http://www.ePlasty.com
GAITHERSBURG, Md. (September 22, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that findings from a comprehensive systematic review and meta-analysis (statistical pooling) of the use of platelet rich plasma (PRP) gel in wound healing were published online in ePlasty, the open-access journal of the Journal of Plastic Surgery. The article, entitled “Use of Platelet Rich Plasma Gel on Wound Healing: A Systematic Review and Meta-Analysis,” can be viewed at the ePlasty website at:
http://www.eplasty.com/index.php?option=com_content&view=article&id=582&catid=15&Itemid=116
According to the review, “On the basis of the last 10 years of research, the results of this systematic review and meta-analysis suggest that PRP therapy can positively impact wound healing and associated factors such as pain and infection in both chronic and acute cutaneous wounds.”
The systematic review was performed to assess studies in cutaneous skin wounds treated with autologous PRP gel. Studies assessing healing efficacy such as complete or partial wound healing, time to heal, healing trajectory, velocity or rate, and wound size reduction were considered critical for this systematic review.
For assessment of PRP treatment human intervention trials, only randomized, controlled trials and comparative studies published in peer-reviewed journals or presented at scientific meetings were considered. There were 21 published studies that met these criteria and were included in this systematic review. Given the physiological and healing differences between acute surgical and chronic wounds, the citations were divided by study design and by type of wound prior to review and meta-analysis. The primary outcomes assessed in this systematic review were the impact of PRP on wound healing and related measures such as infection and pain. Meta-analysis was carried out on those studies that had the following compatible outcomes and reasonable clinical homogeneity: (1) complete wound healing; (2) infection reduction; and (3) pain reduction.
The review showed that in both chronic and acute surgical wound studies, complete wound closure was more likely in wounds treated with PRP therapy. Similar partial healing and wound area/volume reduction outcomes were noted more frequently with the PRP-treated wounds.
The meta-analysis of chronic wound studies revealed PRP therapy is significantly favored for complete healing. Additionally, studies of acute surgical wounds with primary closure demonstrated that the presence of infection and pain was reduced in PRP-treated wounds. Finally, this meta-analysis and other systematic reviews show PRP has sufficient efficacy to stimulate wound healing.
“A systematic review is the highest standard of evidence-based medicine in the scientific community. We are pleased that this comprehensive review and analysis confirms the effectiveness of PRP to successfully treat both chronic and acute surgical wounds, underscoring the value of our AutoloGel™ PRP in chronic wounds and our Angel® PRP to treat acute surgical wounds. In addition, the review revealed that the use of PRP in acute surgical wounds reduced pain levels and infection rates,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix.
“Compelling clinical data such as these should continue to drive adoption of our regenerative biotherapies. Addditionally, this publication and other peer-reviewed publications recently released are important components of the growing body of relevant clinical evidence that underscores our commitment to appropriate coverage and payor reimbursement for standardized autologous PRP as a treatment option for chronic wounds,” added Mr. Rosendale.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination on the submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. LHA
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680
Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
GAITHERSBURG, Md. (September 21, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced publication of an article entitled “Analysis of run-in and treatment data in a wound outcomes registry: clinical impact of topical platelet-rich plasma gel on healing trajectory” in the International Wound Journal as an ePublication ahead of print. The abstract of the publication may be viewed online at:
http://onlinelibrary.wiley.com/doi/10.1111/j.1742-481X.2011.00868.x/abstract
About the Study
Randomized controlled trials in chronic wounds typically exclude patients with comorbidities and other confounding factors. Well-designed observational studies can provide complementary clinical evidence that randomized trials cannot address. This study determined if wound care registry outcomes could be an alternative data source and if the results would be robust and valid.
The entire wound registry consisted of 285 wounds of various etiologies. Within the registry, historical run-in data on 46 wounds in a subset of patients was available and these wounds were representative of the full 285 wound group. The wounds in this subset were recalcitrant to standard and advanced wound care and had remained unhealed during the run-in period with the mean wound age at study start of 52.4 weeks. The results indicated that the short-term use of PRP appears to convert many non-healing wounds into actively healing ones.
Summary of Key Findings
- Statistically significant differences for wound area and depth were observed between run-in and post-treatment period at multiple time points.
- There was a 33% reduction in wound area and a 44% reduction in wound depth between the pre-treatment and post-treatment assessments.
- Wound trajectory comparisons between the last run-in pretreatment and post-PRP treatment showed statistically significant improvement in both wound area (p=0.028) and depth (p=0.00034).
- The length of time to reach the ≥50% reduction marker was >2.5 weeks longer for area and >3.0 weeks longer for depth reduction during the run-in pretreatment time in contrast to the post-PRP treatment time.
