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In the third quarter of 2006, the Company also recognized $117,000 in revenue related to comprehensive wound services provided for a government agency under a limited term contract. This service revenue is not expected to continue.
For the three month period, the increase was attributable to increased royalties of $60,000 and increased sales of $117,000 related to the services mentioned above, partially offset by a $49,000 decrease in product sales. Increases in royalties were due to an additional license agreement entered into during the fourth quarter of 2005. Product sales decreased primarily due to decreased sales to nursing homes, government agencies, and Medicaid customers.
For the nine month period, the increase was attributable to increased royalties of $487,000 and increased sales of $117,000 related to the services mentioned above, partially offset by a $156,000 decrease in product sales. Increases in royalties were due to six new license agreements entered into during 2005. Product sales decreased primarily due to decreased sales to nursing homes, government agencies, and Medicaid customers.
Gross Profit
Gross profit rose $100,000 (40%) to $351,000 and $292,000 (62%) to $761,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year. For the same periods, gross margins rose to 61% from 56% and to 52% from 46%, respectively.
For the three month period, the increase in gross profits was primarily due to the service related revenues described above.
For the nine month period, the increase in gross profits is primarily attributable to the licensing agreements entered into after March 31, 2005 which carry a greater gross margin than previously existing licensing agreements.
Royalties from the licensing agreements with DePuy Spine, Inc., inclusive of the amortization of deferred revenue associated with the initial deposit of $750,000, generates a gross margin of approximately 20%. The Company expects gross margins generated from all other licensing agreements to be in the range of 50-70%.
Operating Expenses
Operating expenses fell $1,496,000 (57%) to $1,113,000 and $3,258,000 (49%) to $3,418,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year.
Salaries and Wages
Salaries and wages fell $943,000 (69%) to $423,000 and $643,000 (28%) to $1,642,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year.
For the three and nine month periods, the decrease was primarily due to lower non-cash equity-based compensation ($863,000 and $660,000, respectively) and fewer employees.
Consulting and Related Party Consulting Expenses
Consulting and related party consulting expenses rose $42,000 (219%) to $61,000 and fell $137,000 (47%) to $156,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year.
For the three month period, the increase was primarily due to consulting fees associated with the Company’s Sarbanes Oxley Section 404 compliance efforts and FDA 510(K) Pre-Market Notification, partially offset by reduced fees due to the expiration of a related party consulting contract.
For the nine month period, the decrease was primarily due to lower non-cash equity-based compensation ($92,000) and the overall reduction in use of outside consultants.
Professional Fees
Professional fees fell $15,000 (8%) to $187,000 and $486,000 (55%) to $396,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year. Professional fees consist primarily of legal and accounting services.
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For the three month period, the change was nominal.
For the nine month period, the decrease was primarily due to decreases in patent litigation related expenditures ($315,000) due to the successful completion of several patent infringement actions in 2005, decreases in fees to securities and general counsel attorneys ($92,000) due primarily to reduced current period activity related to the Company’s listing on the American Stock Exchange, and decreases in accounting fees ($79,000).
Clinical Trial Related Expenses
Clinical trial related expenses fell $430,000 (100%) to zero and $1,325,000 (96%) to $62,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year. The Company completed the active phase of the trial in 2005 and in the first two quarters of 2006 incurred only limited expenses associated with the close out of the trial. The Company does not expect to incur any future expenditures related to this trial.
General and Administrative Expenses
General and administrative expenses fell $149,000 (26%) to $423,000 and $667,000 (38%) to $1,106,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year.
For the three month period, the decrease was due primarily due to decreases in equity-based compensation to the board of directors and outside service providers ($156,000).
For the nine month period, the decrease was due primarily to decreases in equity-based compensation to the board of directors and outside service providers ($417,000), reduced travel related expenditures ($117,000), reduced AMEX filing fees ($52,000), and reduced investor services ($51,000), partially offset by increases in marketing related activities ($46,000).
Other Income/Expenses
Other income fell $68,000 (52%) to $64,000 and rose $1,001,000 (124%) to $1,808,000 comparing the three and nine months ended September 30, 2006, respectively, to the same periods last year.
For the three month period, the decrease was primarily due to decreases in patent litigation settlements ($115,000, net), partially offset by higher interest income ($55,000) as a result of higher interest rates and larger cash balances.
