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Archus Orthopedics Completes World's First Lumbosacral Facet Joint Replacement


REDMOND, Washington, August 30 /PRNewswire/ --

Archus Orthopedics, Inc. today announced that it has successfully
completed the first human implants of its new TFAS-LS(TM) system,
representing the first ever facet joint replacement procedures done at the
lumbosacral spinal level. The cases were performed in Europe by Dr. Scott
Webb from the Florida Spine Institute, assisted by Dr. Radu Prejbeanu and Dr.
Ioan Branea.

The TFAS-LS complements the company's first product, the Total Facet
Arthroplasty System(R) or "TFAS(R)", which has been successfully implanted in
over one hundred patients worldwide, the vast majority treated in the United
States in an ongoing IDE study approved by the U.S. Food and Drug
Administration. Both devices are novel spinal implants 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 moderate to severe spinal stenosis
undergo decompressive laminectomy surgery, which is often accompanied by
spinal fusion. The TFAS and TFAS-LS replace degenerative facet joints with a
prosthetic joint implant intended to restore stability and normal motion to
the spine, eliminating the need for fusion. The TFAS-LS is specifically
designed to conform to the unique anatomy of the lumbosacral spinal level,
which is the junction between the lowest lumbar vertebra and the sacrum.

"These initial cases were very straightforward and I am delighted with
the results," said Dr. Scott Webb. "Spinal stenosis is often seen at the
lumbosacral level and the TFAS-LS will enable facet joint replacement therapy
to be offered to a much broader pool of patients," he added. Dr. Webb, a
pioneering spine surgeon, has been a key advisor to Archus for several years.
He performed the first TFAS implantation in 2005, which was one of the
earliest facet joint replacement procedures ever completed. "There are
several important clinical indications for replacing the facet joint, and I
am very impressed with the family of devices that Archus has developed to
address these conditions," said Dr. Webb.

"This is another significant milestone for Archus Orthopedics," said Jim
Fitzsimmons, chairman and chief executive officer. "In addition to expanding
our stenosis market opportunity, the TFAS-LS is the first of several new
Archus devices utilizing pedicle screw fixation," he added. Fitzsimmons
indicated the company's entire second generation product line has now been
fully developed and is ready for clinical use. "We will soon be reporting
more first implants, including novel devices designed to work in concert with
artificial discs," said Fitzsimmons.

While Archus will conduct clinical trials of the TFAS-LS and other new
products to gain marketing approval in the United States, the company's
entire device family has already received marketing approval in the European
Union. "We expect to pursue a broad but controlled launch in Europe next
year," said Fitzsimmons.

About Archus Orthopedics

Founded in July 2001, Archus Orthopedics is a privately held company
developing a family of reconstructive implants to treat a variety of spine
disorders resulting from degenerative changes in the facet joints. Archus has
received venture capital funding from MPM Capital, InterWest Partners,
Polaris Venture Partners and Johnson & Johnson Development Corporation, in
cooperation with DePuy Spine.

Web site: http://www.archususa.com

© PR Newswire Association LLC.

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