Novoxel Inc. announced the FDA clearance of the Tixel i (pronounced "Tixel Eye") for sale in the United States. The newest member of the Tixel family of products was cleared for application of localized heat and pressure for patients with evaporative dry eye due to meibomian gland dysfunction, the company said in a press release.
The Tixel systems use proprietary Thermo-Mechanical Action (TMA) instead of light or laser energy, allowing Tixel i to be used on all skin tones, all year round. 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.
According to the company, 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).
In June of this year, Novoxel Inc. introduced its 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 very short: only three treatments, spaced 2 weeks apart. What impressed me the most is that after the treatments are finished, the scores continued to improve. And the improvement is sustained for at least 6 months."