21 May Prosidyan® Receives CE Mark for FIBERGRAFT® BG Family of Products
FIBERGRAFT® BG Putty, FIBERGRAFT® BG Putty GPS, FIBERGRAFT® BG Morsels for use in the Lumbar Spine and Anterior Cervical Spine.
NEW PROVIDENCE, N.J. (PRWEB) MAY 20, 2021
Prosidyan, Inc. (http://www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, receives two CE (Conformité Européenne) Marks for FIBERGRAFT BG Putty, FIBERGRAFT BG Putty GPS, and FIBERGRAFT BG Morsels. FIBERGRAFT is an ultraporous synthetic bone graft substitute made from proprietary nano- and micro-sized bioactive glass fibers to provide direct connectivity, high surface area, and optimized resorption rates.
“As a Company, we are excited to achieve this milestone in expanding our international sales footprint. Based on our customer experience, we are confident in the clinical performance of our FIBERGRAFT technology, and continue to focus on evidence generation and research and development. Surgeons want their patients to heal faster with fewer complications and that motivates us to be a trusted partner in delivering such outcomes,” said Charanpreet Bagga, CEO and Co-Founder of Prosidyan in New Providence, NJ.
To support the CE Mark application, Prosidyan collected and analyzed retrospective data from 155 patients at 4 United States centers to meet the strenuous clinical evidence requirements put forth by the European Commission. Standard of care, post-operative imaging was used to assess fusion and provide real-world evidence of successful outcomes with our FIBERGRAFT technology. Considering the EU’s Medical Device Directive’s (93/42/EEC MDD) requirements, “the bar was high and FIBERGRAFT demonstrated fusion rates over 90% in a diverse and heterogenous patient population and across multiple sites and multiple levels of fusion. Due to the strength and diversity of our data sets, we’re pleased to have been granted broad indications for the FIBERGRAFT BG Putty and FIBERGRAFT BG Morsels product portfolios for fusion procedures in the lumbar and anterior cervical spine,” said Bagga.
Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on nano- and micro-sized bioactive glass fibers. 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 graft substitute was performed in May 2014. The Company’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels in combination with Prosidyan’s proprietary bioactive carrier, OSSIGLIDE®. Prosidyan’s latest technology, FIBERGRAFT BG Matrix launched in August 2017, uses Prosidyan’s proprietary Type I collagen-based bioactive carrier. To date, FIBERGRAFT products have been implanted in over 40,000 patients across the United States, Europe, and Hong Kong. Prosidyan is poised to revolutionize synthetic bioactive bone graft options globally, with numerous patents and a robust pipeline of products in development.
SOURCE: PR Web, 20th May 2021