CYTOMEDIX ANNOUNCES EXPANSION OF PHASE 2 STUDY TO TREAT POST-ACUTE ISCHEMIC STROKE AT UP TO 15 U.S. CLINICAL SITES
ALD-401 Phase 2 Study Clears Safety Assessment for First 10 Patients by DSMB
GAITHERSBURG, Md. (May 16, 2012) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced that the independent Data Safety Monitoring Board (DSMB) reviewing the safety data from the ongoing RECOVER-Stroke trial has recommended that the Phase 2 trial of ALD-401, a unique and differentiated stem cell population derived from patients’ own bone marrow, can continue as designed. This determination follows a review of the clinical safety data on the first 10 patients that were treated post-acutely for ischemic stroke.
The double-blind, placebo-controlled trial of 100 patients is designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22 when administered between 13 and 19 days post the ischemic event. The primary endpoint of the study is safety and the secondary efficacy endpoint is neural function based on the modified Rankin Scale assessed at three months following treatment.
Currently being conducted at three clinical sites, the trial will now expand up to a total of approximately 15 U.S. clinical sites with this clearance by the DSMB. The study has gained Investigation Review Board (“IRB”) approval from a number of leading healthcare institutions under the guidance of key opinion leaders in the field of ischemic stroke. Additional DSMB reviews are scheduled at 30 and 60 patients per the clinical protocol.
Commenting on the clearance to continue the Phase 2 trial, Martin P. Rosendale, Chief Executive Officer, stated, “We are very encouraged by the decision of the DSMB to recommend the continuation of the RECOVER-Stroke trial and look forward to expanding this important trial to additional leading stroke clinical sites across the U.S. The only currently approved treatment options (tissue plasminogen activator (tPA) and mechanical retrievers) must be used within a very short time frame from the onset of the stroke. Consequently, less than 5% of stroke patients receive any approved treatments. ALD-401 is being delivered to patients suffering from the often devastating effects of ischemic stroke approximately two weeks following the stroke.
“Strokes remain one of the leading causes of long-term disability. With the majority of strokes occurring in patients 65 years and older, it is also a major financial burden for our healthcare system. Preclinical research with ALD-401 has shown improvements in motor function, in mitigation of the decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow in the brain. We are hopeful that ALD-401 will continue to demonstrate these regenerative activities in this trial and look forward to advancing its clinical development,” added Mr. Rosendale.
“We are grateful to our early investigators, which include the University of Texas Health Science Center at Houston, Duke University Medical Center, and the Los Angeles Brain and Spine Institute, for their support and guidance through the early enrollment of this trial. We also look forward to working with a number of premier academic and private health leaders as we expand the study. Importantly, we want to recognize the care and thoughtful guidance received from our independent DSMB,” commented James Hinson, M.D., Cytomedix’ Chief Medical Officer. “We just concluded an Investigator’s Meeting and were especially pleased and encouraged to see the underlying enthusiasm for this potential treatment option among leading clinicians in stroke treatment and research.”
About Stroke
According to the American Stroke Association, stroke is a disease that affects the arteries leading to and within the brain. It is the fourth leading cause of death and a leading cause of disability in the United States. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts. When that happens, part of the brain cannot get the blood and oxygen it needs, so it starts to die. Strokes are typically classified into two major categories: ischemic and hemorrhagic. Approximately 800,000 patients in the United States suffer a stroke each year and approximately 87% of these strokes are ischemic.
About ALD-401
ALD-401 is the population of ALDHbr stem cells produced using Cytomedix’ proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. These adult stem cells express high levels of the enzyme ALDH, and preclinical research suggests that they may promote the repair of ischemic tissue damage. This is tissue damage caused by inadequate blood flow resulting from the obstruction of blood vessels supplying blood to the tissue. Investigators have completed preclinical research showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow, or perfusion, in the brain.
