Due to an aging population and the spiralling cost of brain disease in Europe and beyond, EDEN2020 aims to develop the gold standard for one-stop diagnosis and minimally invasive treatment in neurosurgery. Supported by a clear business case, it will exploit the unique track record of leading research institutions and key industrial players in the field of surgical robotics to overcome the current technological barriers that stand in the way of real clinical impact. EDEN2020 will provide a step change in the modelling, planning and delivery of diagnostic sensors and therapies to the brain via flexible surgical access, with an initial focus on cancer therapy. It will engineer a family of steerable catheters for chronic disease management that can be robotically deployed and kept in situ for extended periods. The system will feature enhanced autonomy, surgeon cooperation, targeting proficiency and fault tolerance with a suite of technologies that are commensurate to the unique challenges of neurosurgery. Amongst these, the system will be able to sense and perceive intraoperative, continuously deforming, brain anatomy at unmatched accuracy, precision and update rates, and deploy a range of diagnostic optical sensors with the potential to revolutionise today’s approach to brain disease management. By modelling and predicting drug diffusion within the brain with unprecedented fidelity, EDEN2020 will contribute to the wider clinical challenge of extending and enhancing the quality of life of cancer patients – with the ability to plan therapies around delicate tissue structures and with unparalleled delivery accuracy. EDEN2020 is strengthened by a significant industrial presence, which is embedded within the entire R&D process to enforce best practices and maximise translation and the exploitation of project outputs. As it aspires to impact the state of the art and consolidate the position of European industrial robotics, it will directly support the Europe 2020 Strategy.

The main focus of TreatER is conducting a randomized, placebo-controlled, first-in-human, proof-of-concept, safety and efficacy study of intracerebrally administered CDNF protein therapy in patients with Parkinson’s disease (PD), using a neurosurgically implanted Drug Delivery System (DDS), which will also be clinically validated in the study. Thus the TreatER project has two independent goals, either of which alone can have significant impact addressing unmet clinical needs in chronic diseases, and advancing innovative European technologies: 1) Proof-of-concept of CDNF protein therapy for disease modification in PD. The patented European innovation CDNF has further potential in other ER stress related indications. 2) Clinical validation of DDS, an already clinically tested approach for accurately targeted intracerebral infusions in PD. The patented European innovation DDS has also significant potential in other indications needing intracerebral infusions. The clinical study builds on extensive preclinical research and related data on CDNF, including completed acute and chronic toxicology studies in non-human primates supporting an excellent safety profile. Further, the clinical study builds on existing clinical experience on DDS and related neurosurgery. Both conventional and novel means for assessing the efficacy of the treatment will be utilized. This requires strong interdisciplinary expertise and knowledge available in the consortium, including: Regulatory expertise in drug and medical device development; neurological and neurosurgical expertise in PD; PET imaging expertise specific to PD; Scientific expertise in novel neurotrophic factors, in specific CDNF; and GMP manufacturing expertise of novel biological drug compounds. Clinical trial applications are currently being submitted in Finland and Sweden, in accordance with previously obtained scientific advice from regulatory authorities in those countries as well as from MHRA (UK) and EMA's ITF.