GAITHERSBURG, Maryland – May 17, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company’s Chief Operating Officer, has been invited to make a presentation on Partnering & Collaboration at the World Stem Cells & Regenerative Medicine Congress 2013, which will be held May 21-23, 2013 in London, United Kingdom.
Presentation Details
Time: Tuesday, May 21, 2013 @ 11:55am BST (6:55 am EST)
Track Title: Commercialisation through Collaboration: What Does Partnering In This Industry Actually Look Like?
Location: Victoria Park Plaza Hotel, London, UK
During the presentation, Mr. Field will highlight Cytomedix’s two collaborations that are advancing clinical stage therapies. The first is a collaboration with the National Institute of Health (NIH) and the Cardiovascular Cell Therapy Research Network (CCTRN) for conduct of the PACE study, an 80 patient, double-blind, placebo-controlled clinical trial designed to look at the safety and efficacy of ALD-301 in peripheral artery disease patients diagnosed with intermittent claudication. This is the first ever randomized clinical trial to look at the benefits of autologous stem cell therapy in this indication. The second collaboration is with Duke University Medical Center, which is conducting a Phase 1 clinical study with ALD-451 in patients that have been treated for glioblastomas, which is the most aggressive form of brain cancer. This open-label study is designed to enroll up to 12 patients and is intended to demonstrate the safety and feasibility of ALD-451 when administered intravenously in patients with grade IV malignant glioma following surgery, radiation therapy and treatment with temozolomide.
About the World Stem Cells Regenerative Medicine Congress 2013
The World Stem Cells & Regenerative Medicine Congress 2013 is Europe’s largest and most senior conference for the stem cell research and regenerative medicine community. It is now in its 8th year. Topics covered will include streamlining clinical development, commercialising a stem cell-based therapy and exploiting alternative sources of funding. For more information please visit:
http://www.terrapinn.com/2013/stemcells/index.stm.
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 AutoloGelä 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") 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.
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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
Steven Shallcross, EVP, CFO LifeSci Advisors, LLC
David Jorden, Executive Chairman mrice@lifesciadvisors.com
(240) 499-2680 (646) 597-6979
FOR IMMEDIATE RELEASE
CYTOMEDIX REPORTS FIRST QUARTER 2013 FINANCIAL RESULTS
Conference Call Scheduled for Friday May 10th at 8:00am Eastern Time
GAITHERSBURG, Maryland – May 9, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, today reported financial results for the three months ended March 31, 2013.
First Quarter 2013 Financial Highlights (all comparisons are with the 2012 first quarter)
- Product revenue of $2.3 million compared with $1.7 million in the prior year, an increase of 34%.
- Net loss to common stockholders of $5.3 million, or ($0.05) per share. This compares to a net loss of $4.7 million, or ($0.07) per share in the prior year.
- Cash and cash equivalents of approximately $7.2 million at March 31, 2013. In February 2013, the Company received $9.5 million of gross proceeds at closing as part of a comprehensive financing plan.
Clinical and Corporate Highlights for the First Quarter and Recent Weeks
- The Centers for Medicare & Medicaid Services (CMS) granted formal approval of the protocols for AutoloGelTM under Coverage with Evidence Development (CED).
- CMS issued coding and reimbursement claims instructions for AutoloGel in non-healing chronic wounds.
- The Angel® Concentrated Platelet Rich Plasma (cPRP) System was approved for marketing in Australia.
- The Company signed a three year agreement with Vibra Healthcare, LLC, an owner and operator of Long Term Acute Care (LTAC) hospitals and Inpatient Rehabilitation Hospitals (IRF). This agreement will facilitate the use of the AutoloGel System for the treatment of wounds at Vibra Healthcare facilities throughout the United States.
- A comprehensive 2013 financing was executed to raise up to a total of $27.5 million, including $9.5 million in initial gross proceeds.
- Steven A. Shallcross, CPA, was appointed as Executive Vice President, Chief Financial Officer, Secretary and Treasurer.
Management Discussion
“Product sales continued along a steady growth trend, and we are pleased to report total sales of nearly $2.3 million in the first quarter,” said Martin Rosendale, Chief Executive Officer of Cytomedix. “Angel sales of $2.1 million were particularly strong, up 40% year over year. Both Angel and AutoloGel achieved double digit increases sequentially over the prior quarter. We have now placed more than 500 Angel Systems on a worldwide basis. Over 40,000 patients are currently being treated with the Angel System on an annualized basis.”
