FDA Clearance and Indications
The Aurix System is the only platelet-based system to produce a proprietary biodynamic gel formulation that is FDA-cleared for wound management.
Indications for use from FDA clearance
The Aurix System is intended to be used at point-of-care for the safe and rapid preparation of platelet rich plasma (PRP) from a small sample of the patient’s own blood.
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 and surgically debrided wounds.
AURIX is indicated for the following:
- Stalled or difficult-to-manage wounds
- Full or partial thickness
- Exposed bone or tendon
- Undermining, sinus tracks, or tunnels
- Diabetic ulcers, venous ulcers, stage III-IV pressure injuries