Investors are voicing their displeasure with a Tennessee company, after it failed to get approval for one of its products to be sold in the US. Stock in Wright Medical Group took a pounding when the FDA rejected a clinical trial for its bone graft substitute.
Post Tagged with: "Biomimetic"
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).
For more than two years, BioMimetic has been working to get the FDA to sign off on Augment. It’s supposed to help the body grow new bone tissue, eliminating the need for bone grafts. The delays have put a financial strain on the company. Earlier this year, it cut a quarter of its staff, leaving about 50 workers.
Brentwood-based BioMimetic has filed yet another round of paperwork in hopes of gaining federal approval for its bone graft therapy, called Augmentin.
Franklin-based BioMimetic is getting rid of a quarter of its staff.
The studies, tests, and research are done. Now, Franklin-based Biomimetic Therapeutics is ready to ask for FDA approval of its only product.
Middle Tennessee has some catching up to do with Memphis and Knoxville in the field of biotechnology.