Anika Therapeutics' HA-based bone filler receives FDA 510(k) clearance — 4 insights

Written by Eric Oliver | December 27, 2017 | Print  |

The FDA awarded 510(k) clearance to Anika Therapeutics' HA-based bone void filler.

Here's what you should know:

 

1. Physicians can use the filler for bone voids or defects of the skeletal system, which are not required for the stability of the bone.

 

2. After it is injected into the void, the filler hardens at body temperature and is then reabsorbed into the body during the healing process.

 

3. Anika Therapeutics CEO Charles Sherwood, PhD, said, "We’re proud to announce the U.S. regulatory clearance of our innovative injectable HA-based bone void filler, which represents the U.S. commercial debut of our robust regenerative medicine portfolio."

 

4. Anika said 1 million-plus procedures involve bone void filling in the U.S. The company estimates the market for bone filler is around $300 million.

 

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