As
filed
with the Securities and Exchange Commission on March 26, 2008
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Registration
No.
333-147793
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C., 20549
____________________________________
AMENDMENT
NO.1
TO
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
_____________________________________
CYTOMEDIX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
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416
Hungerford Drive
Suite
330
Rockville,
Maryland 20850
(240)
499-2680
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23-3011702
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(State
or other jurisdiction of incorporation or organization)
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(Address,
including zip code, and telephone number, including area code, of
registrant's principal executive offices)
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(IRS
Employer Identification No.)
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Andrew
S. Maslan
Chief
Financial Officer
416
Hungerford Drive
Suite
330
Rockville,
Maryland 20850
(240)
499-2680
(Name,
address, including zip code, and telephone number, including area
code, of
agent for service)
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With
Copies To
:
Michele
Simmons Allgood
Williams
& Anderson PLC
111
Center Street,
22nd
Floor
Little
Rock, Arkansas 72201
(501)
372-0800
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From
time to time after the effectiveness of the registration statement
(Approximate
date of commencement of proposed sale to the public)
If
the
only securities being registered on this Form are being offered pursuant to
dividend or interest reinvestment plans, please check the following box.
o
If
any of
the securities being registered on this Form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other
than securities offered only in connection with dividend or interest
reinvestment plans, check the following box.
x
If
this
Form is filed to register additional securities for an offering pursuant to
Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
o
If
this
Form is a registration statement pursuant to General Instruction I.D., or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box.
o
If
this
Form is a post-effective amendment to a registration statement filed pursuant
to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box.
o
Indicate
by check mark whether the registrant is a "large accelerated filer," "an
accelerated filer," "a non-accelerated filer," or "smaller reporting company"
in
Rule 12b-2 of the Exchange Act.
Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
x
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(Do
not check if a smaller reporting
company)
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CALCULATION
OF REGISTRATION FEE
Title
of each class of securities to be registered
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Amount
to be registered(1)
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Proposed
maximum offering price per unit(2)
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Proposed
maximum aggregate offering price (3)
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Amount
of Registration Fee
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Common
Stock, par value $.0001 per share
|
---
|
---
|
---
|
---
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Preferred
Stock, par value $.0001 per share
|
---
|
---
|
---
|
---
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Debt
Securities
|
---
|
---
|
---
|
---
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Securities
Warrants
|
---
|
---
|
---
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---
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Units
|
---
|
---
|
---
|
---
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TOTAL
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$50,000,000
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100%
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$50,000,000
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$1,535
(3)
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Common
Stock, par value $.0001 per
share
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2,776,033
Shares (4)
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$3.33
(5)
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$9,244,189(5)
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$284
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(1)
There
are being registered hereunder such indeterminate number of shares of common
stock and preferred stock, such indeterminate principal amount of debt
securities, such indeterminate number of securities warrants, and such
indeterminate number of units as shall have an aggregate initial offering price
not to exceed $50,000,000. If any debt securities are issued at an original
issue discount, then the offering price of such debt securities shall be in
such
greater principal amount as shall result in an aggregate offering price not
to
exceed $50,000,000, less the aggregate dollar amount of all securities
previously issued hereunder. Any securities registered hereunder may be sold
separately or as units with the other securities registered hereunder. The
proposed maximum offering price per unit will be determined, from time to time,
by the Registrant in connection with the issuance by the Registrant of the
securities registered hereunder. The securities registered hereunder also
include such indeterminate number of shares of common stock and preferred stock
and amount of debt securities as may be issued upon conversion of or exchange
for preferred stock or debt securities that provide for conversion or exchange,
upon exercise of securities warrants or pursuant to the antidilution provisions
of any of such securities. In addition, pursuant to Rule 416 under the
Securities Act, the shares being registered hereunder include such indeterminate
number of shares of common stock and preferred stock as may be issuable with
respect to the shares being registered hereunder as a result of stock splits,
stock dividends or similar transactions.
(2)
The
proposed maximum offering price per unit will be determined from time to time
by
the Registrant in connection with, and at the time of, the issuance of the
securities and is not specified as to each class of security pursuant to General
Instruction II.D. of Form S-3, as amended.
(3)
Calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended,
based on the proposed maximum aggregate offering price of all securities
listed.
(4)
Shares of common stock offered by selling shareholders. Includes 1,476,033
shares of common stock issuable upon the exercises of certain
warrants.
(5)
Estimated solely for determining the registration fee pursuant to Rule 457(c)
under the Securities Act. The proposed maximum offering price per share and
the
proposed maximum aggregate offering price are based upon the $3.33 average
of
the high and low prices of the Company’s common stock on November 28, 2007, as
reported on the American Stock Exchange.
The
registrant hereby amends this registration statement on such date or dates
as
may be necessary to delay its effective date until the registrant shall file
a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
The information in this prospectus
is not complete and may be changed. These securities may not be sold
until
the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these securities
in
any state where the offer or sale is not
permitted.
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SUBJECT
TO COMPLETION DATED MARCH 26, 2008
CYTOMEDIX,
INC.
$50,000,000
Common
Stock
Preferred
Stock
Debt
Securities
Securities
Warrants
Units
2,776,033
SHARES OF COMMON STOCK
This
prospectus covers the following:
A.
Our
offering of up to $50,000,000 of securities described in this prospectus, either
individually or in units, in one or more offerings in amounts, at prices and
on
the terms that we will determine at the time of offering. We may also offer
common stock or preferred stock upon conversion of debt securities, common
stock
upon conversion of preferred stock, or common stock, preferred stock, or debt
securities upon the exercise of warrants. We may sell these securities to or
through one or more underwriters, broker-dealers or agents or directly to
purchasers on a continuous or delayed basis. Each time we sell any of these
securities offered, we will provide one or more prospectus supplements
containing specific information about the terms of that offering. You should
carefully read this prospectus and the applicable prospectus supplement before
you invest.
B.
The
offering by the selling shareholders listed on page 15 of up to 2,776,033 shares
of common stock, of which
1,300,000
shares are shares of common stock that are issuable as of March 25, 2008, and
1,476,033 shares are shares of common stock that as of March 25, 2008, are
issuable to certain selling shareholders upon exercise of outstanding warrants.
The selling shareholders will act independently in determining the timing,
manner, and size of each sale. The selling shareholders may also sell the common
stock under Rule 144. We will not receive any of the proceeds from the sale
of
the common stock being offered by the selling shareholders. We may receive
proceeds from the selling shareholders' exercise of warrants, but our issuance
of common stock to the selling shareholders is not covered by this prospectus.
Such proceeds, if any, will be used for working capital and other corporate
purposes.
Our
common stock is currently listed on the American Stock Exchange under the symbol
“GTF.” On March 24, 2008, the closing sale price of our common stock was $0.98.
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AN
INVESTMENT IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
CONSIDER THE RISK FACTORS BEGINNING ON PAGE 5 BEFORE PURCHASING SHARES
OF
OUR COMMON STOCK.
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Neither
the Securities and Exchange Commission nor any state securities commission
has approved or disapproved of these securities or passed upon the
adequacy or accuracy of the prospectus. Any representation to the
contrary
is a criminal offense.
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The
date
of this prospectus is March 26, 2008.
TABLE
OF CONTENTS
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Page
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SUMMARY
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3
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RISK
FACTORS
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5
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We
Have Limited Sources of Working Capital
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5
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We
Have a History of Losses
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5
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We
Have a Short Operating History and Limited Operating
Experience
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5
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Our
Intellectual Property Assets Are Critical to Our
Success
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6
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The
AutoloGel™ System and Components Are Subject to Governmental
Regulation
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6
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Clinical
Trials May Fail to Demonstrate the Safety or Efficacy of Our Product
Candidates
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7
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A
Disruption in Healthcare Provider Networks Could Have an Adverse
Effect on
Operations and Profitability
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8
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CMS's
Non-Coverage of AutoloGel™ Could Greatly Restrict Our
Sales
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8
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Royalty
Revenues are Unpredictable
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8
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The
Success of the AutoloGel™ System is Dependent on Acceptance by the Medical
Community
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8
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We
May Be Unable to Attract and Retain Key Personnel
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9
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Legislative
and Administrative Action May Have an Adverse Effect on Our
Company
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9
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We
Could Be Affected by Malpractice Claims
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9
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AutoloGel™
Has Existing Competition in the Marketplace
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10
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Risk
from Economic Downturns and Changes
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10
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Risks
Related to Our Common Stock
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10
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We
May Issue Additional Equity Securities Which May Materially and Adversely
Affect the Price of Our Common Stock
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11
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There
is a Limited Public Trading Market for Our Common
Stock
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11
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We
are Subject to Anti-Takeover Provisions and Laws
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11
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FORWARD-LOOKING
INFORMATION
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11
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RATIO
OF EARNINGS TO FIXED CHARGES
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12
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USE
OF PROCEEDS
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13
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SELLING
SHAREHOLDERS
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13
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PLAN
OF DISTRIBUTION
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16
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DESCRIPTION
OF SECURITIES TO BE REGISTERED
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18
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LEGAL
MATTERS
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27
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EXPERTS
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27
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INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
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28
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WHERE
YOU CAN FIND MORE INFORMATION
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29
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DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT
LIABILITIES
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29
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SUMMARY
This
summary provides an overview of selected information and does not contain all
the information you should consider before investing in our securities. To
fully understand this offering and its consequences to you, you should read
this
entire prospectus carefully, including the “Risk Factors” section beginning on
page 5 and the documents that we incorporate by reference into this prospectus,
before making an investment decision.
As
used
in this prospectus, “Cytomedix,” “Company,” “we,” “our,” “ours,” and “us” refer
to Cytomedix, Inc., except where the context requires otherwise or as
indicated.
Cytomedix
is a biotechnology company that develops and licenses autologous cellular
therapies (therapies using the patient’s own body products), including our
proprietary AutoloGel
™
System,
to produce a platelet-rich plasma gel, AutoloGel™. AutoloGel™ has been used by
physicians in their practice of medicine for the treatment of wounds. To create
AutoloGel™, the patient’s own platelets and plasma are separated through
centrifugation and combined with several reagents. This process releases
multiple growth factors from the platelets, creates a fibrin matrix scaffold,
and forms a gel that is topically applied to a wound. Upon application, we
believe that AutoloGel™ initiates a reaction that closely mimics the body’s
natural healing process.
On
September 20, 2007, we announced that the FDA has granted marketing clearance
for the AutoloGel™ System. The indications for use are as follows: “Under the
supervision of a healthcare professional, the platelet-rich plasma gel produced
by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers,
pressure ulcers, diabetic ulcers and for the management of mechanically or
surgically-debrided wounds.” We may now market our AutoloGel™ System in
accordance with these indications. As part of the clearance, we have agreed
to a
post-market surveillance study to monitor the safety of bovine thrombin used
in
the AutoloGel™ System.
