CYTOMEDIX ANNOUNCES LANDMARK BRIGHT CELL THERAPY STUDY IN PERIPHERAL ARTERIAL DISEASE

Study funded by National Heart, Lung, and Blood Institute (NHLBI) of NIH in collaboration with Cardiovascular Cell Therapy Research Network (CCTRN)

 

GAITHERSBURG, Md. (December 6, 2012) – Cytomedix, Inc. (OTCQX: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the signing of an agreement with NIH to collaborate on a Phase 2 clinical study in patients with intermittent claudication (IC).  IC is caused by peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles of the leg. The study is being funded by NHLBI/NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which is also responsible for enrolling patients. The CCTRN is a network that includes seven centers in the United States with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases.

 

The Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.  The primary endpoints of the study are safety and the change in peak walking time at 6 months compared to baseline.  Additionally, changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging (MRI) will be examined.   These novel MRI techniques are incorporated into the study to assess perfusion, providing a unique set of data potentially supporting the angiogenic mechanism of Bright Cells.  The clinical study has received Investigational New Drug approval from the U.S. Food and Drug Administration (FDA) and is expected to begin enrollment in Q1 2013 upon the Investigational Review Board approvals from the participating centers.

 

Martin P. Rosendale, Chief Executive Officer of Cytomedix, stated, “We are delighted that the CCTRN has chosen to collaborate with Cytomedix on this study.  Our February acquisition of Aldagen and the Bright Cell technology has positioned us well to play a leading role in investigating promising clinical paths in regenerative medicine where there exists significant unmet medical need.  We look forward to supplying a highly differentiated personalized cell therapy product to the participating CCTRN centers involved with this important PAD indication.  Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds.  Our experience with the AutoloGel product and the clinical treatment of lower extremity wounds resulting from CLI has provided us with a full appreciation of the difficult clinical outcomes associated with this compromised patient population.  We are hopeful that improvements in lower leg blood flow will lead to increased peak walking time which has been accepted as an FDA approvable endpoint in pivotal Phase 3 trials in IC.”

 

”This is the first randomized clinical trial to look at the benefits of autologous stem cell therapy in PAD patients with IC. It will collect important mechanistic and clinical information on the efficacy and safety of the direct injection of Bright Cells into these patients. It will also evaluate the utility of advanced imaging endpoints that could be used in the future to further understand the impact of novel therapies in this patient population.” added Lem Moyé, M.D., Ph.D., professor of biostatistics at the University of Texas School of Public Health, Houston, and co-author of the study protocol.

 

PAD is a major unmet medical need affecting approximately 8 to 10 million patients in the U.S. IC is a significant subset of the PAD population and is characterized by pain in the lower legs while in motion that resolves upon rest.  Critical limb ischemia (CLI) is the advanced form of PAD, and is associated with poor clinical outcomes and increased morbidity.  An important goal of medical intervention is to attempt to prevent the progression of patients from IC to CLI.  This clinical study  builds on the strong data showing increased blood flow and improved clinical status from Cytomedix’s previous Phase 1/2 study of ALD-301 in CLI published last year (“A Randomized, Controlled Study of Autologous Therapy with Bone Marrow–Derived Aldehyde Dehydrogenase Bright Cells in Patients with Critical Limb Ischemia” Catheterization and Cardiovascular Interventions 2011).  In the PACE study, ALD-301 will be delivered in the same manner, via direct, intramuscular injection in a grid pattern of the affected lower limb.  Cytomedix will be responsible for manufacturing ALD-301 for the clinical trial and will have certain rights to  data generated during the trial.

 

 

About ALD-301/ALDH Bright Cells

ALD-301 is a population of autologous pluripotent stem cells isolated from the patients’ bone marrow using Cytomedix’ proprietary Bright Cell technology.  These adult stem cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogeneous early stage stem cells.  Preclinical research suggests that ALD-301 may promote the repair of ischemic tissue damage by producing signaling molecules that are involved in cell recruitment, cell adhesion, and angiogenesis. 

