Biomaterial products developer Synergy Biomedical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its BioSphere Flex strip-format bone graft product.
Image: Synergy Biomedical’s BioSphere Flex and BioSphere Granules. Photo: Courtesy of Business Wire.
The BioSphere Flex product, which is based on Synergy’s patented BioSphere technology, features porous, bioactive glass that is integrated within a collagen and sodium hyaluronate scaffold.
The product’s porosity was designed for optimized absorption of bone marrow aspirate. The company is planning to launch the product in the fourth quarter of this year.
Synergy’s BioSphere Technology which is based on spherical form of bioactive glass that allows for a precise control over the osseous healing process.
The BioSphere granules used in BioSphere Flex are claimed to possess a unique bonded spherical structure that offers an optimal porosity for bone growth to take place within the granules.
It is also claimed to have high bioactive glass contents on the market due to its increased granule density compared to other porous bone graft sheets.
Furthermore, the use of specifically formulated collagen and sodium hyaluronate carrier in BioSphere Flex allow the implant to become flexible and moldable when hydrated with bone marrow aspirate.
This helps in graft placement and enables the implant to conform to irregular bone surfaces for maximum graft continuity and healing potential.
Synergy Biomedical president and CEO Mark Borden said: “The FDA clearance of BioSphere Flex adds a key product to Synergy’s synthetic bone graft portfolio. The BioSphere product line provides surgeons with a full spectrum of bone graft forms that can be tailored to a variety of surgical techniques while leveraging the proven advantages of Synergy’s core bioactive technology.
“These options include Biosphere Putty (a robust bone graft material that can be used alone or combined with autograft), Biosphere Mis Putty (with a delivery system specifically designed for targeted graft placement in minimally invasive surgery), and now BIOSPHERE FLEX (developed to be used by surgeons who prefer the characteristics of a flexible strip form and the ability to augment with bone marrow aspirate).”