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24 Month Preliminary Results of a Multi-Center International Study of the PDN-SOLO® Nucleus Replacement Device to be Presented at the 6th Annual Spine Arthroplasty Society Meeting.

MINNEAPOLIS, May 8, 2006— The interim results of an ongoing study, “An International Multi-Center Clinical Evaluation of the PDN-SOLO® Device” conducted by Raymedica will be presented for the first time at the 6th Annual Spine Arthroplasty Society Meeting being held at the The Palais des Congres de Montreal. The presentation will given by Chan-Shik Shim, MD, PhD, of the Wooridul Spine Hospital, Seoul, Korea, on Wednesday, May 10, 2006, at 10:55 a.m., during the 10:30 a.m. to 12:30 p.m. Raymedica Workshop Session.

Patients in the study were implanted with the PDN-SOLO device via a Posterior PDN Approach (PPA), an approach very similar to a microdiscectomy. The preliminary clinical outcomes of 67 patients are to be presented illustrating the clinical effectiveness of the PDN-SOLO device.

The 24 month results reveal that patients treated with the PDN-SOLO device via the posterior approach achieve a 63% improvement of their back pain Visual Analog Score with a decrease from 7.3 pre-op to 2.7 at the 24 month time point. The Oswestry Disability Index decreased from 52 % pre-op to 14% at the 24 month time point, a 73% improvement. The Visual Analog Score and Oswestry Disability Index are validated tests commonly used to assess the benefits of treatment for spinal procedures.

“The data presented here is another confirmation of the clinical experience with the PDN-SOLO device for safely treating degenerative disc disease,” said Dr. Chan-Shik Shim Vice-President of Academic Affairs, at Wooridul Spine Hospital. “We expect these good results to be maintained as we continue to follow these patients and the data matures.”

“The 24 month clinical results of the PDN-SOLO device demonstrate our continued commitment to our core proprietary pre-formed hydrogel technology that provides benefits for surgeons and their patients,” said John J. Viscogliosi, Chairman and CEO of Raymedica. “Innovative and effective nucleus arthroplasty systems are the cornerstones of our business focus and we will continue to optimize our product portfolio in the future.”

The co-investigators of this study include: Björn Branth, MD, Stockholm Spine Center, Stockholm, Sweden; Christian Brinkmann, St. Josef-Stift Hospital, MD, Sendenhorst, Germany; Robert Schönmayr, Horst-Schmidt Kliniken, Wiesbaden, Germany; Panagiotis Selviarides, MD, AHEPA University Hospital, Thessaloniki, Greece; and Mehmet Zileli, MD, Ege University Hospital, Izmir, Turkey.

About Raymedica
Raymedica, based in Minneapolis, Minnesota, is the Pioneer in Nucleus Arthroplasty™ having developed the world’s first nucleus replacement device in 1996. Raymedica develops, manufactures and markets medical device systems designed to treat patients with degenerative disc disease that have been unresponsive to non-surgical treatment. Raymedica’s products are currently available in many countries worldwide, but are limited to investigational use only in the United States. For more information, visit the Company's website at http://www.raymedica.com.

 
       
 


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