For the nine month period, the increase was primarily due to increased interest income ($85,000) as a result of higher interest rates and larger cash balances, increased patent settlement income ($697,000, net), and a one time charge ($228,000) in 2005 recorded for the issuance of 65,000 shares of the Company’s Common stock in return for a full settlement and release of all claims from a lawsuit brought against the Company relating to its emergence from bankruptcy.
Liquidity and Capital Resources
The Company’s operating revenues do not cover the costs of its operations. The cash position of the Company at September 30, 2006 was $4,665,000. The Company believes that it will have adequate cash on hand to fund operations for the next twelve months. However, additional cash may be required if operating revenues do not materialize, the cost of operations increases, or if the Company’s efforts to appeal the FDA’s decision prove unsuccessful and a change in strategy requires significant short-term funding.
The Company has no material commitments for capital expenditures.
Because the Company was in bankruptcy in 2002, the Company may not be able to obtain debt financing. All working capital required to implement the Company’s business plan will be provided by funds obtained through offerings of its equity securities, and revenues generated by the Company.
Prospects for the Future
Cytomedix’s success is directly dependent on the success of AutoloGelTM, which the Company believes has a very good chance for success in the marketplace.
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The Company is aggressively addressing the reimbursement market. The Company believes that in order to capture a significant share of this market, it must first obtain a CMS reimbursement code. Obtaining this code may be more likely if FDA clearance is obtained. As discussed earlier in this Item 2, under the subheading Reimbursement and Clearance, the Company is currently in the process of appealing the FDA’s denial of its claim of substantial equivalence in its application for marketing clearance. The Company cannot predict whether the NSE decision will be reversed, but Cytomedix continues to believe that its high levels of safety and effectiveness indicated by the data from the clinical trial more than meet the level of “reasonable assurance of safety and effectiveness” and demonstrates substantial equivalence to the predicate devices. The Company hopes to share additional information with the FDA, or agree on mitigating measures such as restrictive labeling, that will allow the FDA to provide marketing clearance. Furthermore, the Company is completing a pharmaco-economic study and is optimistic of favorable results. However, even if FDA clearance is obtained, there is no guarantee the Company will receive a CMS reimbursement code. If CMS reimbursement is obtained, it is more likely that reimbursement may be obtained from the various commercial third-party insurers as well, which will help facilitate broad penetration into the reimbursement market. The Company refers the reader to a more detailed discussion regarding the clinical trials and reimbursement earlier in this Part I Item 2 under the heading Reimbursement and Clearance.
If the Company is ultimately unable to obtain marketing clearance for its AutoloGelTM System, the Company’s ability to obtain broad reimbursement for its treatment and execute on its primary business strategy may be placed in significant jeopardy. There are steps the Company could conceivably pursue if its appeal is unsuccessful, but the Company will need to better identify and assess the viability of those options. Also, the Company could pursue other activating reagents such as recombinant thrombin or human thrombin to potentially remove the FDA concern surrounding the Company’s use of bovine thrombin. However, while the Company intends to explore such potential strategic business adaptations, it is currently focusing the large majority of its resources on pursuing the appeal in order to provide the best opportunity for success.
In capitated environments, which are not sensitive to direct reimbursement for AutoloGelTM (e.g., long-term care, long-term acute care, home healthcare), the weekly use of AutoloGelTM saves much of the labor costs associated with daily and multiple dressing changes, while at the same time increasing the percentage of healing as compared to traditional treatments. The Company believes that data from its retrospective studies and current reports from clinicians, and the greater proportion of wound healing as compared to an enhanced control as evidenced in its recently completed clinical trial, prove greater efficacy than any competing treatment with FDA approval or clearance. The Company expects that both the facility/agency providing the care as well as the wound patient will realize direct benefits from the use of AutoloGelTM. Cytomedix is actively pursuing this market, primarily through its distributor, NWT. The Company may also look to more narrowly focus its approach to this market to increase the likelihood of success in the short term. The Company does not believe that its efforts in this “non-reimbursement sensitive” market will be impacted by the recent FDA decision.
