CYTOMEDIX ANNOUNCES PUBLICATION OF ECONOMIC
MODEL INDICATING COST-EFFECTIVENESS OF AutoloGel™ FOR
DIABETIC FOOT ULCERS
ROCKVILLE, MD., December 10, 2008 – Cytomedix, Inc. (NYSE
Alternext US:
GTF) announced today that a cost-effectiveness analysis comparing the Company’s Platelet Rich Plasma (PRP) gel,
AutoloGel™, to alternative technologies for managing non-healing diabetic foot ulcers, has been published in the December edition of Advances in Skin and Wound Care, a peer-reviewed, multidisciplinary scientific journal. The author concludes that the use of
AutoloGel™ may result in improved quality of life and lower cost of care over a five year period versus other indicated technologies for non-healing diabetic foot ulcers.
The analysis was conducted by an independent contractor, B&D Consulting, Washington, DC. The author, Edward Dougherty, Senior Vice President of B&D Consulting, describes a complex economic model developed to simulate weekly direct wound care costs over a five year period and 200,000 observations. Data input was derived from peer reviewed scientific publications of prospective, randomized, controlled trials in diabetic foot ulcers for each technology analyzed.
According to the model, the average five-year direct wound care cost when Cytomedix’s
AutoloGel™ System is utilized, was lower than when either standard of care or other enhanced therapies for treating non-healing diabetic foot ulcers were simulated. In addition to lower cost of care, the model showed that
AutoloGel™ resulted in improved quality of life over a five-year period versus other modalities. These findings suggest that
AutoloGel™ may be an attractive treatment for insurers and healthcare providers to address the cost burden and health effects of non-healing diabetic foot ulcers.
Cytomedix commissioned B&D Consulting to conduct the analysis. However, fees paid were not dependent on the results of the economic model.
“Publication in a respected peer-reviewed journal such as Advances in Skin and Wound Care will be of particular value as we continue our dialogue with the Centers for Medicare and Medicaid Services (CMS) and other third party payors in our efforts to pursue reimbursement. It will also support our current sales and marketing strategy for the
AutoloGel™ System focused on long-term acute care facilities, Veterans Administration medical centers, Public Health Services and others who will benefit from the cost savings provided by AutoloGel,” stated Martin Rosendale, Chief Executive Officer of Cytomedix.
“We are especially pleased with the results of this analysis in which the findings indicate that not only can
AutoloGel™ provide patients with a better quality of life, it may also provide a cost-savings opportunity for insurers and healthcare providers . This information may be particularly relevant in patient care settings where the care is a lifetime commitment. The five year analysis projects longer term benefits rather than simply looking at episodes or short term treatment costs, which is key to managing patient care costs for the longer term.” Mr. Rosendale added.
The AutoloGel™ System is cleared by the U.S. Food and Drug Administration (FDA) and is intended to be used at point-of-care for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of a patient’s own blood. 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, and diabetic ulcers and for the management of mechanically or surgically debrided wounds.
For a link to the abstract of the published study, please visit the Cytomedix website at: http://www.cytomedix.com.ABOUT CYTOMEDIX
Cytomedix is a biotechnology company that develops, sells, and
licenses regenerative biological therapies, including the AutoloGel™
System, a device for the production of platelet rich plasma (“PRP”)
gel derived from the patient’s own blood. The AutoloGel™ System is
cleared by the Food and Drug Administration (“FDA”) for use on a
variety of exuding wounds. The Company is currently pursuing a
multi-faceted strategy to penetrate the chronic wound market with
its AutoloGel™ System. The Company is also moving forward with the
development of other product candidates in its pipeline. Most
notably is its CT-112 product, an anti-inflammatory peptide, that
has shown promise in pre-clinical testing, and for which the Company
is currently preparing an Investigational New Drug (IND) application
for the FDA. Additional information regarding Cytomedix is available
at: http://www.cytomedix.com
ABOUT B&D CONSULTING
B&D Consulting is an independent, national, advisory and advocacy
firm based in Washington, D.C. and is a division of Baker & Daniels
LLP, an international law firm founded in 1863 with offices in
Indiana, Chicago, Washington D.C., and Beijing. B&D Consulting
developed the research methodology, model structure, assumptions,
and inputs from the available peer-reviewed literature. Through its
reimbursement practice, the firm assists medical device,
pharmaceutical, diagnostics and biotechnology companies in
developing robust evidence to support appropriate coverage and
payment for novel medical technologies throughout the product
development and commercialization lifecycle.
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 outcome of development or
regulatory review of CT-112, commercial success or acceptance by the
medical community, competitive responses, Cytomedix’s ability to
execute on its strategy to market the AutoloGel™ System as
contemplated, Cytomedix’s ability to continue its reimbursement
dialogue with CMS and to recognize and capitalize on the potential
market opportunity that might be presented as a result of the B&D
study.
Although Cytomedix paid a fee to B&D Consulting to perform the cost
effectiveness study, Cytomedix was not involved with the structure
or conduct of the study, and can make no guarantees regarding the
adequacy or accuracy of the information contained in the study. The
economic model discussed above was developed by B&D through a review
of the published literature available at the time the model was
developed. Results reported in the cost effectiveness study are
derived from a simulation of the probabilities of various health
outcomes of cohorts of hypothetical subjects. These results are not
intended to predict or guarantee actual treatment outcomes
associated with any of the products discussed. Further, the study
conducted by B&D did not consider all available treatment
modalities. A broader study, including more treatment modalities,
might render different results.
There is no guarantee that CMS, third-party payers such as insurers,
or care providers will consider the study in determining whether to
provide reimbursement coverage for AutoloGel™ or to provide
AutoloGel™ as a treatment alternative. Even if the CMS considers the
cost effectiveness study discussed above, there is no guarantee that
that CMS will reverse its 2008 non-coverage decision which applies
to AutoloGel™, or that third-party payers will provide reimbursement
coverage for AutoloGel™. Even assuming that CMS does reverse its
previous non-coverage decision, there is no guarantee that such
reversal will occur within the immediate future, or that the Company
will be able to capitalize on this reversal in commercializing the
AutoloGel™ System. Based on the Company's current levels of
operations and cash flows, a substantial delay in obtaining a
reversal on the non-coverage decision may render the Company unable
to take advantage of such a decision. Further, even assuming CMS
reverses its non-coverage decision, there is no guarantee that the
Company will receive other third-party reimbursement for its
product, the Company's marketing efforts will be successful, or that
it will be able to achieve its other strategic goals. Even if
reimbursement from CMS and other third-parties is obtained, there is
no guarantee that such reimbursement will be at levels sufficient to
implement the Company's current business plan. There is also no
guarantee that the Company's current capitalization will be
sufficient to attain its goals, that future funding will be
available to the Company on acceptable terms, or that the Company
will ever be able to sustain itself from ongoing operations.
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.
|
