 study, remarked, “The Vitrium material is a fundamental improvement over the current solutions for spinal fusion. The implant uses a clinically proven bioactive material in a form that offers optimal strength and porosity to facilitate bone remodeling throughout the fusion site.”
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...
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 bioactive glass 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.
Tom Cha, M.D., Principal Investigator of the Bio2 study, remarked, “The Vitrium material is a fundamental improvement over the current solutions for spinal fusion. The implant uses a clinically proven bioactive material in a form that offers optimal strength and porosity to facilitate bone remodeling throughout the fusion site.”
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