Impliant Receives CE Mark Approval For The TOPS-on-Fusion(TM) System, The First Integrated Motion Preservation System For Spinal Fusion Patients

Impliant, Inc.
(impliant), a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that its wholly owned subsidiary, Impliant Ltd., has received CE Mark approval for its patented TOPS-on-Fusion(TM)
System. This is the world's first total posterior motion preservation
device that integrates lumbar fusion with total posterior arthroplasty at
two adjacent levels to treat spinal stenosis with or without facet
arthrosis and spondylolisthesis.


"In clinical trials in South Africa, Belgium and Turkey, the
TOPS-on-Fusion(TM) System has demonstrated effectiveness in alleviating
pain stemming from degeneration of the posterior elements," said Marcus
Klarl, European Vice President for Clinical Affairs. "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. The TOPS-on-Fusion(TM) System is the optimal
solution for many of these cases."



The procedures have been performed by Dr. Louis Nel from South Africa,
Dr. Azmi Hamzaoglu from Turkey, and Drs. Bart Conix and Robert Hes from
Belgium.



Drs. Hes and Conix 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."



The TOPS-on-Fusion(TM) System is the second in a family of products at
Impliant that provide surgeons with a broad range of alternatives to
traditional spinal fusion. 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.



Impliant is applying cutting-edge materials and biomechanical
engineering techniques to develop a new class of spine arthroplasty devices
that target more than 400,000 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 in clinical trials and 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
impliant.


Impliant Ltd.

impliant