I did my DD. Here is the approval statement
Cytomedix Chronic Wound Gel Gets FDA Clearance; Company Agrees to Post-Market Study
ROCKVILLE, Md. (AP) -- Biotechnology company Cytomedix Inc. said Thursday it received clearance from the Food and Drug Administration for its AutoloGel System, a gel for treating various types of chronic wounds.
As part of the clearance, Cytomedix has agreed to a post-market study to monitor the safety of bovine thrombin, a clotting agent derived from cows, as used in the AutoloGel System.
The gel produced by AutoloGel is designed to treat wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.
Last October, Cytomedix said the FDA denied the company's marketing claim that its AutoloGel wound treatment is equivalent to similar treatments on the market. The company appealed the decision and in response to the FDA's request, outlined a post-marketing surveillance study, addressing the FDA's concerns on the use of bovine thrombin
Where is this marketing approval limited??? Not only did the FDA approve its use they also approved it for more applications than the company asked for.
PLEASE REPLY! This is now the only FDA approved product that is used when all other wound health procedures have failed. Doctor's with such a patient to treat will not require much convincing at all.
AI