 

 

About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBI

The CCTRN includes seven main stem cell centers in the United States with experience and expertise in clinical trials studying treatments for cardiovascular diseases.  They are the Texas Heart Institute, the University of Florida at Gainesville, Minneapolis Heart Institute, Stanford University, University of Louisville, University of Miami and the Vascular and Cardiac Center for Adult Stem Cell Therapy in Indianapolis, Indiana.  The CCTRN has successfully completed and published the results of three adult stem cell trials to date (TIME, LateTIME, and FOCUS).  Further information on CCTRN is available at: cctrn.org.

 

The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are

available at: nhlbi.nih.gov.

 

 

About Cytomedix, Inc.

Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for 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® cPRP System, a blood processing device and disposable products used for the separation of blood and bone marrow 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 technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit 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 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.                                                                       Media Inquiries

Martin Rosendale, Chief Executive Officer                              Michelle Linn

Andrew Maslan, Chief Financial Officer                                  Linnden Communications      

David Jorden, Executive Chairman                             linnmich@comcast.net          

(240) 499-2680                                                            (508) 362-3087            

Cytomedix’s AutoloGel System Featured in Continuing Education Program at the Paralyzed Veterans of America Summit 2012

Physiologically Relevant Concentrations of Platelet Rich Plasma Shown to Improve Healing of Chronic Pressure Ulcers and Trauma Wounds in Patients with Spinal Cord Injuries 

 

GAITHERSBURG, Md. (September 4, 2012) – Cytomedix, Inc. (OTC/QB: CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies, today announced that the Company’s AutoloGel™ System was highlighted in a continuing education program at the Paralyzed Veterans of America Summit 2012 held August 28 to 30 at the Paris Las Vegas Hotel.

 

The AutoloGel System is a device for the production of autologous platelet rich plasma (“PRP”) gel, and is the only PRP device cleared by the U.S. Food and Drug Administration (“FDA”) for use in wound management.

 

The program, entitled “Platelet Rich Plasma (PRP) Gel for Wounds on Persons with SCI,” was delivered by Laurie Rappl, PT, DPT, CWS, Clinical Development Liaison for Cytomedix.  Ms. Rappl’s discussion addressed the underlying mechanisms of action that allow the Company’s physiologically relevant concentration of PRP in the AutoloGel System to accelerate healing in recalcitrant wounds in patients with Spinal Cord Injuries (“SCI”), and highlighted the clinical data demonstrating rapid reduction in wound area and volume, as well as reduction of undermining and sinus tracts/tunnels in non-healing wounds in patients with SCI.

 

“The physiology of SCI – such as decreased blood flow, blood pressure and blood supply – causes impairment at every step of the wound healing process.  A physiologically relevant concentration of PRP has been shown to improve healing in even the hardest to treat chronic wounds in SCI patients,” noted Ms. Rappl.

 

“It is especially rewarding for Cytomedix to have a continuing education program highlighting the benefits of the AutoloGel System for the treatment of chronic wounds in SCI patients. Pressure ulcers and other chronic wounds are persistent medical challenges that compromise the health and quality-of-life for these paralyzed patients,” stated Martin P. Rosendale, Chief Executive Officer of Cytomedix. “Our clinical data demonstrates how the AutoloGel System’s physiologically relevant concentration of PRP can rapidly restart the healing process in complex and chronic wounds, including wounds that were recalcitrant to other treatments.”

 

About The Paralyzed Veterans of America Summit

Paralyzed Veterans’ Summit 2012 + EXPO brings together more than 700 healthcare professionals in SCI and multiple sclerosis (MS) care. Doctors, nurses, occupational therapists, physical therapist, social workers and researchers convene to explore and implement holistic strategies to strengthen the continuum of care for SCI and MS patients.

 

The Paralyzed Veterans of America Summit serves as an educational venue bringing together professionals representing the full spectrum of SCI and MS healthcare and to support clinicians in their pursuit of maintaining their specialty certification and/or license to practice.  The objectives are to enhance multi-specialty care across the lifespan of individuals with SCI and MS; to assess advances in the delivery of healthcare services; to present innovative models of care management; to improve practice skills of clinicians, surgeons, researchers and administrators; to discuss evidence-based medicine; to increase the body of knowledge on spinal cord injury and multiple sclerosis, their medical complications and consequences; to promote educational opportunities; to identify research priorities; and to present data on new developments in assessment and treatment.

