WOBURN, Mass., Nov. 13, 2018 /PRNewswire/ — Bio2 Technologies, Inc., a privately held orthopedics company, announced today that it received U.S. Food and Drug Administration (“FDA”) approval to begin enrollment 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 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 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 randomized, 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, Ph.D. and 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.
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 advanced bioactive orthobiomaterials utilizing a proprietary process capable of producing resorbable, three-dimensional structures with controlled, interconnected porosity. For further information please visit www.bio2tech.com.
SOURCE Bio2 Technologies, Inc.