Exceed Microneedling device first to receive FDA clearance for the treatment of wrinkles
Published: Sep 25, 2018
BERLIN, Sept. 25, 2018 /PRNewswire/ -- The privately-owned company, MT.DERM GmbH, Berlin, Germany, a manufacturer of medical microneedling, micropigmentation and tattoo equipment is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the brand amiea med, exclusively available to healthcare professionals.
Exceed becomes the first FDA-cleared microneedling device for the treatment of facial wrinkles (K180778).
"Our continuing commitment to the highest standards of quality and safety is demonstrated in the speed in which clearance was granted," said Jörn Kluge, Founder & CEO of MT.DERM. "Our FDA clearance adds to our already existing Medical CE, signifying our ever-expanding global reach. We are proud that the Exceed device, developed and manufactured in Germany, can now also be made available to healthcare professionals in the USA."
Marketing authorization quickly followed the publication in the Journal of Clinical Aesthetic Dermatology (J Clin Aesthet Dermatol. 2018;11(8):29-34.) of the study used to support the FDA clearance. The study titled "Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin," was conducted by Glynis Ablon, MD, FAAD (Ablon Skin Institute, Manhattan Beach, CA and Assistant Clinical Professor at the University of California in Los Angeles, CA).
The study evaluated the efficacy and safety of the Exceed microneedling device when used for the rejuvenation of facial skin among 48 subjects with signs of facial skin aging. Following four microneedling sessions 30 days apart, subjects were assessed for changes in appearance of wrinkles, skin laxity and texture using validated scales. Digital fringe projection technology (PRIMOS) Canfield, New Jersey)) and VISIA Photography, was also utilized as additional methods of assessment.
In the study the subjects demonstrated visible improvement in facial wrinkles and skin texture at the end of the treatment sequence on Day 90 with a statistically significant change in facial wrinkles, skin texture and laxity 60 days later. Results of wrinkle grading and skin texture improvements were both confirmed by 3D profilometry (PRIMOS). Subjects reported similar results to the Principle investigator, citing improvements in facial wrinkles, texture, laxity and pores. No hyperpigmentation was reported amongst the study group.
"This improvement in facial wrinkles demonstrate the cumulative effect of percutaneous collagen induction and ongoing dermal collagen remodeling," said Dr Ablon. "The study confirms previous historical observations described in the literature, although currently I believe that there is no other comprehensive peer reviewed publication of an FDA-cleared microneedling devices".
"Microneedling is an uncomplicated procedure. The device is cost-effective with the only real recurring cost to the operator being the single use needle cartridges. We found the treatment to be well tolerated by patients reporting minimal pain and discomfort and minimal downtime meaning that they are able to get back to their daily routine quickly. Side effects were minor and easily managed compared to other invasive technologies such as laser ablation and radiofrequency. Patients were happy and saw visible improvements in wrinkles, overall skin texture, laxity and pores."
"Given that MT.DERM is the global market leader in cosmetic & medical micropigmentation and tattoo equipment, this expansion into the medical arena in the US market makes perfect sense," said Jan Hodok, Director of the cosmetic and medical division at MT.DERM, "and establishing a US subsidiary for amiea med means that we can bring the same quality, innovation, customer service and personal attention to our US clients that other global markets already enjoy."
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