Less than six months after launching into Australia and New Zealand, Derma Aesthetics’ EXCEED medical micro-needling device has received its second FDA approval.
When the game changing’ micro-needling device. was launched in July, the device had been FDA approved for fine lines and wrinkles and TGA listed as a class 2B medical device in Australia and Medsafe listed in New Zealand.
The device has now been FDA approved to treat acne scars too ‒ making it the first and only FDA-cleared micro-needling device for the treatment of fine lines, wrinkles and acne.
Derma Aesthetics co-founder Reika Roberts said the device had gained its second FDA clearance “thanks to an extensive clinical study”.
“The EXCEED is a real game changer for Collagen Induction Therapy, and even more so with the new approvals,” she said.
The latest study evaluated the efficacy and safety of the EXCEED for the treatment of acne scars in 56 adults aged 18-62-year-olds who were treated with four micro-needling sessions 30 days apart.
According to study lead Dr Glynis Ablon, assistant clinical professor at the University of California, “the epidermis remains relatively intact’ during treatment with the EXCEED so “the procedure induces transforming growth factor β 3 (TGF-β3) which is associated in scar-less healing rather than TGF β1 and β2 which are associated with collagen scar deposition”.
“In addition, we found that improvements in acne scarring was not restricted to the severity of the condition or the Fitzpatrick skin type.
“This is really encouraging as it offers both physicians and patient’s real benefits over the traditional treatments for acne scarring.”
The EXCEED “improves skin regeneration, increases natural collagen formation, minimises fine lines and wrinkles, improves the appearance of acne scarring, and reduces pore size and improves skin texture”.
Its key features include:
- German technology and engineering
- Runs at a low vibration and is super quiet while running
- Consistent power supply to ensure superior results
- Needle precision with a tilting needle plate that adapts to the surface of the skin to ensure perpendicular needle penetration and minimal epidermal trauma
- Patented microneedle cartridges
- Adjustable speed on the digital display
- Corded to ensure consistent speed
- Operated at a frequency of up to 150 microchannels per second
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