Wool Equities Limited announced that three wound dressings developed by its subsidiary, Keratec Limited, in collaboration with its US-based partner, Keraplast Technologies, have been granted approval for use as medical devices by the EU regulatory body through the CE marking process.
The dressings, designed to target chronic wounds in a range of clinical settings, have been independently confirmed as being designed and manufactured to the stringent ISO 13485:2003 Medical Device Quality Management Systems standard.
Elizabeth Hopkins, Keratec CEO commented “These are the first keratin-containing medical devices to gain approval from any global regulatory body and in achieving this milestone, Keratec and Keraplast Technologies are confirmed as the world leaders in this field.
Gaining the CE mark greatly enhances the value proposition for potential partner companies and significantly de-risks the biomedical area of our business”. Keratec is the major investment of Wool Equities, which owns 94.5% of the shares.
The dressings, designed to target chronic wounds in a range of clinical settings, have been independently confirmed as being designed and manufactured to the stringent ISO 13485:2003 Medical Device Quality Management Systems standard.
Elizabeth Hopkins, Keratec CEO commented “These are the first keratin-containing medical devices to gain approval from any global regulatory body and in achieving this milestone, Keratec and Keraplast Technologies are confirmed as the world leaders in this field.
Gaining the CE mark greatly enhances the value proposition for potential partner companies and significantly de-risks the biomedical area of our business”. Keratec is the major investment of Wool Equities, which owns 94.5% of the shares.
