Nantes-based medtech i-Sep has announced the CE marking of its “Same by i-Sep” autotransfusion medical device. This technology has the particularity of recovering both red blood cells and platelets during bleeding in surgical procedures. With this mark, the company will be able to start marketing the Same™ blood recovery device to European hospitals and clinics.
This is a major step in the field of transfusion strategy. Atlantic France company i-Sep has received the authorization of marketing the first autotransfusion system that can recover both red blood cells and platelets. It offers an innovative solution in the context of blood product management under stress.
An innovative device to be marketed to European hospitals and clinics
I-Sep’s technology is able to recover blood from a patient when bleeding occurs during surgery in the operating room, to process it and then retransfuse it. Its distinctive feature is that it can reinject not only red blood cells but also platelets. By obtaining the CE marking certificate, the Nantes-based medtech is allowed to market its solution to European hospitals and clinics.
The company, which counts 25 employees, has recently signed a negotiated contract with UniHA, a cooperative of French public hospital buyers, which will facilitate access to French establishments. In the first year of marketing, 20 centres in Europe could be equipped with this device, with half of them in France.
A fourth round of financing to support the first sales
The technology is assembled by a partner company in the Atlantic France region, with the electronics coming from the Rhône-Alpes region. The consumables are prepared by i-Sep itself in its clean room based in Nantes.
The company already has systems ready to install and should sign its first sales before the end of the year. After a third round of financing in 2019 that enabled it to finalise the clinical trial phase, i-Sep is currently working on a fourth round of financing to support the industrialisation and commercial deployment of its technology.