BioPoly gains FDA clearance for second toe implant
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Fort Wayne-based orthopaedic implant manufacturer BioPoly LLC has received clearance from the U.S. Food and Drug Administration for the BioPoly Lesser Toe System. The system, used for patients with arthritis, is the company’s second product to be cleared by the FDA for sale on the U.S. market.
BioPoly’s first product to be FDA cleared, the BioPoly Great Toe System, is currently being sold in the U.S. for patients with arthritis leading to a stiff or painful great toe.
“Our manufacturing and supply channels are prepared to handle the increasing demand for our BioPoly products,” said Sheila Schwartz, BioPoly COO. “Therefore, as we introduce the BioPoly Lesser Toe System along with the BioPoly Great Toe System, we have ample capacity with room for growth as we add even more implant product lines which are already in the pipeline.”
Recently-appointed BioPoly CEO Ryan Schlotterback says the company plans to launch the lesser toe system into the U.S. market in mid-2023.
“We are excited about achieving our second FDA clearance with BioPoly technology as we continue to build momentum in our extremity portfolio,” said Schlotterback. “The Great Toe System is performing well clinically and we expect the same from our BioPoly Lesser Toe System. In addition, we have some exciting products in the upper extremity that we anticipate announcing in the new year.”
The company says BioPoly is an orthopedic biomaterial that is a combination of polyethylene and hyaluronic acid.