MINNEAPOLIS, Nov. 28 /PRNewswire/ -- Advanced Bio-Surfaces, Inc. (ABS), announced today the availability of OrthoGlide Medial Knee Implant initial clinical data.
Data representing the first complete year of enrollment in the OrthoGlide clinical study was presented on November 10th, 2007 at the American College of Rheumatology's annual meeting in Boston, MA. The data was presented by William Arnold, M.D., Medical Director for ABS. "The OrthoGlide prospective clinical study has enrolled 92 patients with osteoarthritis of the medial compartment that met the inclusion criteria," said Dr. Arnold. "These patients would have been candidates for an invasive Total Knee Replacement (TKR) procedure."
A summary of the data includes 92 patients implanted at 6 approved sites in the United States. Fourteen of the enrolled patients have surpassed the one year implant anniversary. The demographics of the study group include an average age of 60 years, 52% male / 48% female and WOMAC Pain scores which improve from 35 pre-operatively to 72 at 6 months and 74 at one year post- operative. The most serious adverse event reported was the need to convert patients to either a unicompartmental knee or TKR. Nine OrthoGlide patients enrolled (10.2%) were converted, which is comparable to the 9% unicompartmental knee conversion rate at two years post-operative. Also important is the fact that only one patient out of 350 total implants (includes study and non-study patients) experienced a dislocation.
Dr. Arnold summarized the data by saying, "The pain relief experienced by the patients enrolled in this study, along with the return of knee function at one year is similar to TKR results but with a much less invasive procedure."
About Advanced Bio-Surfaces, Inc.
ABS is a privately held company dedicated to the development of innovative joint restoration products. The company's first product, the OrthoGlide Medial Knee Implant, is intended for the treatment of patients with moderate osteoarthritis of the medial compartment. It is securely implanted without bone cutting or rigid fixation, is expected to provide a more rapid recovery than TKR, a shorter hospital stay and no rehabilitation. The company received 510(k) clearance to market in February 2006 and 350 implants have been completed. For additional information contact ABS at 952.912.5400 or visit the website at http://www.advbiosurf.com.
CONTACT: Robert Siegfried, VP, Finance and Administration of Advanced
Bio-Surfaces, Inc., +1-952-912-5400
Web site: http://www.advbiosurf.com/