Silk fibroin tissue grafting for peripheral nerve repair

Peripheral nerve injury is a major source of disability, impairing muscle movement or normal sensations: 4Mn people annually experience traumatic nerve damage. Current solutions do not always achieve full motor and sensory recovery, leading to loss of sensation/function and pain, with a significant impact to patients’ lives. With 50% unsuccessful nerve repair procedures, patients require prolonged rehabilitation, and 30% of them experience permanent disability, producing a high socio-economic burden. KLISBio has developed SILKBridge, a novel cost-effective nerve guide made of silk fibroin for safe and efficient peripheral nerve repair. KLISBio’s solution, clinically tested with a first in human (FIH) study, supports and protects the regenerating nerve from compressive forces, restoring its function, and reducing pain without patient discomfort. SILKBridge enhances nerve healing without immune rejection nor fibrosis, reducing the costs of rehabilitation and prolonged surgeries.

During the project, KLISBio achieved significant technical and scientific progress across several key areas. Robust project management enabled effective coordination, risk mitigation, and alignment with timelines and budgetary targets as close as possible. A comprehensive quality management system was developed, and the ISO 13485 certification has been achieved. The manufacturing process has been scaled up with the introduction of new equipment, process steps automation and optimization, and increased capability of quality controls for product release. Efforts to expand the product range led to the development of an innovative technical solution, with a strong focus on meeting clinical needs. Preparations for clinical trials advanced steadily, with key stakeholders engaged and protocol development underway. Ethical oversight mechanisms were also established to guide the responsible conduct of the project. Collectively, these actions have positioned KLISBio for successful continuation, future clinical and regulatory milestones, and market success.

The KLISBIO project has delivered promising early results in the development and scale-up of a next-generation silk fibroin-based medical device for peripheral nerve repair. Key outcomes include the establishment of a compliant quality management system, progress toward ISO 13485 certification, automation of several manufacturing steps, and the refinement of the product design to align more closely with clinical needs. Clinical trial preparation is also underway, supported by partnerships with key opinion leaders and expert CRO.
The potential impact of these innovations is substantial: KLISBIO aims to provide a biocompatible, resorbable alternative to current nerve grafting techniques, which could significantly improve treatment outcomes and reduce the need for autografts. The technology holds particular promise in addressing small-diameter nerve injuries, which represent the majority of clinical cases.
To ensure successful uptake and long-term impact, several needs must be addressed. These include continued technical development and validation, completion of clinical trial, and successful navigation of regulatory pathways in both the EU and US. Access to further financing will support industrial scale-up and market entry, while strategic support in areas such as IPR management, internationalisation, and health technology assessment will be critical to drive commercialisation. Collaboration with regulatory bodies and standardisation initiatives will also help ensure the innovation is effectively integrated into clinical practice.

Periodic Reporting for period 2 - KLISBio (Silk fibroin tissue grafting for peripheral nerve repair)

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