About Cytomedix, Inc.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair. 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 and 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 On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit www.cytomedix.com
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’ actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’ ability to predict or control, including among many others, risks and uncertainties related to ALD-401’s continuing to demonstrate regenerative capabilities in these upcoming trials, the Company’s ability to successfully manage and advance clinical development of ALD-401, the likelihood of positive reviews at 30 and 60 patient thresholds, the Company’s continuing ability to successfully integrate the Aldagen acquisition and underlying technologies the sustained interest and demand for the ALD-401 treatment option among stroke clinicians, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company’s sales approach and overall marketing strategies, 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. 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, 2011 and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investor Inquiries
Martin Rosendale, Chief Executive Officer Anne Marie Fields
Andrew Maslan, Chief Financial Officer LHA
David Jorden, Executive Chairman afields@lhai.com
(240) 499-2680 (212) 838-3777
Bruce Voss
LHA
bvoss@lhai.com
(310) 691-7100
@LHA_IR_PR
Media Inquiries
Michelle Linn
Linnden Communications
linnmich@comcast.net
(508) 362-3087
Record Product Sales Showed Increase of 23%
Conference Call Begins Wednesday, May 16th at 10:00 a.m. Eastern Time
GAITHERSBURG, Md. (May 15, 2012) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced financial results for the three months ended March 31, 2012.
Financial highlights for the 2012 first quarter include (all comparisons are with the 2011 first quarter):
- Total revenues increased 121% to $3.02 million from $1.37 million
- Product sales increased 23% to $1.69 million from $1.37 million
- Licensing revenue of $1.33 million was recorded as partial recognition of the $4.50 million non-refundable option payments received to date in connection with the potential strategic supply and distribution partnership for the AutoloGel™ System
- Net loss to common stockholders of $4.74 million or $0.07 per share included $3.44 million in non-recurring and/or non-cash expenses and transaction costs, compared with a net loss to common stockholders of $1.50 million or $0.03 per share
- Cash used in operations was $0.51 million compared with $1.29 million
Management Discussion
Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, “The first quarter of 2012 and recent weeks have been noteworthy for Cytomedix. In addition to posting double-digit revenue growth with our commercial products, we made significant inroads with our reimbursement initiatives for AutoloGel and received an additional $2.5 million non-refundable option payment from our potential strategic partner for AutoloGel. Most significantly, we expanded our commitment to regenerative medicine with the acquisition of Aldagen in February 2012 and now have in place the three pillars of regenerative medicine with autologous stem cells, platelet-derived signal molecules and plasma scaffolds.
“The acquisition of Aldagen broadened our footprint in regenerative medicine and provided us with a robust pipeline of product candidates in areas of large unmet medical need. We are in the process of integrating the Aldagen technology into the business and have made progress with ongoing development programs. We have advanced the Phase 2 RECOVER-Stroke trial, which is assessing ALD-401 to treat post-acute ischemic stroke, and saw positive data from a Phase 1 clinical trial of ALD-201 to treat ischemic heart failure published in the American Heart Journal.
“We continued to post significant revenue growth for the Angel® Whole Blood Separation System during the quarter, and we look forward to expanding its potential with enhanced targeted marketing efforts as well as expansion into other indications where we can increase utilization. We have a 510(k) application on file with the U.S. Food and Drug Administration for Angel to process bone marrow and are evaluating our strategy to leverage the utility of this product in sports medicine and orthopedics where there is a growing market opportunity. In addition, we also posted a record revenue quarter for AutoloGel even though our commercial sales focus was on Angel while AutoloGel efforts were dedicated to reimbursement and partnership initiatives.
“During the quarter we substantially strengthened our balance sheet, simplified our capital structure and increased our shareholders’ equity, which along with growing product sales positions us to implement our strategic growth plan. The year is off to a strong start and we remain very encouraged by the prospects for both our commercial products and our pipeline,” concluded Mr. Rosendale.
First Quarter Financial Results
Total revenues for the first quarter of 2012 were $3.02 million, an increase of 121% compared with total revenues of $1.37 million for the first quarter of 2011. The increase was largely attributable to the recognition of $1.33 million in license revenue from the $4.50 million in total non-refundable option fees received to date in connection with the potential agreement with a global pharmaceutical company, as well as from higher sales of the Angel and AutoloGel Systems.
Sales from the Angel product line increased 18% to $1.51 million from $1.28 million in the prior-year first quarter. Record quarterly AutoloGel System sales of $164,000 increased 89% compared with the first quarter of 2011.
