ROCKVILLE, Md., Jan. 13, 2005 (PRIMEZONE) -- Cytomedix, Inc. (OTCBB:CYME) today announced the appointment of Eduardo March to the position of director of quality assurance and regulatory affairs, a newly created position.
"The establishment of this new position is critical for further strengthening the company's focus on this important function. Ed's extensive FDA experience and regulatory background will be invaluable to the company as we get closer to completing clinical trials for our AutoloGel(TM) therapy and seeking FDA clearance for specific clinical indications. He will be responsible for ensuring the company's continuing compliance with FDA's quality systems and other regulations," said Dr. Kshitij Mohan, chief executive officer of Cytomedix.
Commenting on his appointment, March said, "Cytomedix's therapy offers exciting potential for treatment of chronic wounds, and may have significant advantages over currently available treatments. I look forward to working with the company to prove the potential and broaden the availability of this therapy," Initially, he will join Cytomedix on a part-time basis.
March currently serves as senior regulatory consultant for AAC Consulting Group Inc., specializing in FDA device regulatory requirements and activities. His background includes a 15-year career with the Food and Drug Administration and the Center for Devices and Radiological Healthy (CDRH), during which time he served as a reviewer with the Office of Device Evaluation in CDRH as well as a compliance official with the Center's Office of Compliance, responsible for evaluating results of foreign and domestic inspections conducted by the agency.
He received a Bachelor of Science degree from the Virginia Polytechnic Institute in Aerospace Engineering, a Master of Science degree in Management Science from Frostburg State University and a Master of Science degree in Bioengineering from Polytechnic Institute of New York.
Fluent in Spanish, March is a member of Volunteers in Technical Assistance (World Help Organization), American Society for Testing and Materials and the Association for the Advancement of Medical Instrumentation. He was a certified member of the Regulatory Affairs Professional Society from 1992 to 2000.
About Cytomedix
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous platelet releasates for uses in the treatment of wounds and other applications. The current offering is the AutoloGel(TM) system, a technology that utilizes an autologous platelet gel composed of multiple growth factors and fibrin matrix. The company is conducting a well-controlled, blinded, prospective, multi-center clinical trial on the use of its technology in healing diabetic foot ulcers. Cytomedix is working with healthcare providers to offer an advanced therapy at the point-of-care in multiple settings. Additional information is available at: www.cytomedix.com.
Forward-Looking Statements
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix's actual results may differ materially due to a number of factors, many of which are beyond Cytomedix's ability to predict or control, including among others, governmental regulation, acceptance by the medical community and competition. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc.