Founded in 2015 in Nantes (Upper Britany, France), i-SEP is a medtech specialized in intraoperative autotransfusion and Patient Blood Management. At i-SEP, we have developed, patented and now markets an innovative technology for the recovery and separation of blood components.

Together with our clinicians, we develop unique Patient Blood Management solutions for improved patient & stakeholder benefits.

We work closely with specialized clinicians with the aim of improving patient benefits, simplifying physicians’ workflow and helping reduce healthcare cost.

Our innovation brings significant added value compared to currently available solutions, particularly in terms of blood quality.

History

Before-founding
  • First proof of concept
  • First family of patent filed
  • Business plan drafted
2015
  • i-SEP founded in October 2015
2016
  • Market study
  • Engineering and Design team build-up
  • Expert Board set up
  • Separation process developed
2017
  • First working prototype
  • In-vitro evaluation (French National Blood Bank)
  • In-vivo evaluation (Oniris Veterinary School)
  • Regulatory strategy (EU and USA) and quality approach
2018
  • Move to Nantes BioOuest Lab business incubator
  • Clean room and clean lab installation
  • 2nd generation functional prototype development and evaluation
  • Bpifrance Excellence label
2019
  • 3rd generation prototype (1st clinical version) development and evaluation
  • Regulatory validations
  • 2019 Run Innov Awards winner – “Revolution” category
  • Attending first congresses: SFAR and EUROPHARMAT
2020
  • ISO 13485 certification for full activity
  • First batch of clinical system assembled
  • ANSM and FAMHP authorizations granted (French and Belgian Medical & Drug Regulators) to launch CE pre-marking clinical trials (MDR 93/42/CE)
2021
  • Promising preclinical results for patients and physicians, published in Anesthesiology
  • Oral communication of these clinical results at the “Masterclass Workshop transfusion & hemostasis” session of EACTAIC European Association of Cardiothoracic Anaesthesiology and Intensive Care Congress, October 27 to 29
2022
  • same™ by I-SEP medical device obtains CE mark
  • 1st autotransfusion device to receive this certificate according to MDR 2017/745
2023
  •  +500 patients treated with same™
  • 14 systems installed
  • Clinical results published in Anesthesiology
  • Comparative clinical trial launch
2024
  • Comparative results presented during NATA congress

Founding Team

i-SEP is co-founded by three partners: Dr. Francis Gadrat, an anesthesiologist, Bertrand Chastenet, a former manager, consultant in the pharmaceutical industry and advisor to the National Committee of French Foreign Trade, and Sylvain Picot, a Medtech entrepreneur and founder of Biom’up.

i-SEP is financed by venture capital funds and several private investors. i-SEP is supported by Atlanpole and is a member of the Atlanpole Biotherapies competitiveness cluster.

Sylvain Picot

  • Medtech entrepreneur and co-founder
  • CEO of i-SEP

A trained Biosciences Engineer (MSc., INSA Lyon) and experienced entrepreneur

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Dr. Francis Gadrat, MD

  • Inventor and co-founder
  • Chief Medical Officer

Dr. Gadrat practiced anaesthesiology for 40 years at Bordeaux University Hospital (France), as well as in remote locations on humanitarian missions

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An experienced management team

An experienced management team

Guillaume Laurent

Commercial & Marketing Director

Graduated from IDRAC Business School and holder of a Master degree in Management of Technology & Innovation from GEM (Grenoble École de Management), Guillaume brings more than 10 years of experience in France and on the international stage in marketing, launch of innovative medical devices and a solid knowledge regarding the healthcare market and key opinion leaders.

Guillaume joined i-SEP in 2019 to be in charge of the promotion of same™ technology, the marketing strategy and oversee the market release of our innovative intraoperative cell salvage technology in partnership with selected hospitals.

Patricia Forest-Villegas, PhD

CSO, Regulatory Affairs & Quality Manager

A biochemical engineer from the INSA Engineering School of Lyon, Patricia completed her training with a PhD in biological and medical engineering at the faculty of Pharmacy of the University of Lyon, before founding and managing Biom’up with Sylvain Picot for 10 years.

She has developed extensive experience in the registration of medical devices in Europe and the United States and in the implementation of quality systems, especially for ISO 13485 certification. As a regulatory expert, especially for CE Marking, Patricia also intervenes as a trainer or expert for various training institutes or companies.

Stéphanie Perrin, PhD

Clinical Director

A biochemical engineer from INSA Lyon, Stéphanie completed her training with a Ph.D in biological and medical engineering. She then accumulated over 15 years of experience in clinical research on a range of medical devices, firstly in a hospital environment, and then with a CRO. This enabled her to develop solid skills in setting up and piloting clinical studies, but also in regulatory, project and team management aspects and in setting up hospital partnerships.