 

About Cytomedix, Inc.

Cytomedix, Inc. is a fully integrated regenerative medicine 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 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 ("ALDH^br") technology to isolate a unique, biologically active population of a patient’s own stem cells.  A Phase 2 trial evaluating the use of ALDH^br 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 capitalize on the benefits of the above-referenced CMS determination, the Company’s ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, 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 on Form 10-K 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

 

# # #

CYTOMEDIX REPORTS SECOND QUARTER 2012 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Record Quarterly Product Sales Increase 30% Conference Call Moved to Wednesday, August 15th at 9:00 a.m. Eastern Time

GAITHERSBURG, Md. (August 14, 2012) ␣ Cytomedix, Inc. (OTC/BB: CMXI) (the !Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today reported financial results for the three and six months ended June 30, 2012.

Separately, the Company announced that it accepted the early termination of the previously announced exclusivity period granted to a top 20 global pharmaceutical company and ceased negotiations for a distribution agreement for the Company#s AutoloGel$ System in wound care, which would have expired August 30, 2012. The $4.50 million received by Cytomedix to date for this exclusivity was non-refundable. The Company is now free to re-engage with other interested parties experienced in wound care to pursue potential partnerships and commercial agreements for the product.

Financial Highlights for the Second Quarter (all comparisons are with the 2011 second quarter)

• Total revenues increased 164% to $3.69 million from $1.39 million • Product sales increased 30% to $1.81 million from $1.39 million • Licensing revenue of $1.82 million was recorded as partial and final recognition of the $4.50

million non-refundable exclusivity payments received from a potential AutoloGel System

distribution partner • Net loss to common stockholders of $7.46 million or $0.09 per share included $1.84 million in

Aldagen operating expenses and approximately $5.04 million in various non-cash charges to other expense, including a $4.34 million charge for a change in the fair value of the contingent Aldagen consideration; this compares with a net loss to common stockholders of $0.88 million or $0.02 per share in the 2011 period, which included a $0.58 million gain on debt restructuring

• Shareholder#s equity at quarter end was in excess of $42 million Clinical and Corporate Highlights of the Second Quarter and Recent Weeks

• Announced Centers for Medicare & Medicaid Services (!CMS") coverage through its Coverage with Evidence Development (!CED") program for autologous platelet rich plasma (!PRP") in chronic wound care, reversing Medicare#s nearly 20 year non-coverage decision

• Initiated a Phase I clinical trial of ALD-451 in collaboration with Duke University Medical Center to demonstrate the safety of ALD-451 in malignant glioma patients who suffer from treatment-related neuro-cognitive deficits; this study is being funded by the Robertson Clinical & Translational Cell Therapy Program

• Expanded the Phase II RECOVER-Stroke study of ALD-401 in post-acute ischemic stroke to multiple centers in the U.S. following clearance of the sequential safety assessment of the first 10 patients by the Data Safety Monitoring Board (!DSMB")

• Published positive AutoloGel wound healing data in the peer-reviewed journal Ostomy Wound Management demonstrating AutoloGel#s ability to heal complex, severe diabetic and ischemic wounds in patients with poor healing prognosis and probable limb amputation• Presented multiple poster presentations highlighting the clinical merits of the Company#s AutoloGel System in wound management at the 2012 Wound, Ostomy and Continence Nurses Conference and the Symposium on Advanced Care Spring 2012

Management Discussion

Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, !During the second quarter we continued to make significant strides in advancing our position as a fully integrated regenerative medicine company as we achieved a number of key milestones that position us for future growth. In addition, our commercial products posted record quarterly sales and we made important advances with our products and pipeline.

!The agreement to end the exclusivity period and cease negotiations for an AutoloGel distribution agreement is not a reflection of the clinical or commercial value of AutoloGel in wound care, but rather is a result of a unique set of circumstances with the potential partner that precluded arriving at a favorable outcome. I want to emphasize that the decision is in no way tied to the final CMS determination for CED. Moreover, we received $4.50 million in non-dilutive financing for providing the exclusivity period and are now in a position to reengage in discussions with other interested potential partners. We are encouraged by the interest in PRP in wound care since the CMS final decision was published. With the early release of the exclusivity period, we will accelerate discussions with potential experienced wound care partners.

