GAITHERSBURG, Md., Feb. 19, 2015 (GLOBE NEWSWIRE) -- Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced the initiation of a new clinical study (Au Study) that is comprised of three randomized controlled protocols that examine the efficacy of Aurix™, a biodynamic hematogel, for use in diabetic foot ulcers, venous leg ulcers and pressure ulcers (bed sores).
The aim of this study is to demonstrate the effectiveness of complete wound healing in three prospective, open-label, randomized studies in which diabetic foot ulcers, venous leg ulcers and pressure ulcers, respectively, will be treated using Aurix and standard care, and compared one-to-one with patients receiving Usual and Customary Care.
“We’re pleased to be participating in Nuo Therapeutics’ post-market Au Study, as we believe Aurix has the potential to substantially improve the quality of care for people suffering from chronic, non-healing wounds, at a significantly lower cost than alternative treatments,” said Michael Manuel, MD, Medical Director of Wound Care Solutions at Blanchard Valley Hospital.
The Centers for Medicare and Medicaid Services (CMS) has approved these amended protocols under its Coverage with Evidence Development (CED) Program to address coverage of items and services that require additional evidence of the clinical and economic impact on Medicare beneficiary health outcomes. Under this program, CMS will reimburse for Aurix when health care providers agree to collect their Medicare patients’ treatment data for inclusion in the study database.
“We are pleased to have now refined and finalized with CMS the three protocols we will use to populate what will be one of the largest wound care studies of its kind in the U.S.,” said Martin Rosendale, Chief Executive Officer of Nuo Therapeutics. “Since we launched Aurix in October of 2014, our commercial team has been working with customers to prepare them for when the amended protocols would be finalized and the study would formally launch. That time is now.”
The Au Study is an evolution of the Aurix Data Collection program that, with implementation of these amended protocols to include diabetic foot ulcers, venous leg ulcers and pressure ulcers, may integrate into current physician practice operations and broaden valuable inclusion criteria, allowing for greater patient access to the Aurix System in centers across the U.S.
Patient recruitment for the Au Study is underway.
For more information about the Au Study, please visit www.TheAuStudy.com.
About Nuo Therapeutics
Nuo Therapeutics, Inc. is a biomedical company that pioneers leading-edge biodynamic therapies for wound care. The Company’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.nuot.com.
About Aurix
Aurix is the first platelet and plasma therapy system to be cleared by FDA for the management of a broad range of ulcers and exuding wounds, including:
- All types (diabetic foot ulcer, venous leg ulcer, pressure ulcer, etc.),
- All morphologies (partial thickness, full thickness and complex wounds),
- All severities (tunneling, sinus tract, bone, tendon and hardware exposure).
Unlike other cellular-based treatment options, Aurix is an autologous biodynamic hematogel that is derived from a patient’s own platelets and plasma. The product is used at the point-of-care to stimulate the natural wound healing process from deep within the wound bed. For additional information, please visit www.AurixSystem.com.
About Coverage with Evidence Development
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 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 may reimburse for promising new technologies while further evidence is developed. As such, Aurix is nationally covered for the approved protocols under the CED program.
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 Nuo Therapeutics actual results may differ materially due to a number of factors, many of which are beyond Nuo Therapeutics’ ability to predict or control, including, without limitation, the Company’s ability to expand and commercialize its products, to secure (directly or indirectly) necessary regulatory approvals, 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 estimate the potential of the wound care market and to commercialize any of its rebranded products / therapies, successfully execute its Aurix (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 2015 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 Nuo Therapeutics 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 Nuo Therapeutics, Inc. Nuo Therapeutics 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, Nuo Therapeutics 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 September 30, 2014, and other subsequent public filings. These filings are available at www.sec.gov .
CONTACT: Nuo Therapeutics, Inc. Martin Rosendale, CEO Steven Shallcross, EVP/ CFO 240-499-2680 Investors: The Ruth Group Lee Roth 646-536-7012 lroth@theruthgroup.com
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