“We continue to make excellent progress towards reimbursement for AutoloGel which will be covered initially by CMS under the Coverage with Evidence Development (CED) program. We hit another important milestone during the quarter when CMS formally approved the clinical outcomes in the protocols we had submitted in response to the National Coverage Determination (NCD) memo. CMS has also issued coding and reimbursement instructions to its regional contractors. We expect to begin treating Medicare beneficiaries with AutoloGel shortly and will be recording revenues for those AutoloGel treatments soon after the CED implementation date of July 1st 2013.”
“Our Bright Cell technology pipeline continues to move forward. Our clinical development plan includes completion of enrollment in the RECOVER-Stroke Trial with top-line data available in the first half of 2014, and beginning enrollment in the Phase 2 PACE study with ALD-301 in patients with intermittent claudication. The RECOVER-Stroke trial is currently enrolling at 10 sites. The first 30 patients have been enrolled, and we expect to have the planned DSMB review soon.”
“In February 2013, we strengthened our balance sheet by entering into several financing transactions providing access to up to $27.5 million of capital. These included an equity raise, a tranched senior secured term loan facility, and a committed equity facility. We received approximately $9.5 million in initial gross proceeds with commitments for up to an additional $18 million. As such, we believe we will have sufficient cash to sustain the Company at least through 2013”, he concluded.
Financial Results
Three-Month Period Ended March 31, 2013
Total revenues were $2.3 million in the three months ended March 31, 2013, a decrease of approximately $0.7 million compared to the same period last year. The decrease was mostly due to license fee revenue of $1.3 million recognized in 2012 with respect to an option agreement with a top 20 global pharmaceutical company. Product sales in the quarter were $2.3 million, an increase of 34% compared with the same period last year.
Gross margin on product sales decreased to 44% from 50% comparing the three months ended March 31, 2013, to the same period last year. Sales on lower margin products, specifically Angel machines sold to international distributors, made up a more significant portion of the product mix. This, along with the medical device excise tax which took effect in 2013, resulted in a decrease in gross margin on product sales. Overall gross margin decreased to 45% from 72%. The license fee recorded in the first quarter of 2012 had no associated cost of revenue and was the primary reason for the decline in overall gross margin year over year.
First quarter cash margins on product sales were 52%. Cash margins on disposable products in the quarter were 56%. Cash margin is a non-GAAP financial measure, most directly comparable to the U.S. GAAP measure of 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.
Total operating expenses in the quarter were $6.0 million an increase of $1.1 million or 24% compared to the same period in 2012.
Research & Development expenses were $0.9 million, an increase of $544,000 or 152% year over year. The increase was primarily due to research and development costs related to the ALD-401 Phase II clinical trial. Selling, general and administrative expenses were $5.1 million during the quarter, an increase of 14% over the $4.5 million reported in the same quarter in 2012.
The Company recorded a net loss of $5.4 million, or ($0.05) per share in the three-month period ended March 31, 2013, compared to a net loss of $4.8 million, or ($0.07) per share in the comparable period in 2012.
Cash and Liquidity
Cash and cash equivalents were approximately $7.2 million at March 31, 2013. In February 2013, the Company entered into several financing transactions for up to $27.5 million overall, which included a tranched $7.5 million senior secured term loan facility, a $5 million equity raise, and a $15 million committed equity facility. Approximately $9.5 million of gross proceeds was received upon closing with commitments for up to an additional $18 million.
Cash used in operating activities during the quarter was $4.2 million. There were approximately 104.3 million shares of common stock issued and outstanding as of March 31, 2013.
Conference Call & Webcast
Friday, May 10, 2013 @ 8:00am Eastern/5:00am Pacific
Domestic dial in: 866-953-6857
International: 617-399-3481
Passcode: 19959894
Webcast: www.cytomedix.com
Replays – Available through May 26, 2013
Domestic: 888-286-8010
International: 617-801-6888
Passcode: 23997367
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 AutoloGelä 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 ("Lahr") 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.
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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
Steven Shallcross, EVP, CFO LifeSci Advisors, LLC
David Jorden, Executive Chairman mrice@lifesciadvisors.com
(240) 499-2680 (646) 597-6979
GAITHERSBURG, Maryland – May 6, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Company will release financial results for the three-month period ended March 31, 2013, after the close of the market on Thursday, May 9, 2013.