!We were very pleased that CMS reversed its long-standing non-coverage decision for autologous PRP and has now agreed to coverage through its CED program. This provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with AutoloGel consistently experience clinically significant health outcomes. Importantly, payment for the product under CED is expected to be sufficient to cover the anticipated cost of collecting the evidence. We have already begun our interaction with CMS following the release of the final decision memo and look forward to further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."

Commenting on clinical progress with the Company#s ALDH bright cell technology, Mr. Rosendale said, !Our Phase II RECOVER-Stroke trial has expanded to new sites and we look forward to our next milestone, which will be the DSMB safety assessment following the treatment of the initial 30 patients. We reasonably expect this to occur during the fourth quarter and continue to maintain that the ALDH bright cell population offers a novel and differentiated cell population with significant clinical upside. In addition we were pleased to report the initiation of a Phase I collaboration with the Duke University Medical Center with funding from the Robertson Clinical & Translational Cell Therapy Program. We expect to announce and initiate another sponsor-funded Phase II clinical study by year end in a peripheral arterial disease indication. These studies are intended to leverage our positive clinical experiences in critical limb ischemia and stroke.

!The first half of the year was marked by significant progress in areas that are important to our strategic plan. We expect the second half of the year to be equally productive as we work toward achieving a number of value-creating clinical and corporate milestones," concluded Mr. Rosendale.

Second Quarter Financial Results

Total revenues for the three months ended June 30, 2012 increased 164% to $3.69 million compared with total revenues of $1.39 million for the comparable period in 2011. The increase was largely attributable to the recognition of $1.82 million in license revenue from the $4.50 million in total non- refundable exclusivity fees received in connection with the potential agreement with a global pharmaceutical company, as well as from higher sales of the Angel® and AutoloGel Systems.

Total product sales increased 30% to $1.81 million. Sales from the Angel product line increased 27% to $1.63 million from $1.29 million in the 2011 second quarter. Despite limited sales promotion, the Company again posted record quarterly AutoloGel System sales of $170,000, an increase of 55% compared with the 2011 second quarter.

Gross profit for the second quarter of 2012 increased 258% to $2.71 million from $755,000 for the same period in 2011, primarily due to the aforementioned license revenue that had no related cost of revenue. Gross profit on product sales increased 11% to $839,000.

Gross margin on product sales for the three months ended June 30, 2012 was 46% compared with 54% for the comparable 2011 period, due solely to increased sales of lower-margin Angel machines to international distributors. These machine sales are expected to drive future growth in disposable sales to non-US customers.

Second quarter 2012 cash margin on product sales, excluding $137,000 in patent amortization and depreciation expense, was 54%. Cash margin on disposable products in the second quarter of 2012 was 62%, in line with historical norms. 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 second quarter 2012 increased to $5.05 million from $2.00 million in the second quarter 2011. This increase was primarily attributable to Aldagen operating expenses of $1.8 million mentioned above, bonus expense, increased headcount and higher costs related to reimbursement, regulatory and marketing initiatives.

Other expense for the second quarter of 2012 of $5.10 million compared with other income of $452,000 for the second quarter of 2011. The change was primarily due to a $4.34 million non-cash expense related to the increase in the fair value of the contingent consideration mainly due to the change in the Company#s stock price, approximately $200,000 of non-cash interest costs, and a $471,000 non-cash charge due to the settlement of a contingency. The latter expense was a result of a contingency reached during the quarter that will result in 325,000 common shares issued over a period of 15 months to certain pre-bankruptcy preferred shareholders as outlined in the Company#s plan of reorganization in 2002. In addition, there was a gain of $577,000 recognized in 2011 related to the Company#s renegotiation of the note payable due to Sorin.

The net loss to common stockholders for second quarter of 2012 was $7.46 million or $0.09 per share, compared with a net loss to common stockholders of $878,000 or $0.02 per share for the same period in 2011.

