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CYTOMEDIX ANNOUNCES PUBLICATION
OF THE AUTOLOGEL DIABETIC FOOT ULCER PROSPECTIVE TRIAL
(Click
here for a link to the article)
Company Updates Status of
510(K) Premarket Notification with FDA
ROCKVILLE, Md., June 28, 2006 – Cytomedix, Inc. (AMEX: GTF),
a biotechnology company specializing in developing and licensing
systems for use on non-healing chronic wounds including diabetic
ulcers, today announced the publication of the results of its
diabetic foot ulcer prospective trial for the AutoloGel™ System.
The article, entitled “A Prospective, Randomized, Controlled Trial
of Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic
Foot Ulcers,” was published, as the feature article in the June,
2006, issue of Ostomy/Wound Management (OWM). The authors are:
Vickie M. Driver, DPM, MS, FACFAS, Director of Clinical Research at
the Center for Lower Extremity Ambulatory Research; Dr. William M.
Scholl College of Podiatric Medicine, and Chief of the National
Center for Limb Preservation at the Advocate Lutheran General
Hospital of Niles, IL.; Jason Hanft, DPM, FACFAS, Director of the
Doctors Research Network of South Miami, Fla.; Carelyn P. Fylling,
RN, MSN, Vice President of Professional Services for Cytomedix,
Inc.; Judy M. Beriou, RN, MHA, Senior Research and Clinical
Coordinator for Cytomedix, Inc.; and the AutoloGel Diabetic Foot
Ulcer Study Group. The clinical trial was sponsored and funded by
Cytomedix, conducted under a U.S. Food and Drug Administration (FDA)
approved Investigational Device Exemption (IDE) by independent
clinical researchers and managed and monitored by an external
Contract Research Organization.
Ostomy Wound Management (OWM), the premiere journal for information
on wound care and the related, overlapping fields of skin care,
ostomy care, incontinence care, and nutrition, is the only
peer-reviewed, multidisciplinary publication specifically targeted
to the advanced wound care practitioner. Indexed in MEDLINE® and
CINAHL®, OWM is the official journal of the Association for the
Advancement of Wound Care (AAWC). OWM is published monthly and
distributed to 25,000 subscribers.
The published results document that in the 40 wounds per-protocol
group, 13 out of 19 (68.4%) of the AutoloGel and nine out of 21
(42.9%) of the control wounds healed, i.e. the wounds achieved full
closure. After adjusting for wound size outliers (n = 5),
significantly more AutoloGel (13 out of 16, 81.3%) than control gel
(eight out of 19, 42.1%) treated wounds healed (P = 0.036, Fisher’s
exact test). These wound sizes are typical of the wound area treated
in published prospective trials for competitive wound products. The
Kaplan-Meier time-to-healing also was significantly different
between groups (log-rank, P = 0.0177). No treatment-related serious
adverse events were reported.
“The conclusions in this article by the medical professionals who
conducted the study endorse the use of AutoloGel as an effective,
efficient treatment for diabetic foot ulcers,” according to
Cytomedix Chairman and Chief Executive Officer Kshitij Mohan, Ph.D.
“The healing rates of AutoloGel at 81.3% for the most common wound
sizes in the study and 68.4% for all wound sizes are very
competitive with, or better than, most other wound care products
cleared by the FDA and covered by Medicare reimbursement. The
Control group patients were not on placebo; rather, they were
treated using a saline gel cleared by the FDA for use on chronic and
surgical wounds. It is important to point out that if the Control
group patients healed at the originally anticipated rate of 20-30%
(which was based on published literature), the difference between
the healing rates in the AutoloGel group versus the Control group
would have been even more strongly statistically significant.”
The authors added that AutoloGel “may not only enhance healing, but
it may also prevent lower extremity amputations caused by nonhealing
wounds.” Dr Mohan commented that there are two million cases of
diabetic foot ulcers in the U.S. at any one time and statistics show
that between 14 and 24% of the patients will require amputations.
He added, “We are pleased that the researchers concluded that
AutoloGel may reduce or prevent the need for amputations. The
publication of the clinical trial results referenced above, details
the data that was submitted to the FDA as part of the Premarket
Notification 510(k) by the Company. The Company received an Agency
request for further information and analysis related to the conduct
of the study. The Company has completed the collation of the
requested information and the additional statistical analysis and
will send it shortly to FDA for a preliminary review. After FDA’s
review, feedback, and if necessary, discussion in face to face
meetings depending on the Agency’s convenience, Cytomedix will
formally submit the responses to FDA for their decision on the
Premarket Notification application.”
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes
and products derived from autologous platelet releasates for uses
with wounds and other applications. The current offering is
AutoloGel™System, a process that utilizes an autologous platelet gel
composed of multiple growth factors, other platelet releasates, and
fibrin matrix. The Company has announced favorable results from its
blinded, prospective, multi-center clinical trial on the use of its
technology with diabetic foot ulcers. Additional information
regarding Cytomedix is available at: http://www.cytomedix.com
SAFE HARBOR STATEMENT
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, the success of new sales
initiatives, governmental regulation, acceptance by the medical
community and competition. There is no guarantee that the FDA will
complete its review of the Company’s 510(k) submission for a
specific wound healing indication within any estimated timeframe, or
that the FDA will fully agree with the Company in the interpretation
of the data or the regulatory pathway and provide marketing
clearance. Further, even assuming the FDA grants the Company’s
request for marketing clearance, there is no guarantee that the
Company will receive Medicare reimbursement for its product; the
Company’s marketing efforts will be successful; or that it will be
able to achieve its other strategic goals.
There is no guarantee that the information reported by the authors
in the article detailed above is accurate or that further review of
the authors’ conclusions or testing of AutoloGel ™ will prove such
information to be accurate. There is also no guarantee that the
Company’s current capitalization will be sufficient to attain its
goals or that future funding will be available to the Company on
acceptable terms. 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. 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.
SOURCE: Cytomedix, Inc.
The Wall Street Group, Inc.
Ron Stabiner
(212) 888-4848 |
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