In
June
2007, at our request, the Centers for Medicare and Medicaid Services (‘‘CMS’’)
officially opened an National Coverage Analysis (‘‘NCA’’) to reconsider a
previous non-coverage decision rendered in 1992 and amended in 2003 which is
applicable to AutoloGel™. In March 2008, CMS completed this NCA and reaffirmed
its non-coverage decision, citing inadequate evidence. We are disappointed
with
this decision, noting several studies completed subsequent to the 2003 decision
that utilized some of the most rigorous scientific methods recognized by CMS.
We
will
continue to pursue our other business strategies such as seeking collaboration,
licensing agreements, and other commercialization possibilities with other
companies for our technologies and patents related to AutoloGel™ as well as
other patents in our portfolio.
Our
corporate headquarters are located at 416 Hungerford Drive, Suite 330,
Rockville, Maryland 20850. Our telephone number is (240) 499-2680 and our
website is located at www.cytomedix.com. The information on our website is
not a
part of this prospectus.
This
prospectus is part of a registration statement that we filed with the Securities
and Exchange Commission (SEC) using a “shelf” registration process on Form S-3.
This prospectus covers the resale of 2,776,033 shares of our common stock
issuable to certain selling shareholders identified on page 15 of this
prospectus. The selling shareholders acquired these shares, or will acquire
these shares, in transactions exempt from the registration requirements of
the
Securities Act of 1993 (Securities Act). The selling shareholders may sell
the
shares in transactions (including block transactions) at prevailing market
prices, at prices related to the prevailing market prices, or at privately
negotiated prices. The selling shareholders will determine when and how they
will sell the common stock. We will not receive any of the proceeds from the
sale of the common stock offered by the selling shareholders. We may receive
proceeds from the selling shareholders' exercise of warrants, but our issuance
of common stock to the selling shareholders is not covered by this prospectus.
Such proceeds, if any, will be used for working capital and other corporate
purposes.
This
prospectus also covers the potential offering and sale, by us, of our common
stock, preferred stock, debt securities, securities warrants, and units
consisting of any combination of these securities. Such offerings and sales
may
occur from time to time following the effectiveness of the registration
statement of which this prospectus is a part. This prospectus provides you
with
a general description of these securities. Each time we sell securities, we
will
provide a prospectus supplement that will contain specific information about
the
terms of that offering of securities. The prospectus supplement may also add,
update or change information contained in this prospectus. You should read
this
prospectus and the applicable prospectus supplement together with the additional
information described under the heading “Where You Can Find More Information”
before you invest.
The
registration statement that contains this prospectus (including the exhibits
to
the registration statement) contains additional information about us and the
securities offered under this prospectus. That registration statement can be
read at the SEC web site (www.sec.gov) or at the SEC offices mentioned under
the
heading “Where You Can Find More Information.”
You
should rely only on the information contained in, or incorporated by reference
into, this prospectus. We have not authorized anyone to provide you with any
information or to make any representations other than those contained in this
prospectus. Offers to sell, and solicitation of offers to buy, shares of our
common stock pursuant to this prospectus are only being made in jurisdictions
where such offers and solicitations are permitted. The information contained,
or
incorporated by reference into, this prospectus is accurate only as of the
respective dates thereof, regardless of the time of delivery of this prospectus
or any sale of the common stock. It is important for you to read and consider
all the information contained in this prospectus, including the documents
incorporated herein by reference, in making your investment decision. In
particular, you should read and consider the information in the documents we
have referred you to in “Incorporation of Certain Information by Reference” and
“Where You Can Find More Information” below.
RISK
FACTORS
The
securities offered under this prospectus are highly speculative and involve
high
risk. You should purchase them only if you can afford to lose your entire
investment. Prior to investing in us, a prospective investor should consider
carefully the following risk factors which may affect our business and financial
condition. Our business and results of operations could be seriously harmed
by
the following risks, which may cause actual results to differ materially from
those expressed or implied by any forward-looking statement included in this
prospectus. The risks described below are not to be deemed an exhaustive list
of
all potential risks.
We
Have Limited Sources of Working Capital
Because
we were in bankruptcy in 2002 and due to the rights of some of our preferred
shareholders, we may not be able to obtain debt financing. All working capital
required to implement our business plan will be provided by funds obtained
through offerings of our equity securities, and revenues generated by us. No
assurance can be given that we will have revenues sufficient to support and
sustain our operations. If we do not have sufficient working capital and are
unable to generate revenues or raise additional funds, we may delay the
completion of or significantly reduce the scope of our current business plan;
delay some of our development and clinical or marketing testing, our plans
to
pursue Medicare and/or commercial insurance reimbursement for our wound
treatment technologies; or postpone the hiring of new personnel; or, under
certain dire financial circumstances, cease our operations.
We
Have a History of Losses
We
have a
history of losses, are not currently profitable, and expect to incur substantial
losses and negative operating cash flows for the foreseeable future. We may
never achieve or maintain profitability. We will need to generate significant
revenues to achieve and maintain profitability. We cannot assure that we will
be
able to generate these revenues, and we may never achieve profitability. We
expect our expenses will increase for the foreseeable future as we seek to
expand our operations, implement internal systems and infrastructure and hire
additional personnel. These ongoing financial losses may adversely affect our
stock price.
We
Have a Short Operating History and Limited Operating
Experience
We
must
be evaluated in light of the uncertainties and complexities affecting an early
stage biotechnology company. We have only recently implemented our current
business plan. Thus, we have a very limited operating history. Continued
operating losses, together with the risks associated with our ability to gain
new customers for our product offerings may have a material adverse effect
on
our liquidity. We may also be forced to respond to unforeseen difficulties,
such
as decreasing demand for our products and services, regulatory requirements
and
unanticipated market pressures. Since emerging from bankruptcy and continuing
through today, we are developing a business model that includes protecting
our
patent position, addressing our third-party reimbursement issues, and developing
a sales and marketing program. There can be no assurance that our business
model
in its current form can accomplish our stated goals.
Our
Intellectual Property Assets Are Critical to Our Success
We
regard
our patents, trademarks, trade secrets, and other intellectual property assets
as critical to our success. We rely on a combination of patents, trademarks,
and
trade secret and copyright laws, as well as confidentiality procedures,
contractual provisions, and other similar measures, to establish and protect
our
intellectual property. We attempt to prevent disclosure of our trade secrets
by
restricting access to sensitive information and requiring employees,
consultants, and other persons with access to our sensitive information to
sign
confidentiality agreements. Despite these efforts, we may not be able to prevent
misappropriation of our technology or deter others from developing similar
technology in the future. Furthermore, policing the unauthorized use of our
intellectual property assets is difficult and expensive. Litigation has been
necessary in the past and may likely be necessary in the future in order to
protect our intellectual property assets. Litigation could result in substantial
costs and diversion of resources. We cannot assure that we will be successful
in
any litigation matter relating to our intellectual property assets. Continuing
litigation or other challenges could result in one or more of our patents being
declared invalid. In such a case, any royalty revenues from the affected patents
would be adversely affected although we may still be able to continue to develop
and market our products. Furthermore, the unauthorized use of our patented
technology by otherwise potential customers in our target market may
significantly undermine our ability to generate sales. Our patent covering
the
specific gel formulation that is applied as part of the AutoloGel™ System (the
‘‘Worden Patent’’) expires no earlier than February 2019. Our U.S. Knighton
Patent (which is the subject of license agreements between us and Medtronic,
Inc., DePuy Spine, Inc., Biomet Biologics, Inc., COBE Cardiovascular, Inc.,
and
Harvest Technologies Corporation, among others) expires in November 2009. There
is no assurance that we will obtain a significantly increased share of the
wound
care market prior to the expiration of the U.S. Knighton Patent in 2009, after
which we may be more vulnerable to competitive factors because third parties
will not then need a license from us to perform the methods claimed in the
Knighton Patent.
The
AutoloGel™ System and Components Are Subject to Governmental
Regulation
Our
success is also impacted by factors outside of our control. Our current
technology and products may be subject to extensive regulation by numerous
governmental authorities in the United States, both federal and state, and
in
foreign countries by various regulatory agencies. Specifically, our devices
are
subject to regulation by the FDA and state regulatory agencies. The FDA
regulates drugs, medical devices and biologics that move in interstate commerce
and requires that such products receive clearance or pre-marketing approval
based on evidence of safety and efficacy. The regulations of government health
ministries in foreign countries are analogous to those of the FDA in both
application and scope. In addition, any change in current regulatory
interpretations by, or positions of, state regulatory officials where the
AutoloGel™ System is used could materially and adversely affect our ability to
sell products in those states. The FDA will require us to obtain clearance
or
approval of new devices when used for treating specific wounds or marketed
with
specific wound healing claims. We believe that the AutoloGel™ System and all of
our products are legally marketed. The FDA has cleared us to market the
AutoloGel™ System, including the Wound Dressing Kit and Centrifuge II, for use
in exuding wounds such as leg ulcers, pressure ulcers, and diabetic ulcers,
and
the management of mechanically and surgically-debrided wounds. As we expand
and
offer additional products in the United States and in foreign countries,
clearance or approval from the FDA and comparable foreign regulatory authorities
prior to introduction of any such products into the market may be required.
We
have no assurance that we will be able to obtain all necessary approvals from
the FDA or comparable regulatory authorities in foreign countries for these
products. Failure to obtain the required approvals would have a material adverse
impact on our business and financial condition. Compliance with FDA and other
governmental requirements imposes significant costs and expenses. Further,
our
failure to comply with these requirements could result in sanctions, limitations
on promotional or other business activities, or other adverse effects on our
business. Further, recent efforts to control healthcare costs could negatively
affect demand for our products and services.
Clinical
Trials May Fail to Demonstrate the Safety or Efficacy of Our Product
Candidates
Our
product candidates are subject to the risks of failure inherent in the
development of biotherapeutic products. The results of early-stage clinical
trials do not necessarily predict the results of later-stage clinical trials.
Product candidates in later-stage clinical trials may fail to demonstrate
desired safety and efficacy traits despite having successfully progressed
through initial clinical testing. Even if we believe the data collected from
clinical trials of our product candidates is promising, this data may not be
sufficient to support approval by the U.S. or foreign regulatory agencies.
Pre-clinical and clinical data can be interpreted in different ways.
Accordingly, the regulatory officials could reach different conclusions in
assessing such data, which could delay, limit or prevent regulatory approval.
