Healthcare Industry News:  Spinal Stenosis 

Devices Orthopaedic Neurosurgery

 News Release - March 26, 2007

Triangle Orthopaedic Associates and North Carolina Specialty Hospital are first in U.S. to implant the Stabilimax NZ(TM) Dynamic Stabilization System

As part of a clinical study comparing Applied Spine Technologies' Stabilimax NZ to traditional posterolateral fusion

19 other clinical investigation sites expected to receive their IRB approvals soon



NEW HAVEN, Conn.--(HSMN NewsFeed)--Applied Spine Technologies (AST) Inc. (www.appliedspine.com) announced today that Triangle Orthopaedic Associates and North Carolina Specialty Hospital (NCSH), an acute care facility located in Durham, N.C., are the first in the U.S. to implant the Company's Stabilimax NZ Dynamic Spine Stabilization System as part of a randomized, controlled clinical trial, which will compare posterior dynamic stabilization using the Stabilimax NZ to patients receiving traditional fusion stabilization to treat degenerative lumbar Spinal Stenosis. A total of 266 Stabilimax NZ patients and 133 'control' patients are expected to be enrolled in all of the trials.



Stabilimax NZ is a posterior dynamic-stabilization system designed to support an injured or degenerated spine. Stabilimax NZ is intended to be a substantially less-invasive option for many patients who are currently limited to fusion or artificial disc implants. In Europe, Stabilimax NZ is already approved for use.

"The purpose of our study is to evaluate and compare the improvement observed in patients receiving flexible stabilization using the Stabilimax NZ device versus patients receiving the traditional fusion-type stabilization," said Thomas A. Dimmig, M.D., a spine surgeon with Triangle Orthopaedic Associates and a Principal Investigator for the clinical study at North Carolina Specialty Hospital. "The results of our study will be submitted to the U.S. FDA to support the approval application of the Stabilimax NZ device," added Co-Investigator David B. Musante, M.D., also a spine surgeon with Triangle Orthopaedic Associates.

"Spine fusion used to be the only option for patients suffering from chronic back pain," said Tom Wood, President and CEO of Applied Spine Technologies (AST), developer of Stabilimax NZ and the sponsor of the clinical trial. "Stabilimax NZ is designed to be a dramatic advance in back pain treatment by stabilizing the spine without eliminating motion with a therapy that (a) is far less-invasive than fusion, (b) uses traditional surgical techniques, and (c) is easily adopted by most spine surgeons. Equally important, patients can garner the benefits of Stabilimax NZ, which may delay or prevent progression of degenerative spine disease, while leaving the door open to future treatments, such as fusion, should they become necessary."

For more details about this clinical study and to determine eligibility for participation, contact 203-503-0280, x37 or visit http://www.appliedspine.com.

Stabilimax NZ is the culmination of more than 30 years of focused research by Manohar Panjabi, Ph.D., the scientific founder of Applied Spine Technologies and one of the world's foremost spine authorities. Until his recent retirement, Dr. Panjabi was a professor of Orthopedics & Rehabilitation, as well as Mechanical Engineering, at Yale University School of Medicine. As Director of Yale's Biomechanics Research Laboratory, Dr. Panjabi established himself as a world-renowned spine authority for his work on spinal joint function and its implications for motion-preserving implants. Dr. Panjabi has published 267 research papers and written two textbooks.

About Spine Technologies and Stabilimax NZ(TM)

Applied Spine Technologies Inc. is developing Stabilimax NZ, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Stabilimax NZ is expected to offer numerous advantages over current spinal fixation products and even new artificial disc products--including a much less invasive and less traumatic implant procedure, maintenance of spine motion and disc function, and the potential to prevent or slow adjacent-segment disc disease. In addition, it is expected that patients treated with Stabilimax NZ can go on to receive fusion surgery or artificial disc replacement, if necessary.


Source: Applied Spine Technologies

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