Mar 2nd 2017
Amend Surgical Announces 501(K) Clearance for NanoFUSE® BA
Alachua Specialty Medical Device Company to Market Product as Bone Graft Extender
ALACHUA, Fla. — (BUSINESS WIRE) — Amend Surgical, Inc., a medical device company focused on enhancing the regenerative capacity of bone replacement products, announced today 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.”
About Amend Surgical
Amend Surgical is a specialty medical device company focused on enhancing the bone healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, clinically evaluated, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.
Amend Surgical, Inc.
Robby Lane, 386-518-5546
President and CEO