Cytomedix Stock tumbles on FDA Ruling

Shares of Cytomedix Inc. lost more than half of their value on Tuesday after it said U.S. regulators denied the company's claim on a gel for healing diabetic foot ulcers.
A unit of the Food and Drug Administration denied the claim that Cytomedix's AutoloGel is substantially equivalent to a legally marketed device, the company said in a statement. [also there is a chance for host rejection, as bovine thrombin is antigenic.]
The primary grounds for the rejection appeared to be the use of bovine thrombin, a clotting agent derived from cows, in the gel, the company said.

Bovine thrombin is used on humans in surgery and other instances to stop bleeding, but the FDA body cited studies that said it could also lead to a bleeding tendency, the company added.

Cytomedix said it will appeal the agency's decision and expects the process to be completed in 60 to 90 days.

The company's shares were down $1.46 at $1.29 in morning trade on the American Stock Exchange