Submission Makes Compelling Rationale for Coverage and Includes a Systematic Review of the Published Literature, Case Series, Health Benefit Tabulation and Key Opinion Leader Support
GAITHERSBURG, Md. (May 31, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announces the Company has made a formal submission to the Centers for Medicare & Medicaid Services (“CMS”) requesting reimbursement reconsideration for autologous platelet rich plasma (“PRP”) gel, including the AutoloGel™ System.
The comprehensive request proposes that there is sufficient clinical evidence to support the conclusion that the use of autologous PRP gel for chronic, non-healing pressure ulcers and diabetic foot ulcers, compared with standard wound care, significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life in the Medicare-eligible population.
Cytomedix believes that the clinical evidence presented convincingly documents the effectiveness of PRP gel, including demonstrating improved and accelerated wound healing, re-animation of stalled wounds onto a positive wound healing trajectory, reduction and closure of undermining and sinus tracts/tunneling, growth of new wound bed granulation tissue, reduced infection, and reduced pain.
More specifically, Cytomedix believes that the large body of published literature on the use of PRP gel for the treatment of wounds meets the U.S. Food and Drug Administration guidance document recommendation (Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds – Developing Products for Treatment), the individual guidelines published by the Wound Healing Society for Pressure, Diabetic, Venous, and Arterial Insufficiency Ulcers, the Agency for Healthcare Research and Quality (“AHRQ”) standard of evidence, and the Medicare Coverage Advisory Committee “(MEDCAC”) wound therapy evaluation recommendations.
The body of published literature detailed in the submission includes:
- A systematic review of PRP literature published over the past 10 years. The systematic review, which is generally considered to be the highest level of objective evidence, includes 21 comparative studies.
- Nine PRP case series observational studies covering 323 wounds, including the 285 wounds in the Cytomedix prospective wound registry (this data has been peer-reviewed and has been accepted for publication), which demonstrates that wounds in Medicare beneficiaries had the same healing progression as wounds in non-Medicare beneficiaries.
- A tabulation of the Net Health Benefit (Quality of Life) features described in the systematic review and case series, as well as a qualitative research survey conducted regarding the impact of AutoloGel on the lives of patients and their families.
“This submission is the culmination of three years of experience and data collection with the AutoloGel System in wound care. I am very pleased with the body of evidence we have built in support of our request, and am confident that the scientific and clinical data combined with the evidence of cost effectiveness meets the requirements of the guidelines to support a favorable reimbursement determination by CMS,” said Martin P. Rosendale, Chief Executive Officer of Cytomedix. “This submission was joined and submitted with the signatures of five key opinion leaders in the wound care field. We believe their endorsement and support further validates the technology and enhances our prospects for a successful decision.”
“A positive reimbursement decision by CMS will improve wound care for Medicare beneficiaries, lower the cost of care for CMS, improve the quality of life for patients with non-healing wounds, and reduce the number of amputations for Medicare beneficiaries with diabetes,” concluded Mr. Rosendale.
About AutoloGel in Wound Healing:
PRP gel is an autologous blood product containing proteins that regulate tissue growth for wound healing and is used successfully as a therapy to address the chronic wound care problem. Upon activation, platelets release cytokines, growth factors, and chemokines to act on cell receptors to cause cellular growth and migration while the fibrinogen in the plasma converts to a fibrin matrix scaffold upon which the cells can adhere. This biological system is integral to normal wound healing. To help understand this complex biological system, the Company’s submission to CMS provides a detailed description of the established scientific mechanism of wound healing and the role of these PRP proteins in facilitating wound healing, and describes the importance of specific formulations and standardization of PRP gel to achieve consistent wound healing outcomes.
Cytomedix’s submission further outlines the epidemiology of the chronic wound care problem both within the broad population as well as the Medicare-eligible population. The data clearly demonstrates that effective wound care therapies are greatly needed and remain a large unmet medical need.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112), which has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination on the submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
Conference Call Begins Tuesday, May 17th at 10:00 a.m. Eastern Time
GAITHERSBURG, Md. (May 16, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the Company), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today reported financial results for the three months ended March 31, 2011.
Highlights of the first quarter and recent weeks include the following:
- Total revenues for the first quarter of 2011 of $1.37 million, up from $179,000 for the same period in 2010.
- Negotiated a $1.3 million reduction of principal under the promissory note payable to Sorin USA arising from the acquisition of the Angel® assets, by facilitating early retirement of the remaining $3.4 million principal balance in late-April 2011 via a $2.1 million payment. The refinancing reduces the Company’s debt service payments by 90% or $2.2 million over the next 12 months.
- Completed two productive meetings with the Coverage and Analysis Group within the Centers for Medicare & Medicaid Services (CMS) in support of an anticipated reimbursement reconsideration submission.
- Four poster presentations and one podium presentation highlighting the clinical merits of the Company’s AutoloGel™ System in wound management were presented at the 24th Annual Symposium on Advanced Wound Care and Wound Healing Society (SAWC).