Year-to-Date Results

Total revenues for the first six months of 2012 were $6.70 million, up 143% from total revenues of $2.76 million for the first six months of 2011. Total product sales of $3.50 million were up 27% from $2.76 million. Gross margin on product sales for the first half of 2012 declined to 48% from 53% in the same period in 2011. Operating expenses for the first six months of 2012 increased to $9.94 million from $4.20 million for the first six months of 2011.

The net loss to common stockholders for the first half of 2012 was $12.19 million or $0.17 per share, compared with a net loss to common stockholders for the first half of 2011 of $2.37 million or $0.05 per share.

Cash and Liquidity

Cash and cash equivalents as of June 30, 2012 were $8.55 million, compared with $2.25 million as of December 31, 2011. The Company used $3.77 million in cash to fund operating activities during the second quarter of 2012 including a $0.50 million increase in inventory-related items.

Andrew Maslan, Cytomedix#s Chief Financial Officer, commented, !During the second quarter we realized $4.43 million from financing activities. Our cash usage was higher than experienced in this year#s first quarter as a consequence of a full quarter of Aldagen-related expenses including the operation#s clinical development costs, expanded operational expenses, and the build-up of Angel inventory as we prepare for anticipated growth in sales.

!Importantly, we are pleased to report a significant increase in shareholders# equity to over $42 million from just over $3 million at year-end 2011. Our equity balance is now substantially in excess of any required listing minimums and is an important consideration in any potential decision to pursue an up- listing of our shares to a national securities exchange," added Mr. Maslan.

For additional information please see the Company#s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, filed with the U.S. Securities and Exchange Commission on August 14, 2012.

Conference Call

Cytomedix management will hold a conference call to discuss these results and answer questions beginning at 9:00 a.m. Eastern time on Wednesday, August 15, 2012. Shareholders and other interested parties may participate in the call by dialing 800-798-2801 (domestic) or 617-614-6205 (international) and entering passcode 39362501. 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 August 22, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 15244694. 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. is a fully integrated regenerative medicine company commercializing innovative platelet separation systems and developing adult stem cell 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 PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. The Company#s 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 its proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient#s own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. 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. Martin Rosendale, Chief Executive Officer Andrew Maslan, Chief Financial Officer David Jorden, Executive Chairman (240) 499-2680

Investor Inquiries Anne Marie Fields LHA afields@lhai.com (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

Cytomedix, Inc. to Webcast, Live, at RetailInvestorConferences.com on July 12th

Company invites Main Street and Wall Street investors to attend interactive real-time virtual conference

 

NEW YORK / DATE -  Cytomedix, Inc. (OTC: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced that Martin P. Rosendale, Chief Executive Officer, will present at RetailInvestorConferences.com.

 

DATE:   July 12, 2012

TIME:    11:00 AM EDT

LINK:    www.retailinvestorconferences.com > red “register / watch event now” button

 

This will be a live, interactive online event where investors are invited to ask the company questions in real-time - both in the presentation hall as well as the company’s “virtual trade booth.” If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days.

 

It is recommended that investors pre-register to save time and receive event updates.

 

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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.

 

 

About RetailInvestorConferences.com

 

Since 2010, RetailInvestorConferences.com, created by BetterInvesting (NAIC) PR Newswire and MUNCmedia, has been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with retail investors using a graphically-enhanced online platform.

 

Designed to replicate the look and feel of location-based investor conferences, Retail Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network and MUNCmedia’s sophisticated retail investor targeting.

 

 

CONTACT

 

Cytomedix, Inc.

Martin Rosendale, Chief Executive Officer                     

Andrew Maslan, Chief Financial Officer

David Jorden, Executive Chairman    

240.499. 2680

 

RetailInvestorConferences.com

Bradley H. Smith

bradley.smith@prnewswire.com

201.942.7157

CYTOMEDIX ANNOUNCES EXTENSION OF EXCLUSIVITY PERIOD TO GLOBAL PHARMACEUTICAL COMPANY FOR AUTOLOGEL SYSTEM IN CHRONIC WOUND MARKET

Provides Update on Coverage with Evidence Development (“CED”) Progress

GAITHERSBURG, Md. (July 2, 2012) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company” or “Cytomedix”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced today an extension of the exclusivity period and an agreement with the top 20 global pharmaceutical company to negotiate a distribution agreement of the AutoloGel System in the U.S. chronic wound care market.