Gross profit for the first quarter of 2012 increased 201% to $2.17 million from $720,000 for the same period in 2011, primarily due to the $1.33 million in licensing revenue that had no related cost of revenue. Gross profit on product sales increased 16% to $838,000.
Gross margin on product sales for the three months ended March 31, 2012 was 50% compared with 53% for the comparable 2011 period, primarily the result of a shift in product mix to lower-margin products as the Company recorded a significant number of Angel device sales to international distributors and wrote off some obsolete inventory.
First quarter cash margin on product sales, excluding $116,000 in patent amortization and depreciation expense, was 56%. Cash margin is a non-GAAP financial measure, most directly comparable to gross margin, and should not be considered as an alternative thereto. Cytomedix defines cash margin as gross margin exclusive of patent amortization and depreciation expense, and it is a significant performance metric used by management to indicate cash profitability on product sales.
Operating expenses for the first quarter of 2012 increased to $4.89 million from $2.20 million in the prior-year first quarter. This increase was primarily attributable to transaction related costs associated with the Aldagen acquisition of approximately $528,000, and approximately $979,000 in non-recurring, non-cash stock compensation expense for options granted to former Aldagen employees, consultants and board members. The Company also incurred additional expenses in the 2012 first quarter related to reimbursement, regulatory and marketing initiatives.
Other expense for the first quarter of 2012 of $2.0 million compared with other income of $78,000 in the first quarter of 2011. The change was primarily due to approximately $1.50 million in non-cash inducement expense associated with common stock issued in exchange for the early conversion of Series D preferred stock and incentive warrants issued in exchange for the early exercise of existing warrants. Additionally, there was an approximate $424,000 in expense associated with non-cash interest costs and change in fair value of derivative liabilities.
Net loss to common stockholders for the first quarter of 2012 was $4.74 million or $0.07 per share, compared with a net loss to common stockholders of $1.50 million or $0.03 per share for the first quarter of 2011.
Cash and Liquidity
Cash and cash equivalents as of March 31, 2012 were $8.50 million, compared with $2.25 million as of December 31, 2011. The Company used $509,000 in cash to fund operating activities during the first quarter 2012. An additional $1.18 million in cash from warrant exercises was received post quarter end associated with the remaining binding commitments for warrant exercises by June 30, 2012.
Andrew Maslan, Cytomedix’s Chief Financial Officer, noted, “During the first quarter of 2012, we considerably strengthened our balance sheet with the receipt of the additional $2.5 million non-refundable payment in connection with the option agreement with a top 20 global pharmaceutical company to extend the exclusive due diligence period for the rights to negotiate a license agreement for AutoloGel until June 30, 2012. In addition we raised $5.0 million in a private placement from certain Aldagen investors and received $1.1 million from the exercise of existing options and warrants.
“In addition to strengthening our balance sheet, we took a number of steps to simplify our capital structure, including the redemption of Series A and B preferred stock and the conversion of Series D preferred stock. Series E preferred stock issued to Aldagen investors as the upfront consideration in February will automatically convert into common shares upon shareholder approval of an increase to authorized common shares at our upcoming Special Shareholders’ Meeting on May 18th.
“Importantly, we are pleased to report that we have significantly increased shareholders’ equity to $10.3 million from $3.3 million at year-end 2011. We expect a further significant increase of approximately $19 million to equity as the conversion of Series E preferred stock to common stock occurs, and believe maintaining a healthy shareholders’ equity balance will be important as we consider an uplisting to a national stock exchange,” added Mr. Maslan.
For additional information, please refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, filed with the U.S. Securities and Exchange Commission on May 15, 2012.
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 Wednesday, May 16, 2012. Shareholders and other interested parties may participate in the call by dialing 800-291-5365 (domestic) or 617-614-3922 (international) and entering passcode 18305398.The call will also 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 available beginning two hours after its completion through May 23, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 21195416. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix, Inc.
