FDA Clears Amend Surgical’s NanoFUSE BA Synthetic Bone Graft

Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced that they have received 510(k) clearance to market NanoFUSE BA as a bone graft extender for spine and orthopedic applications.
 
NanoFUSE BA is a novel composite containing 45S5 Bioactive Glass and a patent protected carrier that provides optimal surgical handling performance and graft stability. Bioactive glass facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular osteogenesis (bone formation). It creates a highly favorable environment for bone fusion as it remodels into the recipient’s skeletal system and is an important tool for the orthopedic surgeon. With this most recent clearance Amend Surgical now has two U.S. Food and Drug Administration (FDA) cleared product lines.
 
“NanoFUSE BA offers our surgeons and their patients a synthetic alternative to NanoFUSE Bioactive Matrix,” stated Robby Lane, president and chief executive officer of Amend Surgical. “We are continuing to expand our market presence with the only demineralized bone bioactive glass combination product on the market and are excited about the opportunities offered by the launch of NanoFUSE BA. This product provides surgeons the superior handling characteristics they expect with the long and successful clinical history of bioactive glass.”