Martin Rosendale, Chief Executive Officer, will host a conference call beginning at 8:00am Eastern time on Friday, May 10, 2013 to discuss the first quarter results and to answer questions,
Conference Call & Webcast
Friday, May 10, 2013 @ 8:00am Eastern/5:00am Pacific
Domestic dial in: 866-953-6857
International: 617-399-3481
Passcode: 19959894
Webcast: http://www.media-server.com/m/p/d7ortkjw
Replays – Available through May 26, 2013
Domestic: 888-286-8010
International: 617-801-6888
Passcode: 23997367
About Cytomedix:
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
David Jorden, Executive Chairman LifeSci Advisors, LLC
(240) 499-2680 mrice@lifesciadvisors.com
(646) 597-6979
Oral and Poster Presentations Will Outline Benefits of Electronic Health Record System That is Being Used in the CED Program for AutoloGel.
GAITHERSBURG, Maryland – May 2, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that AutoloGelTM will be featured in oral and poster presentations at the Symposium on Advanced Wound Care (SAWC), that is being held in Denver, Colorado on May 1- 5, 2013. Dr. Caroline Fife, Chief Medical Officer of Intellicure and Medical Director at the St. Luke’s Episcopal Hospital The Woodlands Center for Wound Healing will deliver the oral presentation.
Presentation Details
Time: Saturday, May 5, 2013 from 4:30pm-5:30pm
Abstract #: Oral – 40.4
Poster – CR-23
Title: Harnessing Electronic Medical Record Capabilities for Prospective Clinical Research: The Platelet Rich Plasma (PRP) Registry for Coverage with Evidence Development (CED)
Location: Colorado Convention Center, Denver, Colorado
Dr. Fife’s oral presentation will outline the benefits of the EHR (electronic health record) system that is being used in the CED (Coverage with Evidence Development) program for AutoloGel. An EHR system with structured language has been customized to automatically perform the acquisition of data and verification of source in both the randomized trial and non-randomized cohort trials that make up the AutoloGel CED program. Only wound centers utilizing this EHR or who can adapt to it will be able to participate in the program.
The presentation and poster will describe the benefits of using an EHR system for patient recruitment, data management and integrity, and data analysis. Dr. Fife will discuss how an EHR can decrease the cost of a clinical trial, reduce time needed by site staff and monitors, increase data accuracy, reduce training required for investigators and improve safety in monitoring. A well-designed system improves overall data analysis and ensures adequate power in a clinical trial by delivering essentially real time results.
The Centers for Medicare and Medicaid Services (CMS) has agreed to provide reimbursement coverage for AutoloGel in patients with non-healing ulcers under the Coverage with Evidence Development (CED) program. CED is a determination made by the CMS that a medical product is reasonable and necessary, based on the best available clinical data, but where the evidence base has not yet been sufficiently developed.
About the SAWC-SPRING
The Symposium on Advanced Wound Care and Wound Healing Society (SAWC/WHS) meeting is the premier interdisciplinary wound care program within this clinical field and is the largest annual gathering of wound care clinicians in the United States. More than 2,000 physicians, podiatrists, nurses, therapists, and researchers are expected to attend the 2013 SAWC Spring/WHS meeting.
About Intellicure
Intellicure provides innovative solutions that empower wound care providers across the healthcare continuum to deliver world-class outcomes. The company's certified clinical, financial, and connectivity for hospitals and physicians are the essential technologies that enable a connected healthcare community. To learn more about Intellicure, please visit www.intellicure.com.
About Cytomedix:
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
David Jorden, Executive Chairman LifeSci Advisors, LLC
(240) 499-2680 mrice@lifesciadvisors.com
(646) 597-6979
# # #
GAITHERSBURG, Maryland – April 26, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Martin Rosendale, the Company’s Chief Executive Officer, will present at the 12th Annual Needham Healthcare Conference, on Wednesday, May 1, 2013 in New York.
Presentation Details
Time: Wednesday, May 1 at 11:20am Eastern / 8:20am Pacific
Room: Ambassador Room
Location: Westin Grand Central Hotel, 212 E 42nd St, New York, NY
A live webcast of the presentation may be accessed through the Company's website at www.cytomedix.com. A replay of the webcast will be available for one week following the conference.
