Cytomedix Receives FDA Clearance for Autologel
ROCKVILLE, Md., Sep. 20, 2007 – Cytomedix, Inc. (AMEX:
Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgicallydebrided wounds.
The Company may now market its AutoloGelTM System consistent with the indications described above. This marks the achievement of a critical milestone for the Company and places it in a strong position as it seeks to obtain Medicare and other third party reimbursement in its efforts to broadly commercialize the AutoloGelTM System. This clearance also represents a landmark accomplishment for the platelet gel therapy industry. Cytomedix is the first company in the U.S. to complete a randomized, controlled, multi-center, double-blinded, clinical trial for a platelet rich plasma (“PRP”) gel system for use on chronic wounds. The AutoloGelTM System is now the only autologous platelet gel therapy product with FDA clearance for a broad indication that includes various types of chronic wounds.
This clearance has been granted under the Pre Market Notification i.e. 510(k) process. As part of the clearance, Cytomedix has agreed to a post-market surveillance study to monitor the safety of bovine thrombin as used in the AutoloGelTM System. The Company’s clinical trial results demonstrate healing rates of 68% (p-value of 0.125) and 81% (p-value of 0.036) for AutoloGelTM treated patients achieving total wound closure in the per-protocol (i.e. patients treated as provided in the study protocol) and majoritywound (i.e. wound sizes smaller than 7 sq cm in the per-protocol cohort) groups respectively. These are higher healing rates than those in any other similar data for other chronic wound treatment products with which the Company is familiar.
Cytomedix plans to leverage AutoloGelTM’s position as the only FDA cleared PRP gel system with a specific wound indication, the compelling results of the Company’s clinical trial, as well as the unique competitive advantages of the distinct, patented formulation of AutoloGelTM. The Company believes marketing clearance would enhance the Company’s ability to secure Medicare and other third party coverage for AutoloGelTM; develop further marketing data and achieve broad clinical acceptance; and, address the needs of large numbers of patients; all critical factors to the achievement of the Company’s long-term strategic goals.
Dr. Kshitij Mohan, Chairman and CEO of Cytomedix commented, “We are very happy with reaching this critical goal. It is a very positive development for our company and it comes at an opportune time, as we work toward obtaining Medicare and broader third-party coverage. While FDA clearance of our AutoloGelTM System for specific wound treatment is not a prerequisite for a coverage decision by the Centers for Medicare and Medicaid Services (CMS), it is certainly further validation of our product and the results of our clinical trial.”
On June 25, 2007, CMS agreed to Cytomedix’s request to reconsider a 2003 CMS noncoverage decision for autologous blood-derived products (which includes AutoloGelTM). As such, a National Coverage Assessment (NCA) for PRP gel was initiated and a 30 day public comment period was opened. More than 40 public comments were received from medical doctors, clinicians, medical device companies, and others involved with PRP gel, the overwhelming majority of which were favorable to PRP gel. According to the NCA Tracking Sheet maintained by CMS, the proposed decision memorandum due date is December 25, 2007, and the expected NCA completion date is March 24, 2008. Dr. Mohan added, “Those who have followed our company press releases know that the review of our product by FDA has been very thorough and rigorous. It has involved scientists and regulatory leaders at different levels, including the top levels of the Center of Biologics Evaluation and Research as well as external scientific and clinical advisory panel members of FDA’s Center of Devices and Radiological Health. We are very pleased that after such a thorough review, our product has now been cleared for use on patients who suffer from a very serious, and until now, underserved clinical need.
Obtaining FDA clearance for AutoloGelTM marks yet another success in a string of achievements for the Company. With a secure patent position, compelling results from our clinical trial, and the only FDA cleared product for use of a platelet gel therapy in chronic wounds, we are eager to pursue broad reimbursement and commercialization of AutoloGelTM.”