- Received Patent No. 7,927,563 “Kit for the Separation of Biological Fluids” from the U.S. Patent and Trademark Office for the Company’s newly designed AutoloGel™ Separation System, which enables a safer and more convenient point-of-care procedure for the separation of platelets and plasma from whole blood in a single, specially designed syringe system that maintains a closed environment.
- Recruited industry veteran Gary R. Otto as Director of National Accounts to lead all aspects of the Company’s commercial business with major customers such as healthcare networks, group purchasing organizations,U.S.government accounts and managed care organizations.
- Received CE marking certification for the Angel® Whole Blood Separation System (Angel) and the activAT® Autologous Thrombin Processing Kit (activAT), which allows for the sale and distribution of these products in 28 countries acrossEurope.
Management Discussion
Commenting on the Company’s progress, Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, “2011 is off to a strong start with a solid first quarter performance that was highlighted by growing product sales across all product lines, publication and presentation of highly positive data that demonstrates the clinical utility of AutoloGel in wound management, and the continued build-out of our infrastructure to support future growth. Importantly, the early retirement of the remaining debt from the Angel acquisition allows us to strengthen our balance sheet and improve our cash flow over the coming year. This will allow us to focus our efforts on growing sales and expanding the market opportunities for our regenerative platelet rich plasma (PRP) therapies in wound management and surgical applications.
“We are particularly pleased to report continued sales growth of the Angel system, noting that we have achieved sequential growth in each quarter since we acquired the asset in April 2010. During our first year of ownership, we reversed the negative revenue trend existing at the time of the acquisition and are now gaining sales momentum. We are confident we will continue to drive growth with an increasing customer base, product enhancements and geographic expansion. In addition, interest is growing in the Angel system for a number of applications currently under clinical investigation, including bone marrow aspirate, critical limb ischemia and certain cardiovascular indications.
“During the first quarter, we made important and significant progress with our planned submission for reconsideration of reimbursement for AutoloGel with CMS. We held two productive meetings with CMS providing them with the clinical evidence and net health benefit data they requested. The clinical evidence supporting the reimbursement of AutoloGel includes a systematic review of 21 comparative studies, a prospective Cytomedix wound registry of 285 wounds, four additional published and peer-reviewed AutoloGel studies, and one AutoloGel study pending publication. We have confidence in the quality and quantity of evidence demonstrating the AutoloGel System’s clinical utility and economic value proposition in wound management. We expect to file the formal reconsideration submission within the next two weeks, following guidance provided by CMS at our last meeting.
“We continue to advance a number of partnership and business development discussions with potential collaborators with the goal to expand the scope and increase the sales of our regenerative therapies in a variety of wound management, surgical and other applications. We believe that such collaborations offer the opportunity for Cytomedix to branch into new areas and to significantly drive future revenue growth,” concluded Mr. Rosendale.
First Quarter Results
Total revenues for the first quarter of 2011 were $1.37 million, up sharply from total revenues of $179,000 for the first quarter of 2010. The increase was largely attributable to sales of the Angel product line, which the Company acquired on April 9, 2010, and to higher sales of the AutoloGel System. As a result of the November 2009 expiration of the patent underlying the Company’s prior royalty agreements, there were no royalty revenues recorded for the 2011 first quarter, compared with royalty revenue of $115,000 during the first quarter of 2010.
Sales from the Angel product line were $1.28 million in the first quarter of 2011, a 6% increase compared with the fourth quarter of 2010, and importantly, an increase of more than 10% sequentially in the domestic market. AutoloGel System sales of $87,000 increased 38% compared with $63,000 in the first quarter of 2010, and increased 7% compared with the fourth quarter of 2010.
Gross profit for the first quarter of 2011 increased 104% to $720,000 from $353,000 in the prior-year period. This reflects higher product sales offset by lower royalty revenue described above, and by higher costs primarily attributable to amortization of technology acquired from Sorin, depreciation on revenue-generating equipment and certain non-recurring charges associated with the transition of the Angel business to Cytomedix. The 2010 gross profit reflected a credit of $189,000 due to final close out adjustments relating to the prior royalty agreements mentioned above.
Gross margin for the first quarter of 2011 was 53%, down from 76% for the 2010 first quarter. The decrease is primarily due to the amortization of patents and technology acquired from Sorin, depreciation on revenue-generating equipment, higher costs of goods and a higher sales contribution from Angel products, which have historically had lower margins than AutoloGel. As the transfer of manufacturing responsibility is now complete, the Company will seek to streamline its supply chain activities over the coming quarters, and expects a normalized GAAP gross margin in the 60-65% range.