About the Needham Healthcare Conference
Needham & Company’s 12th Annual Healthcare Conference will take place in New York on April 30th and May 1st. This is a forum for institutional investors and venture capital firms to hear the latest updates from senior management teams of both public and private companies in the Biotechnology, Specialty Pharmaceuticals, Medical Technology and Diagnostics sectors. This conference is by invitation only.
About Cytomedix:
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
David Jorden, Executive Chairman LifeSci Advisors, LLC
(240) 499-2680 mrice@lifesciadvisors.com
(646) 597-6979
# # #
GAITHERSBURG, MARYLAND – April 10, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Martin Rosendale, Cytomedix CEO, will present a corporate overview at the 2013 Regen Med Investor Day to be held Wednesday, April 17, 2013 in New York City.
Organized by the Alliance for Regenerative Medicine (ARM) in partnership with leading financial firms Burrill & Company, Maxim Group and Piper Jaffray, this flagship event features 16 of the regenerative medicine field’s leading small- and mid-cap companies. In addition, there will be disease indication-focused discussions between key opinion leaders, top analysts and senior executives from the sector and keynote-style talks by Jeff Jonas, President of Shire Regenerative Medicine and Kieran Murphy, President and CEO, GE Healthcare Life Sciences.
The following are specific details regarding Cytomedix’s presentation at the conference:
Event: ARM’s Regen Med Investor Day
Date: April 17, 2013
Time: 2:30pm EST
Location: Harmonie Club, 4 East 60th Street, New York, NY 10022
A live video webcast of all company presentations will be available at: http://alliancerm.org/rmdaywebcast and will also be published on ARM’s website shortly after the event.
Attendance at this event is for credentialed investors and members of the media only. If you are interested in attending, please contact Laura Parsons at lparsons@alliancerm.org. Please visit http://alliancerm.org/event/regen-med-investor-day for more information.
About Cytomedix:
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
David Jorden, Executive Chairman LifeSci Advisors, LLC
(240) 499-2680 mrice@lifesciadvisors.com
(646) 597-6979
CYTOMEDIX ANNOUNCES APPOINTMENT OF STEVEN A. SHALLCROSS AS CHIEF FINANCIAL OFFICER
GAITHERSBURG, MARYLAND – April 3, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today announced the appointment of Steven A. Shallcross, CPA, as Executive Vice President, Chief Financial Officer, Secretary and Treasurer, effective as of May 10, 2013. Mr. Shallcross has over 25 years of international financial, business and strategic planning experience, primarily working with companies in the pharmaceutical and biotechnology industries.
Martin Rosendale, Chief Executive Officer of Cytomedix commented, “Steve joins Cytomedix at a very exciting time for the company as we continue to expand the commercial opportunity for the Angel® cPRP System, begin Medicare reimbursement for AutoloGelTM and continue to advance our Bright Cell pipeline products through clinical development. His extensive experience in capital market and business development activities, and implementing strategic financial programs makes Steve ideally suited for the position. Going forward, Steve will lead the effort to build the financial and accounting infrastructure necessary to support the significant corporate and commercial opportunities ahead for Cytomedix.”
“I am pleased to be joining Cytomedix, and to have the opportunity to work with this impressive team to drive value for the company and its stakeholders,” said Mr. Shallcross. "I look forward to quickly contributing to the next stage in Cytomedix's evolution as a fully integrated organization focused on innovation and value creation."
Mr. Shallcross replaces Andrew Maslan, CPA who has served as Chief Financial Officer of Cytomedix since 2005 and will resign effective May 10, 2013 to pursue further career opportunities.
Mr. Rosendale added, “The Board of Directors and I wish to thank Andrew for his significant contributions over the years. During his tenure, he and his team played an integral role in Cytomedix’s growth from a development stage company with seven employees, to a fully integrated commercial organization with an international reach and a robust corporate infrastructure.”
Mr. Shallcross presently serves as Executive Vice President and Chief Financial Officer of Empire Petroleum Partners, LLC, a motor fuel distributor. Previously, he served as Acting Chief Financial Officer for Sensors for Medicine and Science, Inc., a medical device company. Prior to that, he was Executive Vice President and Chief Financial Officer of Innocoll Holdings, Inc., a biopharmaceutical company specializing in the development and commercialization of collagen based products. Mr. Shallcross also held Chief Financial Officer and Treasurer positions at Vanda Pharmaceuticals, Inc., and at MiddleBrook Pharmaceuticals, Inc. (formally Advancis Pharmaceutical Corporation).