In
addition, the U.S. regulatory authorities or we may suspend or terminate
clinical trials at any time. Any failure or delay in completing clinical trials
for product candidates, or in receiving regulatory approval for the sale of
any
product candidates, has the potential to materially harm our business, and
may
prevent us from raising necessary, additional financing that may be needed
in
the future.
A
Disruption in Healthcare Provider Networks Could Have an Adverse Effect on
Operations and Profitability
Our
operations and future profitability are dependent, in large part, upon the
ability to contract with healthcare providers on favorable terms. In any
particular service area, healthcare providers could refuse to contract with
us
or take other actions that could result in higher healthcare costs, or create
difficulties in meeting our regulatory requirements. In some service areas,
certain healthcare providers may have a significant market presence. If
healthcare providers refuse to contract with us, use their market position
to
negotiate unfavorable contracts or place us at a competitive disadvantage,
our
ability to market services or to be profitable in those service areas could
be
adversely affected. Provider networks could also be disrupted by the financial
insolvency of a large healthcare provider group. Any disruption in provider
networks could adversely impact our ability to generate revenues or
profits.
CMS’s
Non-Coverage of AutoloGel™ Could Greatly Restrict Our
Sales
The
AutoloGel™ System is marketed to healthcare providers. Some of these providers,
in turn, seek reimbursement from third-party payers such as Medicare, Medicaid,
and other private insurers. Many foreign countries also have comprehensive
government managed healthcare programs that provide reimbursement for healthcare
products. Under such healthcare systems, reimbursement is often a determining
factor in predicting a product’s success, with some physicians and patients
strongly favoring only those products for which they will be reimbursed. With
CMS’s national non-coverage decision, the market for the AutoloGel™ System could
be greatly restricted and it may be difficult, if not impossible, to sell
AutoloGel™ in most care settings. This would hamper our ability to grow our
revenues and could reduce the likelihood that we will ever achieve sustainable
profitability.
Royalty
Revenues Are Unpredictable
While
we
currently have several primary licensing agreements that are expected to
generate on-going royalty revenues, we cannot currently reasonably predict
the
magnitude of those revenues. Royalty streams from these agreements are entirely
dependent on the sales of our licensees and are therefore outside of our
control. Past levels of royalty revenues from these agreements are not
necessarily an indication of future activity.
The
Success of the AutoloGel™ System Is Dependent on Acceptance by the Medical
Community
The
commercial success of our products and processes will depend upon the medical
community and patients accepting the therapies as safe and effective. If the
medical community and patients do not ultimately accept the therapies as safe
and effective, our ability to sell the products and processes will be materially
and adversely affected. While acceptance by the medical community may be
fostered by broad evaluation via peer-reviewed literature, we may not have
the
resources to facilitate sufficient publication.
We
May Be Unable to Attract and Retain Key Personnel
Our
future success depends on the ability to attract, retain and motivate highly
skilled management, including sales representatives. We have retained a team
of
highly qualified officers and consultants, but we cannot provide assurance
that
we will be able to successfully retain all of them, or be successful in
recruiting additional personnel as needed. Our inability to do so will
materially and adversely affect the business prospects, operating results and
financial condition. Our ability to maintain and provide additional services
to
our existing customers depends upon our ability to hire and retain business
development and scientific and technical personnel with the skills necessary
to
keep pace with continuing changes in cellular therapy technologies. Competition
for such personnel is intense; we compete with pharmaceutical, biotechnology
and
healthcare companies. Our inability to hire additional qualified personnel
may
lead to higher recruiting, relocation and compensation costs for such personnel.
These increased costs may reduce our profit margins or make hiring new personnel
impractical.
Legislative
and Administrative Action May Have an Adverse Effect on Our
Company
Political,
economic and regulatory influences may subject the health care industry in
the
United States to fundamental change. We cannot predict what other legislation
relating to our business or to the health care industry may be enacted,
including legislation relating to third-party reimbursement, or what effect
such
legislation may have on our business, prospects, operating results and financial
condition. We expect federal and state legislators to continue to review and
assess alternative health care delivery and payment systems and possibly adopt
legislation affecting fundamental changes in the health care delivery system.
Such laws may contain provisions that may change the operating environment
for
our targeted customers including hospitals and managed care organizations.
Health care industry participants may react to such legislation by curtailing
or
deferring expenditures and initiatives, including those relating to our
products. Future legislation could result in modifications to the existing
public and private health care insurance systems that would have a material
adverse effect on the reimbursement policies discussed above.
We
Could Be Affected by Malpractice Claims
Providing
medical care entails an inherent risk of professional malpractice and other
claims. We do not control or direct the practice of medicine by physicians
or
health care providers who use the products and do not assume responsibility
for
compliance with regulatory and other requirements directly applicable to
physicians. We cannot assure that claims, suits or complaints relating to the
use of the AutoloGel™ System and treatment administered by physicians will not
be asserted against us in the future. The production, marketing and sale, and
use of the AutoloGel™ System entail risks that product liability claims will be
asserted against us. These risks cannot be eliminated, and we could be held
liable for any damages that result from adverse reactions or infectious disease
transmission. Such liability could materially and adversely affect our business,
prospects, operating results and financial condition. We currently maintain
professional and product liability insurance coverage, but we cannot give
assurance that the coverage limits of this insurance would be adequate to
protect against all potential claims. We cannot assure that we will be able
to
obtain or maintain professional and product liability insurance in the future
on
acceptable terms or with adequate coverage against potential
liabilities.
AutoloGel™
Has Existing Competition in the Marketplace
In
the
market for biotechnology products, we face competition from pharmaceutical
companies, biopharmaceutical companies, medical device companies, and other
competitors. Other companies have developed or are developing products that
may
be in direct competition with the AutoloGel™ System. Biotechnology development
projects are characterized by intense competition. Thus, we cannot assure any
investor that we will be the first to the market with any newly developed
products or that we will successfully be able to market these products. If
we
are not able to participate and compete in the cellular therapy market, our
financial condition will be materially and adversely affected. We cannot assure
that we will be able to compete effectively against such companies in the
future. Many of these companies have substantially greater capital resources,
larger marketing staffs and more experience in commercializing products.
Recently developed technologies, or technologies that may be developed in the
future, may be the basis for developments that will compete with our
products.
Risk
from Economic Downturns and Changes
Economic
downturns or other adverse economic changes (local, regional, or national)
can
hurt our financial performance in the form of lower interest earned on
investments and/or could result in losses of portions of principal in our
investment portfolio. While our investment policy requires us to invest only
in
short-term, low risk investments, there is no assurance that principal will
not
be eroded as a significant portion of these investments is in excess of
federally mandated insurance.
Risks
Related to Our Common Stock
The
average daily trading volume in our Common stock is relatively low. As long
as
this condition continues, it could be difficult or impossible to sell a
significant number of shares of Common stock at any particular time at the
market prices prevailing immediately before such shares are offered. In
addition, sales of substantial amounts of Common stock could lower the
prevailing market price of our Common stock. This would limit or perhaps prevent
our ability to raise capital through the sale of securities. Additionally,
we
have significant numbers of outstanding warrants and options that, if exercised
and sold, could put additional downward pressure on the Common stock
price.
We
May Issue Additional Equity Securities Which May Materially and Adversely Affect
the Price of Our Common Stock
Sales
of
substantial amounts of shares of our Common stock in the public market, or
the
perception that those sales may occur, could cause the market price of our
Common stock to decline. We have used, and will likely continue to use, our
Common stock or securities convertible into or exchangeable for Common stock
to
fund working capital needs or to acquire technology, product rights or
businesses, or for other purposes. If additional equity securities are issued,
particularly during times when our Common stock is trading at relatively low
price levels, the price of our Common stock may be materially and adversely
affected.
There
Is a Limited Public Trading Market for Our Common Stock
There
is
a limited public trading market for our Common stock. Without an active trading
market, there can be no assurance of any liquidity or resale value of Common
stock, and stockholders may be required to hold shares of our Common stock
for
an indefinite period of time. In addition, in recent years, the stock market
in
general, and the market for life sciences companies in particular, have
experienced significant price and volume fluctuations. This volatility has
affected the market prices of securities issued by many companies, often for
reasons unrelated to their operating performance, and it may adversely affect
the price of our Common stock. These broad market fluctuations may adversely
affect the price of our securities, regardless of operating
performance.
We
Are Subject to Anti-Takeover Provisions and Laws
Provisions
in our Restated Certificate of Incorporation and Restated Bylaws and applicable
provisions of the Delaware General Corporation Law may make it more difficult
for a third party to acquire control of our Company without the approval of
the
Board of Directors. These provisions may make it more difficult or expensive
for
a third party to acquire a majority of our outstanding voting Common stock
or
delay, prevent or deter a merger, acquisition, tender offer or proxy contest,
which may negatively affect the Common stock price.
FORWARD-LOOKING
INFORMATION
This
prospectus and the documents incorporated by reference herein contain
forward-looking statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
Forward-looking statements represent our management’s judgment regarding future
events. In many cases, you can identify forward-looking statements by
terminology such as “may,” “will,” “should,” “plan,” “expect,” “anticipate,”
“estimate,” “predict,” “intend,” “potential” or “continue” or the negative of
these terms or other words of similar import, although some forward-looking
statements are expressed differently. All statements other than statements
of historical fact included in this prospectus and the documents incorporated
by
reference therein regarding our financial position, business strategy and plans
or objectives for future operations are forward-looking statements.
Without limiting the broader description of forward-looking statements above,
we
specifically note that statements regarding our ability to obtain Medicare
or
third-party reimbursement or to achieve market acceptance of our products are
all forward-looking in nature. We cannot guarantee the accuracy of the
forward-looking statements, and you should be aware that results and events
could differ materially and adversely from those contained in the
forward-looking statements due to a number of factors, including:
·
|
our
ability to secure additional funds;
|
·
|
our
ability to maintain the level of our expenses consistent with our
internal
budgets and forecasts;
|
·
|
the
ability of our contract manufacturers to produce adequate supplies
of our
products for sale;
|
·
|
variability
of our royalty, license and other
revenues;
|
·
|
the
demand for securities of biotechnology companies in general and our
securities in particular;
|
·
|
uncertainty
regarding our patents and patent
rights;
|
·
|
compliance
with current or prospective governmental
regulation;
|
·
|
technological
change; and
|
·
|
general
economic and market conditions.
|
You
should also consider carefully the statements set forth in the section entitled
“Risk Factors” beginning on page 5 of this prospectus, which addresses these and
additional factors that could cause results or events to differ from those
set
forth in the forward-looking statements. All written and oral
forward-looking statements attributable to us or to persons acting on our behalf
are expressly qualified in their entirety by the applicable cautionary
statements. We have no plans to update these forward-looking
statements.
RATIO
OF EARNINGS TO FIXED CHARGES
We
currently do not have outstanding debt. Thus, it is not possible or meaningful
at this time to calculate a ratio of our earnings to fixed charges.
