Novoxel® Reaffirms Tixel's Industry-Leading Safety Record

Thermo-Mechanical Action (TMA^®) Is Not RF Microneedling

KNOXVILLE, Tenn., Nov. 18, 2025 /PRNewswire/ -- Following the U.S. Food and Drug Administration's recent safety warning regarding radiofrequency (RF) microneedling devices, Novoxel, the manufacturer of Tixel^®, is reaffirming the distinct safety and technology advantages of its proprietary Thermo-Mechanical Action (TMA) technology.

"Tixel's unique technology has a safety profile that is industry-leading," added Dr. Ifat Klein, VP of Clinical Affairs at Novoxel. "This FDA warning reinforces the importance of choosing technologies with well-documented safety profiles and scientifically and clinically proven mechanisms of action."

Fundamentally different - Tixel's TMA is the next-generation of energy-based devices:

• Different Mechanism: Tixel uses precisely applied heat to stimulate a therapeutic rejuvenation cascade distinguishing itself from RF and IPL. Unlike needles, Tixel does not penetrate the skin and does not cause bleeding.
• Precisely Controlled Depth: Tixel's thermal energy is confined to the epidermis and upper dermis. This precision avoids depths linked to the risks of subcutaneous fat loss and scarring.

"Tixel's ease of use and reproducible results make it ideal for both my trained staff and me. It's a technology we trust daily to deliver visible improvements safely and without the worry of complications," said Dr. Amy B Lewis MD, Dermatologist at Lewis Dermatology and Associates.

A Decade of Proven Safety and Results

• Exceptional Safety: After hundreds of thousands of real-world treatments on all skin types in the U.S. and globally – 99.99% of real world Tixel treatments lead to safe results with zero reportable complaints related to burns, scarring or fat loss.
• Clinically Proven, Robust Efficacy: Over 30 peer-reviewed clinical studies across 800+ patients prove consistent clinical results with high patient and user satisfaction.
• FDA Clearance: All Tixel devices are FDA cleared.

"Tixel has become part of our daily practice because our team and patients trust it. It's safe year-round for every skin type and delivers visible results without needles or lasers — giving patients comfort, confidence, and natural-looking outcomes," said Dr. Karen Herman, Dermatologist at Rejuvené MD

For more information about Tixel and its unique Thermo-Mechanical Action (TMA) technology, visit www.novoxel.com or contact [email protected].

ABOUT NOVOXEL

Tixel is the next generation of energy-based technology, built on over a decade of scientific and clinical innovation. Established in 2011 as Novoxel Ltd., the company has pioneered Thermo-Mechanical Action (TMA) — a patented technology that delivers pure thermal energy directly to the skin, and is used around the world, including USA, Canada, EU, UK, Australia, Japan, Brazil and Korea. The Tixel family of products provides safe, non-invasive, and radiation-free treatments with minimal downtime — without bleeding, significant pain, or costly single-use cartridges — delivering noticeable clinical results in skin rejuvenation and dry-eye care worldwide.

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SOURCE Novoxel Ltd.