DRUG-ELUTING ELECTRICAL IMPLANT TO REPAIR THE SPINAL CORD

Introduction

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.

Implant Design

In brief, the implant comprised biofunctionalized, conducting polymer-coated carbon microfibres (MFs) that promoted aligned neural cell growth across the lesion, embedded within a drug-eluting hydrogel that filled the tissue defect and reduced fibrosis. These intraspinal elements were complemented with electrodes that provided biphasic electrical stimulation (ES) to the lesion and the perilesional tissue, thus inducing extensive neural regeneration.

Project Development

Building on the initial proof of concept achieved in Neurofibres (TRL 3), DREIMS will mature 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.

Patent and Spin-off

The inventors of the implant filled a patent application (P202230626) on the mentioned results and 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.

Future Goals

DREIMS builds on those results to consolidate the first-in-class drug-eluting electrical implant to repair the spinal cord. The implant will refine and integrate three modules:

1. Microfiber/drug-eluting gel bundles (MIBs) from FUHNPAIIN / SCT S.L. (Spain)
2. Spinal electrode arrays (SEAs) from ALU-FR/IMTEK (Germany)
3. A fully implantable electric pulse generator (IPG) from NEURINNOV (France)

This will form a procedure pack according to the European Medical Device Regulation (MDR) 2017/745.

Regulatory and Business Development

Addressing regulatory requirements and business development activities will increase the market readiness of the implant.