Amend Surgical wins FDA nod for NanoFuse BA bone graft extender

Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications.

The Alachua, Florida-based company’s NanoFuse BA is a composite of bioactive glass and a human demineralized bone matrix that Amend Surgical touts as providing optimal surgical handling performance and graft stability.

Bioactive glass rapidly bonds bones and encourages cellular osteogenesis, or bone formation, helping to contain the operative site graft, according to the company. It also creates a favorable environment for bone fusion while it assimilates into the patient’s skeletal system.

The calcium-based bioactive glass is the 1st man-made material to release calcium and form a direct, strong interfacial bond between the graft and adjacent bony tissue within minutes, Amend Surgical reported.

“NanoFuse BA offers our surgeons and their patients a synthetic alternative to NanoFuse Bioactive Matrix,” president & CEO Robby Lane said in prepared remarks. “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.”

With this regulatory nod, Amend Surgical has 2 FDA-approved product lines in their portfolio.

Animal studies conducted by Amend Surgical and independent groups have shown support for the NanoFuse bioactive matrix as compared to commercially available bone void filler implants that use only demineralized bone matrix.

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