Nuo Therapeutics Receives Favorable CMS Hospital Outpatient Payment Final Ruling for Aurix System
Gaithersburg, MD – November 2, 2015 – Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced the Aurix™ System reimbursement rate under the Hospital Outpatient Prospective Payment System (HOPPS) for the calendar year 2016 has been published by the Centers for Medicare and Medicaid Services (CMS). Aurix was placed in Ambulatory Payment Classification (APC) 5054 (Level 4 Skin Procedures) and will be reimbursed at a national average rate of $1,411 per application effective January 1, 2016. In the text of the ruling, CMS commented they believe the geometric mean cost of the services underlying Aurix is comparable to the geometric mean cost of APC 5054.
"We are extremely pleased with the final HOPPS ruling and are very appreciative of the consideration we received from CMS in response to our request that Aurix be placed in an APC category consistent with the resources required to administer the product in a hospital outpatient setting," said Dean Tozer, President and Chief Executive Officer of Nuo. "We look forward to commenting further about how the 2016 reimbursement rate will impact our plans and expectations for the ongoing commercialization of Aurix during our upcoming third quarter earnings call."
About Nuo Therapeutics
Nuo Therapeutics, Inc. (the "Company" or "Nuo") 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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. 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 "anticipate," "believe," "estimate," "expect," "intend," "the facts suggest," "will be," "will continue," "will likely result" or, in each case, their negative, or words or expressions of similar meaning.
These forward-looking statements include, but are not limited to, our limited sources of working capital; our need for substantial additional financing; our history of losses and future expectations; our short history and limited operating experience; our inability to comply with requirements imposed upon us by certain financing agreements, including from Deerfield Management Company, L.P., or Deerfield; our receipt of a gross royalty stream pursuant to the amended and restated license agreement; that our receipt of a gross royalty stream pursuant to the amended and restated license agreement with Arthrex will offer us a more predictable and valuable royalty stream over the life of that agreement; that Deerfield, or anyone else, will provide ongoing capital support; that Deerfield will agree to restructure our existing credit facility; our ability to implement our realignment plan; our ability to successfully implement the amended and restated license agreement with Arthrex; whether CMS will continue to consider its treatment of the geometric mean cost of the services underlying Aurix to be comparable to the geometric mean cost of APC 5054 in the future; our ability to maintain classification of Aurix as APC 5054 and continue to be reimbursed at a profitable national average rate per application in the future; the liquidity of our common stock resulting from its trading on the OTC Markets Group OTCQX marketplace; our reliance on several single source suppliers; our ability to secure additional debt or equity financing; our ability to protect our intellectual property; our compliance with governmental regulations; the success of our clinical trials; our ability to contract with healthcare providers; our ability to successfully sell and market the Aurix System; our ability to secure Medicare reimbursements at adequate levels; the acceptance of our products by the medical community; our ability to source raw materials at affordable costs; our ability to attract and retain key personnel; our ability to successfully pursue strategic collaborations to help develop, support or commercialize our products; the volatility of our stock price; whether we have correctly estimated the resources necessary to execute under our existing customer agreements and seek partners, co-developers or acquirers for our regenerative therapies under the realignment plan; our ability to successfully attract and retain a larger workforce or one with a different skillset, if ultimately required to implement the realignment plan successfully; whether we accurately estimated the cash and cash equivalents necessary to finance our operations through the fourth quarter of 2015, and other risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements, and our business, results of operations, financial condition and cash flows may be materially and adversely affected. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results. Except to the extent required by applicable law or rules, the Company undertakes no obligation and does not intend to update, revise or otherwise publicly release any revisions to its forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events.