Development of a novel surgical implant to treat pelvic organ prolapse using advanced materials

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Pelvic organ prolapse (POP), a common condition, is the bulging of internal organs down the vaginal canal secondary to weaknesses in the pelvic floor, exacerbated by age and childbirth. A mesh made of polypropylene material was previously used for the surgical management of POP. It has since been banned due to rising concerns that, in the pelvis, the material causes symptoms of chronic pain, chronic inflammation secondary to persistent infection, and fibrous scarring as a result of mesh shrinkage.**Current options:** Management of POP includes watchful waiting or the insertion of a silicone-based pessary to hold up protruding organs, often discontinued due to discomfort. Surgery without an implant results in recurrence in over a third of cases. Currently, there is an unmet clinical need with no competitive alternative to the polypropylene mesh.**Solution:** Hastalex(r) is a trade registered graphene-based material, developed by our company. The material has been patented and with no existing intellectual property that infringes our Freedom to Operate (carried out by Stratagem IPM Ltd, Cambridge). Hastalex harnesses the superior properties of graphene due to its novel formulation. The mechanical strength and elasticity of the material have been tuned to match the properties of pelvic tissue. Other applications of Hastalex, and the biodegradable version BioHastalex(r), include heart valves, tendons, artificial urinary sphincters, and as a tampon-like drug delivery device.The Young Innovator award 2022 provided me with the support and funding to carry out in vitro and in vivo toxicology studies on Hastalex proving it to be non-toxic and biocompatible. I have been working with NanoRegMed, in collaboration with Imperial College London, on the design of a novel implant to be used in prolapse surgery.**Current Proposal:** The aim of this proposal is to further the development of the pelvic implant. The first step includes design and manufacturing via two fabrication methodologies for comparison. 1) Flat Hastalex sheet with patterns cut using laser technology. 2) Knitted membrane with Hastalex fibres, developed recently by the company. Both products will be assessed for treatment efficacy at preclinical animal trials.I will establish contacts with regulatory bodies to sketch the pathway toward clinical feasibility studies. The vision of this project is to implement the membrane in POP surgery with manufacturing either in-house or via the support of a larger medical devices company. Our success would have a major positive impact on the UK economy. The materials and manufacturing are environmentally friendly.