MediSieve, a biotech startup focused on developing novel blood filtration therapies, has received approval to perform a first-in-man (FIM) clinical investigation of its Magnetic Haemofiltration System in The Netherlands.
The study is set to begin in June of 2022 at the Radboud University Medical Center, a leading Dutch medical research institution.
Prof. Peter Pickkers and Dr. Matthijs Kox, both world experts in FIM trials, are leading the study. Prof. Pickkers’ research focuses on pharmacological modulation of the innate immune response, and he is the Head of Research at the Radboud UMC.
The clinical investigation announced by MediSieve is a fundamental moment for the company.
MediSieve’s Founder and CEO, Dr. George Frodsham, said:
“This is a huge step for us as a company – this is the first time our products are going to be used in humans.
“We couldn’t be working with a better clinical team than the one at Radboud, and we are very excited to see the results.
“This study will bring us one step closer to getting our product – the first, we hope, of many for our platform – approved for use in hospitals around the world.”
MediSieve’s pivotal IL-6 product is designed to treat acute cases of IL-6-driven hyperinflammation in patients with Cytokine storms, AKI, ARDS, CRS, Pancreatitis, Cardiac Surgery and others.
Patients with elevated IL-6 levels have high mortality and morbidity rates and put a significant worldwide burden on healthcare systems. Currently, the most common treatment is systemic IL-6 inhibitors.
However, these drugs are unsuitable for the treatment of acute hyperinflammation because they cause long-term immunosuppression that leaves patients more vulnerable to both the initial and newly acquired infections.
