Strong Silk
Preclinical Data

There is already compelling data from numerous studies showing the efficacy of silk for peripheral nerve repair.

Trial data for silk conduits

There is strong preclinical data showing Newrotex nerve conduits perform equivalent or superior nerve regeneration compared to autografts, the current gold standard in nerve repair.

In terms of large-gap repair, a pilot trial of all-silk conduits after 3 months showed nerve regeneration occurred over gaps of 6 cm. This represented the first proof of a device successfully performing in vivo large-gap repair.

Trial data for silk filaments

Multiple trials show luminal silk fibres exhibiting equivalent or superior axonal regeneration compared to autografts, as well as excellent gross motor function recovery.

A study using acellular xenograft tubes containing silk showed nerve regeneration in gaps over 6 cm and excellent motor recovery, with complete degradation within 10 months.

Trials for Newrotex Silk Biomaterials

Animal trials

Newrotex began a trial in 2020 comparing luminal silk fibre types to determine which fibres were most successful at producing axonal regeneration in a peripheral nerve neurotmesis model with repair using a silk conduit.

Earlier Newrotex trials found that silk sheaths filled with silk fibres are as effective as autografts in terms of motor recovery and axonal regeneration. They also significantly outperformed hollow conduits according to the same terms.

Final pre-clinical testing will now focus on Regulatory approval tests for our Newrotex sheath and luminal filaments as well as testing the effectiveness of Newrotex luminal silk elements in commercially available hollow-tube conduits over large gaps.

First human trials

Human trials are anticipated in the near future and will commence upon completion of the required final pre-clinical regulatory assessments. Planning for these trials has already commenced with feedback from regulatory bodies and discussions with key opinion leaders at potential trial sites already underway.