Cytomedix (OTCQX:CMXI), a pioneer in biodynamic therapies, today announced that it will introduce its chronic wound care system, AurixTM, during the Symposium on Advanced Wound Care (SAWC) Fall Meeting, being held October 16-18, 2014 in Las Vegas, Nevada. Cytomedix will be presenting the Aurix System™ at the Company’s exhibition booth (#511).
In addition to introducing Aurix, the Company will discuss its recent collaboration with Pittsburgh-based Net Health. Net Health is integrating functionality into its WoundExpert® software that will allow wound care centers to identify with greater ease patients who may qualify for the Aurix Coverage with Evidence Development (CED) program and establish necessary tracking capabilities for those patients. WoundExpert is the market leading clinical documentation and EHR software in the US wound care industry.
Cytomedix and Net Health will co-sponsor a private event to mark the launch of Aurix on Thursday, October 16, from 8-10 p.m. PT, at the High Roller—the largest Ferris wheel in the world. To gain access to the event, WoundExpert customers should stop by the Cytomedix booth (#511) during exhibit hours on Thursday and request a gold wristband from an Aurix representative.
A case study highlighting the unique healing ability of Aurix titled “Platelet Rich Plasma Gel Consistently Reduces Pressure Ulcer Size” (Poster #CS-020) has been accepted for poster presentation and will be discussed by lead author Carelyn P. Fylling, R.N., M.S.N., C.W.S, C.L.N.C., Vice President, Professional Services on Friday, October 17 starting at 8:00 a.m. PT. The findings, which demonstrated that Aurix reduced pressure ulcer area by 46-50% and volume by 60-67% in just 3.5 weeks, were released and presented during an oral presentation at the SAWC Spring 2014 meeting earlier this year.
Chief Commercial Officer Dean Tozer commented, “We are excited to officially introduce Aurix, our best-in-class wound care system, at such a prominent industry event. As one of the largest and most respected multidisciplinary conferences in wound care, SAWC is the ideal platform to introduce Aurix and its unique healing capabilities to the wound care community. Throughout the event, we plan to educate physicians and potential wound center customers about the numerous benefits of Aurix as a highly effective, safe and individualized wound treatment system.”
Aurix is the first platelet and plasma therapy system to be cleared by the FDA for the management of ulcers and wounds of all types (diabetic foot ulcer, pressure ulcer, venous leg ulcer, etc.) and all severities (partial thickness, full thickness, and complex wounds). It can be used successfully on patients with tunneling, sinus tracts, bone and tendon exposure, and hardware exposure.
Unlike other cellular-based treatment options, Aurix is derived from a patient’s own platelets and plasma (autologous). Once applied, the product goes to work, stimulating the natural healing process to form tissue to fill in wound defects and help reduce wound volume. Aurix produces visible results in days, not weeks and is effective at all stages of wound care for non-healing wounds.
About Coverage with Evidence Development (CED)
The Centers for Medicare & Medicaid Services (CMS) relies on clinical evidence to determine whether particular items and services are reasonable and necessary. CMS developed the Coverage with Evidence Development (CED) Program to address coverage of items and services that were believed to be promising but whose ultimate impact on Medicare beneficiary health outcomes remained unconfirmed. Newly emerging, true “first in class” technological innovations may be more likely to have limited evidence of real world benefit in typical patient care settings. The CED program requires more evidence to be collected to determine the full potential benefit of new technologies. Under the CED program, Medicare reimburses for promising new technologies while further evidence is developed. As such, Aurix is nationally covered for the approved protocols under the CED program.
Cytomedix, Inc. is a biomedical company that pioneers leading-edge biodynamic therapies for wound care. Cytomedix’s flagship product, Aurix is a biodynamic hematogel that harnesses a patient’s innate regenerative abilities for the management of a variety of wounds. 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 launch and rebrand its wound care system in the timeframe and to the extent anticipated, the Company’s ability to commercialize any of its rebranded products / therapies, successfully execute its AurixTM (formerly AutoloGel) sales and commercialization strategies, the Company’s ability to launch Aurix as expected and derive financial and commercial benefits of such launch, to achieve Aurix expected reimbursement rates in 2014 and thereafter, the Company’s ability to comply with the debt covenants and restrictions under the existing loan facilities, the Company’s ability to realize expected benefits from the Arthrex licensing arrangement, the Company’s ability to collect the data necessary for the grant of the unconditional coverage, the Company’s ability to continue in its efforts to expand in the wound care market, its ability to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments, the likelihood of a favorable CMS determination relating to the reimbursement rates for Aurix, to successfully realize sales of the Angel Technology resulting in the royalty stream to the Company, 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 Aurix 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, 2013, the most recent Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014, and other subsequent public filings. These filings are available at www.sec.gov.
The Ruth Group for Cytomedix:
Lee Roth (Investors) / Kirsten Thomas (Media)
646-536-7012 / 7014