September 25, 2018
COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX. Based on Synergy’s patented BioSphere® Technology, BIOSPHERE® FLEX is a strip-format bone graft product composed of porous, bioactive glass that is dimensionally integrated within a collagen and sodium hyaluronate scaffold. The porosity of the BIOSPHERE® FLEX bone graft was specifically designed for optimized absorption of bone marrow aspirate. BIOSPHERE® FLEX is presently in final preparation for commercial launch in the 4th quarter of 2018.
“The FDA clearance of BIOSPHERE® FLEX adds a key product to Synergy’s synthetic bone graft portfolio,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy Biomedical. “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).”
“The addition of BIOSPHERE FLEX to the product portfolio provides Synergy increased coverage of the bone graft market,” stated Kevin Booth, VP of Sales. “With the BioSphere® product line, surgeons have access to next-generation bone graft technology that is compatible with a variety of bone grafting techniques.”
BIOSPHERE® FLEX utilizes Synergy’s patented BioSphere® Technology which is based on an innovative spherical form of bioactive glass that allows for ideal and precise control over the osseous healing process. The BioSphere® granules utilized in BIOSPHERE® FLEX have a unique and innovative bonded sphere structure that provides an optimal porosity for bone growth through the granules. BIOSPHERE® FLEX has one of the highest bioactive glass contents on the market due to its increased granule density compared to other porous bone graft sheets. Additionally, the use of a specifically formulated collagen and sodium hyaluronate carrier in BIOSPHERE® FLEX permits the implant to become flexible and moldable when hydrated with bone marrow aspirate. This aids in graft placement, and enables the implant to conform to irregular bone surfaces for maximum graft continuity and healing potential.
BIOSPHERE® FLEX utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a next-generation bone graft material with the working characteristics of a flexible strip that is designed to absorb and hold bone marrow aspirate in direct contact with porous bioactive glass granules.
About Synergy Biomedical, LLC
Founded in 2011, Synergy Biomedical is a privately-held medical device company focused on bringing innovative biomaterial-based products to the musculoskeletal market. The Company’s BioSphere® Technology has broad, cross-platform surgical applications in the orthopaedic, spine, sports medicine, and joint arthroplasty markets. This technology represents a unique approach to advancing bone healing and improving patient outcomes.