“Using run-in pretreatment data and post-PRP treatment data provides insight into the clinical practice and realities encountered by chronic wound care clinicians. Wound care registries can be valuable in analyzing clinical practice outcomes and this unique approach for evaluating treatment results could set a new standard for wound care studies,” noted Thomas E. Serena, MD, FACS, Founder and CEO of The Serena Group™.
“This is a particularly compelling study because each patient served as his or her own control and the pretreatment run-in periods were included. Moreover, the wound data and outcomes came from real-world patients with a variety of wound etiologies, comorbidities and other confounding factors,” commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination on the submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. LHA
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680
Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
GAITHERSBURG, Md. (September 15, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced the launch of the Company’s Hair Restoration Wound Care Program at the 19th Annual Scientific Meeting of the International Society of Hair Restoration Surgeons being held from September 14-18 in Anchorage, Alaska.
Cytomedix is showcasing the AutoloGel™ System at their exhibit where hair restoration surgeons can learn more about the benefits of AutoloGel PRP Gel to enhance outcomes in hair transplant surgery. In conjunction with this outreach, the Company introduced its web-based marketing initiative with the launch of www.prphairrestoration.com, a website designed to provide hair restoration specialists with the tools to integrate PRP Gel into their post-operative wound care protocols, the rationale for use and the science behind PRP for follicular unit transplant, as well as to generate new patient referrals. The site also provides a fast-growing list of surgeons offering AutoloGel PRP in their practice.
Alan J. Bauman, M.D., Board Certified hair restoration surgeon, Boca Raton, Florida, stated “The use of AutoloGel PRP applied to hair transplant wounds has had a positive impact on the rate and quality of post-operative care. Both our experienced team and our patients are delighted with the simplicity and speed of the PRP gel technique and the visual improvement in wound recovery one day post-surgery.”
“Platelets are crucial to the complete healing of wounds, whether accidental or surgical. In order for a wound to heal naturally, its environment must have the right supply of nutrients. AutoloGel PRP delivers a physiologically relevant concentration of platelets thereby stimulating the natural healing processes in the wounds at the donor and recipient sites during the transplant procedure,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. “Previous studies using AutoloGel PRP by Robert J. Reese, D.O., a Board Certified hair restoration surgeon, Edina, Minnesota, have shown improved healing with less crusting, swelling, and redness after the hair transplant procedure.”
“We are excited to launch our PRP Hair Restoration Wound Care Program before an audience of the world’s leading hair restoration surgeons. With over 100,000 surgical hair restoration procedures performed annually in the U.S.[1], we believe this is an attractive market opportunity for us. AutoloGel is the only PRP product that is cleared by the U.S. Food and Drug Administration for wound management and Cytomedix is the only PRP exhibitor at this important scientific meeting. We expect exposure at ISHRS to drive use of AutoloGel PRP for this private pay indication,” added Mr. Rosendale.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination on the submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. LHA
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680
Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
[1] ISHRS 2010 Practice Census Results
Webcast Scheduled for September 12, 2011 at 4:05 p.m. Eastern Time
ROCKVILLE, Md. (September 8, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will participate in the Rodman & Renshaw 13th Annual Global Investment Conference taking place September 12-13, 2011 at the Waldorf Astoria Hotel in New York City.
Martin Rosendale, President and CEO of Cytomedix, will present a corporate update on Monday, September 12, 2011 at 4:05 p.m. (Eastern time) in which he will provide an overview of Cytomedix’s progress and plans for the future.
Company management will be available for one-on-one meetings with investors participating in the Rodman & Renshaw Global Investment Conference. For those who would like to schedule an appointment with Cytomedix’s management, please contact Anne Marie Fields, LHA, at 212-838-3777 or at afields@lhai.com or contact your Rodman & Renshaw representative.
The presentation will be webcast live at www.cytomedix.com where it will also be archived for 90 days and at http://www.wsw.com/webcast/rrshq20/cmxi.
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination on the submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. LHA
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680
Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
Two Studies Demonstrate Rapid and Effective Wound Improvement with the AutoloGel™ System in a Variety of Indications
GAITHERSBURG, Md. (September 7, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that two poster presentations highlighting the clinical merits of the Company’s AutoloGel™ System in wound management will be presented at the 26th Annual Clinical Symposium on Advances in Skin & Wound Care: The Conference for Prevention and Healing, to be held at the Gaylord National Hotel & Convention Center in National Harbor, Maryland from September 9 through 12, 2011.
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 for use in wound management.
The Advances in Skin & Wound Care Poster Session will take place Saturday, September 10th from 10:30 a.m. to 1:30 p.m. and from 5:00 p.m. to 7:00 p.m. in the Exhibit Hall. Poster presenters will be available during these times. The following posters highlighting Cytomedix’s PRP technology will be presented.
