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BIOTECHFINANCES STRATEGIC INFORMATION FOR BIOTECH DECISION-MAKERS AND INVESTORS Special Issue • Medical Devices Lyon Metropolis 2015-2016 Summary BIOTECH FINANCES: Why is Lyon Metropolis strengthening its position in medical devices? Jacques de Chilly: Lyon Metropo- lis overall strategy in the life sciences has until now mainly been focused on infectious diseases, neurology and can- cer. But the changes we have seen in society, especially an aging population, have led to 6% growth in the medical technology sector, outpacing phar- maceuticals. Medical devices involve crossing boundaries between industry, academia and research to leverage the necessary skills. Lyon-based busi- nesses and engineering schools are particularly active in the fields of me- chanics and materials. The medical device sector also features in the stra- tegy of a regional hub made up of local and city councils: Lyon Metropolis, Saint-Etienne Metropolis, ViennAgglo and CAPI. Lyon and Saint-Etienne complete each other and combine their skills in the mechanics, textiles, plastics and health sectors. BF: And of course the digital sector... JdC: There are indeed crossovers here on a regional level between the digital sector and nanotechnologies, medical imaging and bioinformatics, the latter being prominent in Grenoble and Lyon. All the technological and industrial elements are available for rolling out a real strategy for medical devices. And this actually plays to our strengths in biotechnology, diagnostics and life sciences. The crossovers with medical technology are plentiful. Big companies value our position and they are in talks with us about relocating to and expanding in the Lyon area. In the past we have already supported dialysis leaders Baxter and Fresenius in their investment plans. Fresenius Group in fact completed three projects in a row, worth €100 M altogether. BF: What are the challenges for the years ahead? JdC: We need to bring in new players, new investors to the region. It means lending further support to the whole of the life sciences community, through innovation clusters like Lyonbiopôle and i-Care Cluster, funding for core facilities like the Accinov platform or the technology research institute BIOASTER. It also means working in even closer collaboration with cancer research centers, university colleges, and the University of Lyon Foundation. And we mustn’t forget the start-ups which are the small and medium-sized businesses of the future. Our objective is to coordinate the various city and local councils especially for textiles and medical technology in Saint-Etienne. Lyon is fortunate in that it lies at the crossroads of a number of life science capabilities. We really do have an ace to play internationally for establishing ourselves firmly in the medical device sector and taking the lead. “LYON HAS A REAL ACE TO PLAY IN MEDICAL DEVICES” Jacques de Chilly, former MD of Aderly, Greater Lyon’s economic development agency, now heads economic and international development for Lyon Metropolis, with emphasis and ambition on medical devices. COMPANY TESTIMONIALS ENQUIRIES TO SET UP IN LYON METROPOLIS Jean-Charles Foddis, Adriana C. Toma, Nathalie Laurent, (Invest in Lyon) page 8 2 3 1 4 6 5 1• Michel Thérin, (Medtronic-Covidien) - p 3. 2• Dietrich Wolf, (Eye Tech Care) - p 3. 3• Denys Sournac, (Medicrea) - p 4. 4• Etienne Binant, (Biom’Up) - p 4. 5• Elisabeth Ducottet, (Thuasne) - p 5. 6• Emmanuel Blanc, (Edap TMS) - p 5. 1 2 FEATURED ARTICLE Florence Agostino-Etchetto, head of the Lyonbiopôle cluster Auvergne-Rhône-Alpes, a unique public/private ecosystem for medical devices in France, pages 6-7 Jacques de Chilly “The changes we have seen in society have led to 6% growth in the medical technology sector.” INTERVIEWS 1• David Kimelfeld, (VP Lyon Metropolis) - p 2 2• Emmanuel Blanc, (i-Care Cluster) - p 2

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Page 1: BIOTECHFINANCES - Aderly Setupmarket is fairly unusual for French start-ups which mostly target the US. “But we think we can create value faster in China, and with less investment,”

BIOTECHFINANCESSTRATEGIC INFORMATION FOR BIOTECH DECISION-MAKERS AND INVESTORS

Special Issue • Medical Devices Lyon Metropolis 2015-2016Su

mm

ary

BIOTECH FINANCES: Why is Lyon Metropolis strengthening its position in medical devices? Jacques de Chilly: Lyon Metropo-lis overall strategy in the life sciences has until now mainly been focused on infectious diseases, neurology and can-cer. But the changes we have seen in society, especially an aging population, have led to 6% growth in the medical technology sector, outpacing phar-maceuticals. Medical devices involve crossing boundaries between industry, academia and research to leverage the necessary skills. Lyon-based busi-nesses and engineering schools are particularly active in the fields of me-chanics and materials. The medical device sector also features in the stra-tegy of a regional hub made up of local and city councils: Lyon Metropolis, Saint-Etienne Metropolis, ViennAgglo and CAPI. Lyon and Saint-Etienne complete each other and combine their skills in the mechanics, textiles, plastics and health sectors.

BF: And of course the digital sector... JdC: There are indeed crossovers here on a regional level between the digital sector and nanotechnologies, medical imaging and bioinformatics, the latter being prominent in Grenoble and Lyon. All the technological and industrial elements are available for rolling out a real strategy for medical devices. And this actually plays to our

strengths in biotechnology, diagnostics and life sciences. The crossovers with medical technology are plentiful. Big companies value our position and they are in talks with us about relocating to and expanding in the Lyon area. In the past we have already supported dialysis leaders Baxter and Fresenius in their investment plans. Fresenius Group in fact completed three projects in a row, worth €100 M altogether.

