Nuo Therapeutics Initiates Phase 4 Study of Aurix™ under CMS Coverage with Evidence Development Program
Gaithersburg, MD – February 19, 2015 – 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 Therapuetics’ 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.
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.