ROCKVILLE, Md., Aug. 7, 2009 (GLOBE NEWSWIRE) — Cytomedix, Inc. (NYSE Amex:GTF) (the “Company”) announces the filing of a 510(k) premarket notification with the U.S. Food and Drug Administration (“FDA”) for clearance to market its AutoloGel(tm) Platelet Separation System for use in orthopedics. The application includes the option of mixing of platelet-rich plasma (“PRP”) derived by the AutoloGel(tm) System with autograft and/or allograft bone, intra-operatively, prior to application to an orthopedic site as deemed necessary by clinical use requirements.
Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, “This filing of our Platelet Separation System for orthopedic applications provides further enhancements to our existing AutoloGel(tm) 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.”
