Restoring Skin Pigmentation with Product Overview Single-use class III Medical Device to perform autologous epidermal cell grafting (aka MKTP), recommended to re-pigment 50cm2 to maximum 100cm2 Non-cultured epidermal cell suspension obtained by enzymatic digestion of a patient’s split-skin biopsy and applied with hyaluronic acid Surgeons and dermatologists treating patients with stable vitiligo, showing no progression of lesions and no new lesions for a minimum of 6 months Ready for application in just 30 minutes, total procedure 60 to 120 min Good tolerance Uses patient’s own skin cells for a better tolerated and long-lasting solution HA-enhanced Stability Hyaluronic acid prevents cell dispersion, improving treatment outcomes Safe, CE-marked All-in-one solution, safe, proven in a multi-centric randomized study (1) (1) Assessment of Non-cultured Autologous Epidermal Cell Grafting Resuspended in Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism Lesions: A Randomized Clinical Trial. Bertolotti A, Leone G, Taïeb A, Soriano E, Pascal M, Maillard H, van Geel N. Acta Derm Venereol. 2021 Jul 30; doi: 10.2340/00015555-3870. PMID: 34230975; PMCID: PMC9413657. Treatment outline & benefits (Michel Pascal,Mahsa GHASEMI,Rasta GHASEMI,Khaled Ezzedine (IPCC2014-ABS-1409) Healthy split skin biopsy 10cm2 or 1/5 of the recipient site Thickness 0.3 mm Cell Isolation Tissue digestion Dermoepidermal separation Step 2 Cell suspension Dermatome Local anesthesia (not supplied in the kit) Suspension in HA solution De-epithelialization Buffer solutions Hyaluronic Acid of the lesion by ablative laser or equivalent technique Step 3 Application of the Suspension deposit Drop by drop onto the recipient site cellular graft Dressing & bandage 1st layer Hydrophobic, 5-7 days Step 4 Postpoperative treatment Phototherapy Treatment Excimer lamp or UVB TL01, twice a week For 6 months starting one week after grafting Petri Dish Container & Needles CUTISS INNOVATION, 1360 route de dolines, Chemin de la Nertière, Bâtiment HT1 06560 Valbonne-Sophia-Antipolis, France – [email protected] Not supplied in the kit: - Primary non-adhesive, hydrophobic dressing (Mepitel®, Telfa Clear…) - Occlusive secondary dressing (Hypafix
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