WOBURN, Mass., Aug. 5, 2019 /PRNewswire/ — Bio2 Technologies, Inc., the developer of Vitrium, a unique proprietary structural and resorbable orthobiomaterial, announced the first implantation of an index patient in its randomized, multi-center, non-inferiority IDE Vitrium Cervical Interbody clinical trial. Bio2 received FDA approval to conduct the trial after pre-clinical studies demonstrated Vitrium implants are substituted with newly regenerated bone while exhibiting sufficient strength for use in load-bearing reconstructive surgeries such as spinal fusion.
K. Brandon Strenge, M.D. of The Orthopaedic Institute of Western Kentucky performed the procedure. Dr. Strenge commented, “I am very excited to be a part of this study evaluating a device that harnesses the patient’s own regenerative process to achieve a fusion without metal or plastic left behind. I was particularly impressed with the ability of the spacer to rapidly absorb blood into its structure. This will likely become a compelling option for my patients.”
Tom Cha M.D. of Massachusetts General Hospital/Harvard Medical School, and the Principal Investigator of the Bio2 study added, “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 is enrolling up to 168 patients in a prospective, randomized, non-inferiority study comparing the Vitrium cervical implant to allograft (cadaver bone). “We’re excited to have the first patient implanted with the Vitrium Cervical Interbody Device,” remarked Janet Krevolin PhD, Chief Operating Officer at Bio2. “We look forward to returning to the gold standard outcome of a total biologic fusion with no foreign material remaining in the disc space.”
About Bio2 Technologies, Inc. Bio2 Technologies is a privately held medical device company headquartered in Woburn, Massachusetts. Our team is engaged in the development of implantable devices utilizing Vitrium, a proprietary biomaterial. For further information please visit www.bio2tech.com.
SOURCE Bio2 Technologies, Inc.