Autologous bioengineered skin substitute for the treatment of severe burns, wounds with loss of substance, skin reconstruction and oral mucosa for maxillofacial surgery and reconstruction in urology and gynecology.
Severe Burns. For patients with more than 30-40% of burn corporal surface
Wounds with Loss of Substance of traumatic, surgical or tumor origin Skin Defects: e.g. Nevus
Skin Reconstruction: Epidermolysis Bullosa, Fascitis, necrotizing, etc.
Oral Mucosa for maxillofacial surgery
Mucosa for Urethra, Bladder and Gynecological reconstructions
Kit for Shipment
GMP Clean Room
Manufacturing, Packaging and Shipment
Norms and Procedures
Support to hospital’s Pharmacovigilance Tasks
Our Keratinocytes skin culture with fibroblasts and fibrin is an ‘Advanced Cellular Therapy’ as defined by the EMA under European Parliament Regulation (CE) Nº 1394/ 2007 and has been considered a consolidated medication by it’s Pharmaceutical Committee since October 2012 as an advanced therapy for tissue engineering. As of today it can be distributed under the Specials Medicaments Regulation, described AEMPS RD 477/2014 by EMA. Any hospital willing to use SkinMed has to comply with the new Advanced Therapies regulation.Biodan SkinMed or its commercial distributors will supply all necessary documentation for user registration to any willing hospital. Biodan SkinMed will produce the skin under full GMPs, either internally or via subcontractors.
We operate under Article 5.1 of EU Directive 2001/83/EC.
Biodan SkinMed or its commercial distributors will supply all necessary documentation for user registration to any willing hospital.
Biodan SkinMed or its commercial distributors will produce the skin under full GMPs, either internally or via subcontractors.