The
following table shows our consolidated ratio of earnings to fixed charges for
the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September
30, 2007
|
|
Year
Ended December 31,
|
|
|
2006
|
|
2005
|
|
2004
|
|
2003
|
|
2002
|
|
|
in
millions
|
|
in
millions
|
Ratio
of earnings to fixed charges and preferred stock
dividends(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Since
2002, we have only declared two cash dividends on preferred stock.
All
other preferred stock dividends were paid in additional shares of
our
preferred stock. The cash dividends were declared and paid during
the
years ended December 31, 2005 and 2006 and totaled approximately
$91,000
and $11,000 respectively. As either no cash dividends were paid,
or
earnings were insufficient to cover cash dividends, it is not possible
or
meaningful at this time to calculate a ratio of our earnings to fixed
charges and preferred stock
dividends.
|
USE
OF PROCEEDS
We
will
not receive any proceeds from the sale of common stock offered through this
prospectus by the selling shareholders. We are registering those shares for
sale
to provide the selling shareholders with freely tradable securities. The
registration of these shares does not necessarily mean that any of these shares
will be offered or sold by the selling shareholders. All proceeds from the
sale
of such shares sold under this prospectus by the selling shareholders will
go to
the selling shareholders.
We
may
receive proceeds from the selling shareholders' exercise of warrants, but our
issuance of common stock to the selling shareholders is not covered by this
prospectus. Such proceeds, if any, will be used for working capital and other
corporate purposes.
Unless
otherwise specified in an applicable prospectus supplement, the net proceeds
that we receive from the sale of any of the securities offered by us under
this
prospectus will be available for working capital and other general corporate
purposes. Pending that use, we may invest the net proceeds.
SELLING
SHAREHOLDERS
The
following table sets forth the following information as of March 21,
2008:
·
|
the
name of each selling shareholder;
|
·
|
the
number of shares of our common stock believed to be beneficially
owned by
each selling shareholder prior to the offering for resale of the
shares
under this prospectus;
|
·
|
the
number of shares of common stock being registered for resale by each
selling shareholder (or its permitted pledgee, donee, transferee
or other
permitted successor in interest);
and
|
·
|
the
number of shares of our common stock believed to be beneficially
owned by
each selling shareholder after the offering for resale of the shares
under
this prospectus.
|
The
following table is based upon information provided by the selling shareholders
and other documents filed with the SEC. Except as otherwise indicated in the
table below, the number of shares beneficially owned by each of the selling
shareholders is determined by rules promulgated by the Securities and Exchange
Commission and the information is not necessarily indicative of beneficial
ownership for any other purpose.
The
number of shares offered in this prospectus by the selling shareholders includes
shares of common stock issuable upon exercise of warrants. The number of shares
that will ultimately be issued to the selling shareholders cannot be determined
at this time because it depends on whether and when the selling shareholders
ultimately exercise their warrants. Further the number of shares issuable upon
exercise of the various warrants may be subject to certain adjustments to
prevent dilution resulting from stock splits, stock dividends or similar
transactions.
The
following table assumes that each selling shareholder will sell all of the
shares of common stock being offered by them pursuant to this prospectus.
However, because the selling shareholders may offer all, some or none of the
common stock listed in the table pursuant to this prospectus or otherwise,
no
estimate can be given as to the amount or percentage of common stock that will
be held by the selling shareholders upon termination of the offering. The
selling shareholders may sell all, part, or none of the shares listed.
Except
as
is indicated in the footnotes to the table below, none of the selling
shareholders has had any position, office or other material relationship with
us, other than as a security holder, during the past three years.
The
term
"selling shareholder" includes the shareholders listed below and their
transferees, assigns, pledges, donees or other successors who may later hold
the
selling shareholders’ interests. The percentage of beneficial ownership is based
on 31,938,074 shares of common stock outstanding on March 21, 2008. Shares
of
common stock subject to warrants, options and other convertible securities
that
are currently exercisable or exercisable within sixty days of March 21, 2008,
are considered outstanding and beneficially owned by a selling shareholder
who
holds those warrants, options or other convertible securities for the purpose
of
computing the percentage ownership of that selling shareholder but are not
treated as outstanding for the purpose of computing the percentage ownership
of
any other selling shareholder.
Name
of Selling
Shareholder
|
|
Number
of Shares
Owned
Prior to
Offering
|
|
Maximum
Number
of Shares
to
be Sold
Pursuant
to this
Prospectus
|
|
Number
of Shares
Owned
After
Offering
|
|
|
|
Number
|
|
Percent
|
|
|
|
|
|
Number
|
|
Percent
|
|
Maier
& Company
|
|
|
12,000
|
|
|
*
|
|
|
12,000
|
|
|
1
|
|
|
0
|
|
|
*
|
|
KOL
Bio-Medical Instruments, Inc.
|
|
|
60,000
|
|
|
*
|
|
|
60,000
|
|
|
2
|
|
|
0
|
|
|
*
|
|
Crystal
Research Associates, LLC
|
|
|
125,000
|
|
|
*
|
|
|
125,000
|
|
|
3
|
|
|
0
|
|
|
*
|
|
John
Paul DeJoria
|
|
|
79,999
|
|
|
*
|
|
|
13,333
|
|
|
4
|
|
|
66,666
|
|
|
*
|
|
FEQ
Gas, LLC
|
|
|
920,200
|
|
|
2.8
|
%
|
|
40,200
|
|
|
4,7
|
|
|
880,000
|
|
|
2.7
|
%
|
David
Jorden
|
|
|
2,487,800
|
|
|
7.7
|
%
|
|
42,000
|
|
|
4
|
|
|
2,445,800
|
|
|
7.6
|
%
|
Lon
Frederick
|
|
|
39,100
|
|
|
*
|
|
|
450
|
|
|
4
|
|
|
38,650
|
|
|
*
|
|
Gloria
Frederick
|
|
|
14,300
|
|
|
*
|
|
|
300
|
|
|
4
|
|
|
14,000
|
|
|
*
|
|
William
F. Miller
|
|
|
632,850
|
|
|
2.0
|
%
|
|
15,000
|
|
|
4
|
|
|
617,850
|
|
|
1.9
|
%
|
Charles
Sheedy
|
|
|
1,338,600
|
|
|
4.2
|
%
|
|
20,000
|
|
|
4
|
|
|
1,318,600
|
|
|
4.1
|
%
|
Byron
Rosenstein
|
|
|
1,250
|
|
|
*
|
|
|
1,250
|
|
|
4
|
|
|
0
|
|
|
*
|
|
Chris
Allison
|
|
|
55,000
|
|
|
*
|
|
|
5,000
|
|
|
4
|
|
|
50,000
|
|
|
*
|
|
Chad
Burton
|
|
|
19,780
|
|
|
*
|
|
|
5,000
|
|
|
4
|
|
|
14,780
|
|
|
*
|
|
Stephen
Blake Murchison
|
|
|
128,500
|
|
|
*
|
|
|
10,000
|
|
|
4
|
|
|
118,500
|
|
|
*
|
|
Strand,
Inc.
|
|
|
50,700
|
|
|
*
|
|
|
10,000
|
|
|
4
|
|
|
40,700
|
|
|
*
|
|
Raffaele
Ricci
|
|
|
120,000
|
|
|
*
|
|
|
20,000
|
|
|
4
|
|
|
100,000
|
|
|
*
|
|
Montex
Exploration
|
|
|
20,000
|
|
|
*
|
|
|
20,000
|
|
|
4
|
|
|
0
|
|
|
*
|
|
TIHO
Investments, LLC
|
|
|
28,600
|
|
|
*
|
|
|
28,600
|
|
|
4
|
|
|
0
|
|
|
*
|
|
FEQ
Invesments, Inc.
|
|
|
1,452,900
|
|
|
4.5
|
%
|
|
17,900
|
|
|
4,7
|
|
|
1,435,000
|
|
|
4.4
|
%
|
Steven
B. Rosner
|
|
|
10,000
|
|
|
*
|
|
|
5,000
|
|
|
4
|
|
|
5,000
|
|
|
*
|
|
William
T. Ratliff, Jr.
|
|
|
110,000
|
|
|
*
|
|
|
10,000
|
|
|
4
|
|
|
100,000
|
|
|
*
|
|
Carl
Lessman
|
|
|
57,000
|
|
|
*
|
|
|
5,000
|
|
|
4
|
|
|
52,000
|
|
|
*
|
|
Severn
Trading Partners
|
|
|
10,000
|
|
|
*
|
|
|
10,000
|
|
|
4
|
|
|
0
|
|
|
*
|
|
Ward
Family Foundation
|
|
|
431,250
|
|
|
1.3
|
%
|
|
20,000
|
|
|
4
|
|
|
411,250
|
|
|
1.3
|
%
|
Timothy
E. Levstik
|
|
|
156,577
|
|
|
*
|
|
|
156,577
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Joseph
E. Shipley
|
|
|
113,681
|
|
|
*
|
|
|
113,681
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Fitch,
Even, Tabin, & Flannery
|
|
|
79,987
|
|
|
*
|
|
|
79,987
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Phillip
T. Petti
|
|
|
129,110
|
|
|
*
|
|
|
129,110
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Joseph
T. Nabor
|
|
|
108,722
|
|
|
*
|
|
|
108,722
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Steven
C. Schroer
|
|
|
162,913
|
|
|
*
|
|
|
157,913
|
|
|
5
|
|
|
5,000
|
|
|
*
|
|
Richard
A. Kaba
|
|
|
107,254
|
|
|
*
|
|
|
107,254
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Karl
R. Fink
|
|
|
141,510
|
|
|
*
|
|
|
141,510
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Timothy
P. Maloney
|
|
|
267,577
|
|
|
*
|
|
|
142,977
|
|
|
5
|
|
|
124,600
|
|
|
*
|
|
Mark
W. Hetzler
|
|
|
115,185
|
|
|
*
|
|
|
115,185
|
|
|
5
|
|
|
0
|
|
|
*
|
|
James
P. Krueger
|
|
|
111,749
|
|
|
*
|
|
|
111,749
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Steven
F. Favekeh
|
|
|
119,133
|
|
|
*
|
|
|
119,133
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Richard
E. Wawarzniak
|
|
|
81,202
|
|
|
*
|
|
|
81,202
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Steven
G. Parmelee
|
|
|
109,837
|
|
|
*
|
|
|
109,837
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Thomas
Lebens
|
|
|
54,094
|
|
|
*
|
|
|
54,094
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Kendrew
H. Colton
|
|
|
50,723
|
|
|
*
|
|
|
50,723
|
|
|
5
|
|
|
0
|
|
|
*
|
|
John
F. Flannery
|
|
|
14,096
|
|
|
*
|
|
|
14,096
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Kenneth
H. Samples
|
|
|
49,000
|
|
|
*
|
|
|
49,000
|
|
|
5
|
|
|
0
|
|
|
*
|
|
Robert
F. Coleman
|
|
|
457,203
|
|
|
1.4
|
%
|
|
172,900
|
|
|
5
|
|
|
284,303
|
|
|
*
|
|
Steve
R. Jakubowski
|
|
|
634,836
|
|
|
2.0
|
%
|
|
264,350
|
|
|
6
|
|
|
370,486
|
|
|
1.2
|
%
|
*
Less
than 1%.