Mr. Shallcross is a certified public accountant and his experience includes equity and debt transactions that raised over $600 million in capital, including two initial public offerings. He has also worked on mergers and acquisitions, partnership and product development collaborations, strategic planning and budgeting, SEC reporting, and systems integration. He received a Bachelor’s degree in Accounting from the University of Illinois and an M.B.A. degree from the University of Chicago, Booth School of Business.
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
David Jorden, Executive Chairman LifeSci Advisors, LLC
(240) 499-2680 mrice@lifesciadvisors.com
(646) 597-6979
Conference Call Scheduled for Tuesday March 19th at 8:30am Eastern Time
GAITHERSBURG, Maryland – March 18, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, today reported financial results for the three and twelve months ended December 31, 2012.
Fourth Quarter 2012 Financial Highlights (all comparisons are with the 2011 fourth quarter)
- Product revenue of $2.0 million compared with $1.6 million, an increase of 27%.
- Consolidated revenue of $2.1 million compared with $3.0 million, a decrease of 29%.
- Net loss to common stockholders of $3.8 million, or $0.04 per share. This compares with a net income of $0.8 million, or $0.02 per share in the prior year.
- Cash and cash equivalents of approximately $2.6 million at December 31, 2012. In February 2013, the Company received $9.5 million of gross proceeds at closing as part of a comprehensive financing plan.
Fiscal Year 2012 Financial Highlights
- Consolidated revenue of $10.6 million compared with $7.2 million in 2011.
- Product revenue increased 23% year over year to $7.2 million from $5.9 million in 2011.
- Net loss to common stockholders for the year of $19.8 million, or ($0.24) per share, compared with $3.9 million, or ($0.08) per share in 2011.
Clinical and Corporate Highlights for the Fourth Quarter and Recent Weeks
- Earlier today, the Company announced that the Centers for Medicare & Medicaid Services (CMS) has issued coding and reimbursement claims instructions for autologous PRP in non-healing chronic wounds.
- On March 1st, 2012 CMS granted formal approval of the protocols for AutoloGel under Coverage with Evidence Development (CED).
- A comprehensive 2013 financing was executed to raise a total of up to $27.5 million, including $9.5 million in initial gross proceeds, comprised of a registered equity offering, a senior secured term loan and a committed equity facility.
- The Angel® Concentrated Platelet Rich Plasma (cPRP) System was approved for marketing in Australia.
- CE Mark in Europe was granted for the Angel cPRP System for processing blood and bone marrow aspirate.
- The FDA granted approval for Angel for processing bone marrow aspirate. This approval significantly expands the orthobiologic commercial opportunity for the Angel system, increasing the addressable market to include the 400,000 spinal fusion procedures performed each year in the U.S.
- A Phase 2 clinical study, in collaboration with the NIH, was announced for ALD-301 (Bright Cells) in patients with an intermittent claudication indication associated with peripheral artery disease.
Management Discussion
“We accomplished many of our growth objectives in 2012,” said Martin Rosendale, Chief Executive Officer of Cytomedix. “We were especially pleased by strong double-digit growth in Angel and AutoloGel sales. We have now placed more than 500 Angel Systems on a worldwide basis. Nearly 40,000 patients are currently being treated with the Angel System on an annualized basis.”
“A significant milestone in 2012 was the announcement that CMS had agreed to reimburse AutoloGel under the CED program. We were delighted to report earlier in this month that CMS has formally approved the clinical outcomes in the protocols we had submitted in response to the National Coverage Determination (NCD) memo. This means that clinicians can now use AutoloGel to treat Medicare patients with chronic wounds and receive reimbursement. This should have a significantly positive impact on AutoloGel revenues in 2013. Finally, we announced earlier today that CMS has issued coding and reimbursement instructions to its regional contractors. Consequently, we expect to begin treating Medicare beneficiaries with AutoloGel shortly and recording revenues for AutoloGel as a covered product.”
“Our Bright Cell technology pipeline continues to advance. We are enrolling patients in the RECOVER-Stroke Trial with ALD-401. This clinical trial is currently enrolling at 9 sites and we believe it’s on track to complete enrollment by the end of the year. We also announced late last year the signing of an agreement with NIH to collaborate on a Phase 2 clinical study with ALD-301 in patients with intermittent claudication, caused by peripheral arterial disease (PAD), This is the first randomized clinical trial that will look at the benefits of autologous stem cell therapy in this patient population.”
