BioMimetic Tries Different Tack for FDA Approval

A Franklin biotech company’s signature product is inching closer to FDA approval. BioMimetic is beginning another round of clinical trials of a drug that’s supposed to help the body grow new bone tissue.

Doctors in Canada and Australia are already using Augment. US regulators have been reluctant to sign off, citing safety concerns. For more than three years, BioMimetic has tried to get Augment approved for use in bone and ankle fusions. The new trial is taking a different approach, testing its effectiveness as a treatment for tendinosis (also known as tennis elbow).

The trial comes at an important time for BioMimetic. The long wait for government approval has led to the company cutting a quarter of its staff. Late last year, Memphis-based Wright Medical Group announced it would buy BioMimetic for $190 million. If the FDA approves Augment before the deal closes, Wright’s shareholders will get twice that amount.

Please keep your community civil. Comments will be moderated prior to posting, and Nashville Public Radio reserves the right to approve them at its discretion. Comments containing links promoting goods, services - even noble organizations - will not be published. Your comments may include external links, but all comments with links will be delayed as they are reviewed. Comments containing profanity will be rejected.