Tixel receives FDA approval
Novoxel, Israeli manufacturer of thermo-mechanical ablative skin rejuvenation device Tixel, has announced that the device has received FDA clearance for dermatological procedures requiring ablation and resurfacing of the skin.
The news means Tixel can now be used by practitioners in the US, while it has been available in Europe and other countries for several years.
Novoxel chief executive Evgeny Piven said: “To get the first FDA clearance for Tixel was one of our primary goals. This achievement is the result of hard work by Novoxel employees assisted by our worldwide key opinion leaders.
“We‘re very grateful that we can now offer this product to physicians in the United States. Since launching of Tixel in Europe and many other countries several years ago, we have seen a growing demand from physicians and patients for our unique products”.
Ronen Shavit, chief technology officer, added: “Tixel products are registered and marketed in over 30 countries which are continuously contributing to our clinical experience. 15 clinical studies and research papers have been published in leading peer-reviewed journals.
“Novoxel is focused on continuing its clinical research, product development and expansion of our product portfolio and indications.”
In the UK, Tixel is used for skin tightening, resurfacing and drug delivery, creating tiny pores to allow the penetration of solutions into the skin to target specific indications.
The device uses direct heat and can perform both ablative and non-ablative treatments. It is distributed exclusively by Aztec Services in the UK.