Finally, Cytomedix believes it has a very strong patent position in the platelet gel arena. The Company expects royalty revenues to continue through the life of its process patents and will continue to pursue licensees for its technology where it feels there is a strong business case. The Company also does not believe that its royalties and license agreements are affected in any way by the FDA decision.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The Company does not enter into financial instruments for speculation or trading purposes. In accordance with the Company’s investment policy, cash is to be invested in bank and institutional money market funds, or in T-Bills or short-term T-Notes. At September 30, 2006, the Company’s cash balance of approximately $4.7 million was maintained primarily in bank and institutional money market accounts. These accounts are sensitive to changes in the general level of interest rates. Based on the Company’s cash balances at September 30, 2006, a 100 basis point increase or decrease in interest rates would have an approximately $47,000 impact on the Company’s annual interest income and net loss. Actual changes in rates may differ from the hypothetical assumption used in computing this exposure.
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Item 4. Controls and Procedures
The Company’s CEO and CFO have reviewed and evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934). Based on their evaluation, they have concluded that as of September 30, 2006, the Company’s disclosure controls and procedures are not effective to ensure that information required to be disclosed by Cytomedix in its reports filed with the SEC is recorded, processed, summarized, and reported within the governing time periods.
Cytomedix is subject to Section 404 of the Sarbanes Oxley Act (“SOX404”) for the year ending December 31, 2006. The Company has engaged an outside consultant to assist in its compliance with SOX404 and is in the process of making the necessary preparations.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
At present, the Company is not engaged in or the subject of any legal proceedings.
Item 1A. Risk Factors
There were no material changes from the risk factors as previously disclosed on the Company’s Form 10-KSB filed with the Securities and Exchange Commission for the year ended December 31, 2005, except as discussed below.
There Is No Guarantee That the Company Will Be Able to Obtain FDA Marketing Clearance for AutoloGelTM
On October 13, 2006, the FDA issued a Non-Substantial Equivalence determination letter to the Company in response to its 510(k) application for marketing clearance submitted in January 2006. Although the Company is appealing this decision, there is no guarantee that its efforts will be successful and there is a risk that the Company may not be able to obtain marketing clearance based on the results of its clinical trial. There is also no assurance that a new trial, alterations to the Company’s treatment, or other measures would result in marketing clearance. The inability to obtain such a clearance could significantly jeopardize the Company’s ability to obtain reimbursement from Medicare and/or other third-party insurers and could significantly jeopardize the Company’s ability to execute its strategic goals, including the ability to sustain itself from on-going operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The Company issued 1,766,392 shares of Common stock during the nine months ended September 30, 2006. The following table lists the sources of and the proceeds from those issuances:
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Source | | # of Shares | | Proceeds |
Conversion of series A convertible preferred shares | | | 303 | | | $ | — | |
Conversion of series B convertible preferred shares | | | 3,003 | | | $ | — | |
Exercise of class B warrants | | | 22,500 | | | $ | 33,750 | |
Exercise of series C-1 warrants | | | 548,900 | | | $ | 823,350 | |
Exercise of series C-2 warrants | | | 21,750 | | | $ | 32,625 | |
Exercise of unit offering warrants | | | 1,067,666 | | | $ | 1,601,500 | |
Exercise of options issued under the Long-Term Incentive Plan | | | 79,200 | | | $ | 118,800 | |
Exercise of other warrants | | | 23,070 | | | $ | 23,070 | |
Totals | | | 1,766,392 | | | $ | 2,633,095 | |
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| (1) | The issuance of the shares under the Company’s Long-Term Incentive Plan was registered by the Company’s S-8, which was originally filed on November 1, 2004 and amended on June 12, 2006. |
The Company has used the cash proceeds from these issuances for general corporate purposes. All shares were issued in private offerings exempt from registration pursuant to Section 4(2) of the Securities Act, except as described in footnote 1 to the above table.
On May 1, 2006, the Company completed a Class D Warrant Offer whereby, for each $7.50 of Outstanding Warrants exercised by warrantholders during the offer period, the Company issued one Class D Warrant which the holder may exercise for one share of Cytomedix Common Stock at an exercise price of $3.50. These Class D Warrants have a five year term and are callable at the Company’s discretion if the closing price of the Company’s Common Stock is at least $4.50 for 10 consecutive trading days and certain other conditions are met. Through this offer, the Company received exercises of Outstanding Warrants totaling approximately $2,280,000 and issued 304,033 Class D Warrants. These Class D Warrants carry piggyback registration rights whereby the Company must include the shares underlying these Class D Warrants on any registration statement filed by the Company after the closing of the Offering.
