Bioventus Gains FDA Clearance of SIGNAFUSE Bone Graft Strip

By Julie A. Vetalice

Bioventus Gains FDA Clearance of SIGNAFUSE Bone Graft Strip

Bioventus received FDA 510(k) clearance to market SIGNAFUSE® Bioactive Bone Graft in a strip format. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips. U.S. product launch will occur in 3Q20.

SIGNAFUSE has been available in putty format since 2014. The new strips hydrate rapidly and provide ease of handling properties in multiple sizes ranging from 25 to 200 millimeters in length, with the longer strips providing an option for large, multilevel procedures.

Megan Osorio, Vice President, Marketing, said, “This product is unique in that it offers a great solution for patients that require more significant interventions such as spinal deformity correction.”

“We also believe SIGNAFUSE in the strip format will provide efficiencies for the hospital, either by opening fewer packages or cost savings opportunities vs. alternative grafts,” added John Nosenzo, Chief Commercial Officer, Bioventus.

Product Labels: Synthetic Bone Graft