FDA Clears Synergy Biomedical’s BioSphere Putty

Synergy Biomedical, LLC has received U.S. Food and Drug Administration clearance for its first bone graft product, BioSphere Putty. Utilizing a specialized form of 45S5 bioactive glass with a unique sphere shape and a narrow size range, BioSphere Putty provides an optimized bone graft material that outperforms other bioactive products.

The spherical shape of the BioSphere particles provides uniform and repeatable resorption and ion release. In addition, the 3-D packing of the spheres in a bone defect creates an optimal porosity that allows bone formation throughout the implant. Biosphere putty is composed of bioactive glass spheres that are combined with a moldable phospholipid carrier. The putty has the highest bioactive glass composition on the market, provides excellent handling, and is resistant to irrigation. This combination results in a high performance bone graft that provides faster and more robust bone formation, according to the Collegeville, Pa.-based firm.

“The use of spherical particles has allowed Synergy to identify an optimal form of bioactive glass that improves bone formation,” stated Mark Borden, Ph.D., CEO and founder of Synergy Biomedical. “We are excited to introduce a next generation bone graft product to the orthopaedic community that represents an advancement in bone grafting technology.”

Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial based products to the orthopaedic and spinal markets.