(Boursier.com) — I.Ceram concretizes its innovation plan to finalize the obtaining of CE – MDR markings by setting up a strategic financing envelope of 1.4 million euros to cope with the delay and the increase in costs of notified bodies .
This funding envelope is made up of the issue, for a maximum of 1 ME, of bonds convertible into new shares or to be issued with share subscription warrants from Alpha Blue Ocean (ABO) and a subsidy of 0.4 ME from BPI France as part of the I.Nov project. It will allow I.Ceram to ensure the continuity of its latest clinical and pre-clinical studies, made obligatory by the new MDR regulations for the marketing of its implants loaded with antibiotics.
In accordance with its strategy, I.Ceram is methodically continuing the development of implants loaded with antibiotics used in the treatment of bone infections. The new European regulatory environment implemented in 2019 requires extremely costly pre-clinical and clinical studies, despite the medical and scientific evidence already obtained by I.Ceram and having been published. These steps are therefore essential and become the normative regulatory framework essential for the creation of CE marking files for the marketing of products.
André Kerisit, founder and President of I.Ceram, explains: “In recent years, I.Ceram and its teams have developed disruptive technologies for the treatment of pathologies that are excessively complex to treat, such as sternal osteitis and post-traumatic bone infections with loss of substance. Thus, many surgeons have already successfully implemented this new technology on 27 occasions for patients in therapeutic failure, under exemption from the ANSM (National Medicines Safety Agency) or in the cases of tailor-made implants.
These successes were made possible by the technological and human investments made on the Limoges site allowing total integration of the value chain. Our plan of action was, initially, delayed by inertia linked to the MDR regulation which saw its implementation postponed twice by the European Authorities; then secondly, by the lack of notified bodies capable of accepting and evaluating the files.
On a financial level, the overall cost of a simple mechanical resistance study followed by pre-clinical and then clinical studies, plus the audit costs of the notified body is of the order of 500,000 euros. Faced with these constraints, my responsibility as a business manager, majority shareholder of I.Ceram, requires me to protect the investments and work already carried out, as well as the hopes born from the successes already achieved post-implantation in cases judged desperate with regard to traditional treatments.
In the current period where the design of an implantable medical device is similar to that of a drug and where “classic” financing by capital increase or debt proves impossible for a company still to date focused on innovation, the funding provided by ABO and BPI France will allow us to make our innovations operational on a large scale through the completion of this exceptional work for the benefit of patients.”
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