BioPoly® Announces FDA Approval to Initiate Pivotal Clinical Study for Treatment of Cartilage Defects of the Knee
FORT WAYNE, IN – BioPoly has just announced that the U.S. Food and Drug Administration (FDA) has approved an IDE clinical study for its BioPoly® RS Partial Resurfacing Knee System. The BioPoly knee is used to treat patients with painful cartilage lesions by filling the defect with its proprietary implant material known as BioPoly. According to the Company, initiation of the clinical study in the U.S. will happen soon.
The BioPoly material is comprised of a robust polymer and a biological lubricating molecule (hyaluronic acid) that is found in joint fluid. This combination creates a “self-lubricated” polymer that can carry physiological loads in the knee without causing damage to the other knee tissues. In effect, the BioPoly material behaves like a synthetic cartilage so that the patient can regain a pain-free, active lifestyle. The BioPoly® RS Partial Resurfacing Knee has been implanted successfully in Europe since 2012. Very positive clinical results have been published in the prestigious orthopaedic journal called the Journal of Bone & Joint Surgery (JBJS) <Click for Publication>.
According to Herb Schwartz, President of BioPoly, “This is a significant milestone for our company. We are very excited to bring our BioPoly implants to the U.S. as part of this clinical study.” In addition to the BioPoly knee product line, other BioPoly applications include the BioPoly® RS Partial Resurfacing Patella, Trochlear Groove, and Shoulder product lines. These products are approved by regulatory agencies outside of the U.S.; however, they are not available in the U.S. as they have not yet been approved or cleared for use by the FDA.
BioPoly is also developing additional applications in the knee, foot & ankle, upper extremity, and hip.
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 and orthopaedics. Additional medical applications of the BioPoly® technology in cardiovascular, spinal, and trauma markets are also being pursued.
Additional information about BioPoly LLC and its partial joint resurfacing technology can be found on the BioPoly website, www.biopolyortho.com.