Periodic Reporting for period 1 - DREIMS (DRUG-ELUTING ELECTRICAL IMPLANT TO REPAIR THE SPINAL CORD)
Reporting period: 2023-12-01 to 2024-11-30
In Neurofibres (FET-PROACTIVE, 2017-2021), we accomplished a major therapeutic advance for spinal cord injury (SCI) by combining biomaterials, pharmaceuticals, and electrical stimulation into an innovative implant able to promote the closure of the spinal cord gap, with axonal regrowth and glial cell migration across large lesions in rodent and porcine models of SCI. Building on the initial proof of concept achieved in Neurofibres (TRL 3), DREIMS has the objective of maturing this novel healthcare technology through TRLs 4-5, becoming close to its approval for use in human therapeutics while creating a business plan to support further exploitation steps. The inventors of the implant recently created a spin-off company (Spinal Cord Technologies, SCT S.L.) to pursue the refinement and validation of a successful clinical and commercial medical product. Addressing regulatory requirements and business development activities will increase the market readiness of the implant.
During the first year of the project we had significant advances in all the proposed objectives. In summary:
1. We performed substantial refinement of the microfibers by covalently bonding electroconducting linkers (Azido-phenyl-EDOT) that increase electric charge transfer and prevent polymer detachment.
2. Novel Spinal Electrode Arrays (SEAs) were designed and tested for electrical stimulation of the spinal cord.
3. Novel electrical stimulator devices were fabricated.
4. Novel porcine models of spinal cord injury were developed, demonstrating their similarity to the human pathology and their usefulness for testing neurotherapeutics.
5. A preliminary regulatory plan was developed for the technology.
6. A preliminary business model and business plan were prepared, and the freedom to operate with DREIMS technology was provisionally cleared.
1. We performed substantial refinement of the microfibers by covalently bonding electroconducting linkers (Azido-phenyl-EDOT) that increase electric charge transfer and prevent polymer detachment.
2. Novel Spinal Electrode Arrays (SEAs) were designed and tested for electrical stimulation of the spinal cord.
3. Novel electrical stimulator devices were fabricated.
4. Novel porcine models of spinal cord injury were developed, demonstrating their similarity to the human pathology and their usefulness for testing neurotherapeutics.
5. A preliminary regulatory plan was developed for the technology.
6. A preliminary business model and business plan were prepared, and the freedom to operate with DREIMS technology was provisionally cleared.
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.
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.