BioDuct LLC Receives FDA Clearance on its Meniscal Device
Posted: Apr 24th, 2007
FORT WAYNE, IN — BioDuct LLC, a subsidiary of Fort Wayne based Schwartz Biomedical, received clearance from the FDA (Food and Drug Administration) of its Meniscal Fixation Device for use in humans. In 2005, the company raised capital locally through a private equity offering to complete the product development work in preparation for the clinical market, according to Herb Schwartz, PhD, President and CEO of Schwartz Biomedical LLC and BioDuct LLC. With FDA clearance, BioDuct, LLC can now legally market the Meniscal Fixation Device.
The patented BioDuct™ technology allows orthopaedic surgeons to fix the shock absorbing cartilage (meniscus) in the knee instead of removing it. Prior to BioDuct’s meniscal device, surgeons had no option but to excise the damaged portions of the meniscus, and this, unfortunately for the patient, leads most often to (osteo)arthritis and even total knee replacement.
"BioDuct’s Meniscal Fixation Device is a landscape changer,” according to Dr. Schwartz. “It will significantly alter the algorithm surgeons apply for meniscus injuries. When the Meniscal Fixation Device is released to the market later this year, there will finally be a viable option (rather than just removal) for this all-important shock absorbing tissue.”