Novoxel Inc. announced that the FDA has cleared its Tixel i medical device, intended for use on patients with evaporative dry eye due to meibomian gland dysfunction (MGD).
First up: a company rundown.
Based in Israel (with a U.S. facility in Tennessee) and founded in 2011, Novoxel is a medical equipment manufacturer specializing in developing treatments for “fractional skin rejuvenation”—i.e., targeting a “fraction” of the treatment zone at a time.
With patented products and technology in over 30 countries across the globe, the company’s focus includes both dermatology and ophthalmology, as well as thermo-mechanical application and drug delivery.
A key technology powering its novel product portfolio: TMA technology.
TMA? Tell me about this.
The company’s proprietary thermo-mechanical action (TMA) technology is designed to combine motion and heat with the “forward movement of a medical-grade titanium top.”
As a non-laser fractional tech, TMA rapidly transfers thermal energy to the skin.
How is it transferred?
Via energy emitted through a matrix of tiny pyramid-shaped pins composed of biocompatible material that cover a 1 cm2 treatment area.
- To note: These pins are self-sterilized and heated to 400°C.
During the treatment process: The pins are “introduced to the surface of the skin at a precisely-controlled speed” and briefly (as in, just a few milliseconds) make contact with the skin.
What this does: This allows thermal energy stored within the pins to be transferred to the skin, resulting in “an array of non-ablative coagulation sites.”
- An advantage of this: Skin burns and tissue charring are avoided, as the tiny tip pyramids hold a limited amount of energy.
With this in mind, talk about the Tixel i device.
Incorporating TMA technology, the Tixel system (consisting of two devices, one for dry eye and another for aesthetics) is marketed by Novoxel as “the only fractional skin resurfacing device to transfer thermal energy directly to skin” via conduction and as the “most effective form of heat transfer.”
How this is done: By an application of heat to the skin via a medical-grade in situ self-sterilizing titanium tip designed to trigger the “natural healing and skin rejuvenation process.”
For a visual, see how it works.
Pronunciation check: Tixel i is pronounced “Tixel Eye.”
What makes it unique for MGD?
Most notably, its use of Novoxel’s TMA technology in lieu of light or laser energy.
Why this is important: This enables the device to not only be used on all skin types, but (in the case of MGD) it also allows for it to treat the glands of both the upper and lower eyelids in order to improve the delivery of lubricating oils to the eye surface.
And the treatment process for this?
The compact and lightweight device uses short pulses (6 milliseconds) of high heat applied by an eyecare professional (ECP) using gentle pressure from the titanium-coated tip.
The duration: 2 minutes for both eyes (upper and lower eyelids included).
The frequency: Three treatment sessions, 2 weeks apart.
And how is it designed?
The Tixel system features a user-friendly graphic interface along with:
- Two treatment parameters
- Two light handpieces
- Facial and periorbital option
- Periorbital handpiece ideal for treatment around the eyes)
- Facial and periorbital option
- Medical-grade titanium tip
- Reusable and located in the handpiece
And during treatment, Novoxel has noted there are no fumes, smoke, or bleeding, as well as minimal pain (a reported 3/10 without analglesic cream with a short, one-day downtime).
Has there been any other research into this yet?
Based on data from a U.S.-based multi-site clinical study, the company reported that significant improvements were demonstrated in objective scores such as tear breakup time (TBUT) and meibomian gland score (MGS).
Also observed: A significant reduction in patient-reported symptoms as early as 2 minutes following treatment, as determined via Ocular Surface Disease Index (OSDI) scores.
- As for efficacy: In a 6-month extension of the study, no reduction was observed.
- Meaning: Treatment efficacy is sustained for at least 6 months
See other supporting clinical data.
Lastly … how can I add this to my practice?
Contact the company here.