NovaLign nabs FDA approval for bone fixation system

NovaLign Orthopedics Inc. can now market its first product, a bone fixation system, after it received clearance from the Food and Drug Administration.

NovaLign will bring its fracture fixation system to a market estimated to be worth $700 million in the U.S. for 2009. The company’s system of implants and instruments is a treatment for long-bone fractures, like the humerus in the arm and tibia and femur bones in the leg.

Getting this approval of its first product will allow the company to commercialize new products, NovaLign CEO Jeffrey G. Roberts said in a statement. The company received a 510(k), or pre-market approval from the FDA, which means its product is at least safe and as effective as other products like it on the market now.

NovaLign’s system allows surgeons to repair a fracture without violating nearby joint space by entering a space outside the joint. Trauma surgeons now, in many cases, insert surgical nails through the nearest joint.

The market approval comes after the company raised $10 million in July 2007 from a number of venture capital companies including Versant Ventures in Menlo Park, Calif., SV Life Sciences in Boston, and Accuitive Medical Ventures in Duluth, Ga.

NovaLign was formerly OsteoLign Inc., an early-stage startup founded within The Innovation Factory, a Duluth technology incubator. The company moved to Memphis in September 2007.


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