Cytomedix, Inc. 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 and 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. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit www.cytomedix.com
Non-GAAP financial measures
The non-GAAP financial measures discussed in the text of this press release and accompanying non-GAAP supplemental information are financial measures used by our management to evaluate our operating performance and to calculate our cash profitability. These non-GAAP measures are not in accordance with, or an alternative for, U.S. generally accepted accounting principles (“GAAP”) and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles and management exercises judgment in determining which items should be excluded in the calculation of non-GAAP measures. While we believe that non-GAAP measures have limitations in that they do not reflect all of the amounts associated with our results of operations as determined in accordance with GAAP, we believe that non-GAAP measures are valuable in analyzing our cash profitability. Management analyzes current and future results on a GAAP basis as well as a non-GAAP basis and also provides GAAP and non-GAAP measures in our earnings release. The presentation of non-GAAP financial information is not meant to be considered in isolation or as a substitute for the directly comparable financial measures prepared in accordance with GAAP. The non-GAAP financial measures are meant to supplement, and be viewed in conjunction with, GAAP financial measures. We believe that the presentation of non-GAAP measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors and management regarding financial and business trends relating to our financial condition and results of operations. Investors are advised to carefully review and consider this information as well as the GAAP financial results that are disclosed in our SEC filings.
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’ actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’ ability to predict or control, including among many others, risks and uncertainties related to the Company’s ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company’s sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company’s ability to list its securities on a national stock exchange, 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. 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, 2011 and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investor Inquiries
Martin Rosendale, Chief Executive Officer Anne Marie Fields
Andrew Maslan, Chief Financial Officer LHA
David Jorden, Executive Chairman afields@lhai.com
(240) 499-2680 (212) 838-3777
Bruce Voss
LHA
bvoss@lhai.com
(310) 691-7100
@LHA_IR_PR
Media Inquiries
Michelle Linn
Linnden Communications
linnmich@comcast.net
(508) 362-3087
-Tables to Follow-
# # #
Conference Call Begins Thursday, May 10 at 9:00 a.m. ET
GAITHERSBURG, Md. (May 9, 2012) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed National Coverage Determination (“NCD”) memo for autologous blood-derived products for chronic non-healing wounds. In its decision memo CMS has proposed coverage through its Coverage with Evidence Development (“CED”) program for all three major wound categories: diabetic, venous and pressure wounds.
CED is a process through which CMS provides payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program.
In the proposed decision memo, CMS noted that it, “appreciates the significant burden of chronic non-healing wounds on the beneficiary population, which may lead to frustration on the part of patients, their treating practitioners and their caregivers. Therefore, we believe that it is appropriate to use CED to support the generation of more informative evidence.”
“We are very pleased with the proposed NCD to cover autologous blood-derived products for chronic non-healing wounds through the CED program, particularly as CMS has proposed coverage for all three major wound types. One advantage to CED is that it provides a mechanism for promising therapies like AutoloGel to be covered in clinical practice while evidence generation is underway,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix.
“Importantly, this positive proposed decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for an exclusive U.S. supply and distribution agreement for AutoloGel in wound care,” added Mr. Rosendale.
The release of the proposed NCD follows six months of CMS analysis and consideration subsequent to formal approval of the reconsideration request made by the Company and several clinical practitioners and industry opinion leaders last fall. This request was accepted and initiated on November 9, 2011. Following this proposed NCD, an additional 30-day public comment period has now commenced and the final decision memo will be published on or about August 7, 2012.
Cytomedix’ comprehensive request for Medicare coverage reconsideration proposed that there is sufficient and compelling clinical evidence to validate the use of autologous PRP gel to treat chronic, non-healing pressure ulcers, venous ulcers, and diabetic foot ulcers. The request sets out the reasons why PRP gel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care in the Medicare-eligible population.
The proposed memo also stated that CMS, “believes that PRP may have the potential to benefit Medicare beneficiaries. If PRP can be shown that it provides a meaningful clinical benefit for the treatment of chronic wounds, it could potentially lead to improved patient function, and decreased patient dependence on other aspects of the health care system.”
Mr. Rosendale continued, “We are confident that based on the substantial body of clinical data demonstrating the ability of AutoloGel to enhance and accelerate healing in difficult-to-heal wounds, a CED study will bear out the same positive data in support of a final, favorable coverage determination. In the interim, clinicians using AutoloGel will receive coverage provided they participate in the study. We look forward to continuing to work with CMS in advance of the final NCD in August to determine various aspects of the protocols and clinical questions to be answered through the CED program.”
