The patient can now be his own donor! The i-SEP start-up has just obtained CE marking for its autotransfusion technology. The latter must make it possible to supplement as much as possible the transfusions of blood from collections, which can induce risks of contamination and for which stocks are lacking. Until then, the devices developed for intraoperative blood recovery operated by centrifugation, which only made it possible to extract the red blood cells from the aspirated blood. The other blood components of interest were lost.
From the start of his career at Bordeaux University Hospital in the 1980s, Dr. Francis Gadrat became interested in autotransfusion. He quickly leaned towards filtration, an option little used until then for rich liquids such as blood, which pose problems of clogging and flow speed. But unlike centrifugation, the use of filters can also extract platelets, which help blood coagulation. He then worked for several years on site with the local ecosystem, and in particular Inserm Oenology, in order to take advantage of their skills in filtration.
Concentration, washing and regeneration
Founded in 2015 following this work, the start-up i-SEP was faced with a major challenge: quickly processing the blood collected during the operation. “We needed a fairly strong transmembrane flow, but without going so far as to alter the blood components”, says Francis Gadrat. To achieve this balance, the recovered blood is concentrated and then washed, passing through a hollow fiber cartridge. Red blood cells and platelets are retained in the lumen of the capillary, while contaminating molecules are eliminated. The blood thus performs several passages within the device, until it reaches the targeted washing and hematocrit level.
This device now allows i-SEP to process up to 500 mL of collected blood in 5 minutes. And to make the system last without clogging, the blood flow flows parallel to the filtering membrane. “In addition, membrane regeneration steps are integrated: a counter-flow is used to wash the surface of the filter medium”, explains Sylvain Picot, founder and CEO of i-SEP. Thus, the filter can be used throughout the duration of the operation without being changed.
Humanitarian and military applications
Currently in full fundraising, i-SEP will begin with a commercial pre-launch in around twenty European centers for cardiothoracic surgery, the sector where hemorrhages are the most massive. The device can then be deployed for other surgeries, and in other territories. “We will need to conduct additional validations in order to register the technology in the United States, which is the world’s largest market by value. In American hospitals, professions are not organized in the same way in the operating room. We must therefore validate the usability of the device with the users”, says Sylvain Picot.
In parallel with these first sales, the company does not intend to stop research. “We are working on a more compact version, for military and humanitarian applications. We can also look into the recovery of proteins of interest in the future. » Between commercial challenge and scientific projects, the i-SEP teams will not lack challenges.
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