Fort Wayne company approved for cartilage defects study
By Tim Zink | Greater Fort Wayne Business Weekly
BioPoly LLC, a Schwartz Biomedical company, has announced that the U.S. Food and Drug Administration has approved an investigational device exemption clinical study for its knee treatment system.
The BioPoly RS Partial Resurfacing Knee System is used to treat patients with painful cartilage lesions by filling the defect with its proprietary implant material, also known as “BioPoly.” Initiation of the clinical study in the United States will happen soon, according to the statement.
The implant 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, according to the company.
The implant material behaves like a synthetic cartilage so that the patient can regain a pain-free, active lifestyle. The system has been implanted successfully in Europe since 2012.
“This is a significant milestone for our company. We are very excited to bring our BioPoly implants to the US as part of this clinical study,” Herb Schwartz, president, said in the statement.