CYTOMEDIX CEO ISSUES SHAREHOLDER UPDATE
ROCKVILLE, MD., March 31,
2009 – Cytomedix, Inc. (NYSE
Alternext US:
GTF) announced today that Chief Executive Officer Martin
Rosendale issued the following letter to shareholders
providing a general corporate update:
Dear Cytomedix Shareholders,
A few weeks ago, the Washington Business Journal
published an article on Cytomedix and the AutoloGel™
System. The reporter interviewed one of our newer
customers, and midway through the article the customer
was quoted, “If I hadn’t seen it, I wouldn’t have
believed it”. That simple testimonial statement
concisely sums up the most significant challenge and
opportunity for a product that can appear unbelievable
at first. In this update, I will tell you how we are
addressing some of the challenges and opportunities we
face in 2009 and beyond.
Roughly nine months ago and shortly after assuming the
role of CEO, I issued an open letter to the company’s
shareholders and noted in the letter that one of the
principal attractions of joining Cytomedix was the
science and technology that underlies the company’s
current and potential future product applications. My
conviction in this technology is even stronger today.
The healing of wounds is a complex biological process
that involves a complicated balance of many overlapping
and cascading biological reactions. The company’s basic
technology and value proposition, specifically with
regard to the AutoloGel™ System, is based on restoring
a natural balance to the wound environment, allowing the
body to complete its own natural healing process. Once
you have experienced it in the way our new customer
above did, the AutoloGel™ System becomes a compelling
option for managing the care of patients who suffer with
chronic wounds. As a company, we remain committed to
bringing fundamental improvement to these clinically
challenging situations while at the same time building a
business with lasting and growing value.
We have filed our Annual Report on Form 10-K with the
Securities and Exchange Commission. I will provide some
financial highlights in this update. However, you may
access the 10-K from our website at
www.cytomedix.com
for additional detail.
Our cash and cash equivalents balance at December 31,
2008 was $4.0 million, down $1.1 million from $5.1
million at December 31, 2007. The reduction was due to
cash used in operations of $2.5 million partially offset
by the capital raise last fall of $1.4 million. We
continue making incremental investments in sales and
marketing to promote wider commercial acceptance of the
AutoloGel™ System. Based on our current operating and
spending plans, including expected growth in sales, we
expect our net cash used in operations will range
between $3.4 and $3.9 million in 2009. While our
proprietary formulation patent for AutoloGel™ remains
in force until 2019, the licensing agreements covering
the base platelet releasate patent, which have been the
primary source of our revenues over the past several
years, are set to expire in November this year. It
should therefore come as no surprise that our most
immediate short term goal is to grow our commercial
product sales to the point where these royalty revenues
are effectively replaced on a run rate basis as we enter
2010. I believe that the nature of the customer
relationships we are pursuing and the size of the wound
care market currently targeted and available to us are
sufficient to make this goal achievable.
Given the current economic uncertainty and the ongoing
capital market challenges that small emerging companies
are facing, it is also not particularly surprising that
our Independent Registered Public Accounting Firm has
expressed substantial doubt bout our ability to continue
as a going concern. Consistent with this opinion, we
recorded a one-time non-cash impairment charge for
goodwill and patents. It is important to understand that
these charges have no impact on our cash balances nor in
any way impact the economics of the business. One
consequence, however, is that our shareholder’s equity
has been reduced below the $6 million NYSE Amex
guideline for continued listing. Therefore, we can also
anticipate a NYSE Amex notice regarding the listing
non-compliance. In the event we receive such notice, we
will be prepared to submit our compliance plan outlining
how we intend to regain compliance with the required
listing criteria within the grace period allotted under
the NYSE Amex guidelines.
Despite the domestic economic challenges, we are off to
a good start in 2009. In January, we implemented a
strategic shift in the commercialization tactics for
marketing of the AutoloGel™ System that is driving
encouraging early results. New emphasis has been placed
on scientific and clinical messaging, and the commercial
organization has been realigned to reflect a stronger
requirement for clinical support during the sales
process. We have added two new clinical support staff to
facilitate clinical product evaluations and establish
protocols for the standardized use of the AutoloGel™
System. I have asked our top company executives to join
sales managers and clinical staff in the selling process
to establish a greater sense of importance and
commitment to the AutoloGel™ System and the positive
patient outcomes it produces. Early results of the
strategy indicate sales growth and broader customer
acceptance. We have experienced a marked increase in the
number of product evaluations and interest in the
technology. Our intensive focus over the upcoming weeks
and months will be to convert this heightened interest
and resulting evaluations into lasting commercial
relationships.
