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.
|