Healthcare Industry News:  Novo Ventures 

Devices Orthopaedic Regulatory

 News Release - February 12, 2007

Applied Spine Technologies Receives CE Mark Approval to Market Its Stabilimax NZ(TM) and Stabilimax BAR(TM) Devices in Europe

"NZ" offers advantages over current spinal fixation products and artificial disc products --including (1) a much less invasive and less traumatic implant procedure, (2) maintenance of spine motion and disc function, and (3) the potential to prevent or slow adjacent-segment disc disease

NEW HAVEN, Conn.--(HSMN NewsFeed)--Applied Spine Technologies (AST) Inc. (www.appliedspine.com) announced today that its new Stabilimax NZ Dynamic Spine Stabilization System has received CE Mark approval in Europe for treatment of degenerative lumbar spine stenosis. The Company's initial product, Stabilimax BAR, which was granted 510(k) regulatory clearance in the U.S. last July, also received CE Mark approval in Europe for treatment of degenerative lumbar disease.

Last month, the Company announced that it has received permission under an Investigational Device Exemption (IDE) from the FDA to commence a multi-center, randomized, controlled clinical trial comparing posterior dynamic stabilization using 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 will be enrolled in the trial, which is expected to start this month at 20 sites across the U.S.

Stabilimax NZ is a posterior dynamic-stabilization system designed to support an injured or degenerated spine. Requiring no tissue removal or replacement, 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, patients already are being implanted successfully by Rudolf Bertagnoli, M.D., one of the most experienced motion-preservation spine surgeons in the world.

"Stabilimax NZ, our flagship product, is designed to be a considerable improvement in back pain treatment," said Thomas E. Wood, President and Chief Executive Officer, "by stabilizing the spine without eliminating motion, with a treatment that is far less invasive than fusion or disc replacement but uses traditional surgical techniques that are easily adopted by most spine surgeons. Furthermore, patients can get the benefits of Stabilimax NZ--which may delay or prevent progression of degenerative spine disease--while keeping the door open to future treatments, such as fusion, in the event they become necessary."

The underlying premise of Stabilimax NZ is that painful spine motion increases in an injured spine and that this abnormal motion is most pronounced in the 'Neutral Zone'--the area of laxity in the center portion of the spine's range of motion (ROM). Stabilimax NZ utilizes a novel dual-spring mechanism with a uniquely variable dynamic feature that maximizes stiffness and support in the Neutral Zone, where the spine needs it most, thus returning the Neutral Zone to its normal, limited range. By eliminating abnormal motion, the design of Stabilimax NZ is intended to alleviate abnormal loading on surrounding muscles and tissues.

AST'S scientific founder, Dr. Manohar Panjabi, is 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 text books.

Based in New Haven, Conn., Applied Spine Technologies Inc. is developing Stabilimax NZ(TM), a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion. Investors in AST include: Oxford Bioscience Partners, Bioventure Investors, InterWest Partners, and De Novo Ventures.


Source: Applied Spine Technologies

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