The complete decision memo is available on the CMS website at:
http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=260&NcaName=Autologous+Blood-Derived+Products+for+Chronic+Non-Healing+Wounds&ExpandComments=n&TimeFrame=7&DocType=All&bc=AQAAIAAAIAAA&
Conference Call
Cytomedix management will hold a conference call to discuss the proposed NCD and the CED initiatives and to answer questions beginning at 9:00 a.m. Eastern time on Thursday, May 10, 2012. Shareholders and other interested parties may participate in the call by dialing 866-730-5769 (domestic) or 857-350-1593 (international) and entering passcode 40442064. The call will also 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 available beginning two hours after its completion through May 17, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 61561051. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Coverage with Evidence Development Program
Coverage with Evidence Development (“CED”) is a process through which the Centers for Medicare & Medicaid Services (“CMS”) provides conditional payment for items and services while generating additional clinical data to demonstrate their impact on health outcomes. CED is an evolving paradigm used by CMS to bring a new rationale to coverage decisions and, ultimately, cost savings to the Medicare program.
First introduced in 2005 and then refined in 2006, CED links Medicare coverage of specific promising technologies to a requirement that patients participate in a registry or clinical trial. Ultimately, the data generated is intended to be used as the basis for future coverage decisions once it is determined whether a treatment is reasonable and necessary. CED has also been referred to as a way to develop a “learning-based health care system” and the coverage to support it.
About AutoloGel™ System
The AutoloGel System utilizes a proprietary unique technology that enables rapid isolation and activation of platelet rich plasma from a patient’s own blood. PRP is subsequently processed to produce a gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be low and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors.
The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds. Cytomedix’s clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared to control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well.
About Cytomedix, Inc.
Cytomedix, Inc. is a regenerative therapies company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company’s advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company’s patient-derived platelet rich plasma (PRP) systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of patients’ own stem cells. A Phase 2 trial evaluating the use of ALDHbr Bright Cells for the treatment of ischemic stroke is underway. For additional information please visit www.cytomedix.com.
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’ actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’ ability to predict or control, including among many others, risks and uncertainties related to the Company’s reimbursement related efforts, the Company’s ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company’s sales approach and overall marketing strategies, 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. 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, 2011 and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investor Inquiries
Martin Rosendale, Chief Executive Officer Anne Marie Fields
Andrew Maslan, Chief Financial Officer LHA
David Jorden, Executive Chairman afields@lhai.com
(240) 499-2680 (212) 838-3777
Bruce Voss
LHA
bvoss@lhai.com
(310) 691-7100
@LHA_IR_PR
Media Inquiries
Michelle Linn
Linnden Communications
linnmich@comcast.net
(508) 362-3087
GAITHERSBURG, MD (May 9, 2012) – Cytomedix, Inc. (OTC/BB: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company will release financial results for the three months ended March 31, 2012, following the close of the market on Tuesday, May 15, 2012.
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 Wednesday, May 16, 2012, to discuss the first quarter 2012 financial results and to answer questions. Shareholders and other interested parties may participate in the call by dialing 800-291-5365 (domestic) or 617-614-3922 (international) and entering passcode 18305398. The call will also 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 available beginning two hours after its completion through May 23, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 21195416. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.
About Cytomedix, Inc.
Cytomedix, Inc. 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. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit 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’ actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’ ability to predict or control, including many among others, risks and uncertainties related to the Company’s ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and intergrated business enterprise, viability and effectiveness of the Company’s sales approach and overall marketing strategies, 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. 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. Investor Inquiries
Martin Rosendale, Chief Executive Officer Anne Marie Fields
Andrew Maslan, Chief Financial Officer LHA
David Jorden, Executive Chairman (afields@lhai.com
(240) 499-2680 (212) 838-3777
Bruce Voss
LHA
(bvoss@lhai.com)
(310) 691-7100
@LHA_IR_PR
Media Inquiries
Michelle Linn
Linnden Communications
(linnmich@comcast.net)
(508) 362-3087