(1)
Issuable upon the exercise of warrants to purchase 12,000 shares of common
stock
dated August 18, 2004, with an exercise price of $1.24 per share and an
expiration date of August 18, 2009.
(2)
Issuable upon the exercise of warrants to purchase 60,000 shares of common
stock
dated March 7, 2005, with an exercise price of $2.55 per share and an expiration
date of March 7, 2010.
(3)
Issuable upon the exercise of warrants to purchase 125,000 shares of common
stock dated April 18, 2005, with an exercise price of $3.14 per share and an
expiration date of April 18, 2010.
(4)
Issuable upon the exercise of Class D Warrants as described in our Current
Report on Form 8-K filed with the SEC on May 2, 2006. The Class D Warrants
have
an exercise price of $3.50 per share and expire on April 12, 2011.
(
5)
The
identified persons are attorneys with Fitch, Even, Tabin & Flannery (“Fitch,
Even”) or The Coleman Law Firm (“CLF”), law firms which have served as our
outside counsel in connection with various patent and litigation issues. As
described in our Current Report on Form 8-K filed with the SEC on August 8,
2007, we entered into a Term Sheet Agreement with Fitch, Even and CLF with
an
effective date of August 2, 2007. Pursuant to this Term Sheet, we are obligated
to issue a total of 1.3 million shares of our common stock as directed by Fitch,
Even and CLF, as well as warrants to purchase an additional 975,000 shares
of
our common stock, at exercise prices of $1.25 (warrants to purchase 325,000
shares of common stock); $1.50 (warrants to purchase 325,000 shares of common
stock); and $1.75 (warrants to purchase 325,000 shares of common stock). The
warrants will expire on February 2, 2015.
(6)
Includes 5,000 shares of common stock issuable upon exercise of Class D warrants
(see footnote 4 above) and 259,350 shares issuable directly and upon the
exercise of warrants Mr. Jakubowski received pursuant to the Term Sheet
agreement in his capacity as outside counsel to the Company (see footnote 5
above).
(7)
FEQ
Gas, LLC, and FEQ Investments, Inc., are both controlled by Mr. Ernest
Bartlett.
PLAN
OF DISTRIBUTION
Generally
speaking, we and the selling shareholders may offer and sell the securities
offered by this prospectus in any of three ways:
·
|
through
underwriters or dealers; or
|
·
|
directly
to one or more purchasers.
|
The
selling shareholders will act independently of us in making decisions with
respect to the timing, manner and size of each sale of securities. Additionally,
the selling shareholders may transfer their shares in other ways not involving
market makers or established trading markets, including directly by gift
distribution, or other transfer. The selling shareholders also could sell their
shares under Rule 144 of the Securities Act rather than under this prospectus.
Generally under Rule 144, each person holding restricted securities for a period
of one year may, every three months, sell in ordinary brokerage transactions
or
to market makers an amount of shares up to and including the greater of 1%
of a
company's then-outstanding common stock or the average weekly trading volume
for
the four weeks prior to the proposed sale. Such sales, if any, will not form
part of the plan of distribution described in this prospectus.
We
will
pay the costs and fees of registering the shares, but the selling shareholders
will pay any brokerage commissions or underwriting discounts relating to their
sale of the shares. We will not receive any of the proceeds from the sales
of
the common stock by the selling shareholders. We can provide no assurance that
all or any shares of the common stock offered by the selling shareholders will
be sold by the selling shareholders.
With
regard to offers and sales by the Company, we will file an applicable prospectus
supplement that will set forth the specific terms of the offering of securities,
including:
·
the
securities offered;
·
the
price
of the securities;
·
the
proceeds to us from the sale of the securities;
·
the
names
of the securities
exchange
if any, on which the securities are listed;
·
the
names
of underwriters or agents;
·
anyunderwriting
discounts, agency fees or other compensation to underwriters or agents;
and
·
any
discounts or concessions allowed or paid to dealers.
We
may
authorize underwriters, dealers and agents to solicit offers from specified
institutions to purchase the securities from us at the public offering price
listed in the applicable prospectus supplement. These sales may be made under
“delayed delivery contracts” that provide for payment and delivery on a
specified future date. Any contracts like this will be subject to the conditions
listed in the prospectus supplement. The prospectus supplement also will state
the commission to be paid to underwriters, dealers and agents who solicit these
contracts.
Any
underwriter, dealer or agent who participates in the distribution of an offering
of securities may be considered by the SEC to be an underwriter under the
Securities Act. Any discounts or commissions received by an underwriter, dealer
or agent on the sale or resale of securities may be considered by the SEC to
be
underwriting discounts and commissions under the Securities Act. Under
agreements with us or the selling shareholders, underwriters, dealers and agents
may be entitled to indemnification by us or the selling shareholders against
some civil liabilities, including liabilities under the Securities Act.
Underwriters, dealers and agents also may be entitled to contributions for
any
payments the underwriters, dealers or agents are required to make with respect
to some civil liabilities, including liabilities under the Securities Act.
Underwriters and agents and their affiliates are permitted to be customers
of,
engage in transactions with, or perform services for us or our affiliates or
the
selling shareholders or its affiliates in the ordinary course of
business.
Unless
otherwise indicated in the applicable prospectus supplement, the obligations
of
the underwriters to purchase any offered securities will be subject to certain
conditions precedent, and the underwriters will be obligated to purchase all
of
the offered securities if any are purchased.
Unless
otherwise indicated in the applicable prospectus supplement, all securities
offered by us under this prospectus, other than the common stock, will be new
issues of securities with no established trading market. Any underwriters to
whom we sell securities for public offering and sale may make a market in the
securities. However, these underwriters will not be obligated to make a market
in the securities and may discontinue any market-making at any time without
notice. We cannot assure you that the trading market for any of the securities
will be or remain liquid at any time.
DESCRIPTION
OF SECURITIES TO BE REGISTERED
Common
Stock
We
are
authorized to issue 65,000,000 shares of non-assessable voting common stock,
$.0001 par value per share, of which 31,938,074 shares are outstanding as of
March 21, 2008. In addition, approximately 7.7 million shares are issuable
upon
the conversion of outstanding preferred stock and the exercise of outstanding
warrants and options. Furthermore, approximately 325,000 additional shares
of
common stock are issuable under our bankruptcy plan of reorganization
immediately upon our earning an aggregate of $10 million in gross revenues
over
four consecutive quarters (such issuance is not covered by this
prospectus).
The
common stock is fully paid and nonassessable. All of our common stock is of
the
same class, and each share has the same rights and preferences. Holders of
our
common stock are entitled to one vote per share on each matter submitted to
a
vote of the shareholders.
In
the
event of liquidation, holders of common stock are entitled to share ratably
in
the distribution of assets remaining after payment of liabilities, upon giving
a
liquidation preference of $1.00 per share for each share of outstanding Series
A
convertible preferred stock and Series B convertible preferred stock, and a
liquidation preference amount of $10,000 per share for each share of outstanding
Series C convertible preferred stock. The common stock is subordinate to the
Series A convertible preferred, Series B convertible preferred, and Series
C
convertible preferred, and to all other classes and series of equity securities
which by their terms rank senior to the common stock, in the event of a
liquidation, dissolution, or winding up or with regard to any other rights,
privileges or preferences.
Holders
of common stock do not have any cumulative voting rights, preemptive rights,
conversion rights, redemption rights or sinking fund rights.
Holders
of common stock are entitled to receive dividends as may from time to time
be
declared by the board of directors at their sole discretion. We did not pay
dividends to holders of our common stock during 2004, 2005, 2006 or 2007. We
do
not anticipate paying cash dividends on our common stock in the foreseeable
future, but instead will retain any earnings to fund our growth. In fact, we
are
prohibited from declaring dividends on our common stock as long as any dividends
on shares of Series A, Series B or Series C convertible preferred are unpaid
and
outstanding. Once there are no dividends unpaid and outstanding on any shares
of
Series A, Series B or Series C convertible preferred, any decision to pay cash
dividends will depend on our ability to generate earnings, our need for capital,
our overall financial condition, and other factors our Board deems relevant.
Our
transfer agent for our Common Stock is StockTrans, located at 44 West Lancaster
Ave., Ardmore, Pennsylvania 19003. All inquiries may be made at 1-800-733-1121.
The transfer agent’s internet website address is
www.stocktrans.com.
Preferred
Stock
This
section summarizes the general terms and provisions of the preferred stock
that
may be offered by this prospectus. The prospectus supplement will describe
the
specific terms of any series of preferred stock offered under that prospectus
supplement and any general terms outlined in this section that will not apply
to
that series of preferred stock. Because this is only a summary, it does not
contain all of the details found in the full text of the certificate of
designation containing the rights and preferences of the preferred stock. The
certificate of designation will be filed or incorporated by reference as an
exhibit to the registration statement to which this prospectus relates. For
additional information, please read the full text of the certificate of
designation.
We
are
authorized to issue 15,000,000 shares of preferred stock, with a par value
of
$.0001. To date, our Board of Directors has certified the rights and preferences
of three series of preferred stock: Series A Convertible Preferred Stock, Series
B Convertible Preferred Stock, and Series C Convertible Preferred Stock.
Series
A Convertible Preferred Stock
We
have
authorized a maximum of 5,000,000 shares of Series A convertible preferred
stock, par value $.0001.
As
of
March 21, 2008, there are approximately 91,000 shares of Series A convertible
preferred stock outstanding.
The
Series A convertible preferred has a stated liquidation preference of $1.00
per
share and has preference over and ranks (i) senior to the Series B convertible
preferred stock, (ii) senior to the common stock, and (iii) senior to all other
classes and series of equity securities which by its terms do not rank senior
to
the Series A convertible preferred. The Series A convertible preferred contains
a negative covenant prohibiting us from granting any security interest in our
patents and/or future royalty streams.