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On July 31, 2006, the Company’s common stock closed above $3.00 on the American Stock Exchange for the tenth consecutive trading day. As authorized by Section 8 of the Series C-1 Warrants and the Unit Offering Warrants, Cytomedix issued a Call Notice to call all warrants that were eligible and remained outstanding. As a result of an amendment to the terms of the warrant, which was accepted by a majority of the warrantholders, the exercise period was extended, giving the warrantholders until October 20, 2006 to exercise their warrants. The total number of warrants called was 1,605,734 at an exercise price of $1.50 per warrant. If all eligible outstanding warrants are exercised, the Company will receive approximately $2,400,000. As of September 30, 2006, 106,400 warrants were exercised pursuant to the Call Notice, resulting in proceeds of $159,600. The company will pay $0.01 for each warrant that is not exercised, for a potential total of approximately $15,000.
The following table summarizes the stock options granted by the Company during the three and nine months ended September 30, 2006. These options were granted to employees and board members under the Company’s Long-Term Incentive Plan.
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Three Months Ended September 30, 2006 | | Nine Months Ended September 30, 2006 |
Options Granted | | Price Range | | Options Granted | | Price Range |
231 | | | $1.50 – $1.50 | | | | 222,121 | | | | $1.50 – $6.00 | |
Under the terms of his employment agreement, the CEO was entitled to 100,000 options as of April 20, 2006. These options are included in the figures above.
No dividends were declared or paid on the Company’s Common Stock in any of the periods discussed in this report. The Company does not anticipate paying cash dividends on its Common Stock in the foreseeable future, but instead will retain any earnings to fund growth. The Company is prohibited from declaring dividends on its Common Stock as long as any shares of Series A, B, or C convertible preferred stock are outstanding unless all accrued dividends on these classes of preferred stock have been paid. Once there are no shares of Series A, B, or C convertible preferred stock outstanding, any decision to pay cash dividends on the Common Stock will depend on the ability to generate earnings, the need for capital, the overall financial condition, and other factors the Board deems relevant.
Item 3. Defaults Upon Senior Securities
N/A
Item 4. Submission of Matters to a Vote of Security Holders
A majority of the warrantholders of the Series C-1 Warrants and the Unit Offering Warrants accepted an amendment to extend to October 20, 2006 the exercise period resulting from a Call Notice issued by Cytomedix on July 31, 2006 to call all such warrants that were eligible and remained outstanding.
Item 5. Other Information
N/A
Item 6. Exhibits
The exhibits listed in the accompanying Exhibit Index are furnished as part of this report.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
CYTOMEDIX, INC.
| By: | /s/ Kshitij Mohan
Kshitij Mohan, CEO and Chairman of the Board of Directors |
Date: November 14, 2007
In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
| By: | /s/ Kshitij Mohan
Kshitij Mohan, CEO and Chairman of the Board of Directors |
Date: November 14, 2007
| By: | /s/ Andrew S. Maslan
Andrew S. Maslan, Chief Financial Officer and Chief Accounting Officer |
Date: November 14, 2007
Signed originals of this written statement have been provided to Cytomedix, Inc. and will be retained by Cytomedix, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
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EXHIBIT INDEX
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Exhibit | | Exhibit Table |
2.1 | | First Amended Plan of Reorganization with All Technical Amendments (Previously filed on June 28, 2002, on Form 8-K, File No. 000-28443). |
2.2 | | Amended and Restated Official Exhibits to the First Amended Plan of Reorganization of Cytomedix, Inc. with All Technical Amendments (Previously filed on May 10, 2004, on Form 10-QSB for the quarter ended March 31, 2004, File No. 000-28443). |
3.1 | | Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
3.2 | | Amendment to Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 15, 2004, on Form 10-QSB for quarter ended September 30, 2004, File No. 000-28443). |
3.3 | | Restated Bylaws of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
