The turnover for the 1st half of 2023 of I.Ceram, specialist in innovative biocompatible ceramic implants, amounted to 606 K€, penalized by the modifications linked to the new MDR regulations.
The turnover of the historical activity (non-ceramic implants) amounted to 530 K€. The 25% drop compared to the first half of 2022 reflects the changes initiated by the implementation of the new MDR regulations, which are now extremely penalizing due to the lack of notified bodies. This new regulation has seen its application postponed for a second time to 2027 by the European authorities, under certain conditions for products already CE marked.
Sales of ceramic implants amounted to €56K in the 1st half of 2023, compared to €106K in the 1st half of 2022. I.Ceram has decided to terminate the distribution contract with Bio Distribution in force since 2018, and to resume direct marketing of its range of ceramic sternal implants not loaded with antibiotics from September 2023.