FDA response on Autologel Sytem Expected Soon (AMEX:GTF)

On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System. The 510(K) submission was made to obtain pre market approval from the FDA. We anticipate they will get a response from the FDA after 6 months, i.e. on or around February 7, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.

So, what exactly is a 510(K) submission? It is an application submitted to the Centre for Devices and Radiological Health (CDRH), an organ of the FDA), by companies who want to commercialize a line of medical devices that they have developed. Almost all medical devices need the submission and approval of the 510(K) application. The 510(K) submission basically allows the company to prove to the Food & Drug Administration that the medical device is both safe and effective. On the other hand, the 510(K) submission may also show how the medical device is same as a predicate device, that is, a device that is already legally available in the market and does not require submitting a pre market approval to the FDA.

The company has carried out clinical trials on Autologel™ system. The trials found out that the PRP (platelet-rich plasma) that has been achieved by the medical device must be mixed with bones (autograft and allograft) before the Autologel™ system is applied on the orthopedic site.

Martin P. Rosendale, who is the Chief Executive Officer of Cytomedix, Inc., said:

“This filing of our Platelet Separation System for orthopedic applications provides further enhancements to our existing AutoloGel™ System and streamlines the process to produce the gel, thereby making the clinical process more efficient. Upon clearance, we will look forward to bringing these advances to our growing customer base, with opportunities for expanded indications of use.”

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