The parties agreed to extend the exclusivity period until August 30, 2012. In addition, the parties are now negotiating the material terms and provisions of a distribution agreement, and expect to commence sales under such distribution arrangement immediately upon execution on or before August 30, 2012. The distribution arrangement will include mutual options to convert the arrangement into an exclusive license and supply agreement.

The exclusivity extension and agreement to pursue a short term distribution agreement represent a continuation of the discussion of commercialization opportunities in the U.S. chronic wound care market previously disclosed by the Company.

“We look forward to finalizing a distribution arrangement that will allow our potential partner to initiate sales through its dedicated, hospital based sales force as we bridge towards a broader license agreement,” said Martin P. Rosendale, Chief Executive Officer of Cytomedix. “As we await final decisions from Centers for Medicaid & Medicare Services (“CMS”), this is a positive and logical step towards building a broader relationship. Importantly, such an agreement would provide a means to expand sales and enhance brand awareness for AutoloGel through a significantly larger sales force.

“As an update to reimbursement and Medicare coverage of AutoloGel under CED, we submitted our public comment on June 8th and met with the CMS Coverage and Analysis Group last week. During that meeting, we acknowledged CMS’ randomized clinical trial (“RCT”) requirements as described in its proposed decision memorandum on May 9th and detailed our view that rigorous and clinically robust answers to the RCT study requirements are possible with well designed protocols and randomized, prospective, observational studies. Such studies would focus on effectiveness and should benefit from results that generalize across broader, real world patient populations. Between now and the release of the final decision memorandum, which is expected on or before August 7, 2012, we continue to refine the proposed protocols with a view towards submitting them shortly thereafter. We will remainactively engaged with CMS to finalize these trial protocols and remain optimistic that the pragmatism underlying CED, which is intended to provide access to promising therapies while additional clinical data is collected and assessed, will be beneficial to all stakeholders – patients, payors and partners.”

“Finally, the ongoing partnership opportunity has provided Cytomedix with $4.5 million in non- refundable exclusivity payments to date and the Company ended the second quarter of 2012 with approximately $8.4 million in cash, including approximately $4.7 million dedicated for clinical trials and related matters. We remain well positioned to pursue our strategic goals and opportunities and look forward to continued sales growth in our commercial markets,” concluded Mr. Rosendale.

The above-referenced preliminary financial data relating to the Company’s cash position for the second quarter ended June 30, 2012 is prepared by, and is the responsibility of, Cytomedix management. The Company's closing process for the second quarter of fiscal 2012 has not yet been completed. Therefore, such financial data presented in this press release is estimated and is subject to change as a result of the period-end closing process.

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 AutoloGelTM 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 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 many others, the successful negotiation and execution of the distribution and/or exclusive license and supply agreement during the exclusivity period, the Company’s ability to commence sales even when the distribution agreement is executed when and as contemplated, the Company’s ability to secure CMS reimbursement if and to the extent 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,", “remain optimistic”, "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, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.

Contacts: Cytomedix, Inc. LHA Anne Marie Fields (afields@lhai.com) (212) 838-3777, Bruce Voss (bvoss@lhai.com) (310) 691-7100

Martin Rosendale, CEO Andrew Maslan, CFO David Jorden, Executive Chairman (240) 499-2680

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CYTOMEDIX ANNOUNCES MULTIPLE POSTER PRESENTATIONS AT THE 44th ANNUAL CONFERENCE OF THE WOUND OSTOMY CONTINENCE NURSES SOCIETY

Data Shows AutoloGel Saves Money and Accelerates Healing in Difficult to Treat Wounds

 

GAITHERSBURG, Md. (June 8, 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 four poster presentations highlighting the clinical merits of the Company’s AutoloGel™ System in wound management will be presented at the 44th Annual Conference of the Wound Ostomy and Continence Nurses Society (“WOCN^®”) being held in Charlotte, North Carolina from June 9-13, 2012.

