Lamina.One

Lamina.One® product is composed of two main components

- Therapeutic implantable biodegradable wound dressing as an implantable medical device (MD) for bone regeneration - Autologous mesenchymal stem cells as a cell therapy product hydrogel mixture for cartilage regeneration as an advanced therapy medicinal product (ATMP) Lamina.One product has been classified as a combined advanced therapeutic medicinal product (cATMP) by European Medicines Agency’s (EMA) Committee of Advanced Therapies (CAT) under the Regulation (EC) No 1394/2007 and Directive 2001/83/EC Lamina.ONE’s technology offers a single intervention. Our solution consists of a mini-invasive protocol, with a low risk of complications, resulting in a short recovery time and high success rate avoiding Total Knee Replacements (TKA). With our manufactured Lamina.ONE kit and authorizations from the EMA and ANSM we are moving to clinical trial phase I in Strasbourg, France (CHRU Strasbourg, Direction de Recherche Clinique et Investigation (DRCI), PUI Hospital Pharmacy and Clinical Investigation Ceneter (CIC), Fondation Force) for isolated osteochondral lesions in the knee (first quarter of 2025).