KLISBio’s first product in pipeline is SILKBridge, a silk fibroin absorbable medical device for peripheral nerve repair. The promising results of the first clinical study on SILKBridge conducted by Prof. Maurizio Calcagni, Deputy Clinic Director at Department of Plastic Surgery and Hand Surgery at University Hospital Zurich, will be presented on Tuesday, June 7 at 11:30 London time at ExCeL Conference Centre in Room 5 Surgeon – South Gallery room 7-10 during the 2022 IFSSH, IFSHT & FESSH Combined Congress.

Peripheral nerve injuries affect more than 300,000 patients annually in the US, and over one million worldwide, leading to a loss of motor, sensory and autonomic functions, with a devastating impact on a patients’ quality of life. Once a discontinuous nerve injury is identified, the intrinsic ability of the peripheral nervous system to restore that damage is not sufficient and requires microsurgical interventions to support regeneration across the defect. The multilayered silk-based structure of SILKBridge is developed to confer ideal porosity and compression resistance to the device to promote safe nerve regeneration and functional recovery, while showing an optimized degradation profile that allows the conduit to support the nerve throughout its healing process. SILKBridge is anticipated to be available for clinical use in the US Market in 2023.

The FIH clinical study was a pre-market, monocentre, pilot study on adult patients with digital nerve defects. The goal of this trial was to ascertain the feasibility and safety of the procedure using SILKBridge for the regeneration of sensory nerve fibres and to obtain an indication of sensory recovery. The Primary Outcome Measure was safety in a time frame of 12 month. The Secondary Outcome Measure were sensory recovery after nerve reconstruction by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing, pain evaluation via VAS scale, and patients' overall impression of change.

“We are thrilled to share the results of our first-in-human pilot study on SILKBridge. This represents an important starting point for KLISBio and paves the way to the development of SILKBridge future clinical strategy” said Antonio Alessandrino, CTO and Founder of KLISBio. “I’d like to thank all of the participating subjects, Prof. Maurizio Calcagni, Principal Investigator, and KLISBio’s team members who have contributed to this study.”

KLISBio holds patents in Silk regenerated Fibroin + Native Silk Fibroin Pairing, Silk-based Composites and Core-Shell Silk Nanofibers. The Company is powered by a group of world leaders in MedTech including Grecchi, CEO; Antonio Alessandrino, President & Chief Technology Officer and Giuliano Freddi, Chief Scientific Officer. KLISBio recently announced that Rodrigo Bianchi will serve as Chairman of the Board, joining the company with more than three decades’ 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.