 |
 |
||||||
[July 2007]
Exactech Announces FDA Approval for Novation Ceramic Articulation Hip System
Exactech Inc (Gainesville, FL, USA), a developer and producer of bone and joint restoration products including orthopaedic implants and biologic materials, has announced that it has received pre-market approval from the U.S. Food and Drug Administration (FDA) for the Novation™ Ceramic Articulation Hip System™ thereby granting Exactech permission to market the system.
The new system adds a high demand, hard bearing option to Exactech offerings for total joint replacement. Featuring alumina ceramic, the system is designed to improve implant longevity and has demonstrated up to 2,000 times less wear debris generation than traditional metal and polyethylene bearings. Exactech's sizing scheme allows the use of larger femoral heads in the majority of patients which provides a competitive advantage compared to other ceramic systems. The system also features femoral stems designed to increase range of motion for patients.
Exactech also said it is increasing its full-year sales targets from the US$112 million to US$118 million range to an updated estimate of US$115 million to US$120 million.
Chief Financial Officer Joel Phillips said: “The company has performed exceptionally well during the first half of 2007 by delivering new products on or ahead of schedule and by realizing positive sales results from products released during the past year. We expect to meet our revenue plan for the second quarter and have confidence in our ability to sustain this momentum through the remainder of the year and beyond”.
www.exac.com
ENDS