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

在全球范围内，有320万患者接受终末期肾病（ESRD）治疗，每年增加6%。肾移植是终末期肾病患者最大的希望，可以让他们过上正常的生活。不幸的是，由于缺乏合适的捐赠器官，以及移植的风险，大多数肾衰竭患者将永远不会接受移植。这些病人依靠透析来维持生命。血液透析是最常见的慢性透析类型，通常每周需要3次，并且涉及通过称为“透析器”的人工肾脏泵送患者的全部血液供应，提供去除健康肾脏通常去除的液体和废物的人工手段。令人震惊的是，透析患者的预期寿命只有正常人的三分之一，一半接受血液透析的患者死于心血管并发症。血液透析过程中对心血管健康的压力和损害是由患者先天免疫系统引发的炎症过程引起的，该系统将透析膜识别为大型异物并对其进行攻击。尽管单次血液透析的损害很轻微，手术的重复性通常导致更严重的损伤、并发症和死亡。炎症还与透析后常见的流感样症状有关，这些症状通常会使患者非常虚弱，显著降低他们的生活质量。Invizius Limited正在开发H-Guard技术，以满足这一长期存在的关键医疗需求。H-Guard是一种新型医疗器械涂层技术，其作用类似于“隐形斗篷”，可将透析器隐藏在免疫系统中并防止炎症过程。通过防止免疫反应和随后的炎症，H-Guard将显着减少心血管损伤，延长血液透析患者的预期寿命，降低与住院和心血管并发症治疗相关的医疗费用。该项目旨在进行首次人体研究，以评估（急性）H-在用于血液透析患者之前，在标准临床透析设置期间，作为预充液给药，以涂覆透析器和血液管路套件。该项目的成果将使Invizius能够通过进一步的临床研究迅速取得进展，到2026年获得欧洲监管机构的批准。

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\.