Holders
of Series A convertible preferred are entitled to receive cumulative dividends
at the rate of 8% of the stated liquidation preference amount per share per
annum, payable quarterly in arrears. These dividends are prior and in preference
to any declaration or payment of any distribution on any outstanding shares
of
common stock or any other equity securities ranking junior as to the payment
of
dividends. Dividends are to be paid in additional shares of Series A convertible
preferred or, in the sole discretion of the Board, in cash. If we fail to pay
dividends as required for six consecutive quarters, a majority of the holders
of
Series A convertible preferred will have the power to elect one director to
the
Board, either by filling an existing vacancy on the Board or by removing a
director of their choice. Each share of Series A convertible preferred stock
is
entitled to vote on all matters voted on by holders of the common stock voting
together as a single class with the other shares entitled to vote.
Beginning
on July 11, 2003, and every six months thereafter, holders of the Series A
convertible preferred may convert up to 25% of their remaining holdings of
Series A convertible preferred into common stock. The shares converted based
on
the liquidation preference amount and the conversion price of the common stock
is equal to 90% of the twenty-day average closing ask price of the common stock,
but in no case shall the conversion price be less than $3.00 per share.
We
may
redeem all of the then outstanding shares of Series A convertible preferred
stock upon proper notice of not less than ten days nor more than sixty days
prior to the redemption date. The per share redemption price is equal to (i)
105% of the Series A liquidation preference amount plus all accrued but unpaid
dividends if the shares are redeemed within one year of the date of issuance;
(ii) 104% of the Series A liquidation preference amount plus all accrued but
unpaid dividends if redeemed later than one year from the date of
issuance.
Series
B Convertible Preferred Stock
We
have
authorized a maximum of 5,000,000 shares of Series B convertible preferred
stock, par value $.0001. As of March 21, 2008, there are approximately 85,000
shares of Series B convertible preferred stock outstanding. These shares have
a
stated liquidation preference of $1.00 per share. They are subordinate to the
Series A convertible preferred, but have preference over and rank senior to
(i)
the common stock, and (ii) all other classes and series of equity securities
which by their terms do not rank senior to the Series B convertible preferred
stock. The Series B convertible preferred contains a negative covenant
prohibiting us from granting any security interest in our patents and/or future
royalty streams.
Holders
of Series B convertible preferred are entitled to receive cumulative dividends
at the rate of 8% of the stated liquidation preference amount per share per
annum, payable quarterly in arrears. These dividends are prior and in preference
to any declaration or payment of any distribution on any outstanding shares
of
common stock or any other equity securities ranking junior as to the payment
of
dividends. Dividends are to be paid in additional shares of Series B convertible
preferred or, in the sole discretion of the Board, in cash. If we fail to pay
dividends as required for six consecutive quarters, a majority of the holders
of
Series B convertible preferred will have the power to elect one director to
the
Board, either by filling an existing vacancy on the Board or by removing a
director of their choice. Each share of Series B convertible preferred stock
is
entitled to vote on all matters voted on by holders of the common stock voting
together as a single class with the other shares entitled to vote.
Beginning
on July 11, 2003, and every six months thereafter, holders of the Series B
convertible preferred may convert up to 25% of their remaining holdings of
Series B convertible preferred into common stock. The shares converted based
on
the liquidation preference amount and the conversion price of the common stock
is equal to 90% of the twenty-day average closing ask price of the common stock,
but in no case shall the conversion price be less than $3.00 per share.
We
may
redeem all of the then outstanding shares of Series B convertible preferred
stock upon proper notice of not less than ten days nor more than sixty days
prior to the redemption date. The per share redemption price is equal to (i)
105% of the Series A liquidation preference amount plus all accrued but unpaid
dividends if the shares are redeemed within one year of the date of issuance;
(ii) 104% of the Series A liquidation preference amount plus all accrued but
unpaid dividends if redeemed later than one year from the date of issuance;
or
(iii) 103% of the Series B Liquidation Preference Amount plus all accrued but
unpaid dividends if redeemed later than two years from the date of
issuance.
Series
C Convertible Preferred Stock
We
have
authorized a maximum of 1,000,000 shares of Series C convertible preferred
stock, par value $.0001. As of March 21, 2008, there are no shares of Series
C
convertible preferred stock outstanding.
The
Series C convertible preferred stock ranks junior to the Series A convertible
preferred stock regarding distributions upon liquidation of the Company. Series
C convertible preferred stock ranks junior to the Series B convertible preferred
stock solely with respect to the priority security interest in our intellectual
property. The shares accrue dividends at 6% of the stated liquidation preference
amount from the date of issuance and increase to 8% commencing on September
25,
2005, are payable annually in cash or shares of stock at our option. The Series
C convertible preferred stock ranks pari passu with Series A convertible
preferred stock and Series B preferred stock with respect to payment of
dividends. The Series C preferred stock has no voting rights except with respect
to transactions upon which they are entitled to vote as a class. Each dollar
of
liquidation preference amount is initially converted into one share of common
stock (subject to certain anti-dilution privileges).
The
holders of Series C convertible preferred stock can require us to redeem the
stock plus accrued dividends at 125% of the liquidation price upon the (i)
consolidation, merger or business combination of the Company, (ii) sale of
more
than 50% of our assets or (iii) a sale of more than 50% of our outstanding
common stock. However, we have the option to pay in cash or shares of common
stock.
Additional
Series of Preferred Stock
As
provided in our Amended and Restated Certificate of Incorporation, our Board
of
Directors is authorized, by resolution or resolutions, to establish, out of
the
unissued (including previously issued and subsequently retired) shares of
preferred stock not then allocated to any series of preferred stock, additional
series of preferred stock. Before any shares of any such additional series
are
issued, the Board of Directors will fix and determine, by resolution or
resolutions, the number of shares of preferred stock constituting such series
and the distinguishing characteristics and the relative rights, preferences,
privileges and immunities, if any, and any qualifications, limitations or
restrictions of the preferred stock that are not inconsistent with the Amended
and Restated Certificate of Incorporation. Without limiting the generality
of
this paragraph, the Board of Directors may fix and determine:
·
|
the
designation of such series and the number of shares which shall constitute
such series;
|
·
|
the
rate of dividend, if any payable on shares of such
series;
|
·
|
whether
the shares of such series shall be cumulative, non-cumulative or
partially
cumulative as to dividends, and the dates from which any cumulative
dividends are to accumulate;
|
·
|
whether
the shares of such series may be redeemed, and, if so, the price
or prices
at which and the terms and conditions on which shares of such series
may
be redeemed;
|
·
|
the
amount payable upon shares of such series in the event of the voluntary
or
involuntary dissolution, liquidation or winding up of the affairs
of
Cytomedix;
|
·
|
the
sinking fund provisions, if any, for the redemption of shares of
such
series;
|
·
|
the
voting rights, if any, of the shares of such
series;
|
·
|
the
terms and conditions, if any, on which shares of such series may
be
converted into shares of capital stock of any other class or
series;
|
·
|
whether
the shares of such series are to be preferred over shares of capital
stock
of any other class or series as to dividends, or upon the voluntary
or
involuntary dissolution, liquidation, or winding up of the affairs
of
Cytomedix or otherwise; and
|
·
|
any
other characteristics, preferences, limitations, rights, privileges,
immunities or terms not inconsistent with the provisions of our Amended
and Restated Certificate of Incorporation.
|
Change
In Control
We
are
subject to Section 203 of the General Corporation Law of Delaware. Subject
to
certain exceptions, Section 203 prevents a publicly held Delaware corporation
from engaging in a “business combination” with any “interested stockholder” for
three years following the date that the person became an interested stockholder,
unless the interested stockholder attained such status with the approval of
our
board of directors or unless the business combination is approved in a
prescribed manner. A “business combination” includes, among other things, a
merger or consolidation involving us and the “interested stockholder” and the
sale of more than 10% of our assets. In general, an “interested stockholder” is
any entity or person beneficially owning 15% or more of our outstanding voting
stock and any entity or person affiliated with or controlling or controlled
by
such entity or person. This provision may have the effect of delaying,
deterring, or preventing a change of control without further action by the
shareholders.
Debt
Securities
The
following description, together with the additional information we include
in
any applicable prospectus supplement, summarizes the material terms and
provision of any debt securities that we may offer under this prospectus. While
the terms we have summarized below will apply generally to any future debt
securities we may offer, we will describe the particular terms of any debt
securities that we may offer in more detail in the applicable prospectus
supplement. The terms of any debt securities we may offer under a prospectus
supplement may differ from the terms described below. For any debt securities
that we may offer, an indenture (and any relevant supplemental indenture) will
contain additional important terms and provisions and will be incorporated
by
reference as an exhibit to the registration statement that includes this
prospectus, or as an exhibit to a current report on Form 8-K, incorporated
by reference in this prospectus.
With
respect to any debt securities that we issue, we will issue such debt securities
under an indenture, which we would enter into with the trustee named in the
indenture. Any indenture would be qualified under the Trust Indenture Act
of 1939.
With
respect to any debt securities that we issue, we will describe in each
prospectus supplement the following terms relating to a series of debt
securities:
·
|
the
principal amount being offered, and if a series, the total amount
authorized and the total amount
outstanding;
|
·
|
any
limit on the amount that may be
issued;
|
·
|
whether
or not we will issue the series of debt securities in global form,
and if
so, the terms and who the depository will
be;
|
·
|
the
principal amount due at maturity;
|
·
|
whether
and under what circumstances, if any, we will pay additional amounts
on
any debt securities held by a person who is not a United States person
for
tax purposes, and whether we can redeem the debt securities if we
have to
pay such additional amounts;
|
·
|
the
annual interest rate, which may be fixed or variable, or the method
for
determining the rate and the date interest will begin to accrue,
the dates
interest will be payable and the regular record dates for interest
payment
dates or the method for determining such
dates;
|
·
|
whether
or not the debt securities will be convertible into shares of common
stock
or preferred stock and, if so, the terms of such
conversion;
|
·
|
whether
or not the debt securities will be secured or unsecured, and the
terms of
any secured debt;
|
·
|
the
terms of the subordination of any series of subordinated debt;
|
·
|
the
place where payments will be
payable;
|
·
|
restrictions
on transfer, sale or other assignment, if
any;
|
·
|
our
right, if any, to defer payment or interest and the maximum length
of any
such deferral period;
|
·
|
the
date, if any, after which and the conditions upon which, and the
price at
which, we may, at our option, redeem the series of debt securities
pursuant to any optional or provisional redemption provisions and
the
terms of those redemptions
provisions;
|
·
|
the
date, if any, on which, and the price at which we are obligated,
pursuant
to any mandatory sinking fund or analogous fund provisions or otherwise,
to redeem, or at the holder’s option to purchase, the series of debt
securities and the currency or currency unit in which the debt securities
are payable;
|
·
|
whether
the indenture will restrict our ability to pay dividends, or will
require
us to maintain any asset ratios or
reserves;
|
·
|
whether
we will be restricted from incurring any additional indebtedness,
issuing
additional securities, or entering into a merger, consolidation or
sale of
our business;
|
·
|
a
discussion of any material or special United States federal income
tax
considerations applicable to the debt
securities;
|
·
|
information
describing any book-entry features;
|
·
|
provisions
for a sinking fund purchase or other analogous fund, if
any;
|
·
|
any
provisions for payment of additional amounts for
taxes;
|
·
|
whether
the debt securities are to be offered at a price such that they will
be
deemed to be offered at an “original issue discount” as defined in
paragraph (a) of Section 1273 of the Internal Revenue
Code of 1986, as amended;
|
·
|
the
denominations in which we will issue the series of debt securities,
if
other than denominations of $1,000 and any integral multiple
thereof;
|
·
|
whether
we and/or the debenture trustee may change an indenture without the
consent of any holders;
|
·
|
the
form of debt security and how it may be exchanged and
transferred;
|
·
|
description
of the debenture trustee and paying agent, and the method of
payments; and
|
·
|
any
other specified terms, preferences, rights or limitations of, or
restrictions on, the debt securities and any terms that may be required
by
us or advisable under applicable laws or
regulations.
