APRIL 07, 2011

KneeAlign® 2 receives FDA Market Clearance

Aliso Viejo, CA - April 7, 2011 - OrthAlign, Inc., a privately held medical device company, received 510(k) market clearance from the US Food and Drug Administration for the next generation KneeAlign® system, which now combines tibial and femoral knee replacement navigation in a single, disposable, palm-sized device. KneeAlign® 2 eliminates the need for an intramedullary rod by enabling the orthopedic surgeon to locate the center of the femoral head with a simple intraoperative maneuver.

"We were encouraged by clinicians' positive reactions to KneeAlign® 2 prototypes when showcased at the American Academy of Orthopaedic Surgeons in San Diego earlier this year" said Pieter Wolters, President and CEO of OrthAlign: "Building on the clinical success and early market acceptance of KneeAlign® 1, today's market clearance prepares us to bring another revolutionary product to orthopedic surgeons, and helps them bring the best possible surgical outcomes to their patients. We look forward to make KneeAlign® 2 commercially available in the US during the second half of 2011."

About KneeAlign®: Introduced in late 2010, KneeAlign® 1 has been widely endorsed by surgeons for its unique combination of precision and ease of use. In March 2011, the Journal of Arthoplasty published successful interim data of an ongoing KneeAlign® 1 clinical study. A total of 42 knees underwent a total knee replacement using KneeAlign® 1. Postoperative standing anteroposterior hip-to-ankle and lateral knee-to-ankle radiographs demonstrated that 97.6% of the tibial components were placed within 90° ± 2° to the mechanical axis in the coronal plane, and 96.2% of the components were placed within 3° ± 2° to the mechanical axis in the sagittal plane. (Click here to view abstract). KneeAlign® is compatible with all total knee replacement implant systems and offers the surgeon a clear and simple user interface within the operative field.

About OrthAlign, Inc.: OrthAlign, Inc. is committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. Our technology raises the standard of care in joint replacement surgery by making consistent and measurable results accessible to all surgeons, hospitals and patients. OrthAlign was established in Southern California in 2008.

Contact Information:
Sandy Guzman - Marketing Manager - (949) 525-9027 - sandy@orthalign.com
Gary Scheel - VP Sales - (949) 525-9044 - gary@orthalign.com
OrthAlign Customer Service - (866) 582-0879 - info@orthalign.com