Redermo Wound Matrix

The Redermo Wound Matrix is a sterile, single-use, absorbable three-dimensional matrix device composed of biodegradable polymer fibers. It is intended for managing various types of wounds including partial and full-thickness wounds, pressure ulcers, diabetic ulcers, surgical wounds, and trauma wounds by providing a scaffold for tissue healing and eventual complete degradation within approximately 28 days.

Redermo is composed of the same polymer materials (poly(lactic-co-glycolic) acid and polydioxanone) as the predicate device Restrata and uses identical electrospinning fabrication technology. Both devices are soft, pliable, trimmable, sterilized via E-beam sterilization with double sterile barrier packaging. Redermo includes less than 1% poloxamer 188 for wettability and includes internal desiccant packaging to extend shelf life.

ISO 10993 biocompatibility testing, ISO 10993-18 heavy metal safety testing, ISO 11137-2 sterilization validation (achieving 10^-6 SAL), and accelerated stability aging (183 days at 45°C) with real-time data validation up to 24 months.

Redermo is substantially equivalent to the predicate Restrata because both devices share identical indications for use, are composed of the same polymer materials, use the same electrospinning manufacturing process, have comparable physical handling characteristics, demonstrate equivalent safety and biocompatibility profiles, and achieve identical biodegradation and resorption timelines. Non-clinical testing demonstrates equivalent or superior performance across all key safety and effectiveness metrics.