Known for its wines and historic 1,000-year-old cathedral, there is more to Strasbourg and the Alsace region of France than grapes and gothic architecture. In fact, there is a thriving medical device industry, along with the ambition to create a global center for new medical technology.
The key driver for this is IRCAD – the Strasbourg-based institution that is pioneering minimally invasive surgery techniques, and its spin-off, the Institute for Image Guided Surgery, which is pioneering the use of imaging systems in these surgical procedures. Around these two institutes, local and regional governments are building a medtech campus where they envision start-ups from around the world developing new medical technology.
This is the eco-system in which medeuronet is fortunate to sit. And, to give you a glimpse of this rich environment, with this article on Strasbourg-based start-up, Defymed, we will start to feature some of the exciting innovation under development.
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By Kathleen Mackay
An estimated 20 million people in the world suffer from Type 1 diabetes, according to 2012 figures. Since Type 1 diabetes leads to impaired insulin production, patients with the condition require frequent insulin injections.
Now, hope is on the horizon for the millions of sufferers of Type 1 diabetes to dramatically improve their treatment. A startup in Strasbourg, France, Defymed, a small scale enterprise (SME) is developing implantable bio-artificial medical devices for a wide range of applications, with a first focus on Type 1 diabetes.
Defymed is part of the Alsace BioValley, a French competitive cluster that supports businesses and laboratories in the health, life sciences and biotech sectors looking to create, grow or locate in the Alsace region. The BioValley area is home to many companies which are developing therapeutic innovations. Pharma/biotech experts in the region identify new business growth opportunities, financing and innovation.
Defymed is a spin-off of the Centre Européen d’Etude du Diabète (CeeD), also part of the Alsace BioValley. CeeD was founded in 1991 in order to work on innovative projects to treat diabetes, one of which is the design of a bio-artificial pancreas. At its inception, the project was purely in the research and conceptual stage. Dr. Séverine Sigrist, director of the CeeD lab, brought the research to the next level with the idea of an implantable device, named MAILPAN®, and founded Defymed in 2011. She is now the company president and has won national recognition for an innovative business startup. Among other honors, Dr. Sigrist was awarded the Chevalier d’Ordre National du Mérite in 2013.
Public and private funding
With the awareness of the great public need for this innovative product to treat Type 1 diabetes, a number of public and private partners came together to make Defymed a reality.
In 1996, the European Commission funded the BARP project under the fourth Framework Program, which funded CeeD, as a coordinator, until 2000. In 2004 the European Commission co-funded the BARP+ project under the sixth Framework Program, which continued until 2007. This work was carried out by CeeD in collaboration with STATICE and CTTM (Centre de Transfert de Technologies du Mans). In 2009, Dr. Sigrist went to several organizations seeking help for founding Defymed, among them, Alsace’s incubator Semia and the Alsace BioValley. She was then granted funding by Alsace region, BPI, the French government and the European Commission. Defymed was created in 2011, and the company and its partners have since raised 10-11 million euros to support its work.
Dr. Richard Bouaoun (picture below), director of operations of Defymed, explains, “The first product designed by Defymed is the macro-encapsulation of pancreatic islet (MAILPAN®) device, a bioartificial pancreas intended to be implanted in diabetic patients to restore normal blood sugar levels. It is like a bag to hold cells for insulin production, and it protects cells from the immune system.” The project, called BIOSID, has seven European partners. “We are in pre-clinical development on small and large animals. If everything goes well, we can begin clinical trials on humans at the end of 2016 or in early 2017,” says Dr. Bouaoun.
The second project Defymed is coordinating is the MECABARP project, which includes five French partners. It assesses the safety of the MAILPAN® on animal models and on test benches. Researchers are ensuring MAILPAN® will meet the standards of regulatory studies that will be conducted later.
Benefits of being in Alsace
The Alsace BioValley is one of the fastest-growing biotechnology regions in Europe. Even before the BioValley project began, there were more than 300 life sciences companies and institutions in the region, including two global players, 40 private and university institutions and four universities. The vision of the BioValley was conceived in 1996 by the entrepreneur Georg H. Endress in the wake of the merger between Ciba and Sandoz to form Novartis, and the resulting loss of 3000 jobs in the life sciences. Endress saw that a horizontal network of equal partners in the region would produce more jobs. No new structures had to be built, it was simply the coming together of scientists, entrepreneurs, politicians, banks and venture capital companies from this region of Europe. This led to a boom in creativity and innovation.
Dr. Bouaoun affirms that being in Alsace helps Defymed. “Alsace is a very innovative region with a lot of organizations supporting medical research and development. For example, the Alsation incubator Semia and the life sciences cluster Alsace BioValley, helped us obtain funding and partners.” Among the partners identified for Defymed is BPI, a public funder.
In turn, Defymed also helps Alsace. “We have created employment,” states Dr. Bouaoun, “and we have kept our headquarters in Alsace. We bring national and international visibility to the region. In the years to come, when the product comes to market with our partners in Big Pharma, we will create a great many jobs.”
Main challenges of the market
Dr. Bouaoun describes the challenges in bringing Defymed’s bioartificial pancreas to market. “We are developing a device, and we are not a producer of the cells that go in it. Without the cells the device would not work. Conversely, the cells cannot work without the device. The challenge for us was deciding which category to focus on: the device or the drugs.”
“Whether Defymed takes the device route or the drug route, each has regulatory standards we have to meet. We have chosen to focus on the device route, and let Big Pharma take the drug route, where their expertise lies,” he states. Among the pharmaceutical companies who are in the Alsace BioValley network are Novartis and Roche, and labs and production facilities of Eli Lilly and Sanofi.
In creating the startup and its innovative medical product , Dr. Bouaoun reflects on the greatest lessons the company has learned.
“We have learned the value of partnerships,” he says. “We wanted to work with others to bring the product to the patient. We have mounted a lot of collaborations, and are working with those who are among the best in the world in this type of medical research. We are small, but we have a large network.” These partners include the UCL (Université Catholique de Louvain) in Brussels, IRCAD in Strasbourg and the University of Oxford in the UK. Other collaborators include key opinion leaders, small scale enterprises, physicians and others.
“If you manage these collaborations well, you can succeed,” Dr. Bouaoun concludes. Success will mean that Defymed, with its bioartificial pancreas, can help to improve treatment—and quality of life — for millions of sufferers of Type 1 diabetes around the world.