Knoxville-based Novoxel gets FDA clearance for latest Tixel device
In 2 minutes, patients report significant reduction of dry eye symptoms. Improvement continues and lasts for 6 months.
In late November, Novoxel’s Chief Executive Officer and President, Lee Pannell announced clearance by the Food and Drug Administration for the company’s newest “Tixel” device.
Teknovation.biz first featured Novoxel in October (see here), when they received clearance on their first Tixel device. That clearance launched its first sales efforts in the United States from a Knoxville base.
“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 Pannell. “The Tixel I treatment regimen is very short: only three treatments, spaced two weeks apart. What impressed me the most was that after the treatments were finished, the scores continued to improve. And the improvement is sustained for at least six months.”
Tixel i 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 and, possibly more importantly, a significant reduction in patient-reported symptoms (OSDI).
Furthermore, since Tixel i uses proprietary Thermo-Mechanical Action (TMA) versus light or laser energy, it can be used on all skin tones year-round. The proprietary TMA technology permits treatment of the glands in both the upper and lower eyelids to help improve the delivery of lubricating oils to the eye surface.
Physicians around the country are already hopping on the list for purchasing the medical device.
Dr. Gregg J. Berdy, 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.”
Novoxel has been around since 2011, with manufacturing facilities in Germany and Isreal. However, all sales, marketing, operations, and technical support for the “Tixel” products comes from the Knoxville office.
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