“We announced last month a $27.5 million comprehensive financing, which includes an equity raise, a tranched senior secured term loan facility, and a committed equity facility. We received approximately $9.5 million in initial gross proceeds with commitments for up to an additional $18 million. This capital infusion provides us with the necessary capital to fund our priority activities in 2013 which include the launch of AutoloGel under CED, sales expansion for the Angel cPRP System, business development and partnering activities, and completion of the RECOVER-Stroke phase 2 study.”
Financial Results
Three-Month Period Ended December 31, 2012
Consolidated revenue of $2.1 million was comprised of product sales of $2.0 million and $0.1 million from licensing and royalty fees. This compares with $3.0 million in consolidated revenue recorded in the same period of 2011. The difference year over year was due to lower license fees in 2012, partly offset by higher product sales.
Gross margin on product sales declined to 47% in 4Q12 from 55% in the 4Q11, primarily due to mix shift to lower margin machines and disposables sold to distributors in Europe, the Middle East, and Australia. Gross margin on product sales was up sequentially from 42% in 3Q12.
Fourth quarter cash margins on product sales were 56%. Cash margins on disposable products in the quarter were 61%. 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 in the fourth quarter were $4.6 million, a $2.6 million increase from the same period in 2011, primarily resulting from $1.5 million of legacy Aldagen business operating expense, salary increases (associated with new sales, marketing, operations, and administration positions), additional R&D expenses, stock compensation and general expenses associated with expanded commercial operations.
Total research and development expenses were $0.9 million in the fourth quarter of 2012, compared to no expense in the same period of 2011. Selling, general and administrative expenses were $3.7 million in the fourth quarter of 2012, compared to $2.0 million in the same period of 2011.
The Company recorded a net loss of ($3.8) million, or ($0.04) per share in the three-month period ended December 31, 2012, compared to a net income of $0.8 million, or $0.02 per share in the comparable period in 2011.
Twelve-Month Period Ended December 31, 2012
Consolidated revenue of $10.6 million was comprised of product sales of $7.2 million and $3.3 million from licensing and royalty fees. This represents a 46% increase from the $7.2 million in consolidated revenue recorded in the same period of 2011, which was comprised of product sales of $5.9 million and $1.3 million from licensing fees.
The $7.2 million in product revenues in 2012 included AutoloGel sales of $0.6 million and Angel sales of $6.6 million. Product sales growth of 23% over prior year was mainly driven by continuing commercial efforts to increase Angel sales. The 20% growth in Angel sales was driven by 8% growth domestically and 212% internationally.
Gross margin on product sales for the year decreased to 46% from 54% in 2011. The decrease was primarily due to shift to lower margin machines and disposables sold to distributors in Europe, the Middle East, and Australia.
Total research and development expenses were $3.4 million in 2012, as compared to $0.1 million in 2011. Selling, general, and administrative expenses were $16.2 million, which included non-cash charges of $2.3 million, compared to $7.9 million in 2011, which included non-cash charges of $0.5 million.
The Company recorded a net loss to common stockholders of ($19.8) million, or ($0.24) per basic and diluted share in the twelve-month period ended December 31, 2012, compared to a net loss of ($3.9) million, or ($0.08) per basic and diluted share in 2011.
Cash and Liquidity
Cash and cash equivalents were approximately $2.6 million as of December 31, 2012. In February 2013, the Company announced financing for up to $27.5 million overall, which included a tranched $7.5 million senior secured term loan facility, a $5 million equity raise, and a $15 million committed equity facility. Approximately $9.5 million of gross proceeds was received upon closing with commitments for up to an additional $18 million.
Cash used in operations was $4.2 million in the fourth quarter and $11.4 million for the year. There were approximately 94 million shares of common stock issued and outstanding as of December 31, 2012.
Conference Call & Webcast
Tuesday, March 19, 2013 @ 8:30am Eastern/5:30am Pacific
Domestic: 866-700-0161
International: 617-213-8832
Passcode: 42664770
Webcast: www.cytomedix.com
Replays – Available through March 26, 2013
Domestic: 888-286-8010
International: 617-801-6888
Passcode: 23856984
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 AutoloGelä 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 ("Lahr") 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.
