ULURU Inc. has developed a novel, permanent sub-dermal filler utilizing hydrogel nanoparticles that take advantage of their inherent biocompatibility and allow the formation of a sub-dermal filler implant by injection. The nanoparticles are composed primarily of pHEMA (poly-2-hydroxyethyl methacrylate). pHEMA has an extensive safety record as a biological implant and is employed in many medical devices including contact lenses, burn and cutaneous ulcer dressings. The hydrogel particles are generally accepted as safe (GRAS), non-toxic and highly biocompatible. Aggregates have been optimized to perform with elastic, shear and bulk moduli that mimic biological tissue found at different levels of the dermal strata. The resulting stable suspension of nanoparticle aggregates irreversibly when injected into tissue forming a pliable hydrogel. ULURU sub-dermal filler is ideally suited for procedures in filling the deeper defects into the skin, e.g. nasolabial fold.

• ULURU’s sub-dermal filler is formed by injection of a suspension of purified hydrogel nanoparticles which result in a permanent, porous hydrogel implant.

• Aggregates have minimal inflammatory response in long-term implant studies.

• The rate of pore formation and cellular infiltration can be controlled to optimize fibrous capsule formation.

• Nanoparticle aggregates are composed of a polymer that has been FDA approved and used in implantable devices.

• Hydrogel nanoparticle dermal filler being composed of pHEMA, has excellent biocompatibility properties.

• Sub-dermal filler is easily administered through a small 30 or 32 gauge needle.