|
Securities
Warrants
The
following description, together with the additional information we may include
in any applicable prospectus supplement, summarizes the material terms and
provisions of any securities warrants that we may offer under this prospectus
and the related warrant agreements and warrant certificates. While the terms
summarized below will apply generally to any securities warrants that we may
offer, we will describe the particular terms of any series of securities
warrants in more detail in the applicable prospectus supplement. The terms
of
any securities warrants offered under a prospectus supplement may differ from
the terms described below. With respect to any securities warrants that we
offer, specific warrant agreements will contain additional important terms
and
provisions and will be incorporated by reference as an exhibit to the
registration statement that includes this prospectus or as an exhibit to a
current report on Form 8-K, incorporated by reference in this prospectus:
·
|
the
specific designation and aggregate number of, and the price at which
we
will issue, the warrants;
|
·
|
the
currency or currency units in which the offering price, if any, and
the
exercise price are payable;
|
·
|
if
applicable, the exercise price for shares of our common stock or
preferred
stock and the number of shares of common stock or preferred stock
to be
received upon exercise of the
warrants;
|
·
|
in
the case of warrants to purchase debt securities, the principal amount
of
debt securities purchasable upon exercise of one warrant and the
price at,
and currency in which, this principal amount of debt securities may
be
purchased upon such exercise;
|
·
|
the
date on which the right to exercise the warrants will begin and the
date
on which that right will expire or, if you may not continuously exercise
the warrants throughout that period, the specific date or dates on
which
you may exercise the warrants;
|
·
|
whether
the warrants will be issued in fully registered form or bearer form,
in
definitive or global form or in any combination of these forms, although,
in any case, the form of a warrant included in a unit will correspond
to
the form of the unit and of any security included in that
unit;
|
·
|
any
applicable material U.S. federal income tax
consequences;
|
·
|
the
identity of the warrant agent for the warrants and of any other
depositaries, execution or paying agents, transfer agents, registrars
or
other agents;
|
·
|
the
proposed listing, if any, of the warrants or the common stock issuable
upon exercise of the warrants on any securities
exchange;
|
·
|
if
applicable, the date from and after which the warrants and the common
stock will be separately
transferable;
|
·
|
if
applicable, the minimum or maximum amount of the warrants that may
be
exercised at any one time;
|
·
|
information
with respect to book-entry procedures, if
any;
|
·
|
the
anti-dilution provisions of the warrants, if
any;
|
·
|
any
redemption or call provisions;
|
·
|
whether
the warrants are to be sold separately or with other securities as
parts
of units; and
|
·
|
any
additional terms of the warrants, including terms, procedures and
limitations relating to the exchange and exercise of the
warrants.
|
Before
exercising their warrants, holders of warrants will not have any of the rights
of holders of the securities purchasable upon such exercise, including:
·
|
in
the case of warrants to purchase debt securities, the right to receive
payments of principal of, or premium, if any, or interest on, the
debt
securities purchasable upon exercise or to enforce covenants in the
applicable indenture; or
|
·
|
in
the case of warrants to purchase common stock or preferred stock,
the
right to receive dividends, if any, or, payments upon our liquidation,
dissolution or winding up or to exercise voting rights, if
any.
|
The
transfer agent and registrar for any warrants will be set forth in the
applicable prospectus supplement.
Units
We
might
issue units comprised of one or more debt securities, shares of common stock,
shares of preferred stock and securities warrants in any combination. Each
unit
will be issued so that the holder of the unit is also the holder of each
security included in the unit. Thus, the holder of a unit will have the rights
and obligations of a holder of each included security. The unit agreement under
which a unit is issued may provide that the securities included in the unit
may
not be held or transferred separately, at any time or at any time before a
specified date. We will file as exhibits to the registration statement of which
this prospectus is a part, or will incorporate by reference from a current
report on Form 8-K that we file with the SEC, the form of unit agreement,
warrant and any supplemental agreements that describe the terms of the series
of
units we are offering before the issuance of the related series of units.
We
may
choose to evidence each series of units by unit certificates that we would
issue
under a separate agreement. If we choose to evidence the units by unit
certificates, we will enter into a unit agreement with a unit agent and will
indicate the name and address of the unit agent in the applicable prospectus
supplement relating to the particular series of units.
LEGAL
MATTERS
The
validity of the securities will be passed upon for us by Williams & Anderson
PLC, Little Rock, Arkansas.
EXPERTS
The
financial statements as of December 31, 2007 and for the year ended December
31,
2007 incorporated in this Prospectus by reference to the Annual Report on Form
10-K for the year ended December 31, 2007 have been so incorporated in reliance
on the report of PricewaterhouseCoopers LLP, an independent registered public
accounting firm, given on the authority of said firm as experts in auditing
and
accounting.
The
financial statements of Cytomedix, Inc. as of December 31, 2006, and for each
of
the years in the two year period ending December 31, 2006, have been
incorporated by reference herein in reliance upon the report of L J Soldinger
Associates, LLC, independent registered public accountants, given their
authority as experts in accounting and auditing.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
We
incorporate by reference the documents listed below, except as superseded,
supplemented, or modified by this prospectus, and any future filings we make
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934, other than information that is furnished but deemed by the rules
of
the SEC not to have been filed:
·
|
our
Annual Report on Form 10-K for the fiscal year ended December 31,
2007,
filed with the SEC on March 25,
2008;
|
·
|
our
Current Reports on Form 8-K as filed with the SEC on April 13, 2007,
August 8, 2007, September 24, 2007, October 16, 2007, November 7,
2007,
January 29, 2008 and March 18, 2008;
and
|
·
|
the
description of our common stock set forth in the registration statement
on
Form 8-A/A filed with the SEC on May 31,
2005.
|
As
stated
above, all future filings we make with the SEC under Sections 13(a), 13(c),
14,
or 15(d) of the Securities Exchange Act of 1934 (other than information that
is
furnished but deemed by the rules of the SEC not to have been filed) are deemed
to be incorporated by reference into this prospectus.
Upon
written or oral request from any person, including any beneficial owner, to
whom
this prospectus is delivered, we will provide, at no cost to such person, a
copy
of any or all of the information that has been incorporated by reference into
this prospectus. Such requests should be submitted to:
Cytomedix,
Inc.
Attn:
Chief Financial Officer
416
Hungerford Drive
Suite
330
Rockville,
Maryland 20850
(240)
499-2680
WHERE
YOU CAN FIND MORE INFORMATION
This
prospectus is part of a Registration Statement on Form S-3 that we filed with
the SEC. Certain information in the Registration Statement has been omitted
from
this prospectus in accordance with the rules of the SEC. We file annual,
quarterly and current event reports, along with proxy statements and other
information, with the SEC. You may read and copy all reports and other materials
filed with the SEC at the SEC's Public Reference Room at 100 F Street, NE,
Washington, D.C. 20549. You may obtain information on the operation of the
Public Reference Room by calling the SEC at1-800-SEC-0330. The SEC also
maintains a website where you can view and print all reports, proxy and
information statements, and other information filed with the SEC. The address
of
this website is www.sec.gov.
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION
FOR
SECURITIES ACT LIABILITIES
Our
Amended and Restated Certificate of Incorporation and Bylaws provide generally
that we shall indemnify any person who was or is a party or is threatened to
be
made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other than an action
by or in the right of the Company) by reason of the fact that he is or was
a
director, officer, employee or agent of the Company, or is or was serving at
the
request of the Company as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise. This
indemnification is reflected in the employment agreements we enter into with
our
executive officers.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons of the Company pursuant
to the foregoing provisions, or otherwise, we have been informed that in the
opinion of the SEC such indemnification is against public policy as expressed
in
the Securities Act and is, therefore, unenforceable.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
OTHER
EXPENSES OF ISSUANCE AND DISTRIBUTION
The
following table sets forth the estimated expenses in connection with this
Registration Statement. The expenses are merely estimates, other than the filing
fees payable to the Securities and Exchange Commission.
Securities
and Exchange Commission Filing Fee
|
|
$
|
1,819
|
|
|
|
|
|
|
Legal
Fees and Expenses*
|
|
|
40,000
|
|
|
|
|
|
|
Printing
Fees and Expenses*
|
|
|
7,500
|
|
|
|
|
|
|
Accounting
Fees and Expenses*
|
|
|
10,000
|
|
|
|
|
|
|
Miscellaneous
Expenses*
|
|
|
10,000
|
|
|
|
|
|
|
Total*
|
|
$
|
69,319
|
|
*
Estimated.
INDEMNIFICATION
OF OFFICERS AND DIRECTORS
Generally
speaking, Section 145 of the Delaware General Corporation Law permits a
corporation to indemnify any person who might be a party to an action by reason
of the fact that the person is or was a director, officer, employee or agent
of
the corporation if the person acted in good faith and in a manner reasonably
believed to be in or not opposed to the best interests of the corporation,
and,
with respect to any criminal action or proceeding, had no reasonable cause
to
believe his conduct was unlawful.
Article
10 of our Amended and Restated Certificate of Incorporation provides that our
directors shall not be personally liable to us or our stockholders for monetary
damages for breach of fiduciary duty as a director except for liability (i)
for
any breach of the director's duty of loyalty to us or our stockholders, (ii)
for
acts or omissions not in good faith or which involve intentional misconduct
or a
knowing violation of law, (iii) under Section 174 of the Delaware General
Corporation Law, or (iv) for any transaction from which the director derived
any
improper personal benefit.
