Replication Medical, Inc.: GelFix(TM) Posterior Spinal Distraction Implant Receives CE Mark

CRANBURY, N.J., March 8 /PRNewswire/ -- Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant. A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.

The CE mark for this implant follows the approval the company received last year from the Food and Drug Administration (FDA) to market its EnGuard(TM) Vessel Guard. The EnGuard device is indicated for use as a protective cover for blood vessels following anterior spine surgery and is composed of the same biocompatible polymer.

Commenting on these developments, Ann Prewett, President and CEO, said, "The GelFix implant provides a unique, minimally invasive solution for treating spinal stenosis, a leading cause of back pain." The GelFix device acts as a dynamic spacer, compressing under load yet maintaining separation of the interspinous space. In this manner, some of the complications associated with rigid spacers such as breakage of the bones of the spinous process or subsidence may be avoided.

The GelFix interspinous implant may not only reduce pain, but also increase the mobility of the patient. "The key to the procedure is the minimally invasive technique which can be used to implant the device. We insert the implant between the appropriate spinous processes and in 8-10 hours, the implant increases in size and gives us the stability that we need," said Carl Lauryssen, M.D., one of Replication Medical's surgeon advisors.

ABOUT REPLICATION MEDICAL

Replication Medical, Inc. is a developer of proprietary, hydrogel based products for the spinal market and other surgical applications. Headquartered in Cranbury, New Jersey, the Company is a leader in the design and development of novel biometic hydrogel implants.

CONTACT: Terry Zielinski, Director of Communications, Replication Medical
Inc., sales@replicationmedical.com, +1-609-860-0330, Ext. 117