Significant medical needs associated with spinal cord injuries

Traumatic spinal cord injuries often lead to permanent paraplegia and represent a serious medical and health economics problem. There are around 140,000 people living with this condition in Germany, with approximately 2,000 to 2,500 new cases each year. Treatment costs per patient can amount to as much as EUR 4 million.

Despite surgical stabilisation of the spine, there is as yet no causal treatment to effectively prevent or reverse the neurological damage. A key challenge is the complex cascade of inflammation and oedema following the injury, which is difficult to target with medication.

Locally active implant with controlled drug release

NEUROLITH-2 develops an implantable therapeutic system that is inserted at the site of the lesion during surgery. The implant combines a structural protective function with local, time-controlled drug release.

The release of the active substance is tailored to the temporal progression of the damage processes following injury, ensuring that therapeutic effects are achieved within the relevant clinical time windows. The aim is to specifically target the pathophysiological mechanisms following injury.

Interdisciplinary development and a translational approach

The joint project is organised on a strictly interdisciplinary basis. Within Charité – Universitätsmedizin Berlin, it is jointly led by the Department of Trauma and Reconstructive Surgery and the Department of Neurosurgery at the Benjamin Franklin Campus. The Charité coordinates the project and is responsible for implant production and pre-clinical in vivo studies, as well as regulatory and business analyses, amongst other things. The Helmholtz Centre Hereon develops biodegradable material components for the implant. The Fraunhofer Institute for Silicate Research ISC is developing bioresorbable drug delivery systems and supporting regulatory documentation processes.

In parallel with the technical development, a comprehensive commercialisation strategy is being drawn up. This includes business modelling, health economic analyses, regulatory planning in accordance with the EU Medical Devices Regulation, as well as preparations for a potential spin-off and follow-up financing.

The aim is to demonstrate a pre-clinical proof of principle for an implantable therapy system that, for the first time, simultaneously addresses multiple pathophysiological processes following spinal cord injuries.

To learn more about funded GO-Bio projects, visit the overview page.