Nuo Therapeutics' Au Study Goes Digital
Gaithersburg, MD – July 30, 2015 – Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced that its previously reported collaboration with Net Health to add data collection functionality within WoundExpert® for the Aurix™ Coverage with Evidence Development (CED) program (Au Study) will go live in August.
WoundExpert, a leading electronic health record (EHR) software for outpatient wound care facilities, now has integrated functionality that makes identifying and tracking patients in Nuo's Au Study paper-free, easy, and efficient. Once launched, on August 17th, WoundExpert clients that elect to participate in the Au Study can turn on this functionality in their systems and find the necessary patient screening and data collection protocols embedded into their workflow. Additionally, the functionality will assist participating WoundExpert clients by generating documentation required for the Medicare claims process.
"The Au Study is a pioneering effort in wound care, yet until now, patient screening and data collection for our study have been paper-based processes," said Dean Tozer, Chief Commercial Officer of Nuo Therapeutics. "Feedback we have received from site participants indicated a desire for a simpler and more streamlined way of identifying and tracking patients enrolled in the Au Study, and we are thrilled to be collaborating with Net Health to offer them this solution. We believe this new WoundExpert functionality will remove some of the barriers previously responsible for the slower than anticipated enrollment in this study."
The Au Study, launched under the Centers for Medicare & Medicaid Services (CMS) CED program, is comprised of three randomized controlled protocols that examine the efficacy of Aurix, a biodynamic hematogel used at the point-of-care for the treatment of diabetic foot ulcers, venous leg ulcers and pressure ulcers.
"We're pleased to be working with Nuo Therapeutics on this CED program because we believe in driving quality of care, and expanding care options, through data-based evidence," said Christopher F. Hayes, Chief Technology Officer of Net Health.
With this integrated functionality, Au Study sites that use WoundExpert will be alerted when a patient is pre-qualified to participate in the Au Study. In addition, WoundExpert will allow the site to generate documentation required to confirm the patient's eligibility for study participation and Medicare reimbursement, as well as capture the necessary study-related data during typical wound care visits.
About Nuo Therapeutics
Nuo Therapeutics, Inc. (the "Company") 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.
Safe Harbor Statement
This press release contains "forward-looking statements" pursuant to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "believes", "forecasted," "projects," "is expected," "remain confident," "will", "estimate," "target," "plan," "should", "would," "is likely," "may," and/or similar expressions. The information contained in the forward-looking statements, including without limitation those about the Company's estimated revenue, product sales, product placements, gross margin, operating expenses and other income or expenses, is inherently uncertain, and the Company's actual results may differ materially from these forward-looking statements. These forward-looking statements include, without limitation, statements concerning the Company's ability to successfully launch and rebrand its wound care system in the timeframe and to the extent anticipated, product placement with the VA System, enlistment of wound care centers, 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 sales and commercialization strategies, the Company's ability to commercialize Aurix as expected and derive financial and commercial benefits of such launch, to achieve Aurix expected reimbursement rates beyond 2015, the Company's ability to comply with the debt covenants and restrictions under its existing loan facilities including from Deerfield Management Company, L.P., 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, and its ability to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatment. Forward-looking statements are also subject to many risks and uncertainties that could cause our actual results and the timing of certain events to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, risks as to whether the Company may achieve future favorable CMS determinations relating to the reimbursement rates for Aurix, the Company's ability 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 ability to realize its expectations of favorable future dialogue with potential strategic partners, its ability to identify, proceed with and consummate strategic initiatives, its ability to successfully manage contemplated clinical trials, its ability to manage and address the capital needs, human resources, management, compliance and other challenges of a larger, more complex and integrated business enterprise, the viability and effectiveness of the Company's sales approach and overall marketing strategies, its ability to secure Medicare reimbursements at adequate levels; its ability to realize commercial success or acceptance by the medical community, the Company's ability to raise additional capital or issue additional securities and to continue as a going concern, and the Company's ability to execute on its strategy to market the Aurix System as contemplated, and other risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Undue reliance should not be placed on forward-looking information. Nuo Therapeutics operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. 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.