Symatix corneal device preclinical evaluation

This project will progress the development of the Symatix medical device for corneal repair and evaluate the device’s efficacy in vivo. The Symatix device is an innovative, synthetic biomaterial designed to support healing in cornea repair and recalcitrant wounds. It can replace the use of Human Amniotic Membrane (HAM) which has been successfully used for several decades despite having up to 40% failure rate due to its variable nature as a tissue-derived material.

HAM is expensive and its availability limited by the complicated supply chain from tissue donation through to implantation. This is a particular problem in developing countries with low tissue donation rates and poor regulatory infrastructure where the clinical need is greatest due to high levels of corneal trauma in manual labour. As a synthetic product, the Symatix device will provide the surgical benefits of HAM but with a step change in availability, affordability and product reliability.

If successful, the Symatix device can offer more predictable outcomes to patients, reduce the number of patients that need repeated treatment and extend the opportunity for such treatment to a much greater pool of potential patients. To date, Symatix membrane has been tested in a range of laboratory studies. Product design and development has been guided by surgeons including Dr Sangwan, Director at Dr Shroff's eye hospital in new Delhi and the LVPrasad eye institute in Hyderabad and Harminder Dua, Professor of Ophthalmology at University of Nottingham (UoN) and Consultant ophthalmologist at QMC Nottingham, partner in this application.

Both are interested in clinical evaluation of the product. In this project TECL will conduct pre-clinical efficacy tests on the Symatix device and prepare the device for pre-clinical biocompatibility testing. It will improve the manufacturing process to ensure reproducibility and scalability.

The University of Nottingham will conduct in vitro cell tests and laboratory evaluations on samples to compare the performance of the Symatix device with HAM and lead on clinical trial design and patient involvement. The output of the activities will be: • Data on the performance of Symatix, also in comparison to HAM

• Negotiations with licensing partners to take the device development forward and fund subsequent biocompatibility tests