- Using Platelet Rich Plasma Gel (PRP Gel) for Rapid Size Reduction in Pressure Ulcers Presented by Carelyn P. Fylling, R.N., M.S.N., C.W.S, C.L.N.C., Vice President, Professional Services and Laurie M. Rappl, PT, DPT, CSW, Clinical Development Liaison at Cytomedix, Inc.
- Positive Wound Healing Progress Using Platelet Rich Plasma (PRP) Gel in Patients With Low Albumin and Hemoglobin Presented by Carelyn P. Fylling
“We are delighted to have these two compelling clinical studies presented at this year’s conference before an audience of some 1,000 multidisciplinary practitioners, including nurses, physicians, podiatrists, physical therapists, dietitians and others who manage skin and wound care patients across the continuum of care. These data underscore the clinical utility of AutoloGel to rapidly and effectively improve healing in a variety of wound management indications,” noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. “The ongoing presentation and publication of positive clinical data forms the foundation of our sales and marketing strategy, and should provide the impetus to drive clinical adoption of the AutoloGel System as it significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life for patients suffering with these non-healing wounds.”
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination by the CMS following the Company’s submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
GAITHERSBURG, Md. (September 1, 2011) – Cytomedix, Inc. (OTC/BB: CMXI) (the “Company”), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, announced today the recent submission of a 510(k) to the U.S. Food and Drug Administration (“FDA”) for use of the Angel® Whole Blood Separation System for processing a bone marrow aspirate. The expanded indication includes processing a mixture of blood and bone marrow, a rich source of stem cells.
In vitro performance testing supporting the 510(k) compared Cytomedix’s Angel System to the predicate device for preparing platelet rich plasma (“PRP”) from blood and bone marrow. The test results yielded statistically significant data showing the Angel System:
- increased the concentrations of hematopoietic progenitor/stem cells;
- reduced the presence of pro-inflammatory cells that can be detrimental for treating certain medical indications; and
- provided better separation of PRP and red blood cells compared with the predicate device
Expanded use of the Angel System for the production of PRP containing stem cells increases Cytomedix’s ability to support and advance markets within personalized regenerative medicine. In the U.S., approximately 300,000 spinal fusion procedures are perfomed each year and the application of bone marrow or bone marrow concentrates has been the historical gold standard to support effective fusion. The biologics market associated with spinal fusion procedures is approximately $800 million annually. While the Angel System is currently being used at a limited number of clinical sites for this purpose, FDA clearance for this expanded indication will allow Cytomedix to market the Angel System for this significant opportunity. The ease-of–use, separation efficiencies, and high quality output, are of notable benefit and competitive advantage compared with other commercially available systems.
In addition to spinal fusion procedures, the stem cell enriched concentrates produced by the Angel System offer clinical opportunities currently being evaluated for the treatment of critical limb ischemia and cardiac ischemia. Significant clinical investigation is underway in numerous studies in both therapeutic conditions involving various aspects of autologous stem cells. The Angel System is well positioned as a best-in-class device to participate in this evolving therapeutic arena.
“We are pleased to have filed this 510(k) for a bone marrow concentrate indication as it expands the versatility and competitive positioning of the Angel System for both new and existing customers. Importantly, this indication serves a number of large markets that we believe the Angel System is well-poised to penetrate,” said Martin P. Rosendale, Chief Executive Officer of Cytomedix. “We continue to explore a variety of indications where the Angel System can provide added therapeutic benefit and expect its clinical results and ease-of-use will help drive sales in these expanded market indications.”
About Cytomedix, Inc.
Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of platelet rich plasma (“PRP”) gel derived from the patient’s own blood for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (“PPP”) and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. The Company is pursuing a multi-faceted strategy to penetrate the chronic wound market with its products, as well as opportunities for the application of AutoloGel™ and PRP technology into other markets such as hair transplantation and orthopedics while actively seeking complementary products for the wound care market. Additional information regarding Cytomedix is available at www.cytomedix.com.
Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the likelihood of obtaining a positive reimbursement determination by the CMS following the Company’s submission, the likelihood and the extent of beneficial effect of such determination on CMS costs and care, viability and effectiveness of the Company’s sales approach and overall marketing strategies, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated, the Company’s ability to successfully integrate the Angel® and activAT® product lines into its existing business, to assume and satisfy certain liabilities related to the Angel® and activAT® product lines. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as “believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.
Contacts:
Cytomedix, Inc. Lippert/Heilshorn & Associates
David Jorden, Executive Board Member Anne Marie Fields
Martin Rosendale, CEO (afields@lhai.com)
Andrew Maslan, CFO (212) 838-3777
(240) 499-2680 Bruce Voss
(bvoss@lhai.com)
(310) 691-7100