FDA approves BioSphere Flex strip-format bone graft product

Synergy Biomedical has received approval from the FDA for its BioSphere Flex strip-format bone graft product, a porous, bioactive glass that is incorporated into a sodium and collagen hyaluronate carrier, allowing the implant to become flexible and moldable when hydrated with bone marrow aspirate. The BioSphere granules used in the product have a bonded spherical structure that creates an ideal level of absorbency for bone growth to take place within the granules, aiding graft placement and facilitating the implant to adapt to asymmetrical bone surfaces for maximum graft continuity and healing ability.
Mark Borden, Synergy Biomedical president and CEO said: “The FDA clearance of BioSphere Flex adds a key product to Synergy’s synthetic bone graft portfolio. The BioSphere product line provides surgeons with a full spectrum of bone graft forms that can be tailored to a variety of surgical techniques while leveraging the proven advantages of Synergy’s core bioactive technology. “