Innovative medical device same™ by i-SEP : promising clinical results

25 October 2021

MedTech – Autotransfusion or IntraOperative Cell Recovery

Recovery of platelets in addition to red blood cells, a world premiere

Following the publication of preclinical results in May 2021, i-SEP’s clinical results are now attracting the support of the scientific community. In the context of a pandemic the i-SEP teams managed to complete the First in Man study of the same™by i-SEP autotransfusion device with results that surpassed expectations.

  • The 50 patients have been included in the university hospitals of Rennes (coordinating center), Bordeaux, Paris Georges Pompidou European Hospital and Nantes between September 2020 and April 2021.
  • The clinical results confirm and surpass the preclinical data published in May 2021 in the journal “Anesthesiology”, with notably a platelet yield higher than 50 % on average.
  • This major milestone brings i-SEP one step closer to marketing its patented Intra Operative Cell Salvage (IOCS) technology capable of recovering both red blood cells and platelets for the benefit of patients.

The abstract presenting the results of this study is selected for an oral communication in the “Masterclass Workshop transfusion & Hemostasis” session of the EACTAIC European Congress to be held from October 27 to 29. This is a recognition before the market launch of
this innovative device.

“This clinical study is a major milestone for i-SEP and for bringing our innovative same™ autotransfusion system to market. The level of involvement of the clinical centers and our investigators has been extremely strong in a context of pandemic and significant tensions for the teams in the operating room. We would therefore like to thank once again the entire medical profession for this mobilization around our project, which aims to improve the surgical management of the greatest number of patients who do not currently benefit from a satisfactory solution. We are very happy to be able to share the complete results with the European KOLs during the EACTAIC congress which will be held at the end of October in virtual. Our ambition is to obtain our CE mark in the first half of 2022 to meet the needs and requests of centers to integrate the same™ by i-SEP intra operative cell recovery device into their clinical practice”, says Sylvain Picot, President and co-founder of i-SEP.

same™ by i-SEP: the 1st and only intraoperative autotransfusion technology capable of preserving platelets in addition to the patient’s red blood cells, evaluated for the first time in humans

The study was conducted on 50 cardiothoracic surgery patients over an 8-month period (September 2020 – April 2021), at the Rennes University Hospital (coordinating center), the Bordeaux University Hospital, the Georges Pompidou European Hospital in Paris and the Nantes University Hospital. This multicenter clinical trial aimed to confirm the performance and safety of the same™ by i-SEP RSPO system, on the one hand in terms of blood processing (device safety), and on the other hand in terms of red blood cell and platelet restitution (performance).

The first use of the same™ by i-SEP device in humans was performed in September 2020 in the anesthesiaintensive care department of Professor Alexandre Ouattara at the Bordeaux University Hospital.

The results of the clinical study confirm and surpass the preclinical in-vitro results obtained in 2020 and published in May 2021 in the journal Anesthesiology, with notably a platelet yield higher than 50 % on average.