Healthcare Industry News:  degenerative disc disease 

Devices Neurosurgery Orthopaedic Regulatory

 News Release - November 30, 2006

Interventional Spine, Inc. Announces CE Mark Approval of Its Percutaneous Dynamic Stabilization for the Treatment of Spinal Disease

IRVINE, Calif.--(HSMN NewsFeed)--Interventional Spine, Inc. (formerly Triage Medical®, Inc.) today announced its European notified body has granted CE Mark approval for the Company's Percutaneous Dynamic Stabilization ("PDS") System for the early-stage treatment of spinal disorders. This approval will allow the Company to begin marketing the PDS in European Union countries and other countries around the world that recognize the CE Mark approval process.

To the Company's knowledge, the PDS System is the only procedure available that can provide dynamic stabilization of the spine via a percutaneous access puncture. All other dynamic stabilization systems and procedures require a major or minimally invasive surgical incision to provide pain relief to patients with degenerative spinal disc disease.

Dynamic stabilization is an alternative to medical management, corticosteroid injections and when indicated, invasive surgical fusion therapies, to over 200,000 patients in the United States and approximately 500,000 patients on a worldwide basis who suffer from degenerative disc disease of the spine. Dynamic stabilization provides relief from the pain of degenerative disc disease while maintaining far greater motion compared to patients of spinal fusion surgery. Third-party experts have estimated that the market of dynamic stabilization products will grow to over $500 million within the next five years.

In addition to providing the least invasive approach to dynamic stabilization, the results from the Company's initial pilot clinical study indicate that the PDS System provides greater relief from pain for individuals suffering from spinal disc disease than any other dynamic stabilization product or procedure. Interventional Spine intends to conduct a series of extensive clinical trials and continue to prove the clinical value.

Commenting on this CE Mark approval, Interventional Spine CEO, Walter A. Cuevas, said, "This approval enables us to launch the PDS System in European markets during 2007. Dynamic stabilization has become a rapidly growing procedure in Europe and we believe that the PDS System has significant clinical and patient advantages over the dynamic stabilization devices currently available. This approval also gives us the impetus to both initiate a series of clinical studies in Europe to broaden the application of the PDS System to an even wider group of patients and move forward to begin our first pivotal clinical study in the United States."

Interventional Spine changed its name from Triage Medical, Inc. in November 2006 to more effectively communicate the clinical and business strategic emphasis of the Company. In addition to the PDS System, Interventional Spine also has both U.S. FDA market clearance and CE Mark approval for the Company's PLS System. The PLS products allow the least invasive method of providing fixation of the vertebral structures following conventional spinal fusion procedures. Rather than needing a surgical incision to implant the required vertebral fixation devices, the PLS System can accomplish such fixation with one small percutaneous access puncture. This improves patient compliance, recuperation time and lowers the cost of such procedures.

Interventional Spine, Inc. is a closely-held private company based in Irvine, California. Interventional Spine develops and markets products based upon CLASP® Technology and TELEPORT® Access Technology for the treatment of degenerative spinal disc disease as well as a broad range of orthopedic applications. For additional information about Interventional Spine please visit the Company's website at

Source: Interventional Spine

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