Positive Data from Study of the AutoloGel System to Treat Complex Chronic Wounds Published in Ostomy Wound Management
Healing Improved in 97% of Wounds Evaluated, Including Those Recalcitrant to Other Treatments
Rockville, MD, . (June 16, 2010) – Cytomedix, Inc. (AMEX: GTF), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that positive results from a prospective study evaluating the AutoloGel™ System to treat advanced, chronic wounds was published in the June 2010 issue of Ostomy Wound Management in a peer reviewed article entitled, “Chronic Wounds Treated With a Physiologically Relevant Concentration of Platelet-rich Plasma (PRP) Gel: A Prospective Case Series.” The article is available at http://www.owm. com/content/chronic-wounds-treated-physiologically-relevant-concentration-plateletrich- plasma-gel-prosp.
The study’s lead author is Robert G. Frykberg, DPM, MPH, Chief, Podiatry and Residency Director, Phoenix VA Healthcare System in Phoenix, Arizona. The study enrolled 49 patients with 65 chronic wounds, 35% of which had areas of undermining and 15% of which had sinus tracts/tunneling (ST/T). Pressure ulcers, venous ulcers and diabetic foot ulcers were the most prevalent wounds. The mean previous wound duration without healing was 47.8 weeks. Mean baseline wound area was 19 cm2 and volume was 36.2 cm3. The study was conducted in various care settings including eight long-term acute care hospitals and three outpatient foot or wound clinics.
The study concluded that treatment with physiologically relevant concentrations of PRP derived from the AutoloGel System “showed the product can be utilized by healthcare providers in various healthcare settings to restart the healing process in complex chronic wounds, even wounds recalcitrant to other treatments, and in patients with advanced age, compromised lab values, and co-morbidities. Sixty-three (63) of 65 (97%) wounds responded with reductions in area, volume, undermining, and/or ST/T in a mean of 2.8 weeks with 3.2 treatments. These results have important clinical implications and suggest this treatment can reverse the non-healing trend in chronic wounds.”
The study defined clinical relevance as the potential of a therapy to provide positive results in a group of patients, the magnitude of the response, the length of time, and the number of treatments to achieve the response. It also noted that in a healthcare system trying to save time and money with the best impact of a modality, the concept of clinical relevance assists clinicians in determining efficient treatment options.
In an average of 2.8 weeks with a mean of 3.2 AutoloGel treatments, the proportion of wounds responding and the amount of the response for all etiologies included: in 58 of 65 (89%) wounds, volume decreased 62%; in 55 of 65 (85%) wounds, area decreased 51%; and in 23 of 23 (100%) of the wounds with undermining and/or ST/T, wound size was reduced 78% and 46%, respectively.
Commenting on this study, Martin P. Rosendale, President and CEO of Cytomedix, Inc., said, “These data further confirm our thesis that providing physiologically relevant concentrations of PRP is critical to restarting the body’s natural healing processes, as was clearly demonstrated with the AutoloGel System in these previously non-healing, chronic wounds.”
“We are especially pleased that the AutoloGel System provided a rapid reduction in wound size for nearly all of these chronic wounds, offering a safe and effective treatment for patients suffering from long-term, non-healing wounds. Chronic wounds are a growing medical concern with few treatment options. We firmly believe the concept of clinical relevance to be an important aspect of this data set. In a variety of care settings, a critical element to effective and successful wound management is the prompt initiation of a positive wound healing trajectory. By offering physiologically relevant concentrations of PRP and effectively harnessing the body’s natural healing processes the AutoloGel System can have a positive and significant impact in short treatment windows,” he added.
About Cytomedix, Inc.
Cytomedix is a biotechnology company that develops, sells, and licenses regenerative biological therapies, to primarily address the areas of wound care, inflammation, and angiogenesis. The Company currently markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for separation of whole blood into red cells, platelet poor plasma and platelet rich plasma (“PRP”) in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from platelet poor plasma. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is currently pursuing a multi-faceted strategy to penetrate the chronic wound market with its products. Cytomedix is also pursuing opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics, as well as actively seeking complementary products for the wound care market. The Company also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing, or sale. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication 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, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, its ability to successfully commercialize its product in Japan under the terms of the license agreement, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. 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. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.