Synergy Biomedical Announces FDA Clearance of BIOSPHERE FLEX

Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX and is targeting a launch in the 4th quarter of 2018.  Based on Synergy’s BioSphere® Technology, BIOSPHERE® FLEX is composed of porous, bioactive glass granules combined with a porous collagen and sodium hyaluronate scaffold.  The porosity of BIOSPHERE® FLEX bone graft was specifically designed to absorb bone marrow aspirate. 

“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical.  “The BIOSPHERE® product line provides surgeons with a variety of bone graft forms that can be tailored to their surgical technique.  This includes BIOSPHERE® PUTTY which is a robust bone graft material that can be used alone or combined with autograft, BIOSPHERE® MIS PUTTY which was specifically designed for minimally invasive surgery, and BIOSPHERE® FLEX which was developed to be used by surgeons who prefer to mix in bone marrow aspirate.”