FORT WAYNE, IN – BioPoly LLC has announced that the U.S. Food and Drug Administration has granted clearance for its BioPoly® Great Toe Implant.  With this FDA clearance, the BioPoly technology is available for the first time in the U.S.

BioPoly first received regulatory approval in 2012 for its knee implants in Europe. “Although we have been in patients in Europe with our knee implants for nearly 10 years, we are extremely excited to be able to enter the US market with our BioPoly technology,” said Herb Schwartz, President of BioPoly. “We have a porous and non-porous stem design and are moving very quickly to get sterile product to the shelf. The plan is to be ready for first surgeries by the end of 2nd Quarter 2021.  Our team has accomplished some amazing feats here. I am very proud of them.”

According to Sheila Schwartz, VP of Operations for BioPoly, “The 1st MTP (Great Toe) market needs an implant like BioPoly. With its unique ability to articulate with native cartilage, the BioPoly® Great Toe replaces only one side of the joint, allowing the healthy side to remain intact.”  The BioPoly Great Toe implant replaces a portion of the head of the first metatarsal bone and interacts with the opposite side of the joint so that only the damaged tissue is repaired. The BioPoly surface properties are similar to cartilage; therefore, the frictional forces between BioPoly and cartilage are nearly the same as that of cartilage on cartilage. In vitro testing results indicate that BioPoly material is more “cartilage-friendly” than metallic implant materials, causing significantly less cartilage wear.

BioPoly is a unique orthopedic material that is a microcomposite of polyethylene (UHMWPE) and hyaluronic acid. This proprietary combination results in a strong, hydrophilic (water attracting) material. U.S. patients with great toe issues have other surgical options such as fusion, metallic implants, or polymeric spacers; however, with the BioPoly® Great Toe implant, we believe a better option is now available, one that is cartilage-friendly yet that is well-fixed in the bone and is robust enough to survive the anatomical joint forces.

With this being the first BioPoly product to be approved in the US, the Company has plans to obtain FDA clearance for additional BioPoly orthopedic applications in the near future.

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 orthopedics markets. Additional medical applications of the BioPoly® technology in spinal, cardiovascular and trauma markets are also being pursued.

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