Exceed Microneedling device first to receive FDA clearance for the treatment of wrinkles and acne scarring.
BERLIN, Aug. 6, 2019 /PRNewswire/ -- The privately-owned company, MT.DERM GmbH, Berlin, Germany, a manufacturer of medical microneedling, micropigmentation and tattoo equipment is excited to announce further expansion into the US market of its medical microneedling devices, exclusively available to healthcare professionals.
Exceed becomes the first and only FDA-cleared microneedling device for the treatment of both acne scars (K182407) and facial wrinkles (K180778).
"We continually seek the highest standards in respect to regulatory compliance and this is demonstrated by our ongoing expansion of our indications for use in the US market," said Jörn Kluge, Founder & CEO of MT.DERM. "Our second FDA clearance within 12 months demonstrates our desire to expand the range of indications available to our current client base and new users and I am proud that we are the first microneedling device to offer both of the major indications for facial wrinkles and acne scars.
Marketing authorization for acne scarring was supported by an extensive clinical study.
The study evaluated the efficacy and safety of the Exceed microneedling device when used for the treatment of acne scars in subjects 18 – 62 years of age. Fifty-six subjects were treated with four microneedling sessions 30 days apart Subjects were assessed for changes in acne scarring using an internationally recognized acne grading scale.
The study demonstrated a statistically significant improvement in facial acne scarring, with 85% of subjects exhibiting a visible improvement in their facial acne scars at the end of the study. No subject's acne scarring worsened. When questioned, 86% of subjects noticed a visible improvement in their acne scars compared to the start of the study, with 88% of subjects suggesting they would recommend the treatment to family and friends.
"Previous acne scarring studies using this technology have been largely criticized for poor study design," noted Glynis Ablon, MD, FAAD (Ablon Skin Institute, Manhattan Beach, CA and Assistant Clinical Professor at the University of California in Los Angeles, CA) "however this study successfully reports on a suitably sized group of subjects with Fitzpatrick skintypes I-IV. In addition, the clinical data has been scrutinized as part of a 510k submission by the US Food and Drug Administration."
"The benefit of microneedling is that the epidermis remains relatively intact and because of this the procedure induces transforming growth factor ? 3 (TGF-?3) which is associated in scar - less healing rather than TGF ?1 and ?2 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 skintype. This is really encouraging as it offers both physicians and patient's real benefits over the traditional treatments for acne scarring."
"MT.DERM is the global leader in cosmetic & medical micropigmentation and microneedling," said Jan Hodok, Director of the cosmetic and medical division at MT.DERM, "and therefore it makes perfect sense for us to be leading the development and regulatory compliance of this technology. We are pleased to offer with our Exceed device the highest precision and quality for both facial wrinkles and acne scar treatment to our rapidly expanding customer base."
For further information on the Exceed microneedling device and how the Exceed microneedling device can add value to your practice please contact:
SOURCE MT.DERM GmbH
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