FORT WAYNE, IN – BioPoly LLC announced today the publication of 5-year clinical study results on their BioPoly Knee Partial Resurfacing System in the Journal of Bone and Joint Surgery (JBJS). This follows the publication of their interim 2-year report in JBJS in 2017. See the publication here: https://tinyurl.com/BioPolyKnee
“We’re proud of the results of our clinical study with our knee system in Europe and are encouraged with the continued positive clinical outcomes”, says Ryan Schlotterback, President & CEO of BioPoly. “We believe these results continue to demonstrate the value and clinical efficacy of our BioPoly technology in the exciting early intervention market. Given our recent Breakthrough Device designation by the FDA in April and these recently published results, we continue to actively work to accelerate our BioPoly knee system into the United States (US) market. Our knee system will be available in the US via our approved clinical trial in the coming months.”
The BioPoly Knee System is indicated for partial resurfacing in the femoral condyle or trochlear facet and can be used with or without bone cement. This implant provides surgeons with an early intervention option to address cartilage damage using bone sparing and minimally invasive techniques. According to Sheila Schwartz, RPh, COO and Co-Founder of BioPoly, “Running this 5-year UK study from the US has not been an easy task; however, it is so rewarding because patients are truly benefiting with real pain reduction and improved activity levels over a long period of time.”
“We remain focused on the sales expansion of our FDA cleared and commercially available extremity portfolio. We are excited about supporting our Knee Study here in the US and believe that the release of our BioPoly Knee System in the US market is a critical step in our overall strategy and commercial growth plan.” says Justin J. Kaler, Vice President of Sales and Marketing.
BioPoly LLC is an ISO 13485 certified orthopedic implant manufacturer located in Fort Wayne, Indiana. The Company develops, manufactures, and markets orthopedic implants that use its proprietary BioPoly material to replace damaged cartilage in joints. BioPoly currently has multiple FDA cleared products and is actively developing additional products for the US market.