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News :: Archus Orthopedics, Inc. Initiates U.S. Clinical Trial Enrollment

REDMOND, Wash., Aug. 30, 2005 -- Archus Orthopedics, Inc. today announced that it has formally initiated enrollment in the U.S. clinical trial of its Total Facet Arthroplasty System™ ("TFAS®"). The first U.S. TFAS® case was successfully performed on August 26th by Dr. Scott Webb from the Florida Spine Institute. The company previously announced receipt of IDE approval from the U.S. Food and Drug Administration, allowing Archus to begin treating patients in the United States.

The TFAS® is a novel, patented spinal implant designed to treat spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. The TFAS® replaces the degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion.

"The case went extremely well and I am delighted with the outcome," said Dr. Webb. "I see the TFAS® as an important new treatment option for my spinal stenosis patients." A total of ten TFAS® cases have been successfully performed to date worldwide, with the longest patient follow-up at four months. Patients have regained mobility without pain, and follow-up radiographic and fluoroscopic images show the TFAS® correctly aligned and functioning properly.

Commenting on the case, Jim Fitzsimmons, chairman and chief executive officer of Archus Orthopedics, said, "This is the first facet joint replacement ever performed in the United States and is not only a significant achievement for Archus, but an important milestone in the emerging field of spinal joint replacement."