Further,
Article VIII of our Restated Bylaws provides generally that we shall indemnify
any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative (other than an action by or in the
right of Cytomedix) by reason of the fact that he is or was a director, officer,
employee or agent of Cytomedix, or is or was serving at our request as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement actually and reasonably
incurred by him in connection with such action, suit or proceeding if he acted
in good faith and in a manner he reasonably believed to be in or not opposed
to
our best interests, and, with respect to any criminal action or proceeding,
had
no reasonable cause to believe his conduct was unlawful. To the extent that
a
director, officer, employee or agent of Cytomedix has been successful on the
merits or otherwise in defense of any action, suit or proceeding referred to
above, he shall be indemnified against expenses (including attorneys' fees)
actually and reasonably incurred by him in connection therewith. No
indemnification shall be made in respect of any claim, issue or matter as to
which such person shall have been adjudged to be liable to us unless and only
to
the extent that the court in which such action or suit was brought shall
determine upon application that, despite the adjudication of liability but
in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the court shall deem proper.
The
indemnification and advancement of expenses provided by, or granted pursuant
to,
our Restated Bylaws shall not be deemed exclusive of any other rights to which
those seeking indemnification or advancement of expenses may be entitled under
any bylaw, agreement, vote of stockholders or disinterested directors or
otherwise, both as to action in his official capacity and as to action in
another capacity while holding such office.
Furthermore,
our Restated Bylaws provide that we have the power to purchase and maintain
insurance on behalf of any person who is or was a director, officer, employee
or
agent of Cytomedix, or is or was serving at our request as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust
or
other enterprise against any liability asserted against him and incurred by
him
in any such capacity, or arising out of his status as such, whether or not
we
would have the power to indemnify him against such liability under the
provisions of the Restated Bylaws.
We
also
include indemnification provisions in our employment contracts with our
executive officers. Generally speaking, these provisions provide that we shall
indemnify our officers against, and shall pay and advance, all reasonable
expenses, including attorneys’ fees and disbursements, and any judgments, fines,
and amounts paid in settlement incurred by our officers in connection with
a
claim, action, suit, proceeding, or appeal therefrom, in the event our
directors' and officers' insurance lapses, to the fullest extent permitted
under
our Amended and Restated Certificate of Incorporation, Restated Bylaws, or
applicable law.
EXHIBITS
4.1
|
Amended
and Restated Certificate of Designation of the Relative Rights and
Preferences of Series A Preferred, Series B Preferred and common
stock of
Cytomedix, Inc. (Previously filed on March 31, 2004, on Form 10-KSB
for
year ended December 31, 2003, File No. 000-28443).
|
4.2
|
Certificate
of Designation of the Relative Rights and Preferences of the Series
C
Convertible Preferred Stock of Cytomedix, Inc. (Previously filed
on March
29, 2004 on Form 8-K, File No.
000-28443).
|
4.3
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated August
18,
2008, issued to Maier & Company (Previously filed as Exhibit 4.3 to
the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.4
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated March
7,
2005, issued to KOL Bio-Medical Instruments, Inc. (Previously filed
as
Exhibit 4.4 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.5
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated April
18,
2005, issued to Crystal Research Associates, LLC (Previously filed
as
Exhibit 4.5 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.6
|
Term
Sheet Agreement between Cytomedix, Inc., Fitch, Even, Tabin &
Flannery, and The Coleman Law Firm dated August 2, 2007 (Previously
filed
as Exhibit 4.12 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.7
|
Shareholders
Agreement between Cytomedix, Inc., and certain named shareholders
dated
August 2, 2007 (Previously filed as Exhibit 4.13 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.8
|
Registration
Rights Agreement between Cytomedix, Inc., and certain named shareholders
dated August 2, 2007 (Previously filed as Exhibit 4.14 to the Form
S-3
filed on December 3, 2007, File No.
333-147793).
|
4.9
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.15 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.10
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.16 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.11
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.17 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.12
|
Form
of Registration Rights Agreement between Cytomedix, Inc., and the
Class D
Warrantholders dated April 12, 2006 (Previously filed as Exhibit
4.2 to
the Current Report on Form 8-K filed on May 2, 2006, File No.
001-32518)
|
4.13
|
Form
of Class D Warrant To Purchase of Shares of Common Stock dated April
12,
2006 (Previously filed as Exhibit 4.1 to the Current Report on Form
8-K
filed on May 2, 2006, File No.
001-32518).
|
5.1
|
Opinion
of Williams & Anderson PLC
|
23.1
|
Consent
of Williams & Anderson PLC (included in Exhibit
5.1)
|
23.2
|
Consent
of L J Soldinger Associates LLC
|
23.3
|
Consent
of PricewaterhouseCoopers LLP
|
UNDERTAKINGS
A.
The
undersigned registrant hereby undertakes:
(1
)
To
file,
during any period in which offers or sales are being made, a post-effective
amendment to this Registration Statement:
(i)
To
include any prospectus required by Section 10(a) (3) of the Securities Act
of 1933;
(ii)
To
reflect in the prospectus any facts or events arising after the effective date
of the Registration Statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the Registration Statement.
Notwithstanding the foregoing, any increase or decrease in volume of securities
offered (if the total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form prospectus filed
with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than a 20% change in the
maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective Registration Statement; and
(iii)
To
include any material information with respect to the Plan of Distribution not
previously disclosed in the Registration Statement or any material change to
such information in the Registration Statement;
provided,
however
,
that
clauses (i), (ii) and (iii) do not apply if the information
required to be included in a post-effective amendment by those clauses is
contained in reports filed with or furnished to the SEC by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act
that are incorporated by reference in the Registration Statement, or is
contained in a form of prospectus filed pursuant to Rule 424(b) that is part
of
the Registration Statement.
(2)
That,
for
the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new Registration
Statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3)
To
remove
from registration by means of a post-effective amendment any of the securities
being registered that remain unsold at the termination of the
offering.
B.
The
undersigned Registrant hereby undertakes that, for purposes of determining
any
liability under the Securities Act of 1933, each filing of the Registrant’s
annual report pursuant to Section 13(a) or Section 15(d) of the
Exchange Act that is incorporated by reference in the Registration Statement
shall be deemed to be a new Registration Statement relating to the securities
offered therein, and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
Insofar
as indemnification for liabilities arising under the Securities Act may be
permitted to our directors, officers, and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion
of
the Securities and Exchange Commission such indemnification is against public
policy as expressed in the Securities Act and is, therefore, unenforceable.
In
the event that a claim for indemnification against such liabilities (other
than
our payment of expenses incurred or paid by one of our directors, officers
or
controlling persons in the successful defense of any action, suit or proceeding)
is asserted by such director, officer, or controlling person in connection
with
the securities being registered, we will, unless in the opinion of our counsel
the matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question of whether such indemnification by us
is
against public policy as expressed in the Securities Act and will be governed
by
the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies
that
it has reasonable grounds to believe that it meets all of the requirements
of
filing on Form S-3 and had duly caused this Amendment No. 1 to its registration
statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Rockville in the State of Maryland on March 26,
2008.
|
|
|
|
CYTOMEDIX,
INC.
|
|
|
|
|
|
/s/ Kshitij
Mohan
|
|
Kshitij
Mohan, Chief Executive
|
|
Officer
|
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed by the following persons in the capacities and on the dates
stated:
|
|
|
|
|
/s/ Kshitij
Mohan
|
|
Kshitij
Mohan, as Chief Executive
Officer
and as a Director
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ Andrew
Maslan
|
|
Andrew
Maslan, as Chief Financial
Officer,
and the chief accounting officer
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ David
P.
Crews
|
|
David
Crews, Director
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ Arun
K.
Deva
|
|
Arun
K. Deva, Director
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ James
S.
Benson
|
|
James
S. Benson, Director
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ David
F.
Drohan
|
|
David
F. Drohan, Director
Date:
March 26, 2008
|
|
|
|
|
|
|
|
/s/ Mark
T.
McLoughlin
|
|
Mark
T. McLoughlin, Director
Date:
March 26, 2008
|
|
|
EXHIBITS
4.1
|
Amended
and Restated Certificate of Designation of the Relative Rights and
Preferences of Series A Preferred, Series B Preferred and common
stock of
Cytomedix, Inc. (Previously filed on March 31, 2004, on Form 10-KSB
for
year ended December 31, 2003, File No. 000-28443).
|
4.2
|
Certificate
of Designation of the Relative Rights and Preferences of the Series
C
Convertible Preferred Stock of Cytomedix, Inc. (Previously filed
on March
29, 2004 on Form 8-K, File No.
000-28443).
|
4.3
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated August
18,
2008, issued to Maier & Company (Previously filed as Exhibit 4.3 to
the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.4
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated March
7,
2005, issued to KOL Bio-Medical Instruments, Inc. (Previously filed
as
Exhibit 4.4 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.5
|
Common
Stock Warrant for the Purchase of Shares of Common Stock dated April
18,
2005, issued to Crystal Research Associates, LLC (Previously filed
as
Exhibit 4.5 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.6
|
Term
Sheet Agreement between Cytomedix, Inc., Fitch, Even, Tabin &
Flannery, and The Coleman Law Firm dated August 2, 2007 (Previously
filed
as Exhibit 4.12 to the Form S-3 filed on December 3, 2007, File No.
333-147793).
|
4.7
|
Shareholders
Agreement between Cytomedix, Inc., and certain named shareholders
dated
August 2, 2007 (Previously filed as Exhibit 4.13 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.8
|
Registration
Rights Agreement between Cytomedix, Inc., and certain named shareholders
dated August 2, 2007 (Previously filed as Exhibit 4.14 to the Form
S-3
filed on December 3, 2007, File No.
333-147793).
|
4.9
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.15 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.10
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.16 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.11
|
Form
of Common Stock Warrant for the Purchase of Shares of Common Stock
dated
August 2, 2007 (Previously filed as Exhibit 4.17 to the Form S-3
filed on
December 3, 2007, File No.
333-147793).
|
4.12
|
Form
of Registration Rights Agreement between Cytomedix, Inc., and the
Class D
Warrantholders dated April 12, 2006 (Previously filed as Exhibit
4.2 to
the Current Report on Form 8-K filed on May 2, 2006, File No.
001-32518)
|
4.13
|
Form
of Class D Warrant To Purchase of Shares of Common Stock dated April
12,
2006 (Previously filed as Exhibit 4.1 to the Current Report on Form
8-K
filed on May 2, 2006, File No.
001-32518).
|
5.1
|
Opinion
of Williams & Anderson PLC
|
23.1
|
Consent
of Williams & Anderson PLC (included in Exhibit
5.1)
|
23.2
|
Consent
of L J Soldinger Associates LLC
|
23.3
|
Consent
of PricewaterhouseCoopers LLP
|
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