BioDan SkinMed

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Regenerative Medicine and Healing

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.

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Autologous Bioactive Skin

We can create 4.400cm² of the patient’s own skin within just 22 days from just a small biopsy and have already produced over 2.500m² of skin for burns, wounds and reconstruction processes.

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Patented Technology

The BioDan SkinMed product and manufacturing process is protected under Global Patent PCT – FP200100494: ‘Dermis and Production Method’. A unique product with keratinocytes and fibroblasts, creating a full 2 layer skin without animal components.

Therapies

BioDan SkinMed technology has a wide range of applications

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Severe Burns. For patients with more than 30-40% of burn corporal surface

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Wounds with Loss of Substance of traumatic, surgical or tumor origin Skin Defects: e.g. Nevus
Skin Reconstruction: Epidermolysis Bullosa, Fascitis, necrotizing, etc.

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Oral Mucosa for maxillofacial surgery

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Mucosa for Urethra, Bladder and Gynecological reconstructions

Benefits and cost savings


  • Better healing properties derived from fibrin inducement to wound closure
  • Stable final functional/aesthetic coverage
  • Eliminates risks and pain of autografts
  • Avoids needs for autografting
  • Definitive and stable coverage
  • Allows for coverage of patients with very little skin suitable for transplant
  • Two layer structure similar to the skin: Fibroblasts and Keratinocytes
  • Robustness: Easy to use
  • The fibrin matrix promotes migration, proliferation and differentiation of recipient cells
  • Resistance and mechanical stability
  • Easy to handle in surgery1
  • 1 Martínez-Santamaría L1, Guerrero-Aspizuas S, Del Río M. Skin Bioengineering: pre-clinical and clinical application. Actas Dermosifiliogr.
  • High take percentages
  • Increases chances of survival2
  • 2 Gómez C. Galán JM, Torero V, Ferreiro I, Pérez D, Palao R, et al. Use of an autologous bioengineered composite skin in extensive burns: Clinical and functional outcomes. A multicentric study. Burns. 2011 Jun:
    37(4): 580-9
  • Strong cell expansion capability: 4.400cm² in 22 days
  • Simple preservation
  • Easy transportation by courier
  • Full take/integration due to its autologous nature
  • Improve the appearance of scars in surgical wounds
  • The aesthetic and functional results were similar to auto transplantation, according to patient perceptions2
  • 2 Gómez C. Galán JM, Torero V, Ferreiro I, Pérez D, Palao R, et al. Use of an autologous bioengineered composite skin in extensive burns: Clinical and functional outcomes. A multicentric study. Burns. 2011 Jun:
    37(4): 580-9
  • SkinMed’s autologous bioactive skin saves the Spanish National Health Service 50 days of Intensive Care hospitalization for patients with corporal skin burns of between 50-60%
  • SkinMed’s autologous bioactive skin saves the Spanish National Health Service 53 days of Intensive Care hospitalization for patients with corporal skin burns of 80%3
  • 3 Cost analysis of Burn Patient Treatments, Dossier of Burn Values (2015)

Biodan Skinmed´s Product Lyfe Cycle

BioDan SkinMed is a cellular therapy present throughout a product's life cycle

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Biopsy

Materials
Kit for Shipment
Tracking

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Skin Production
Cell Culture

GMP Clean Room
Manufacturing, Packaging and Shipment

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Point of Care
Hospital

Norms and Procedures
GCP/ISO

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Pharmacovigilance

Support to hospital’s Pharmacovigilance Tasks

Clinical Experience


Regulation


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.

  1. European Parliament Regulation (CE) Nº 1394/November 13th, 2007 “Advanced Therapies” - Chapter 8, Article 28

  2. Hospital exemption for ATMPs (implementation of Art 28(2) of Regulation 1394/2007): update on feedback received by the Commission

  3. Real Decreto 477/2014, de 13 de junio, por el que se regula la autorización de medicamentos de terapia avanzada de fabricación no industrial

  4. La Agencia Española de Medicamentos y Productos Sanitarios advierte sobre la posible confusión en la oferta de tratamientos con células madre. 22 Octubre 2012

  5. European Comission grants BioDan Group orphan designation (EU/3/14/1407) for Allogeneic Skin for use in Epidermolysis Bullosa. December 16 2014

  6. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relationg to medicinal products for human use

Miñano
Manufacturing Facilities: GMP / Clean room located in Miñano Plant, Alava, Spain.