 

The AutoloGel System, a device for the production of autologous platelet rich plasma (“PRP”) gel, is the only PRP device cleared by the U.S. Food and Drug Administration (“FDA”) for use in wound management.

 

The following posters highlighting Cytomedix’s PRP technology will be presented at WOCN 2012:

 

• Fistula and Pseudostoma Management Using Platelet Rich Plasma Gel by lead author Janice Wilson, RN, CWOCN, Karl Branch, RN, Asheville Specialty Hospital, Asheville, North Carolina.  Poster Number 6241

 

• Calculating Saved Costs When Using Platelet-Rich-Plasma Gel in Place of NPWT in 17 Complex Wound Patients by lead authors Janice Wilson, RN, CWOCN and Karl Branch, RN, Asheville Specialty Hospital, Asheville, North Carolina. Poster Number 6240

 

• Response of Wounds of Spinal Cord Injured Persons to 1x Autologous Platelet Rich

Plasma Gel by lead author Laurie M. Rappl, PT, DPT, CWS, Cytomedix, Inc., Gaithersburg, Maryland.  Poster Number 6266

 

• The Impact of Autologous Platelet Rich Plasma Gel on Chronic Wounds by lead authors Carelyn P. Fylling, RN, MSN, CWS, CLNC, Cytomedix, Inc, Vice President of Professional Services, and Laurie M. Rappl, PT, DPT, CWS, Cytomedix, Inc. Clinical Development Liaison, Poster Number 6210 

 

 

“This body of clinical data demonstrates AutoloGel’s ability to accelerate wound healing in common wound etiologies and also shows its effectiveness on fistulas, pseudostomas, and pressure ulcers in persons with spinal cord injury, which are all notoriously difficult to heal wounds.  In addition, the data shows that AutoloGel saves money while increasing healing rates and decreasing staff time,” commented Carelyn P. Fylling, RN, MSN, CWS, CLNC, Cytomedix’s Vice President of Professional Services.

 

 

“We are pleased to have these four posters presented at WOCN as it offers an ideal venue to reach and educate a large audience of clinicians who specialize in wound management on the clinical merits of AutoloGel to heal these challenging wounds.  These data, collectively and individually, demonstrate the clinical utility of AutoloGel to heal a variety of hard-to-heal wounds,” commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.  “Compelling clinical results such as these should favorably impact the adoption of AutoloGel in a variety of wounds and wound care settings, and further strengthen final negotiations with our potential top 20 global pharmaceutical partner.”

 

The posters will be available at WOCN as follows:  

 

Sunday, June 10         6:30 am – 8:00 pm   Poster Viewing

Monday, June 11         9:00 am – 5:30 pm   Poster Viewing

Tuesday, June 12        7:00 am – 9:00 am   Authors Session and Awards Presentation

9:00 am – 6:30 pm   Poster Viewing

Wednesday, June 13   8:00 am – 12:00 pm Poster Viewing

 

 

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 ("ALDH^br") 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

CYTOMEDIX ANNOUNCES EXPANSION OF PHASE 2 STUDY TO TREAT POST-ACUTE ISCHEMIC STROKE AT UP TO 15 U.S. CLINICAL SITE

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 ALDH^br 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 ("ALDH^br") 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

 

CYTOMEDIX REPORTS FIRST QUARTER 2012 FINANCIAL RESULTS

Record Product Sales Showed Increase of 23%

 

Conference Call Begins Wednesday, May 16^th 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 ("ALDH^br") 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-

 

 

 

 

 

 

 

# # #

CYTOMEDIX ANNOUNCES PROPOSED NATIONAL COVERAGE DETERMINATION MEMO BY CMS FOR AUTOLOGOUS PRP GEL IN CHRONIC WOUND CARE

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 ("ALDH^br") technology to isolate a unique, biologically active population of patients’ own stem cells.  A Phase 2 trial evaluating the use of ALDH^br 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

 

Cytomedix to Host First Quarter 2012 Financial Results Conference Call on Wednesday, May 16, 2012

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 ("ALDH^br") 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