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 Stock of Cytomedix, Inc. as filed with the Delaware Secretary of State on March 25, 2004 (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). |
4.3 | | Form of Class B Warrant issued to New Investors and DIP Lenders (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). |
4.4 | | Form of Series C-1 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). |
4.5 | | Form of Series C-2 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). |
4.7 | | Form of warrant issued to investors in the 2004 Unit Offering (Previously filed on May 11, 2004, on Form SB-2, File No. 333-115364). |
4.8 | | Form of D Warrant to Purchase Common Stock of Cytomedix, Inc. (Previously filed on May 2, 2006, on Form 8-K, File No. 001-32518). |
10.1 | | Royalty Agreement, dated as of December 26, 2000, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on January 17, 2001, on Form 8-K, File No. 000-28443). |
10.2 | | First Amendment to Royalty Agreement, dated as of April 20, 2001, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on May 25, 2001, on SB-2/A, File No. 333-55818). |
10.3 | | Second Amendment to Royalty Agreement, dated as of December 5, 2002, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on March 31, 2003, on Form 10-KSB for year ended December 31, 2002, File No. 000-28443). |
10.4 | | Cytomedix, Inc. Long-Term Incentive Plan (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). |
10.5 | | License Agreement dated March 21, 2001, by and between Cytomedix, Inc. and DePuy AcroMed, Inc. (Previously filed on April 16, 2001, on Form 10-KSB for year ended December 31, 2000, File No. 000-28443). |
10.6 | | Amendment dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). |
10.7 | | Second License Agreement dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). |
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Exhibit | | Exhibit Table |
10.8 | | Settlement and License Agreement dated May 1, 2005 by and between Cytomedix, Inc. and Medtronic, Inc. (Previously filed on May 10, 2005, on Form 8-K, File No. 000-28443). |
10.9 | | Settlement Agreement and License Agreement dated May 23, 2005, by and between Cytomedix, Inc., and Harvest Technologies Corporation (Previously filed on May 27, 2005, on Form 8-K, File No. 000-28443). |
10.10 | | Settlement and License Agreement dated June 26, 2005, by and between Cytomedix, Inc., and Perfusion Partners and Associates Inc. (Previously filed on August 15, 2005, on Form 10-QSB for the quarter ended June 20, 2005, File No. 000-28443). |
10.11 | | License Agreement dated October 7, 2005, by and between Cytomedix, Inc., and COBE Cardiovascular, Inc. (Previously filed on October 11, 2005, on Form 8-K, File No. 000-28443). |
10.12 | | Settlement and License Agreement dated October 12, 2005, by and between Cytomedix, Inc., and SafeBlood Technologies, Inc. (Previously filed on November 9, 2005, on Form 10-QSB, File No. 000-28443). |
10.13 | | Employment Agreement with Ms. Carelyn P. Fylling (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). |
10.14 | | Employment Agreement with Kshitij Mohan, Ph.D., dated April 20, 2004 (Previously filed on May 7, 2004, on Form 8-K, File No. 00028443). |
10.15 | | Employment Agreement dated June 3, 2005, by and between Cytomedix, Inc., and Andrew Maslan (Previously filed on June 20, 2005, on Form 8-K, File no. 000-28443). |
10.16 | | First Addendum to Letter Agreement dated October 4, 2006, by and between Cytomedix, Inc. and Andrew Maslan. |
10.17 | | Distributor Agreement dated October 31, 2005 by and between Cytomedix, Inc. and National Wound Therapies, LLC. (Previously filed on March 23, 2006, on Form 10-KSB, File No. 001-32518). |
10.18 | | Settlement and License Agreement dated May 19, 2006, by and between Cytomedix, Inc., and Biomet Biologics, Inc. (Previously filed on August 9, 2006, on Form 10-Q, File No. 001-32518). |
20.1 | | Definitive Proxy Statement (Previously filed on September 22, 2006, File No. 001-32518). |
31.1 | | Certification of Chief Executive Officer of Cytomedix, Inc., pursuant to Rule 13a-14(a)/15d-14. |
31.2 | | Certification of Chief Financial Officer of Cytomedix, Inc., pursuant to Rule 13a-14(a)/15d-14. |
32.1 | | Certificate of Chief Executive Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. |
32.2 | | Certificate of Chief Financial Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. |
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