NeoMatriX® Wound Matrix is intended for the management of wounds including:

 

 

 

 

 

 

 

 

 

 

 

This device is terminally sterilized using gamma irradiation and is intended for one-time use.

• Partial and full-thickness wounds

• Pressure ulcers

• Venous ulcers

• Diabetic ulcers

• Chronic vascular ulcers

• Tunneled/undermined wounds

• Surgical wounds (donor sites/grafts

   post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)

• Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears)

• Draining wounds

Biocompatibility & safety Testing

NeoMatriX® has been rigorously tested in accordance with recognized biocompatibility standards

 

 

 

 

 

 

 

 

 

• Cytotoxicity

• Sensitization

• Irritation/intracutaneous reactivity

• Acute systemic toxicity

• Pyrogenicity

• Subacute and sub-chronic toxicity

• Genotoxicity

• Endotoxin testing was conducted according to AAMI ST72

• Sterilization validation using gamma radiation to a sterility assurance level of 10-6

• Viral inactivation testing was also performed

• Pre-clinical testing showing non-inferiority in a porcine wound healing model

• Clinical testing indicating that NeoMatriX Wound Matrix does not raise     aimmunogenicity concerns when used in humans