Clinical development of H-Guard, a novel hemocompatibility coating for haemodialysis

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Globally, there are 3.2 million patients treated for end-stage renal disease (ESRD), a number increasing by 6% each year. A kidney transplant is the best hope for ESRD patients and can allow them to lead a normal life. Unfortunately, due to a lack of suitable donor organs, and the risks of transplant, most patients with kidney failure will never receive a transplant. These patients depend on dialysis to stay alive. Haemodialysis is the most common type of chronic dialysis, a procedure which is typically required 3x per week and involves pumping the patient's entire blood supply through an artificial kidney called a "dialyser", providing an artificial means of removing the fluid and waste products that healthy kidneys normally remove. Shockingly, life expectancy on dialysis is just one-third of normal, with half of patients receiving haemodialysis dying from cardiovascular complications.Stress and damage to cardiovascular health during the haemodialysis procedure is caused by inflammatory processes initiated by the patient's innate immune system which recognises the dialysis membrane as a large foreign body and attacks it. Although the damage from a single haemodialysis session is slight, the repetitive nature of the procedure generally leads to more profound damage, complications, and death. The inflammation is also associated with the flu-like symptoms commonly experienced after dialysis, which are often highly debilitating for patients, significantly reducing their quality of life.Invizius Limited are developing the H-Guard technology to address this long-standing and critical healthcare need. H-Guard is a novel medical device coating technology which acts like an 'invisibility cloak' to hide the dialysers from the immune system and prevent the inflammatory processes. By preventing the immune response and ensuing inflammation, H-Guard will significantly reduce cardiovascular damage, extend haemodialysis patient life expectancy and reduce healthcare costs associated with hospitalisations and the treatment of cardiovascular complications.This project aims to deliver a First-in-Human study to assess the safety and performance of (acute) H-Guard administration as a priming solution to coat dialysers and blood tubing sets during the standard clinical dialysis set-up prior to use in haemodialysis patients. Outcomes from this project will enable Invizius to progress rapidly through further clinical studies to gain regulatory approval in Europe by 2026\.