We continue to develop and pilot new approaches to the
market intended to simplify the clinical process. Our
scientific and clinical message is consistently
reflected in our marketing communications (brochures,
trade shows, website) clarifying the role of platelet
rich plasma in the management of chronic wounds and the
AutoloGel™ System. In addition, we have developed a new
packaging concept, based on customer feedback, which
will be introduced in the second half of this year. The
new design will improve the customer experience, reduce
process steps and simplify the preparation of
AutoloGel™.
We continue to publish in trade journals and at industry
conferences. Two abstracts demonstrating the use of the
AutoloGel™ System have been accepted for publication at
next month’s Symposium on advanced Wound Care (SAWC),
and an AutoloGel™ case series authored by one of our
customers is scheduled for May publication in the
journal Wounds. These publications, other published
literature, and the data we continue to collect through
product evaluations, will support our marketing efforts
and help build a compelling case for Medicare Part B
reimbursement with the Centers for Medcare and Medicaid
Services (CMS).
While we prepare to reengage CMS regarding coverage for
the AutoloGel™ System, the new presidential
administration and Congress are changing the leadership
and resources available at CMS. The American Recovery
and Reinvestment Act has authorized additional funds for
CMS to compare the effectiveness of related therapies,
and a committee has recently been named to make
recommendations regarding the use of the funds. Through
our network of contacts, and consultants we have
retained to help us navigate the CMS process, we are
monitoring and analyzing these changes to identify
appropriate opportunities. I remain confident that
additional data and publications, legislative support,
patient and clinician advocacy, and the appropriate
timing will convince CMS to allow coverage for the
AutoloGel™ System.
Recent events, including the publicity of procedures for
high profile athletes with sports injuries, have led to
a heightened interest in using platelet rich plasma in
orthopedic procedures. We have been developing a
platelet rich plasma system appropriate for these
orthopedic applications and anticipate filing a 51(k)
submission with the FDA in the 2nd quarter of this year.
The development of our anti-inflammatory peptide,
CT-112, is progressing well under the leadership of Dr.
Pete Clausen. Pre-clinical in vivo and in vitro studies
have been completed, and we are preparing for an IND
submission to the FDA and a Phase I clinical study. In
the fourth quarter of 2008, we entered into an agreement
with a California based peptide manufacturer to
synthesize and purify the first production lot of the
CT-112 peptide. The manufactured peptide met purity
requirements, and the anti-inflammatory activity was
confirmed with both oral and subcutaneous dosing in a
rodent model. The bioanalytical method to be used in the
Phase I study for measuring levels of CT-112 in patient
blood samples is currently being validated by an outside
laboratory.
We have retained the Frankel Group, a New York, NY and
Cambridge, MA based life science strategy consulting
firm, to assist with the identification of
commercially-relevant high value indications for CT-112
that may be pursued in early clinical trials. We expect
the joint conclusions that arise from this effort to be
available within a number of weeks. Efforts to raise
additional capital for continued development of CT-112,
including the expansion of its intellectual property
position and possibly the Phase I clinical study, have
been intensified. Potential collaborators have been
engaged in early discussions, and the outcome of our
work with the Frankel Group will help guide our efforts
to find suitable strategic partners and sources of
funding.
There is little doubt that economic conditions will
continue bringing unique challenges for emerging
companies in 2009. We are fortunate, however, in that we
believe our current cash resources are sufficient to
fund the business, as budgeted, through the remainder of
the year. Our history of conservative financial
management has kept us in a good position with no debt,
and, unlike many emerging life science companies today,
we have an FDA cleared product on which we can build a
platform for our future success.
On behalf of Cytomedix, its employees and Board of
Directors, I thank you for your continued confidence and
support.
Sincerely,
Martin P. Rosendale
Chief Executive Officer
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. 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
outcome of development or regulatory review of CT-112,
commercial success or acceptance by the medical community,
competitive responses, viability and effectiveness of the
Company’s sales approach and overall marketing strategies,
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.
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