Healthcare Industry News:  Spinal Stenosis 

Devices Orthopaedic Neurosurgery

 News Release - May 7, 2007

Impliant TOPS(TM) System Demonstrates Positive Outcomes at Two-Year Follow-up

PRINCETON, New Jersey, May 7 (HSMN NewsFeed) -- Impliant, Inc. (www.impliant.com), a developer of novel spine arthroplasty alternatives to fusion surgery, reported positive results on a series of 32 TOPS(TM) System patients with the longest follow-up to date of two years. The TOPS(TM) System is a total posterior arthroplasty device for patients suffering from debilitating leg and back pain stemming from Spinal Stenosis, a common back condition that may also be accompanied by degenerative spondylolisthesis and facet arthrosis.

Dr. Luiz Pimenta, the first investigator to treat patients with the TOPS(TM) System in January 2005, presented the outcomes of a multi-center prospective study at the Spine Arthroplasty Society Meeting in Berlin on May 4th. The findings included a 40-point improvement in the Oswestry Disability Index (57 to 17 at two-years), a 64-point improvement in Visual Analog Scale (84 to 20 at two-years), and a 36-point improvement in the Zurich Claudication Score (58 to 22 at two-years). Dr. Paul McAfee presented the radiographic findings from the study, which demonstrated no incidence of mechanical screw loosening or breakage, no post-op increase in spondylolisthesis, as well as maintenance of segmental motion.

The multi-center study is being conducted by Dr. Pimenta at Santa Rita Hospital in Brazil, by Dr. Azmi Hamzaoglu in the Florence Nightingale Hospital in Turkey, by Drs. Robert Hes and Bart Conix in Middleheim Hospital in Belgium, and by Drs. Yizhar Floman, Yigal Mirovsky, and Yoram Anekstein at Assaf Harofe Hospital in Israel.

"We are very pleased with the results to date," said Ron Sacher, CEO of Impliant. "The quality of the prospective study and its excellent outcomes speak to the potential of the device. The TOPS(TM) System is emerging as a viable posterior alternative to fusion that allows surgeons to decompress all pain generators and still maintain motion."

Impliant is applying cutting-edge materials and biomechanical engineering techniques to develop a new class of spine arthroplasty devices that target the more than 400,000 patients worldwide who undergo fusion surgery each year and could benefit from a total posterior arthroplasty solution.

About the TOPS(TM) System

Impliant's TOPS(TM) System is a mobile posterior device designed to stabilize but not fuse the affected vertebral levels to alleviate pain stemming from Spinal Stenosis, which is the narrowing of the spinal canal and the impingment of nerve roots. The disease may be accompanied by degenerative facet arthrosis-where the joints becomes inflamed and worn-and by spondylolisthesis, or the pain-inducing slip of one vertebral body forward relative to the adjacent vertebrae. Following a decompression of the lamina and medial facets to remove the bone elements pressing on nerves, 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 in a pivotal US clinical trial and 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 Princeton, NJ with research facilities located in Ramat Poleg, Israel. For more information about Impliant, please visit www.impliant.com.


Source: Impliant

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