E!1066, ADHFIX, Biomedical Bonding AB and RISE

Important results from the project

The main goal of the project has been to prepare BMB´s product AdhFix for the market. To sell the product, CE marking and certification according to ISO-13485 are required. In addition, clinical safety studies are required. Some of the most important activities successfully completed in the project have been the development of a QMS and a product kit. All validations for sterilization, packaging and shelf life, biological safety and mechanical tests have been carried out.

Expected long term effects

A new patent application has been filed with the EPO, covering future AdhFix products with degradable properties. This strengthens BMB´s protection of its innovations and opens up the way for the development of new products. The clinical collaborations established during the development of AdhFix will be used to market and further develop future products. ISO-13485 certification and clinical studies mean that BMB can attract additional funding and develop new products.

Approach and implementation

The project has focused on preparing AdhFix for market by meeting regulatory requirements. Key activities include QMS development, packaging, validations for sterilization and shelf life, mechanical testing and. Biological safety has been reviewed and includes animal studies. After the end of the project, certification, clinical studies in humans and launch on the European market are planned, with collaborations established within the healthcare sector in Sweden, Denmark and Spain.