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Aurix™
Aurix™ is a biodynamic hematogel that harnesses a patient's innate healing mechanisms to jumpstart the natural healing process for a broad range of chronic non-healing wounds.
Nuo Therapeutics
Nuo Therapeutics
Nuo Therapeutics, Inc. is a commercial stage medical device company that creates biodynamic therapies by focusing on harnessing the power of the patient's own innate healing potential.
Kit includes wound dressing kit and reagent kit. Supplied in quantities of 1, 5, and 10 kits.
• Clinically proven with demonstrated efficacy
• FDA approval for all chronic wounds
• Rapid point of care treatment, 1 minute spin
• Treatment for chronic wounds at any stage
• Reimbursed by CMS
Aurix™ is intended to be used at the point-of-care for the safe and rapid preparation of platelet-rich-plasma (PRP) gel from a small sample of a patient's own blood. Under supervision of a health care professional, the PRP gel produced by the Aurix™ system is suitable for exuding wounds, such as leg ulcers, pressure injuries, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Contraindicated for use in: patients known to be sensitive to components and/or materials of bovine origin; patients on chemotherapeutic agents; patients with the following abnormal laboratory test levels: hemoglobin
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Precautions: Throughout the processing procedure and the application of Aurix™, use universal precautions as defined by the facility policy and procedure manual.
Warnings: Reagent kit and dressing contain dry natural rubber. Aurix™ is produced with the use of bovine
thrombin.
Allergic reactions may be encountered in persons known to be sensitive to bovine materials.
Because of thrombin's action in the clotting mechanism, Aurix™ must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting may occur.
Storage, wound dressing kit: At room temperature, 15°C-25°C (59°F-77°F)
Storage, reagent kit: Upon arrival or within 14 days of shipment, store at 2°C-8°C (36°F-46°F)
Aurix™ is applied onto the wound area by first filling any undermined areas, tunnels, or sinus tracts using the blunt needle. Apply the selected primary dressing (non absorbent, non-cytotoxic) over the contact layer interface. Apply a secondary dressing (absorbent) to further secure and protect the primary dressing. These dressings may be left in place until the next Aurix™ treatment. If the secondary dressing becomes soiled, it should be changed. However, the primary dressing should be undisturbed for 24-48 hours post application. If the primary dressing is changed between Aurix™ applications, the wound bed may be carefully cleaned using extreme care to avoid disturbing new granulation tissue. No cytotoxic cleansers, anti-infectives, or pressurized cleansing should be used. Appropriate moist wound dressings may then be applied until the next Aurix™ application.
TECHNICAL SPECIFICATIONS:
The Aurix System™ includes: Aurix™ Centrifuge II leased from Nuo Therapeutics, Aurix System™ Wound Dressing Kit, Aurix System™ Reagent Kit, A single application license to use the patented PRP gel process
The Aurix System™ Wound Dressing Kit contains single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the Aurix™. The Aurix System™ Reagent Kit contains components, such as thrombin, that activate platelets and ascorbic acid which assist with the gel consistency. Our small, quiet portable centrifuge has a 60 second spin cycle to produce biodynamic hematogel efficiently at the point-of-care. The disposable kit components eliminate shelf life and transportation issues. The small-volume blood draw, ease of operation and portability make the Aurix System™ ideal for all types of clinical care settings.