On joining i-SEP, Stéphanie was tasked with leading the clinical development, supporting regulatory compliance, completing the scientific and medical development, and launching the technology in partnership with hospital teams.

Stéphane Chollet

Technical Director

A Health & Safety Engineer from the University of Compiègne, Stéphane has more than 20 years of experience in the health sector, including a dozen years spent in development, industrialization, manufacturing and management positions in the field of blood management and transfusion products.

Stéphane joined i-SEP to oversee the technical and analytical development and industrialization phases. His solid skills in the development of blood consumables gleaned during his time with Macopharma and his experience as Quality Director give him a broad understanding of the subject.

Thibault Cretinon

Machine Division Director

Electronics engineer from CPE Lyon, Thibault began his career at Fresenius Vial within the R&D department, and he took positions as a Designer, Electronics Project Manager and then Technical Leader. After 7 years of experience, he chose to continue his career at Maatel, a Grenoble-based SME specialising in the development and production of custom-made devices for medical applications. By managing the Design Office, he consolidated his ability to manage teams, to carry out complex multidisciplinary design projects, but also to develop solid experience in the industrialization and manufacturability of medical devices.

In 2023, Thibault chose to join i-SEP by taking in charge the management of the machine division to manage the development, validation and industrialization activities of the electro-medical device.

Ludwig Magueur

Head of Finance

Graduated in Corporate Finance & Internal Audit from Sorbonne Graduate Business School (Paris), Ludwig has a strong financial acumen in fast-paced environments, in France and abroad (UK and Canada).

He has a track record in innovative startups, and resulting missions such as obtaining grants, filing tax credits, and analysing hypergrowth scale ups.

His responsibilities at i-SEP include all aspects of administrative & financial management, cash management, as well as human resources management.

Commitment & Quality

Since our creation, we have embraced a quality-focused approach to ensure the safety and performance of our devices. The ISO 13485: 2016 certification of its entire quality system in January 2020 was a fundamental step for the laboratory and the certification of its technologies and demonstrates i-SEP’s expertise and complete control of all its activities.

Our teams are fully committed to ongoing improvement and we work in full compliance with the regulations in force.

Our overriding goal is to develop innovative medical devices to improve patient care and generalize the use of its devices by offering safe, effective and intuitive solutions for anesthetists and patients.

i-SEP is ISO 13485: 2016 certified since 2020.

i-SEP has embraced a quality-focused approach to ensure device safety and performance since its inception.

same™ is CE marked with the latest European regulations MDR 2017/745.

Post-Market Clinical Follow-up (PMCF) is performed under MDR.

Partners &
investors

Institutional Partners

Hospital Partners

Investors

Private investors

Since 2017, i-SEP has opened its capital to private investors, including several entrepreneurs, business angels and family offices, some them from the healthcare sector are bringing specific expertise in the clinical field or medical biology.

The fund raising round carried out in June 2019 with the support of GWENNEG consolidated our shareholder base with the arrival of new Business Angels and Family offices.

 

GO CAPITAL is a venture capital firm managing €400 million in assets. The firm is mainly active in innovative, technology-intensive and sustainable companies in the territories.

The GO CAPITAL Amorçage fund, which invested in the capital of i-SEP, was raised with the support of the Fonds National d’Amorçage, managed by Bpifrance Investissement as part of the PIA Investing-for-the-Future Program, the European Investment Fund, the Regions of Brittany, Pays de la Loire, Normandy and a selection of banking partners (Crédit Mutuel ARKEA, Caisses Régionales du Crédit Agricole and Caisse d’Epargne de Normandie).

GO CAPITAL is recognized as one of the most active seed capital investors in France in the healthcare field.

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Interested in investing?

Our mission is to improve patient benefit, simplify the work of physicians and help reduce healthcare costs.

By putting the patient at the heart of its priorities, i-SEP develops innovative medical devices, including an autotransfusion system capable of recovering both red blood cells and platelets during hemorrhagic surgery, using equipment that is ergonomic and intuitive.

If you are interested in investing in a Medtech with strong ambitions and unique expertise, feel free to contact us.

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Sylvain Picot

Medtech entrepreneur and co-founder
CEO of i-SEP

A trained Biosciences Engineer (MSc., INSA Lyon) and experienced entrepreneur, Sylvain received his Master in Entrepreneurship and Innovation from Lyon School of Management prior to starting Biom’up, which he managed for 10 years. His track record includes the introduction of innovative implantable medical devices, from research to deployment across Europe and the U.S.

Dr. Francis Gadrat, MD

Inventor and co-founder
Chief Medical Officer

Dr. Gadrat practiced anaesthesiology for 40 years at Bordeaux University Hospital (France), as well as in remote locations on humanitarian missions.

Early on, he focused on Patient Blood Management, with a strong desire to reduce side effects from surgical bleeding, and improve post-op patient recovery.