FDA Clears Novoxel's Tixel for the Treatment of Meibomian Gland Dysfunction

Isreal-based Novoxel announced the the FDA clearance of its Tixel device for application of localized heat and pressure for patients with evaporative dry eye due to meibomian gland dysfunction (MGD).

The Tixel systems use proprietary Thermo-Mechanical Action (TMA) instead of light or laser energy. This allows the device to be used on all skin tones, all year round, according to Novoxel. The proprietary TMA technology permits treatment of the glands in both the upper and lower eyelids to help improve delivery of lubricating oils to the eye surface.

A multi-site clinical study demonstrated significant improvements in the objective scores (such as TBUT and MGS) and a significant reduction in patient-reported symptoms (OSDI), according to Novoxel.

"Unlike other systems, the procedure is simple: anesthesia is not required, no coupling gel is needed, there are no complicated applicators, and there are no bright flashes of light," Gregg J. Berdy, MD, FACS, an ophthalmologist in St. Louis who was part of the clinical study, stated in a company news release. "And, the Tixel is simple and safe enough for my staff to perform the procedures. The upper and lower eyelids of both eyes can be treated in less than 2 minutes. Most patients say their eyes feel more watery during the actual treatment."

"In June of this year, Novoxel Inc. introduced our new Tixel 2 system for aesthetic procedures. Just a short while later, we are excited to launch another member of the Tixel family," said Lee Pannell, CEO of Novoxel Inc. "

The Tixel i treatment regimen is only three treatments, spaced 2 weeks apart, stated Lee Pannell, CEO of Novoxel.

All US sales, marketing, and technical support for the Tixel family of products are handled at Noxoxel's Tennessee facility.