We have designed a drug-releasing electroactive implant to tackle the complex, unmet challenge of human spinal cord repair. Through the execution of the planned activities and objectives for the first year of the project, the consortium in already progressing towards the delivery of the long-term expected impacts in the scientific, economic, societal and industrial fields. Specifically, we are advancing in the key steps to pursuing the maturation of a DREIMS-TS Minimum Viable Product, based in significant preclinical evidence for efficacy and succeeding in all relevant criteria for functional neural repair. This progress settles in the microfiber refinement and electrical stimulator design and its integration with the spinal electrode arrays, as well as in the preclinical testing in porcine animal models. Also, tasks in the scope of the pathway’s preparation for market approval are ongoing, which were leveraged by the creation of SCT S.L. to support the regulatory and commercialization aspects. In that sense, a regulatory diagnosis and strategy were developed, and a preliminary business model and plan and FTO clearance was achieved.
Further research is in progress to achieve the final optimization of the electroconducting microfibers and to determine the optimal pro-regenerative electrical stimulation parameters, as well as for testing the safety and efficacy of the complete implantable electrical stimulator in the long-term. Subsequently, GMP fabrication and clinical investigations in humans must be performed. Our current needs are accessing to finance for the previously mentioned innovation steps.
