BioStructures, LLC, a privately held orthobiologics company, announced that it has hit a milestone of 4,000 implantations of Signafuse® Bioactive Bone Graft Putty. Signafuse was FDA 510(k) cleared in early 2014 as a bone void filler indicated for standalone use in posterolateral spine fusion procedures. This is a distinguished status among recently cleared bone graft products, as less than 6% of new synthetic products have received clearance with a standalone indication for posterolateral spine fusion procedures over the past 3 years.
John Brunelle, PhD, Chief Technology Officer (CTO) of BioStructures explained, “Signafuse was intentionally designed to support the complex healing requirements of posterolateral spine fusion surgery, without the aid of autologous extenders or enhancers. Following a comprehensive evaluation of the best available bone graft technologies, published clinical data and surgeon feedback, paired with an intuitive understanding of the fusion healing environment, we conceived a composite bone graft that would thrive in the complex fusion healing environment.”
The result is Signafuse, a moldable bone graft comprising a proprietary combination of patented bioactive glass particles and biphasic mineral granules suspended in a patented resorbable polymer carrier.
Dr. Brunelle added, “Through the synergistic combination of these scientifically and clinically validated biomaterials, in the most optimized forms available, Signafuse provides a bone graft that meets the intra-operative handling needs of the surgeon and effectively facilitates structural fusion development in the posterolateral spine.”
Russell Cook, CEO of BioStructures stated, “Hitting this milestone in such a short timeframe is a testament to the clinical benefits of the Signafuse technology and that taking the right approach in design will produce what we think is the best bone graft substitute on the market. Our highly focused, clinically driven commercialization strategy has minimized development time and allows us to provide a larger number of patients with the most advanced technology. BioStructures was founded in 2009 with the objective to develop and commercialize proprietary first-in-class products and Signafuse is proof that we are achieving our goals. Signafuse has become a significant addition to our Bioactive, Collagen, Synthetic, DBM and Allograft suite of products.”
About BioStructures, LLC
BioStructures is a leading medical device company focused on developing innovative proprietary platforms in bioresorbable bone graft products for a broad range of spinal and orthopedic fusion procedures. BioStructures’ global mission is to develop and commercialize new and innovative products focused on improving bone regeneration and remodeling for related clinical procedures. For additional information on BioStructures, please visit our website at www.biostructures.net.
SOURCE BioStructures, LLC