Spine

Replication Medical Receives Grant of Nearly $250,000.00 on the Heels of Successful Clinical Results With its Innovative GelStix(TM) Treatment for Low Back Pain

CRANBURY, N.J., Nov. 11, 2010 /PRNewswire/ — Replication Medical, Inc., a developer of proprietary, hydrogel based products for spine and other surgical applications, reported today that it has been awarded a Qualifying Therapeutic Discovery Project (QTDP) grant from the U.S. government in the amount of $244,479 based on Replication Medical’s 2009 GelStix related research expenditures.  The GelStix product is intended to treat chronic lower back pain which impacts nearly 10-15% of adults and is associated with a condition known as degenerative disc disease.

Early stage treatments for degenerative disc disease (DDD) include non-surgical pain management such as anti-inflammatory medications and exercise programs.  Traditional surgical interventions include spinal fusion and disc replacement, which can be debilitating and risky for patients, especially the elderly. The Replication Medical Inc. GelStix™ device is a matchstick-sized implant placed into the intradiscal space using a small needle and doesn’t require surgery.  Once implanted, GelStix absorbs bodily fluids and expands many times in volume to rehydrate and repressurize the disc.  The product represents an important step in filling the continuum of care gap for DDD.  “There are few suitable treatment options for older patients dealing with chronic back pain,” commented Dr. James Yue, Co-Chief of Spine and Orthopedic Medicine at Yale University.  “Often we have little to offer these patients other than repetitive injections that provide only short term pain-relief.  Alongside Dr. R. Morgenstern (Barcelona, Spain), I treated the first 59 year old patient to receive the device.  Based upon personal experience, I am impressed with GelStix ease-of-use and the near complete elimination of back pain symptoms.  GelStix has the potential to provide real hope for this large, underserved patient population.”

GelStix received the CE Mark in early 2010 and is now available for sale and distribution within the European Union.  As the population ages there is increasing pressure to develop a non-surgical treatment for chronic back pain which provides lasting clinical benefit and attendant reduced costs.  “This cash infusion following promising clinical results in Europe will enable us to continue the commercialization of GelStix outside of the United States and fund the clinical development needed for FDA approval, stated  Ann Prewett, PhD, President & CEO of Replication Medical.

SOURCE Replication Medical, Inc.

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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