i-SEP has obtained authorisations from ANSM and AFMPS to launch its clinical trial in France and Belgium

1 July 2020

I-SEP, a French MedTech (Nantes) specialising in blood processing and Patient Blood Management, has developed and patented a pioneering technology for separating blood components. This strategy uses a cross-flow system to collect a patient’s red blood cells and platelets during haemorrhagic surgery.

Following its ISO 13485:2016 certification in January 2020, i-SEP has just obtained ANSM and AFMPS authorisation to launch its European clinical trial in France and Belgium. This trial will seek to confirm the promising preclinical results of the in vitro and in vivo studies. Given the stresses surrounding the increasingly frequent lack of availability of stocks of labile blood products (LBP), especially in terms of platelets, i-SEP’s solution represents a major innovation breakthrough that will benefit patients and physicians.

This multi-centre European clinical trial aims to endorse the performance and safety of the blood collection system (POBC) system developed by i-SEP, both in terms of the blood cleansing process and of the return of red blood cells and platelets. The challenge will be to validate the very promising preclinical results and to determine whether they reduce the need for allogeneic transfusions, or limit patient blood loss during surgical procedures. This clinical trial will be conducted on a group of 50 patients at 4 Hospital Centres in France (CHU Bordeaux, CHU Rennes, HEGP Paris, CHP Rennes) and 2 in Belgium (CHU Charleroi, CHU Liège), with the aim of obtaining CE marking by end June 2022.