MALVERN, Pa.–(BUSINESS WIRE)–Orthovita, Inc. (NASDAQ:VITA), a leading orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CORTOSS Bone Augmentation Material for treatment of vertebral compression fractures.
CORTOSS is an injectable, bioactive composite that mimics the physiological properties of human cortical bone and is the first alternative to polymethylmethacrlyate (PMMA) cement that has been evaluated in a large-scale, multi-center, randomized, controlled clinical study and cleared in the United States for the treatment of vertebral compression fractures. “Every year roughly 250,000 people in the United States undergo augmentation procedures such as vertebroplasty and kyphoplasty for painful fractures in the spine. Since the inception of the vertebroplasty procedure in the mid 1980s, PMMA has been the only viable implant for vertebral augmentation,” stated Antony Koblish, President and CEO of Orthovita. “CORTOSS is the first FDA-cleared alternative in this product category. Our experience and research to date shows that physicians and their staff are pleased with the innovative handling and biomechanical characteristics that CORTOSS offers. We believe these features, supported by our extensive human clinical data demonstrating safety and effectiveness, offer physicians and facilities substantial value and a clear rationale for adopting CORTOSS.”