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News :: Archus Orthopedics, Inc. Completes First Clinical Implants

REDMOND, WA - May 25, 2005 - Archus Orthopedics, Inc. today announced successful completion of the first clinical implants of its Total Facet Arthroplasty System™ ("TFAS®"). The cases were performed in Europe by Dr. Scott Webb, assisted by local surgeons trained by Dr. Webb under a fellowship program at the Florida Spine Institute. All cases were successful with no complications, and all patients are reported to be doing well post operatively.

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.

Commenting on the cases, Dr Webb said "The procedures were very straightforward and I am pleased with the outcomes. The instrument set developed by Archus made it very easy to select implant components and achieve precise placement, alignment and assembly." He added "Given that these were the first TFAS® clinical cases ever performed, things could not have gone better."

On March 28th, Archus announced that the U.S. Food and Drug Administration conditionally approved an Investigational Device Exemption ("IDE") for the TFAS®, allowing the company to initiate a pivotal clinical trial of the device in the United States. "Based on our experience in Europe, I am convinced that TFAS® is ready for the U.S. trial", said Dr. Webb, who will serve as a Phase I investigator. "TFAS® is an exciting alternative to spine fusion and I'm anxious to begin evaluating the device at the Florida Spine Institute", he added.

"This is an exciting and rewarding milestone for the company and we are delighted with our early clinical success", said Jim Fitzsimmons, chairman and chief executive officer. While he acknowledged that there are other posterior stabilization devices being evaluated in the clinic, both in the U.S and Europe, Fitzsimmons stressed the clear differentiation between TFAS® and these other devices. "None of them fully restore both the stability and complete range of motion in all planes allowed by the normal facet joint." He added "This full functionality makes TFAS® the only true facet joint replacement device, and joint replacement is where we are going in spine care."

Treatments for degenerative spine disease represent the fastest growing segment of the orthopedic market. Each year hundreds of thousands of patients undergo a surgical intervention to address their low back condition. Many of these procedures include fusion of one vertebra to another to stabilize the spine or eliminate motion that produces pain. Sometimes ineffective, spinal fusion alters the normal biomechanics of the spine, which can create new problems at adjacent vertebral segments, often requiring re-operation.