MEMPHIS, Tenn., (March 25, 2009) – – – NovaLign™ Orthopaedics, Inc., formerly known as OsteoLign, Inc., received its first 510(k) clearance from the U.S. Food and Drug Administration to market its Intramedullary Fixation System, a new system of implants and instruments for the treatment of long bone fractures, including the humerus, tibia and femur. This regulatory clearance allows NovaLign™ to enter the intramedullary fracture fixation market, estimated to be $700 million in the United States for 2009. NovaLign™ has filed multiple U.S. and foreign patent applications related to its technology.
“Attainment of this key milestone enables the company to move forward with its plans to commercialize new products that provide innovative treatment options for long bone fracture repair,” said Jeffrey G. Roberts, president and CEO of NovaLign™.
Extensive preclinical testing in accordance with internationally recognized testing standards and applicable FDA guidances support NovaLign’s 510(k) clearance. The company plans to initiate clinical studies in Europe and the United States later this year.