Videregen Limited, a clinical stage regenerative medicine company developing personalised organ replacements, has been awarded European orphan medicinal product status for its lead tissue-engineered replacement trachea product. The designation, for severe tracheal stenosis (narrowing of the windpipe), is an important recognition by the European Medicines Agency of the potential of the replacement trachea in the treatment of this life-limiting rare disease. Orphan drug status will help expedite development of the replacement trachea, which is beginning a Phase I clinical trial, into a commercially available product.