GAITHERSBURG, MD--(Marketwire -09/05/12)- Cytomedix, Inc. (CMXI), a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company's AutoloGel™ System will be highlighted in an oral abstract and a poster presentation at the 4th Congress of the World Union of Wound Healing Societies (WUWHS 2012) being held from September 2-6, in Yokohama, Japan.
The AutoloGel System is a device for the production of autologous platelet rich plasma ("PRP") gel, and is the only PRP device cleared by the U.S. Food and Drug Administration ("FDA") for use in wound management.
"The Impact of Autologous Platelet Rich Plasma (PRP) Gel on Chronic Wounds" will be presented September 5th from 3:00 to 4:30 p.m. JST as part of the Tissue Engineering and Regenerative Medicines in Wound Healing session. The poster, OR 206, will be presented by Laura Parnell, MSc, CWS, Precision Consulting on behalf of Carelyn P. Fylling, RN, MSN, CWS, CLNC, Vice President of Professional Services of Cytomedix and lead author on the poster.
Key Study Findings (all data reflects mean outcomes)
- In 2.2 treatments over 2.8 weeks, 90.5% (258/285) of wounds decreased 63.6% in volume and 86.3% (246/285) of wounds reduced 47.5% in area
- In 2.8 treatments over 2.2 weeks, 89.4% (59/66) of wounds with undermining reduced 71.9% in size.
- In 2.5 treatments over 1.8 weeks, 85.7% (24/28) of wounds with sinus tracts/tunneling had a mean reduction of 49.3% in depth.
- Wounds in patients with low hemoglobin ( ≤ 10.5) and low albumin ( ≤ 2.5) progressed to healing as rapidly as those with normal values
The study concluded that AutoloGel PRP Gel "initiated rapid size reduction in long-standing non-healing wounds of multiple etiologies in multiple health care sites even in patients with compromised status."
In addition, Dr. Chugo Rinoie, DPM, ABPO, CWS, Chief of Podiatric Surgery, Wound Healing Center, Methodist Hospital of Southern California, Arcadia, Calif., and Medical Director, Millennia Wound Management, Inc., Los Angeles, will present Poster 125, entitled "Healing Complex, Severe Diabetic and Ischemic Wounds in Japan Using Platelet-Rich Plasma Gel" in the Exhibit Hall as part of the Diabetic Foot, Critical Limb Ischemia and Foot Care session.
"We are honored to have these two presentations of positive data in support of the use of AutoloGel to accelerate wound healing in a variety of chronic wounds selected for presentation at WUWHS 2012, as more than 1,200 abstracts were submitted for inclusion at this prestigious international Congress," noted Martin P. Rosendale, Chief Executive Officer of Cytomedix. "The data from these studies support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of healing, speed and progress to healing as compared with previous experience with standard wound care alone. The complexity and co-morbidities associated with the wounds treated in these studies would have excluded them from any randomized controlled trial, making the findings from these real-world studies even more compelling."
"We believe we will continue to generate data such as these through the comprehensive collection of evidence we are undertaking through the Centers for Medicare and Medicaid Services' Coverage with Evidence Development program. We are confident such data will continue to strongly support the ongoing coverage for autologous PRP gel for the benefit of the various stakeholders in improving clinical wound care outcomes while lowering overall costs," added Mr. Rosendale.
About the Congress of the World Union of Wound Healing Society
The Congress of the World Union of Wound Healing Societies is held once every four years and provides an international forum for announcement of the latest research relating to wound healing that draws between 3,500 to 5,000 clinicians, researchers and professionals who serve the wound care markets around the world. The Congress also helps to ensure the exchange of information, the improvement and development of education, international person-to-person support and the promotion of industrial collaboration. The ultimate aim is to develop the field of wound healing. Despite the fact that "wounds" are a fundamental component and important target for surgery, there are still many factors that have yet to be clarified or fully understood.
About Cytomedix, Inc.
Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel™ System, cleared by the FDA for wound care and the Angel® Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDHbr") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit www.cytomedix.com.
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's reimbursement related efforts, the Company's ability to capitalize on the benefits of the above-referenced CMS determination, the Company's ability to successfully and favorably conclude the negotiations and related discussions with the above-referenced global pharmaceutical company, the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.
- Wound Healing
Chief Executive Officer
Chief Financial Officer
Anne Marie Fields