21 Rue de la Noue Bras De Fer
44 200 NANTES
FRANCE
Company
i-SEP is a French Medtech, founded in 2015 in Nantes, specialized in intraoperative autotransfusion and Patient Blood Management. At i-SEP, we have developed and patented an innovative technology for the recovery and separation of blood components.
Our ambition is to become the first laboratory to market intraoperative cell salvage technology (IOCS) capable to wash and recover both red blood cells and platelets during hemorrhagic surgery, using equipment that is ergonomic and intuitive.
We work closely with teams of reference anesthetists and resuscitation specialists with the aim of improving patient benefits, simplifying the work of physicians and helping to reduce healthcare costs.
Our innovation brings significant added value compared to currently available solutions, particularly in terms of blood quality.
History
- First proof of concept
- First family of patent filed
- Business plan drafted
Founded
- €860,000 seed capital from the Go Capital Amorcage venture capital fund
- Market study
- Team formed
- Board of experts set up
- Separation process developed
- First working prototype
- In-vitro evaluation (French National Blood Bank for Nantes – Pays de la Loire)
- In-vivo evaluation (Oniris Veterinary School)
- Fundraising (round 1) of €1.23 million from Go Capital Amorçage and Business Angels
- Regulatory strategy (EU and USA) and quality approach
- Move to Nantes BioOuest business incubator
- Installation of a clean room and clean laboratories
- Development and evaluation of the 2nd generation functional prototype
- Fundraising (round 2) of €500,000 from Go Capital Amorçage
- Bpifrance funding of €2.339 million and ERDF funding of €519,000 to support Mobile Blood Keeper project
- Bpifrance Excellence label
- Development and evaluation of the 3rd generation prototype (clinical version)
- Regulatory Validations
- €2.134 million from Go Capital Amorçage and private investors
- Winner in the “Revolution” category at the 2019 Run Innov Awards (Pays de La Loire)
- Participation and communication in first congresses : SFAR, EUROPHARMAT
- ISO 13485 certification for the complete activity
- Manufacturing of clinical machines
- Authorization from ANSM and FAMHP, Medical Drug Regulators of France and Belgium respectively to launch clinical trial for CE pre-marking
- Promising preclinical results for patients and physicians published in the prestigious journal Anesthesiology
- Oral communication of the clinical results in the “Masterclass Workshop transfusion & Hemostasis” session of the EACTAIC European Congress, October 27 to 29.
- Same™ by I-SEP medical device has obtained the CE mark and started marketing. First autotransfusion device to obtain the CE marking certificate according to MDR 2017/7451
i-SEP was co-founded by three partners: Dr Francis Gadrat, an anesthesiologist, Bertrand Chastenet, a former company director, 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 the Go Capital venture capital fund and a number of private investors. i-SEP is supported by Atlanpole and is a member of the Atlanpole Biotherapies competitiveness cluster.
Dr. Francis GADRAT, inventor and co-founder, i-SEP Chief Medical Officer
Francis practiced for more than 40 years as an anesthesiologist at the Bordeaux University Hospital. He has also taken part in humanitarian missions. Very involved in the field of Patient Blood Management, Francis wants to reduce the side effects induced by surgical bleeding and to improve the post-operative recovery of patients. His clinical research work has led to the creation of an innovative intraoperative cell salvage technology (IOCS) capable of recovering both red blood cells and platelets. As a key contact for physicians and opinion leaders in Patient Blood Management, Francis makes sure that the device can simplify the work of physicians.
Bertrand CHASTENET, expert in the pharmaceutical sector, co-founder and Member of the i-SEP Strategic Committee
Bertrand brings i-SEP a strong management experience in the pharmaceutical sector. As Managing Director of FURT Laboratories for 20 years, Bertrand has collaborated with the Institut Curie on cancer research programs and has also been a consultant for the international development of several pharmaceutical companies. He currently acts as Advisor to the National Committee of French Foreign Trade in several educational programs. Bertrand assists i-SEP with the elaboration of its development strategy.
Sylvain PICOT, Medtech entrepreneur, co-founder, Chairman and CEO of i-SEP
A Biosciences Engineer from INSA Lyon and an experienced entrepreneur, Sylvain completed his training at the Lyon School of Management before setting up Biom’up which he managed for 10 years. Sylvain oversaw the development of new implantable medical devices from research to market in Europe and the USA. Sylvain joined Francis and Bertrand to found i-SEP to manage the development, approval and marketing of the innovative intraoperative cell salvage technology. In particular, Sylvain brings i-SEP his experience in launching an innovative activity in the field of surgical medical devices.
The team now counts about fifteen people managed by 4 experienced managers
Commitment and 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.
Partners and investors
Partners
Partners
PRIVATE Investors
Since 2017, i-SEP has opened much of its capital to private investors, including several entrepreneurs from the healthcare sector who bring 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 fund managing over €200 million in assets. The fund is mainly active in innovative, technology-intensive companies based in the West of France.
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.
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.
