CENTERS FOR MEDICARE AND MEDICAID
SERVICES (CMS) REACHES FINAL COVERAGE DECISION ON PRP GEL
Cytomedix to Focus on Sales Efforts, Additional Data Generation, and
Development of Other Patents Company to Host Conference Call on
Thursday, March 20 at 11:00 a.m. EDT
Rockville, MD, March 19, 2008 – Cytomedix, Inc. (AMEX:
GTF) today announced that the Centers for Medicare
and Medicaid Services (CMS) has issued a national coverage determination applicable to platelet rich plasma
(PRP) gel for use on chronic wounds. This decision reaffirms an existing CMS 2003 decision and, in essence,
continues non-coverage of PRP gel, citing inadequate evidence. In its decision memorandum, CMS stated,
“suggestive evidence is now available for review; however this evidence is significantly limited in quality and
therefore inadequate.” The full decision is available at the CMS website via the following link:
https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=208
The Company is disappointed with this outcome and believes that the evidence, including data from its own
randomized, controlled, multi-center, double-blinded clinical trial, and other published studies, is adequate to
support the reversal of the 2003 non-coverage decision, at least as related to diabetic foot ulcers, the focus of the
Company’s clinical trial and the emphasis of the Company’s recent submissions to CMS. The Company is
currently seeking a meeting with CMS to obtain clarification of further data and information that may be required
by CMS to arrive at a positive coverage determination.
“We believe that the CMS determination tends to foster a two-tiered system whereby those who can afford to pay
for PRP gel will receive it, but those who can’t will go without access to a technology that, in our view, is
supported by good science and evidence of clinical and cost effectiveness benefits and strongly deserves to be
reimbursed through Medicare,” said Dr. Kshitij Mohan, Chairman and Chief Executive Officer of Cytomedix. “We
are determined to see Medicare and other third-party payers cover this technology, and are evaluating the most
expeditious path to achieve that goal,” Dr. Mohan added.
The Company will also focus its efforts on its recently implemented sales and marketing strategy. The Company
officially launched the AutoloGel™ System in the first quarter of 2008 and continues to devote significant
resources and efforts toward its recently implemented sales and marketing strategy targeting the existing large
non Medicare-sensitive markets such as Long-Term Acute Care Hospitals (LTAC’s) and Veterans Administration
Hospitals (VA’s), which are not expected to be impacted by the CMS determination. A pharmaco-economic study
commissioned by the Company and conducted by an independent consulting firm indicates that the AutoloGelTM
System compares favorably against alternative wound management technologies for which comparable
performance data was publicly available. The Company believes that this should be viewed positively by LTACs,
which generally operate in a capitated payment environment, and VAs, which are sensitive to budgetary
considerations.
“We will continue to invest in our sales and marketing efforts as we can now market our product for its
intended use on chronic wounds, and we believe that we are the only company with a published, prospective,
randomized, and controlled clinical trial and a PRP gel technology that has a chronic wound indication. To further
hasten the commercialization of our product, we have been strengthening both our sales force and senior
leadership of our sales, marketing, and commercialization efforts,” said Dr. Mohan.
While maintaining a focus on the AutoloGel™ System, Cytomedix also plans to further strengthen its on-going
efforts and discussions with other companies to commercialize other technologies based on its patents in areas
such as hair restoration and angiogenic and anti-inflammatory peptides.
CONFERENCE CALL
The Company will host a conference call tomorrow, Thursday,
March 20, 2008 at 11:00 am Eastern time. To participate, dial
1-877-407-9205 approximately 10 minutes before the conference
call is scheduled to begin. Hold for the operator and reference the
Cytomedix, Inc. conference call. International callers should dial
201-689-8054.
Access to a recording will also be available for seven days
following the conference call. Dial 1-877-660-6853 to access
playback. For international callers, dial 201-612-7415. Enter
account number 286. The Conference I.D. is 279411.
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from autologous
platelet releasates for use on wounds and other applications. The current offering is the AutoloGel™ System, a
process that utilizes an autologous platelet gel composed of multiple growth factors, other platelet releasates,
and fibrin matrix. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.
SAFE HARBOR STATEMENT
All statements in this news release that are not based on historical fact are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this press release, include, without limitation, the Company’s plans and intentions
relating to its sales and marketing strategy, its expectations relating to the effect of the CMS determination on the
non-Medicare sensitive markets, its expectations as to how LTAC’s and VA’s will view the merits of the
Company’s AutoloGel™ System, its ability to generate the data that would be satisfactory for CMS to arrive at a
positive coverage decision, and its ability to commercialize technologies based on its other patents. While
management has based any forward-looking statements contained herein on its current expectations, the
information on which such expectations were based may change. These forward-looking statements rely on a
number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other
factors, many of which are outside of our control, including among others, the success of sales initiatives,
governmental regulation, acceptance by the medical community and competition, that could cause actual results
to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not
necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2006, as updated, from time to time, in the Company’s Quarterly Reports on
Form 10-Q. We operate in a highly competitive and rapidly changing 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. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking
statements. Readers are also urged to carefully review and consider the other various disclosures in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2006, as well as other public filings
with the SEC since such date.
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