CYTOMEDIX ANNOUNCES THAT CMS
PRELIMINARILY AFFIRMS NON-COVERAGE OF PRP GEL
Company to Vigorously Seek
Change for Final Decision Due March,2008
ROCKVILLE, Md., Dec. 20, 2007 – Cytomedix, Inc. (AMEX:
GTF) today announced that the Centers for Medicare and
Medicaid Services (CMS) has proposed to reaffirm its 2003 national
non-coverage decision for autologous blood derived products for
chronic non-healing wounds in a draft response to a national
coverage reconsideration requested by Cytomedix. CMS cited a lack of
adequate evidence and a need for further study of the product in the
surgical and chronic wound care setting, the setting for which
Cytomedix sought the broadest national coverage.
Cytomedix will vigorously seek a change to this preliminary
decision, to be incorporated into CMS’s final decision, due March
24, 2008. The proposed decision memorandum is available at the CMS
website via the following link:
https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=208
“We are undoubtedly disappointed by the agency’s actions in this
draft decision, but we understand that this is a process,” stated
Dr. Kshitij Mohan, Ph.D., Chairman and Chief Executive Officer of
Cytomedix. “We faced similar challenges when seeking FDA clearance,
but prevailed through the merits of our arguments and our ability to
convince the FDA through their fair and objective appeals process
that our product deserved market clearance. With a similar mindset,
we will do all in our power to work with CMS to make this technology
available to so many patients who need it,” Dr. Mohan said.
“In the meantime, consistent with our existing strategy, we intend
to aggressively pursue our efforts related to the launch of the
AutoloGel™ System, set for mid first quarter 2008, targeting a
significant portion of the market that does not depend on Medicare
reimbursement. This includes capitated environments such as Long
Term Acute Care Facilities and government agencies such as the
Veterans Administration. The sales department now totals six and is
focused on most key regions in the United States, complemented by an
independent representative to handle sales and distribution in
select areas of the country. Further additions to the sales and
marketing department are anticipated later in 2008,” Dr. Mohan
added.
Cytomedix strongly disagrees with this proposed decision on several
grounds, including, but not limited to, the following:
- The strength of its
prospective, well-controlled, double-blinded, randomized
clinical trial that shows higher healing rates in diabetic
foot ulcers than any other technology including several that
are reimbursed by Medicare without having been reviewed
nationally in a formal coverage decision.
- Food and Drug
Administration (FDA) clearance recently obtained by
Cytomedix for the use of its AutoloGel™ System in exuding
wounds including chronic wounds and other surgically or
mechanically debrided wounds.
- FDA clearance for
licensees of Cytomedix patented technology for use of
platelet-rich plasma (PRP) products in surgical wounds and
other applications such as use with bone chips for
orthopedic surgeries.
- The unmet need for
diabetic foot ulcer and other chronic wound patients who
suffer from a lack of advanced treatments with consistent,
reliable clinical benefit.
According to CMS’s website, a 30
day public comment period commenced immediately following the
preliminary decision, which will be followed by a quiet period,
culminating in CMS’s final decision, due March 24, 2008. Those
wishing to make public comment may do so via the following link:
https://www.cms.hhs.gov/mcd/public_comment.asp?id=&cov_id=&state_id=&list_type=&goto=publiccomment&nca_id
=208&basketitem
Cytomedix plans to submit a written response during the public
comment period and follow-up with a face-toface meeting with CMS
within the next 30 days. The nature of Cytomedix’s efforts during
the period leading up to a final decision will be aimed at achieving
coverage, in some form, for PRP gel for use in chronic wounds.
Cytomedix believes there are a number of scenarios, individually or
in combination, under which CMS could provide coverage which
include, but are not limited to, the following:
- Limitation on Coverage – CMS
could limit the coverage to chronic wounds for those treatments
that have obtained FDA clearance. This would respond to CMS’s
desire to provide coverage only in those cases that are
supported by a sufficiently high standard of clinical evidence.
- Coverage with Evidence
Development (CED) – CMS could provide coverage while Cytomedix
continues to gather further data for clinical outcomes using
mechanisms such as a prospective wound registry. This further
data would allow CMS to adapt its coverage in the future to best
serve patient needs.
Cytomedix believes that some form
of coverage would greatly facilitate patient access to this
technology. Based on its experience and results, it is Cytomedix’s
opinion that this technology provides greater clinical benefit and
cost effectiveness than many other technologies including several
that have received coverage or payment through Medicare.
Cytomedix believes it is critical that coverage be granted for use
on chronic wounds. Chronic wounds are an ailment that causes
tremendous physical pain, emotional suffering, and financial
hardship to millions of patients. The care of these wounds places a
great cost burden on the healthcare system and there exist only
limited treatment alternatives with consistent, reliable clinical
benefit. Cytomedix believes the data strongly indicates significant
clinical benefit to the use of PRP gel in chronic non-healing
wounds.
The Company believes that the performance of its technology and the
quality and quantity of the supporting clinical and
cost-effectiveness data compares favorably with those of several
other products that are reimbursed by Medicare. Furthermore, of the
61 public comments received by CMS under this National Coverage
Assessment, all but three were supportive. Of the three that were
non-supportive, one restricted its comments only to acute surgical
incisions and another based its objections primarily on the grounds
that the AutoloGel™ System did not have FDA clearance, an assertion
that is clearly no longer accurate.
“We believe that, given the evidence that has been presented with
our own randomized trial and other clinical studies and data, all
Medicare patients, and not just those that can afford to pay for PRP
therapy, should have access to it,” said Dr. Mohan. “Furthermore,
certain advanced therapies are paid for by Medicare despite the fact
that they do not have any data developed under randomized,
controlled trials or their performance does not show improvement
over commonly available alternatives. This is in contrast to
Cytomedix, as we have conducted our own randomized, controlled
trial, and also commissioned a pharmaco-economic study comparing
clinical and cost effectiveness across wound care therapies
indicating that our technology is dominant over the other
technologies to which it was compared,” Dr. Mohan added.
ABOUT CYTOMEDIX
Cytomedix, Inc. is a biotechnology company specializing in processes
and products derived from autologous platelet releasates for uses on
chronic 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 and is intended for use on diabetic ulcers,
pressure ulcers, leg ulcers and the management of mechanically or
surgically debrided wounds. 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 sales initiatives,
governmental regulation, acceptance by the medical community and
competition.
Cytomedix cannot predict whether CMS will reverse its preliminary
non-coverage decision which applies to AutoloGel™, and there is no
guarantee that CMS will provide any level of coverage, even limited
coverage or coverage with evidence development. Even if CMS reversed
its preliminary 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. 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. |