Tuesday, September 18, 2012

Innocutis Announces the FDA Approval of Nuvail (Poly-Ureaurethane, 16%) for the Treatment of Nail Dystrophy


CHARLESTON, S.C.Sept. 18, 2012 -- Innocutis is pleased to announce the FDA approval of Nuvail (poly-ureaurethane, 16%) nail solution, a novel prescription product to help manage fragile, damaged or brittle nails with cracking or splitting, a condition medically referred to as "nail dystrophy."

Among the most common forms of nail dystrophy is Brittle Nail Syndrome (BNS), which often is referred to simply as "brittle nails." Studies show that, on average, 20% of the population is affected by BNS and women are affected twice as often as men.(1) BNS may have various origins and is characterized by increased fragility of the nail plate. Patients who experience BNS, or other types of nail dystrophy, report their nails are painful and impair daily activities, which often negatively impacts their occupational abilities.

Nuvail is formulated to mechanically support the damaged nail plate using a proprietary polymer blend that creates a strong adhesion to the nail surface, forming a breathable barrier while protecting and strengthening the nail. This breathable barrier allows for oxygen transfer to the nail plate while blocking water absorption therefore preventing the wet-dry cycle that leads to damaged nails. Daily application of Nuvail also protects the nail from harm caused by work activity such as direct abrasion and friction. The clinical benefits of Nuvail have recently been documented in a peer-reviewed clinical study published by the Journal of Drugs in Dermatology.  

"Innocutis is proud and excited to introduce Nuvail as a unique and innovative breakthrough in the treatment and protection of damaged and dystrophic nails.  For the first time, patients will have a nail treatment that allows the nail to breathe but is still non water-soluble and is able to protect the nail from the impact of moisture and friction," said Jonathan Alba, Innocutis Chief Operating Officer.