i-SEP Reports Results of Its 1st Clinical Study Conducted on 50 Cardiac Surgery Patients

i-SEP develops sameTM, the first and only intraoperative autotransfusion solution which can preserve platelets in addition to the patient's red blood cells. The Nantes-based medtech publishes the results of its first clinical study, demonstrating its effectiveness

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Carried out on 50 patients, of which 18 (36%) underwent isolated coronary artery bypass grafting, 26 (52%) valvular surgery and 6 (12%) aortic root surgery, this clinical study demonstrated that sameTM enabled 52% of platelets to be recovered. Furthermore, these platelets’ activation and function, assessed by flow cytometry, were not altered by the device, with no adverse effect recorded.

Published in the prestigious journal Anesthesiology, this study is a milestone in i-SEP’s story, enabling the scientific community to measure the results of this unique solution.

“This clinical study is a major milestone for i-SEP, a testament to many years of investment and hard work. This publication in Anesthesiology is a great reward for our team and our partners, who have worked relentlessly to bring this technology to life. It will open many doors in France and globally.” – Sylvain Picot, Chairman of i-SEP.

A TECHNOLOGY WITH MULTIPLE BENEFITS

With unprecedented pressure on blood product stocks worldwide, care providers are implementing “Patient Blood Management” policies. The aim is to improve blood resources management and use.

With its unique autotransfusion technology, i-SEP addresses a major challenge. Using sameTM makes it possible to limit scarce and costly allogeneic blood product consumption, triggering significant savings. Recovered blood resources saved during sameTM operations can be reallocated elsewhere, relieving pressure on hospital blood stocks.

SameTM brings significant benefits to patients. Transfusing them with their own blood using sameTM, their exposure to allogeneic blood products, as these can sometimes cause complications. Indeed, despite rigorous planning, subtle differences between donor and recipient blood can occur, and significantly reduce transfusion effectiveness.

“This is an innovative device, developed by a young French medtech. It is easy to use, and saves blood platelets at well as red blood cells. The effects on hemorrhagic cardiac surgery post-operative transfusion are quite spectacular. We have seen transfusion rates drop by up to 30% for red blood

cells, and much more for platelets. This device’s added cost are largely offset by the drop in demand for blood products, not to mention the fact that access to transfusion carries its own risks (infection, immunization, shortage),” says Professor Fadi Farhat, cardiovascular surgeon at the Protestant Infirmary in Lyon.

Ultimately, this means an improved care for patients, and several hundred thousand euros in potential annual savings for facilities equipped with sameTM.

i-SEP CONTINUES TO GROW

In France, 5 centers are already equipped with sameTM, with a dozen more in final acquisition phase. i-SEP is gradually expanding to Switzerland and Belgium, with another 5 hospitals soon to be equipped. Next steps include deploying its solution in Germany, Spain and Italy.

But the Nantes-based start-up also intends to tackle the American market. It hopes to obtain U.S. approval by late 2024, early 2025.

“This clinical study is a major milestone for i-SEP, a testament to many years of investment and hard work. This publication in Anesthesiology is a great reward for our team and our partners, who have worked relentlessly to bring this technology to life. It will open many doors in France and globally.” – Sylvain Picot, Chairman of i-SEP.