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 execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company’s ability to successfully integrate the Aldagen acquisition, the Company’s ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company’s expectations of favorable future dialogue with potential strategic partners, and its ability 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, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Contacts:
Cytomedix, Inc. Investors
Martin Rosendale, Chief Executive Officer Michael Rice
Andrew Maslan, Chief Financial Officer LifeSci Advisors, LLC
David Jorden, Executive Chairman mrice@lifesciadvisors.com
(240) 499-2680 (646) 597-6979
Assignment of HCPCS code establishes reimbursement mechanism for physicians and other healthcare providers
GAITHERSBURG, Maryland -- March 18, 2013 – Cytomedix, Inc. (OTCQX: CMXI) (the “Company”), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Center for Medicare & Medicaid Services (CMS) has issued reimbursement coding and claims payment instructions to its regional contractors for the use of autologous PRP in chronic non-healing wounds. The assignment of a Healthcare Common Procedure Coding System (HCPCS) code establishes the reimbursement mechanism for physicians and other providers submitting claims for services provided to Medicare beneficiaries. A new HCPCS code, G-0460, has been assigned for:
“Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment.”
Martin Rosendale, Chief Executive Officer of Cytomedix commented, “The assignment of a HCPCS code for the use of AutoloGel is another critical element to the near term clinical treatment of chronic non-healing wounds with commercial reimbursement. We recently received protocol approval under the Coverage with Evidence Development (CED) program, and detailed coding and payment instructions have now been issued to CMS’ regional contractors and fiscal intermediaries. Our interaction with CMS continues to be productive and appropriately collaborative. We are enthusiastic that Medicare beneficiaries will soon be treated with AutoloGel and look forward to this opportunity to improve the health outcomes of patients dealing with non-healing chronic wounds.”
The assigned “G” code is a temporary code that will be used for the coverage of both the service and product initially. In addition to the “G” code, all Medicare claims submissions for treatments using the AutoloGel System will include an identification number that is specific for AutoloGel and the appropriate protocol. Medicare contractors have been instructed to pay claims in the following care settings: hospital outpatient departments, skilled nursing facilities, rural health clinics, comprehensive outpatient rehabilitation facilities, federally qualified health centers, and critical access hospitals. Claims processing will begin with an implementation date of July 1, 2013 for claims with dates of service after August 2, 2012.
About The AutoloGel™ System
The AutoloGel System utilizes a proprietary unique technology that enables the rapid isolation and activation of PRP from a patient’s own blood. The PRP is subsequently processed to produce a bioactive 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 impaired 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 on 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 with 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 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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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 commercialize the AutoloGel technology in the time frame and manner currently anticipated, 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.
Martin Rosendale, Chief Executive Officer
Andrew Maslan, Chief Financial Officer
David Jorden, Executive Chairman
(240) 499-2680
# # #
GAITHERSBURG, Maryland – March 15, 2013 – Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company’s Chief Operating Officer, has been invited to make a presentation at the Canaccord Genuity Musculoskeletal Conference, which will be held on Tuesday, March 19, 2013.
Presentation Details
Time: Tuesday, March 19 at 8:30am CT / 9.30am EDT
Room: Huron A Room, Track III
Location: Westin Michigan Avenue, 909 North Michigan Avenue, Chicago
A live webcast of the presentation may be accessed through the Company's website at www.cytomedix.com. A replay of the webcast will be available for one week following the conference.
Cytomedix will also be hosting an exhibit at the American Academy of Orthopedic Surgeons (AAOS) annual meeting, which will take place, March 19th – 22nd at the McCormick Place convention center in Chicago. Please visit the Company at booth #4453.
About the Canaccord Genuity Musculoskeletal Conference
The Canaccord Genuity Musculoskeletal Conference will explore the current state of orthopedics, biologics, imaging, robotic surgery, tissue sculpting, and regenerative tissue companies. This event is expected to have 60 companies present, both public and private. The conference directly precedes the American Academy of Orthopedic Surgeons Annual Meeting in Chicago.
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® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture 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. Michael Rice
Martin Rosendale, Chief Executive Officer Founding Partner
Andrew Maslan, Chief Financial Officer LifeSci Advisors LLC
David Jorden, Executive Chairman 646 597 6979
(240) 499-2680
# # #