BioPoly® Resurfacing Knee Study Indicates BioPoly Patient Outcomes are Significantly Improved Over Microfracture at 2 Years
FORT WAYNE, IN – BioPoly LLC has announced that the Journal of Bone & Joint Surgery (OA) has published 2-year clinical results of patient outcomes for the BioPoly® RS Partial Resurfacing Knee Implant. The results indicate statistically significant (p < 0.025) and clinically meaningful improvement in knee pain and function (KOOS, VAS pain, SF-36) as a result of the BioPoly surgery. When comparing the 2-year data for BioPoly to microfracture, the BioPoly patient has significantly improved outcomes, especially in quality of life and sports measures (KOOS). BioPoly patients are allowed to fully bear weight immediately after surgery; therefore, their activity levels also increased as was evidenced by their significantly improved Tegner activity scores. It is interesting to note that the positive outcomes were not age-dependent as no significant differences were detected between younger (<40 years) and older patients (>40 years).
According to Prof Vladimir Bobic, Chief Investigator for the study (Orthopaedic Surgeon and Director of the Chester Knee Clinic & Cartilage Repair Centre in the UK), “These early and positive clinical results are important to the orthopaedic community because they show that the BioPoly implant is safe and that BioPoly patient outcomes are clinically improved, even over the standard of care (microfracture).” Longer term clinical data is being collected for the cohort of patients in this study, and the investigating surgeons plan to publish 5-year results when they become available.
BioPoly LLC is the only medical device company in the world who has access to the unique and proprietary BioPoly® material. Through an innovative combination of a lubricating molecule found in cartilage and an orthopaedic polymer, the BioPoly material behaves like a synthetic self-lubricating cartilage. With this material, the Company is able to design implants that replace only the damaged portion of joints rather than replace entire (total) joints. So, BioPoly partial resurfacing implants, like in this study, have been used clinically to address painful cartilage lesions of the knee and patella since they received European regulatory approval (CE mark) a number of years ago. The BioPoly RS Partial Resurfacing Shoulder has also recently received CE mark approval. So, multiple families of BioPoly implants are approved and available in Europe. According to the Company, implant solutions are being developed for other joints as well. The BioPoly implants are not yet FDA approved; therefore, they are not available in the US.
About BioPoly LLC
BioPoly LLC is an ISO 13485 certified orthopaedic implant manufacturer located in Fort Wayne, Indiana. The Company is developing, manufacturing and marketing products for use in sports medicine, orthopaedics, and spinal markets. Additional medical applications of the BioPoly® technology in cardiovascular and trauma markets are also being pursued.