GAITHERSBURG, Md., Oct. 14, 2014 (GLOBE NEWSWIRE) -- Cytomedix (OTCQX:CMXI), a pioneer in biodynamic therapies, today announced that it has re-launched its AutoloGel chronic wound care system under the AurixTM brand. The formal launch of Aurix is an integral part of the Company's full scale marketing plan for the commercialization of Aurix in the multi-billion dollar U.S. chronic wound care market.
The Aurix System™ website (www.aurixsystem.com) launched today in preparation for management's participation at The Symposium on Advanced Wound Care (SAWC) Fall Meeting, being held October 16-18, 2014 in Las Vegas, Nevada.
"Since April of this year we have been laser-focused on refining the marketing strategy and commercial model, including recruiting the sales team to successfully launch Aurix into the U.S. marketplace," said Dean Tozer, Chief Commercial Officer of Cytomedix. "With a direct sales team of nearly twenty representatives now in place in the hospital outpatient as well as Veterans Affairs settings, we are poised to begin full scale product promotion. The broad Aurix label provides clearance from the FDA for the product to treat multiple types of chronic wounds, which total more than 6 million wounds every year in the United States."
The Aurix System itself has not been changed in any way and will continue to offer physicians and patients a proven solution for hard to treat skin ulcers and wounds that can have significant impact on a patient's quality of life. Aurix is a biodynamic hematogel that harnesses a patient's innate healing mechanisms in order to jumpstart the healing process from deep within the wound bed.
Chief Executive Officer, Marin Rosendale added, "Over the last 10 months, Cytomedix has transformed its organizational focus, with an emphasis on developing the commercial capabilities necessary to support this re-launch. We have out-licensed non-core assets, closed our R&D facility and raised the necessary capital to build and equip a world-class commercial team. The launch of Aurix signals the first major milestone in this new commercial strategy."
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.
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 SystemTM 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.
CONTACT: Cytomedix, Inc. Martin Rosendale, CEO Steven Shallcross, EVP/CFO 240-499-2680 email@example.com firstname.lastname@example.org Investors The Ruth Group Lee Roth 646-536-7012 email@example.com Media The Ruth Group Kirsten Thomas 646-536-7014 firstname.lastname@example.orgSource:Cytomedix, Inc.