Comparative evaluation of nerve repair and local tissue response following ReFeel^® nerve cuff implantation in a rat sciatic model

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Introduction Peripheral nerve injuries (PNIs) pose a persistent clinical challenge, with current repair strategies limited by material biocompatibility, degradation, and regenerative efficacy. This study evaluates the in vivo performance of ReFeel®, a novel bioresorbable alginate-polyglycolic acid (PGA) nerve cuff, in two rat sciatic nerve models, compared to commercial collagen-based repair devices NeuroMatrix® (conduit) and NeuroMend® (wrap). Methods Two studies were conducted in Sprague-Dawley rats using either a 10 mm sciatic nerve gap model (ReFeel® vs. NeuroMatrix®) or a no-gap intact sciatic nerve perineural wrap model (nerve exposed but not transected), comparing ReFeel® with NeuroMend®. Functional, histological, immunohistochemical, and morphometric assessments were performed at 1 week, 8 weeks, and 26 weeks (gap model) and 1 week, 8 weeks, and 13 weeks (wrap model). Tissues were analyzed using hematoxylin and eosin (H&E), Masson's trichrome, Safranin-O, NF200, S-100, and toluidine blue staining. Degradation, host response, axon regeneration, Schwann cell activity, and fibrosis were quantified. Results ReFeel® demonstrated superior Schwann cell alignment and axonal regeneration, particularly at 26 weeks, with near-complete scaffold resorption and minimal fibrotic encapsulation. Quantitative scores showed higher axon densities and comparable G-ratios versus NeuroMatrix®

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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