The implants are constructed with Bio2's Vitrium biomaterial exclusively composed of bioactive glass, a resorbable material with a well-studied mechanism of action and long track record of safe clinical use, according to the company. Following years of research and pre-clinical testing, Bio2 has successfully applied its proprietary process technology to produce a rigid, bioactive and osteoconductive material with an interconnected porous structure that facilitates ingrowth and remodeling of healthy bone.
"The fusion device is our second market clearance of a Vitrium product application, joining our line of osteotomy wedges for reconstructive surgery of the mid- and hind foot in our extremities portfolio. We believe the properties of Vitrium offer musculoskeletal surgeons an attractive alternative to allograft (cadaver bone) and synthetic materials such as beta-tricalcium phosphate," President/CEO Paul Nichols said.
A limited product release of the fusion device is planned for the second quarter of 2016.
Bio2 Technologies is a privately developer of orthopedic surgical devices that incorporate CLM•BG, a proprietary resorbable biomaterial. The firm is based in Woburn, Mass.