FDA News

Cytomedix Receives FDA Clearance for AutoloGel

(Sept 21, 2007)-- Cytomedix, announced that the FDA has granted marketing clearance for the AutoloGel(tm) System. The indications for use are as follows:

Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel(tm) System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

The Company may now market its AutoloGel(tm) System consistent with the indications described above.

This marks the achievement of a critical milestone for the Company and places it in a strong position as it seeks to obtain Medicare and other third party reimbursement in its efforts to broadly commercialize the AutoloGel(tm) System. This clearance also represents a landmark accomplishment for the platelet gel therapy industry. Cytomedix is the first company in the U.S. to complete a randomized, controlled, multi-center, double-blinded, clinical trial for a platelet rich plasma ("PRP") gel system for use on chronic wounds. The AutoloGel(tm) System is now the only autologous platelet gel therapy product with FDA clearance for a broad indication that includes various types of chronic wounds.

This clearance has been granted under the Pre Market Notification i.e. 510(k) process. As part of the clearance, Cytomedix has agreed to a post-market surveillance study to monitor the safety of bovine thrombin as used in the AutoloGel(tm) System.

Share or bookmarklet this web page at: