Scott Clark, Media Relations 254-724-3047 Email: sdclark@swmail.sw.org FOR IMMEDIATE RELEASE May 9, 2006

Scott & White to evaluate investigational device for spine surgery
 - First patient to receive artificial disc in unique research study-

Temple, Texas – Scott & White has been chosen as one of a select group of hospitals for a clinical research study to assess an investigational device for spine surgery. The study will evaluate the safety and effectiveness of an artificial spinal disc for the treatment of shoulder and arm pain, along with the weakness caused by chronic cervical (neck) disc degeneration.

Scott & White spinal surgeons Dr. Christopher D. Chaput and Dr. Mark Rahm are conducting the surgeries using the PCM® cervical disc replacement. Dr. Chaput has worked closely with the medical team at Cervitech, developers of the PCM® system.

The first procedure using this device at Scott & White was May 8. The primary treatment of advanced cervical disc degeneration has been surgery to remove the affected discs and fuse the vertebra. It is estimated that nearly 400,000 people in the U.S. undergo fusion procedures each year“Among spine surgeons, there is a lot of hope that we can do less destruction and more reconstruction when treating painful disorders in the neck,” said Dr. Chaput. “We are at a point where we are trying to apply the same principles of motion preservation to the cervical spine that are currently used in hip and knee replacement.”

The intent of the PCM® disc replacement system is to provide spine surgeons with a possible alternative to the current standard of spinal fusion. Spinal fusion is a highly successful operation and usually relieves pain and other symptoms, but does result in loss of motion in the fused joint. For that reason, devices such as the PCM® have been developed to potentially provide the relief of pain and symptoms, with the possibility of retaining motion at the treated joint.

The PCM® system is constructed of two endplates, made of a cobalt chromium alloy, surrounding a special grade plastic core that together could potentially help to restore/maintain motion in the affected vertebral segments after removal of the diseased disc and bone. These are the same materials that are used in artificial hip and knee replacements.  While the possibility of preserving motion at the treated level has yet to be proven, the concept offers appeal to surgeons and is therefore being studied.

PCM® is a registered United States trademark of Cervitech, Inc.

For more information, contact research coordinator Chris Herrick at 254-724-9292.

Frequently Asked Questions About Cervitech and the PCM®

Who is Cervitech?

• Cervitech was founded by Helmut Link of Waldemar Link GmbH & Co. The Link companies have been a pioneer for decades in artificial joint technologies.

What has been the company experience in joint replacement?

• Today, other parts of the Link family of companies focus on complex hip and knee replacement implants.

What about the Link company experience within spinal joint replacement?

• Beginning in the late 1980’s, Waldemar Link GmbH & Co. partnered with the inventors of one of the first artificial discs for the lower (lumbar) spine, to develop a functional product. The SB Charite III total lumbar disc replacement device is commonly used in Europe and around the rest of the world in the treatment of specific lumbar degenerative disc disease patients and was approved by the U.S. Food and Drug Administration (FDA) in November, 2004, for use in the United States.  Leading up to the FDA approval, the SB Charite III product line was sold by Waldemar Link GmbH to Depuy Spine, a division of Johnson and Johnson.

What is Cervitech’s focus?

• Cervitech is 100 percent focused on channeling company experience in hip, knee and spinal joint replacement into the development and manufacturing of investigational artificial disc replacement solutions for the upper (cervical) region of the spine.

What does the Cervitech product line look like today?

• The flagship product of the Cervitech company is the investigational PCM® artificial cervical disc replacement system.  The PCM® is available in many footprints and heights to match various anatomical situations.

What are some of the design principles of the PCM®?

• The PCM® is an “unconstrained” prosthetic device.  In an effort to create a more natural motion pattern following disc replacement, the PCM® is designed to be constrained only by the surrounding soft tissues (muscles and ligaments) as opposed to by the implant itself.

What materials are used in the manufacture of the PCM®?

• The outer “endplates” of the implant are manufactured out of cobalt chromium alloy and coated with titanium and calcium phosphate. This design is intended to promote bony attachment to the surrounding vertebrae. The inner “core” is made out of ultra high molecular weight polyethylene (UHMWPE), which allows the upper endplate to move over, across, and around it, intended to mimic the natural motion of the native disc. These are the same materials that are used in joint replacements throughout the rest of the body.

What is the status of the PCM® in the United States?

• The PCM® is currently under an FDA regulated clinical study to assess the safety and efficacy of the device.

Who is a candidate for the study?

• A more detailed list of study indications can be found at www.cervitech.com.  A summary of these indications includes patients between 18-65 years of age who are suffering from disc degeneration and/or herniation at a single level in the cervical region of the spine.

How will the study work?

• Patients who meet the eligibility requirements and are enrolled in the study will randomly be assigned either the investigational PCM® artificial cervical disc replacement, or today’s gold standard which is spinal fusion with a block of bone, a metal plate, and screws.  Patients who are part of the study will have follow up visits for at least two years and will be compared in their outcomes with regards to improvement in pain, function, return to work, and other criteria.

Where is the study being conducted?

• There are 20 sites throughout the country that are part of the investigative team.  A complete list of sites can be found at www.cervitech.com.

Facts About the Spine

The Problem

• Pain associated with spinal problems represent one of the most common reasons for a trip to the doctor’s office in the United States.
• Nearly 80 percent of all Americans will suffer from at least one significant episode of back and/or neck pain in their lifetime.
• Back and/or neck pain is the leading cause of disability for people age 19-45, representing 16 percent of all workers compensation claims.
• Because the spinal cord and its branching nerve roots send signals throughout the body, a disc herniation (which presses on the cord or roots) is felt along a “path” as opposed to just at a “spot.”)  Example: A disc herniation in the neck can be felt in the shoulder, down the arm, and even into the hand.

The Treatment

• Arm and shoulder pain resulting from problems in the cervical spine resolves without the need for surgery in the vast majority of cases with conservative treatments like rest, massage, heat, and others.
• Chronic pain that is non-responsive to conservative therapy is often treated with today’s gold standard for spine disorders: removal of the diseased disc and bone followed by fusion of the vertebrae.
• Approximately 400,000 spinal fusion procedures are done each year to decompress the spinal cord or nerve roots and to rigidly fuse two vertebrae together via implantation of metal plates, rods and screws.
• Spinal fusion is very successful in resolving the pain. The principal aim is to eliminate motion in the problem area of the spine.
• By eliminating motion following removal of the offending disc or bone material, the spinal cord and nerve roots are no longer “pinched” or pressed upon, and the pain is alleviated.

The Question

• While spinal fusion is quite successful at resolving pain, it does result in a loss of motion within the fused joint.
• There has been recent interest in “motion preservation” technologies.
• This study is being conducted to address these issues in a scientific fashion. 

Bottom line

• Will an investigational artificial cervical disc that potentially restores/maintains motion do an equivalent or superior job of resolving painful spinal conditions without some of the side-effects of fusion?