First quarter 2011 operating expenses increased to $2.2 million from $1.4 million in the prior-year first quarter. The increase was primarily due to higher consulting costs relating to regulatory compliance and CMS reimbursement efforts, and the addition of dedicated consultants in the areas of marketing, clinical, and European operations. In addition, during the first quarter of 2011, the Company had higher salaries due to additional employees, and incurred increases in independent agent commissions, fees relating to Angel and activAT manufacturing set-up, and other general administrative expenses.
The net loss to common stockholders for the first quarter of 2011 was $1.5 million or $0.03 per share, compared with a net loss to common stockholders of $1.1 million or $0.03 per share reported for the first quarter of 2010.
Cash and Liquidity
Cash and cash equivalents as of March 31, 2011 were $1.1 million, compared with $639,000 as of December 31, 2010. The Company used $1.3 million to fund operating activities during the 2011 first quarter.
“Over the past year, our operating expenses have increased as we have invested in building our infrastructure in order to integrate the Angel acquisition and to successfully grow sales of our regenerative therapies in wound management and surgical applications. Moving forward, we are focused on driving efficiencies and streamlining our supply chain so as to lower these expenses. Importantly, the early retirement of our debt obligation to Sorin not only provided us an attractive $1.3 million discount on the note balance, but also lowers our debt service obligations over the next 12 months by 90%, or approximately $2.2 million. In combination, we expect that these initiatives will lower our expenses, enhance our margins, and increase our cash flow flexibility,” commented Andrew S. Maslan, Cytomedix Chief Financial Officer.
To date in 2011, the Company has drawn down approximately $2.0 million under a committed financing arrangement with Lincoln Park Capital. The Company has access to an additional $8.8 million over the next 17 months under the agreement.
For additional information, please refer to the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 16, 2011.
Conference Call
Cytomedix management will hold a conference call to discuss these results and answer questions beginning at 10:00 a.m. Eastern time on Tuesday, May 17, 2011. Shareholders and other interested parties may participate in the conference call by dialing 866-202-1971 (domestic) or 617-213-8842 (international) and entering passcode 85026436. The call also will be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
A replay of the conference call will be accessible two hours after its completion through
May 23, 2011 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 47899275. The call will also be archived for 90 days at
www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112), which has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines, or its ability to service the deferred payments related to the acquisition of the Angel® and activAT® product lines. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
GAITHERSBURG, MD (May 11, 2011) – Cytomedix, Inc. (OTC/BB: CMXI), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will release financial results for the three months ended March 31, 2011, following the close of the market on Monday, May 16, 2011.
Martin Rosendale, Chief Executive Officer, and Andrew Maslan, Chief Financial Officer, will host a conference call beginning at 10:00 a.m. Eastern Time on Tuesday, May 17, 2011 to discuss the first quarter 2011 financial results and to answer questions. Shareholders and other interested parties may participate in the conference call by dialing 866-202-1971 (domestic) or 617-213-8842 (international) and entering passcode 85026436. The call also will be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
A replay of the conference call will be accessible two hours after its completion through
May 23, 2011 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 47899275. The call will also be archived for 90 days at
www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112), which has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines, or its ability to service the deferred payments related to the acquisition of the Angel® and activAT® product lines. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
Reduces Debt Service Payments by 90% over Next Twelve Months
GAITHERSBURG, Md. (May 2, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced the refinancing of all remaining debt incurred in April 2010 in connection with the purchase of the Angel® assets from Sorin USA. Specifically, the remaining $3.4 million balance on the note was repaid early and in full with a $2.1 million payment on Friday. In return, Sorin will release both the security interest in the Angel assets and the limited guarantees supporting the note.
The $2.1 million payment is being funded by a new $2.1 million, four-year, interest-only loan due April 2015. The note will bear interest at 12%, payable quarterly beginning September 30, 2011, and is secured by the same Angel acquisition assets. Certain insiders and existing shareholders who funded and/or guaranteed repayment of the new loan will receive an aggregate of up to 2.5 million warrants to purchase shares of common stock at a price of $0.50 per share under certain circumstances. In addition, the Company raised $325,000 in a private placement sold to accredited investors at a price of $0.33 per share. No warrants were issued in connection with this private placement and no placement agent or investment banking fees were paid in conjunction with the transactions. For more detailed information, please refer to the Company’s Form 8-K, to be filed with the Securities and Exchange Commission.
“The refinancing of our acquisition-related debt lowers our debt service to 10% of the originally scheduled principal payments that would have been due between now and next April. This significantly reduces our external capital needs over the next 12 to 24 month planning period, and allows us to focus on and invest in growing our business,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. “The four-year maturity on the interest-only obligation will allow us to more aggressively implement our plans for the commercial expansion and sales growth of our regenerative biologic therapies in wound management and surgical applications.”
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma (“PRP”) gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Cytomedix also seeks to monetize other product candidates in its pipeline through strategic partnerships, out-licensing or sale. Most notably is its anti-inflammatory peptide (designated CT-112), which has shown promise in preclinical testing. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines, or its ability to service the deferred payments related to the acquisition of the Angel® and activAT® product lines. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100