NovaLign(TM) Orthopaedics, Inc. Announces Its First 510(K) Clearance From The FDA For New Intramedullary Fixation System

Main Category: Bones / Orthopedics
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 26 Mar 2009 - 4:00 PDT

email to a friend   printer friendly   opinions  

NovaLign(TM) 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(TM) to enter the intramedullary fracture fixation market, estimated to be $700 million in the United States for 2009. NovaLign(TM) 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(TM).

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.

Using current surgical approaches, trauma surgeons insert rigid intramedullary nails through the nearest joint. "The NovaLign(TM) extra-capsular intramedullary device allows a surgeon to repair a long bone fracture without violating the nearby joint space," said James P. Stannard, M.D., professor of surgery at the University of Alabama at Birmingham. By entering the medullary canal from outside of the joint, NovaLign's goal is to avoid damage to the surrounding tissue thereby minimizing the complications that may be experienced with traditional surgical techniques.

In July 2007, NovaLign(TM) successfully raised $10 million in its Series-B financing round from a consortium of leading venture capital companies, including Versant Ventures in Menlo Park, Calif., SV Life Sciences in Boston, Mass., and Accuitive Medical Ventures in Duluth, Ga.

About NovaLign(TM) Orthopaedics Inc:

NovaLign(TM) (http://www.novalign.com), formerly known as OsteoLign, Inc., is an early-stage start-up company founded in 2005 within The Innovation Factory, a Duluth, Ga.-based technology incubator with a history of successfully developing medical device companies covering a broad range of medical specialties. In September 2007, the company relocated to Memphis, Tenn., and is continuing to build upon its current team of orthopaedic industry professionals.

NovaLign(TM) Orthopaedics, Inc.
http://www.novalign.com

• Additional
• References
• Citations