Prosidyan Announces FDA Clearance and Commercial Launch of its FIBERGRAFT® BG Matrix for Postero-Lateral Spinal Fusion
Warren, NJ, October 26, 2017: NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today FDA 510(k) clearance and full commercial launch of FIBERGRAFT® BG Matrix – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT® BG Matrix is the third generation product in the company’s FIBERGRAFT® line of bioactive glass fiber based products. FIBERGRAFT® BG Matrix leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary type I collagen based bioactive carrier.
FIBERGRAFT® BG Matrix – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseaous 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 Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
Here are some comments from the early users of FIBERGRAFT® BG Matrix:
Dr. Paul Slosar MD of the San Francisco Spine Institute commented,
“ I have an interest in the growing scientific research focused on bone graft extenders and am impressed by the FiberGraft®‘s basic science data. I recently had the opportunity to use the Fibergraft® Matrix in several cases where I needed to augment my posterior fusion, when we didn’t have enough autograft. The Fibergraft® had excellent handling characteristics and interdigitated very nicely with the host bone. The Fibergraft® provided me with an excellent option to reinforce my bone graft and, based on their scientific data, I anticipate excellent clinical fusion results.”
Dr. Adam Bruggeman MD of the Texas Spine Care Center commented,
“Fibergraft® Matrix from Prosidyan is an innovative update to their leading fiber based bioglass portfolio. Matrix is easy to manipulate, allowing for
multiple applications. It is now my preferred graft for all biologic
applications in the spine.”
Dr. Todd Allen, MD, PhD Associate Professor Orthopaedic Surgery UCSD commented,
“The structural and handling features are dynamic and second to none with an innate ability to wrap around bony structures and wick needed blood and cells to the region. The structural and biologic capabilities of this unique synthetic are powerful, and make this a great product for the future of spine surgery, both in open and MIS applications.
Prosidyan’s Founder & CEO Charanpreet Bagga informed that FIBERGRAFT® BG Matrix was presented at the 2017 North American Spine Society Innovative Technology Presentations on October 25th by Dr. William Walsh PhD, of UNSW. There were only seven technologies selected for presentation at this forum and FIBERGRAFT® is the only synthetic bone graft substitute selected for this prestigious forum.
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. 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 9,000 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.
ABOUT Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.