Biomimetic Ready to Ask for FDA Approval

The studies, tests, and research are done. Now, Franklin-based Biomimetic Therapeutics is ready to ask for FDA approval of its only product.

Simply put, the product “Augment” helps the body grow new bone tissue, eliminating the need for grafts. Chief Operating Officer Steve Hirsch says using it is simpler than taking a graft from another part of the patient’s body because it only requires one surgery. And he says Augment has something that sterilized cadaver or artificial bones don’t.

“The difference with Augment is we’re providing the same scaffolding but then we put in the active growth factor that actually does the biological part of what you need to do with the bone graft, and that is initiate the regenerative processes.”

To start, Biomimetic wants approval for Augment to be used in foot and ankle fusions, with hopes of later moving into therapies for bones throughout the body.

Speaking recently to potential investors, Hirsch said the company is poised to file its final set of paperwork with the Food and Drug Administration. Once the data is reviewed, the FDA will schedule a panel to discuss Augment. Hirsch anticipates that will take place around August or September.

“If we get a strong, positive panel recommendation, we could get FDA approval around the end of the year, which would have us launching the product early in 2011.”

Augment was approved by Canadian health officials in November. The company began shipping the product out less than a month later.

Biomimetic has been entirely focused on bringing Augment to market since 2008. Before that, the company developed a periodontal product that grows tissue in a similar fashion. The rights to that product were later sold to another company.