Milan, Italy Jun. 25, 2025
KLISBio Announces Publication of mid-term outcomes of the first in-human digital nerve reconstruction using the SILKBridge®
Milan, Italy (June 25th, 2025) – Today, KLISBio, a MedTech company challenging the status quo in regenerative medicine by leveraging a silk-based technology platform, announces the publication of the mid-term results of SILKBridge® pilot study in the Journal of Peripheral Nerve System (JPNS) – available at: https://doi.org/10.1111/jns.12675. The study, titled “Digital nerve reconstruction with a new composite silk fibroin nerve conduit”, was conducted by Prof. Maurizio Calcagni, Primary Investigator, and a distinguished team of researchers from the University Hospital Zurich and Cantonal Hospital Aarau. The study aims to examine digital nerve reconstruction with SILKBridge® Nerve Guide in terms of sensory recovery, complications rate, patients' reported outcomes and biological behavior.
The study evaluated four patients with digital nerve injuries treated with SILKBridge® (length range of the nerve guide 10–26 mm). At a mean follow-up of 32 months, all patients demonstrated satisfactory sensory recovery and reported minimal to no pain post-reconstruction. Sonographic assessments confirmed effective bio-integration, with no signs of inflammation or scarring. All patients were satisfied with the result, while none reported a foreign body sensation. Thus, the study highlights preliminary safety, efficacy and biocompatibility results of SILKBridge®.
“These promising mid-term clinical results highlight SILKBridge®’s potentiality in peripheral nerve repair,” said Antonio Alessandrino, Chief Technology Officer and Founder at KLISBio. KLISBio remains dedicated to expanding clinical research and further validating the benefits of SILKBridge® in larger patient cohorts in its upcoming pivotal clinical study in the EU to secure the CE Mark.
SILKBridge® is an off-the-shelf, absorbable medical device made of Bombyx mori silk fibroin and is intended for the surgical repair of peripheral nerve discontinuities. SILKBridge® multilayered structure has an optimized balance between biomechanical and biological properties, complementing the high strength of native silk fibers and the enhanced biomimicry of electrospun silk. The inner and outer electrospun layers are specifically designed to promote cell adhesion and resorb faster. The morphological properties of electrospun fibers mimic the nanoscale structure of the extracellular matrix. The intermediate textile layer is made of a textile component and is designed to confer high mechanical performance and resistance to the device and to resorb at a slower rate. SILKBridge® is not yet cleared nor available for commercial sale in the US, EU or other countries.
KLISBio holds patents covering a variety of silk-based technologies. The Company is powered by a group of world leaders in MedTech including Gabriele Grecchi, CEO and Co-founder; Antonio Alessandrino, Chief Technology Officer and Founder, Giuliano Freddi, Chief Scientific Officer and Co-founder; Rodrigo Bianchi, serving as Chairman of the Board with more than three decades of experience in global healthcare. In addition to its strong leadership team, KLISBio works with physicians, engineers, researchers, chemists and biologists worldwide who represent excellence in the biomedical space.
About KLISBio: KLISBio is a clinical-stage regenerative medicine company focused on developing innovative technology platforms entirely based on natural silk fibroin. The company currently has several assets under development, such as peripheral nerve repair, rotator cuff repair, vascular grafting, and bone graft substitutes. KLISBio is now headquartered at Via Ludovico Ariosto, 21 – 20090 Bresso (MI) – Italy. The above-mentioned address serves as its official address for all business requirements.