Novoxel Inc. announces the U.S. FDA clearance of the Tixel i (pronounced "Tixel Eye") for sale in the USA.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 (MGD).
The multi-site clinical study demonstrated significant improvements in the objective scores (such as TBUT and MGS) and, possibly more importantly, a significant reduction in patient-reported symptoms (OSDI).Tixel® systems use proprietary Thermo-Mechanical Action (TMA®) instead of light or laser energy. Therefore, Tixel i can be used on all skin tones, all year round – even during summer.
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.
SIMPLE RELIEF:
Gregg J. Berdy M.D., F.A.C.S., an ophthalmologist in St. Louis, Missouri, said, "I was part of the clinical study, so I was excited to purchase the first Tixel i because my patients reported significant relief of their symptoms. 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. And, the Tixel i 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."
CONTINUED INNOVATION:
"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 very short: only three treatments, spaced two 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 six months."
LOCAL SUPPORT: The Tixel i systems are manufactured in Germany and Israel, but the company has a direct presence in the USA. At the Tennessee facility, the Novoxel Inc. team handles all USA sales, marketing, and technical support for the entire Tixel family of products. For more information, please visit www.Tixel.us/DryEye or call 888-Tixel-US (888-849-3587).
