September 25, 2007 – The FDA has granted clearance for Cytomedix Inc. to market its platelet rich plasma (PRP) gel produced under the AutoloGel System name to be used under the supervision of a healthcare professional for exuding wounds, such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
The company says the clearance places it in a strong position as it seeks to obtain Medicare and other third party reimbursement in its efforts to commercialize the AutoloGel 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 System is currently 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 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 System.
The company’s clinical trial results demonstrate healing rates of 68 percent and 81 percent for AutoloGel treated patients achieving total wound closure in the per-protocol (i.e. patients treated as provided in the study protocol) and majority-wound(i.e. wound sizes smaller than 7 square centimeters in the per-protocol cohort) groups respectively. These are higher healing rates than those in any other similar data for other chronic wound treatment products with which the company is familiar.
Cytomedix plans to leverage AutoloGel’s position as the only FDA cleared PRP gel system with a specific wound indication and the results of the clinical trials.
For more information: www.cytomedix.com