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Viticell Fact Sheet

Viticell Fact Sheet
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Viticell Fact Sheet

Product catalog summary
Product Overview
VitiCell® is a single-use class III medical device designed for autologous epidermal cell grafting, also known as MKTP. It is recommended for re-pigmenting areas of 50cm2 to a maximum of 100cm2. The device is ready for application in 30 minutes, with the total procedure taking between 60 to 120 minutes. It utilizes the patient's own skin cells, which enhances tolerance and provides a long-lasting solution. Hyaluronic acid is used to prevent cell dispersion, improving treatment outcomes.
Key Benefits
The VitiCell® Kit is an all-in-one solution that is safe and has been proven effective in a multi-centric randomized study. The kit includes an enzyme and heat pad, buffer solutions, hyaluronic acid, a petri dish, container, and needles. It provides a non-cultured epidermal cell suspension obtained through enzymatic digestion of a patient's split-skin biopsy, applied with hyaluronic acid for enhanced stability.
Intended Users
This device is intended for surgeons and dermatologists treating patients with stable vitiligo, where there has been no progression of lesions and no new lesions for at least six months.
Procedure Steps
  1. Biopsy: A healthy split skin biopsy of 10cm2 or 1/5 of the recipient site is taken, with a thickness of 0.3 mm.
  2. Cell Suspension: Cells are isolated, tissue is digested, and dermoepidermal separation occurs, followed by suspension in a hyaluronic acid solution.
  3. Application of the Cellular Graft: The lesion is de-epithelialized using an ablative laser or equivalent technique, and the suspension is deposited drop by drop onto the recipient site.
  4. Postoperative Treatment: Dressing and bandage are applied with a hydrophobic first layer for 5-7 days, followed by phototherapy treatment using an excimer lamp or UVB TL01 twice a week for six months starting one week after grafting.
Additional Information
The VitiCell® Kit requires a dermatome and local anesthesia, which are not supplied in the kit. CO2 laser and primary non-adhesive, hydrophobic dressing, as well as occlusive secondary dressing, are also not included.
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Catalog excerpts

Viticell Fact Sheet-1

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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