Prosidyan® receives FDA clearance of its FIBERGRAFT® BG Putty for postero-lateral spinal fusion
Warren, NJ, June 1, 2017: NJ-based Prosidyan® (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it has received FDA 510(k) clearance of FIBERGRAFT® BG Putty – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT® BG Putty is the second generation product in the company’s FIBERGRAFT® line of bioactive glass based products. FIBERGRAFT® BG Putty leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan®’s proprietary bioactive carrier, OSSIGLIDE®.
FIBERGRAFT® BG Putty – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® BG Putty must be used with autograft in the posterolateral spine. FIBERGRAFT® BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Dr. Babak Barcohana MD of the Southern California Orthopedic Institute commented,
“I have had outstanding clinical results with FIBERGRAFT® BG Morsels over the last three years and look forward to continued clinical success with this next generation product from Prosidyan®.”
Dr. Stephen Tolhurst MD of the Texas Back Institute commented, “FIBERGRAFT® BG Putty is backed by great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”
Dr. Brian Kwon MD from New England Baptist Hospital called FIBERGRAFT® BG Putty
“The most intelligent bone graft on the market and your best bone graft decision in the OR”
Prosidyan® was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan®’s first product, FIBERGRAFT® BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT® BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT®BG Morsels delivered through Prosidyan®’s proprietary bioactive carrier, OSSIGLIDE®. To date, FIBERGRAFT® products have been implanted in over 7,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.