Anulex reduces staff after receiving an FDA warning letter regarding Xclose anular repair system |

Anulex reduces staff after receiving an FDA warning letter regarding Xclose anular repair system

Layoffs occur at Anulex following FDA’s warning letter (MedCityNews)

The FDA had granted Anulex a 510(k) approval for the Xclose soft tissue repair system to be used for general and orthopaedic surgery. But after the company did a post-market study to see how Xclose performed when used to repair the annulus, the FDA took offense because the company had not applied for an investigational device exemption prior to doing so.

  • Anulex has raised $66M since 2003
  • Anulex has revenue in the $5M to $25M range.
  • Anulex had 46 employees before the layoffs

Leave a Reply

Your email address will not be published. Required fields are marked *