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Impliant Ltd. Enrolls First Patient In Clinical Trial For The TOPS-On-Fusion(TM) System, The First Integrated Motion Preservation System For Spinal Fusion Patients


10/24/2006 2:22:01 PM

MILFORD, Conn., Oct. 24 /PRNewswire/ -- Impliant, Inc. (www.impliant.com), a developer of novel spine arthroplasty alternatives to fusion surgery, announced that it has enrolled its first patient in a trial of its two-level TOPS-on-Fusion(TM) System. The device integrates lumbar fusion with Total Posterior Arthroplasty at two adjacent levels to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.

The procedure was performed by Dr. Louis Nel, M.D., Senior Spine Surgeon with vast experience in all forms of spine surgeries at Eugene Marais Hospital in Pretoria, South Africa. He was assisted by Dr. Yoram Anekstein. Dr. Nel stated, "The TOPS-on-Fusion(TM) device provides an integrated fusion and motion preservation solution for patients with two-level disease. It is common to have patients with advanced disc and posterior disease at one level and isolated posterior problems at the adjacent level. The TOPS-on-Fusion(TM) System stabilizes both segments while allowing motion at the level adjacent to fusion by effectively replacing all the posterior structures removed during the decompression. I was very satisfied with the simplicity and ease of the procedure."

"Surgical intervention is delayed for as long as possible in favor of conservative treatment. By the time many patients reach the operating room, their spine disease has advanced to two levels," said Marcus Klarl, European Vice President for Clinical Affairs. "The TOPS-on-Fusion(TM) System is the optimal solution for many of these cases."

Impliant is enrolling 20 patients in a prospective, non-randomized study to establish the safety and efficacy of the TOPS-on-Fusion(TM) System. The device is indicated for L3-L5 and L4-S1 patients where the inferior segment is fused and the superior level is treated with Total Posterior Arthroplasty.

"The TOPS-on-Fusion(TM) System is the first in a family of product extensions that provide surgeons with a broad range of alternatives to traditional spinal fusion," said Ron Sacher, CEO of Impliant.

Impliant is applying cutting-edge materials and biomechanical engineering techniques to develop a new class of spine arthroplasty devices that target over 500,000 patients worldwide who undergo fusion surgery and could benefit from a Total Posterior Arthroplasty solution.

About the TOPS(TM) System

Impliant's TOPS(TM) System, a mobile posterior device, is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis, and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS(TM) System could benefit patients worldwide undergoing spinal fusion surgery each year. The TOPS(TM) System is not approved for sale in the United States.

About Impliant, Inc.

Impliant, Inc. is a privately held company engaged in the development of novel spine arthroplasty solutions for motion preservation. The company is currently developing the TOPS(TM) System, which is designed to alleviate pain resulting from degenerative facet arthrosis, spondylolisthesis, and spinal stenosis by stabilizing but not fusing the affected vertebral level. Impliant is headquartered in Milford, CT with research facilities located in Ramat Poleg, Israel. For more information about Impliant, please visit www.impliant.com.

Contacts: Ron Sacher, CEO Todd Potokar, President 917-270-5538 203-877-8884 rsacher@impliant.comtpotokar@impliant.com

Impliant, Inc.

CONTACT: Ron Sacher, CEO, +1-917-270-5538, rsacher@impliant.com, or ToddPotokar, President, +1-203-877-8884, tpotokar@impliant.com, both ofImpliant, Inc.



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