E!10668 eBIONERVE: Personalized nerve grafts for treating human nerve injuries, NovaHep AB

Purpose and goal

There is a significant medical need for peripheral nerve regeneration, and eBionerve wants to develop a potential solution. The overall purpose of the project has been to make this new and unique technology as ready as possible for upcoming clinical trials and market approval. Process development, large animal studies, preparation for GMP production and preparation of regulatory documents are among the most important goals that have been successfully achieved. In other words, our project results lead to entirely new medical and commercial opportunities for the future.

Expected results and effects

The project has now taken a first-generation promising product candidate through a series of important preclinical and regulatory development steps. The single most important result is positive in vivo data in a relevant disease model in large animals. At the same time, knowledge and expertise in this field has been built up and important partnerships and networks have been started. This platform will be very valuable and will serve as a basis for continued research and development. This gives Europe´s industry a prominent role in one of Life Science´s most interesting future areas.

Planned approach and implementation

eBionerve is a multi-task project where the partners have collectively performed as many key-steps as possible on the way from promising in vitro data to a complete set of preclinical activities, all in order to make the technology ready for commercial-scale up and clinical trials in the years to come. The commercial partner VERIGRAFT has covered process development and all documentary and commercial tasks, while the academic partner and subcontractors have made various in vivo disease models possible. In focus for the collaboration has been to pave the way a first product-candidate.