AutoloGel System regulatory update

Cytomedix said the Centers for Medicare & Medicaid Services (CMS) issued a final decision memo supporting coverage of autologous platelet-rich plasma (PRP) gel under its coverage with evidence development (CED) mechanism to treat chronic, non-healing diabetic, venous and/or pressure wounds. The company said the decision, which is in line with a proposed decision issued in May, reverses a nearly 20 year non-coverage determination for PRP. The company also said it is in discussions with an undisclosed global pharma to distribute the gel in the U.S., with an agreement expected to be reached by month end (see BioCentury, May 21). ...