SOURCE: Impliant, Inc.

August 23, 2006 02:44 ET

Impliant Receives FDA Approval to Begin Pivotal Clinical Trial for Patented TOPS™ System

The TOPS™ System, a Total Posterior Arthroplasty System Designed to Treat Spinal Stenosis With or Without Facet Arthrosis and Spondylolisthesis, to Commence Pivotal IDE Trial

MILFORD, CT -- (MARKET WIRE) -- August 23, 2006 -- Impliant, Inc. (www.impliant.com), a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has received Conditional Approval from the FDA to enroll patients in a pivotal IDE trial. The patented TOPS™ System is the world's first total posterior motion preservation system to address the leading pathologies of the posterior spinal column.

"We are pleased that the FDA has recognized the validity of our pre-clinical testing and extensive international clinical activities in allowing Impliant to go straight to a pivotal trial with the TOPS™ System," said Barry Sands, Vice President, Regulatory, Clinical, and Quality Affairs of Impliant. "We are thankful to our clinicians in Europe, Asia, and South America who have diligently followed patients for over a year to establish the safety of our device."

Impliant plans to enroll patients in a randomized study comparing the TOPS™ System to traditional fusion. "We have twenty centers ready to get started," said Todd Potokar, President of Impliant. "Our Surgeon Investigators view the TOPS™ System as a viable alternative to spine fusion to treat patients with late stage degenerative pathologies."

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 spine arthroplasty solution. The Investigation Device Exemption process involves a thorough review of all clinical and bench top testing data by the FDA before granting companies the approval to introduce a device into the United States for clinical testing purposes.

About the TOPS™ System

Impliant's TOPS™ 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™ System could benefit patients worldwide undergoing spinal fusion surgery each year. The TOPS™ System is not approved for sale or use 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™ 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.

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