BF: What are the challenges for the years ahead? JdC: We need to bring in new players, new investors to the region. It means lending further support to the whole of the life sciences community, through innovation clusters like Lyonbiopôle and i-Care Cluster, funding for core facilities like the Accinov platform or the technology research institute BIOASTER. It also means working in even closer collaboration with cancer research centers, university colleges, and the University of Lyon Foundation. And we mustn’t forget the start-ups which are the small and medium-sized businesses of the future. Our objective is to coordinate the various city and local councils especially for textiles and medical technology in Saint-Etienne. Lyon is fortunate in that it lies at the crossroads of a number of life science capabilities. We really do have an ace to play internationally for establishing ourselves firmly in the medical device sector and taking the lead.

“LYON HAS A REAL ACE TO PLAY IN MEDICAL DEVICES”Jacques de Chilly, former MD of Aderly, Greater Lyon’s economic development agency, now heads economic and international development for Lyon Metropolis, with emphasis and ambition on medical devices.

COMPANY TESTIMONIALS

ENQUIRIES TO SET UP IN LYON METROPOLIS

Jean-Charles Foddis, Adriana C. Toma, Nathalie Laurent, (Invest in Lyon) page 8

2

31

4 6

5

1• Michel Thérin, (Medtronic-Covidien) - p 3. 2• Dietrich Wolf, (Eye Tech Care) - p 3. 3• Denys Sournac, (Medicrea) - p 4. 4• Etienne Binant, (Biom’Up) - p 4. 5• Elisabeth Ducottet, (Thuasne) - p 5. 6• Emmanuel Blanc, (Edap TMS) - p 5. 1

2

FEATURED ARTICLE Florence Agostino-Etchetto, head of the Lyonbiopôle cluster Auvergne-Rhône-Alpes, a unique public/private ecosystem for medical devices in France, pages 6-7

Jacques de Chilly

“The changes we have seen in society have led to 6% growth in the medical

technology sector.”

INTERVIEWS1• David Kimelfeld, (VP Lyon Metropolis) - p 2 2• Emmanuel Blanc, (i-Care Cluster) - p 2

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2 BIOTECHFINANCES • 2015-2016

Special Issue • Medical Devices Lyon Metropolis 2015-2016INTERVIEWS

“Our strategy draws on Lyon’s long-standing medical tradition, on figures like Alain Mérieux, and also on the Lyonbiopôle cluster which has played a pivotal role in shaping the sector and attracting large corpo-rations. Without such a coordinated approach, Sanofi might never have decided to maintain and relocate some of its head offices in Lyon or to invest in its new facility at Neuville-sur-Saône. At the same time the region has witnessed the growth of a number of technology and R&D platforms like the Accinov platform and the BIOASTER Technology Research Institute, all of which contribute to the region’s business appeal. This vibrant hub has also spurred the growth of start-ups like Adocia, Biom’up, Medicrea... Lyon-Gerland Biodistrict is another core component of our stra-tegy. The investment made in road networks and public areas, and in an wholly open-air campus with direct connections to the city’s main hospitals, has really put Lyon on the map of the Euro-pean and global healthcare industry. Other areas near Lyon are also benefiting from the international strategy. The region’s appeal

undoubtedly influenced the decisions of German group Fresenius and the homeopathy lab Boiron to further invest in their plants in Lyon area. Another sign of our high global visibility is the confirmed presence of the International Agency for Research on Cancer (IARC). This agency is part of the World Health Organization (WHO) and is due to move into new premises within Biodistrict Lyon in 2020. There is no other agency like it in the world.”

THE INDUSTRIOUS WINNING STRATEGY OF LYON METROPOLISDavid Kimelfeld is the Vice-President of Lyon Metropolis – the authority for the Greater Lyon area – and in charge of economic development. He explains Lyon’s growth strategy for life sciences and medi-cal devices.

BIOTECH FINANCES: What is special about the regional businesses involved in medical devices?Emmanuel Blanc: Lyon is particularly strong in the digital sector, and for electronic patient records. Grenoble has a strong robotics sector and Saint-Etienne is long tradition in textile innovation. The region is currently experimenting the use of cutting-edge technologies under its digital healthcare scheme called Digital Healthcare Territory and led by the Regional Health Agency. On the world stage too, Auvergne-Rhône-Alpes is shaping up well; it is home to large international groups such as Medtronic (former Covidien), Fresenius, Baxter and Gambro.

BF: How do regional businesses compare to other European clusters in particular?E.B.: Auvergne-Rhône-Alpes is mirroring the Paris region which ranks top for medical devices nationally. But France needs to continue its efforts as it remains a challenger. We need to redress our trade balance that is in the red by €800 M in the medical device sector, and ensure our regions take a greater market share. We may not be in the same league yet as Lausanne for instance, but we do have the means to substantially raise our game. What will help us here is our healthcare system; industry and business leaders are able to collaborate with clinical teams and labs from Inserm and CNRS which are particularly skilled in ultrasound and medical imaging. If we are able to bring these academic, clinical and in-dustrial worlds closer together, then we’ll have a real trump up our sleeve.

BF: Do French businesses have critical mass?E.B.: This is the big difference with German businesses. French ones cover an extremely broad range of products, from tubulation to ultrasound, but more big names are needed like BioMérieux for in vitro diagnostics, or medium-sized companies like Trixell in Grenoble, or Thuasne in Saint-Etienne. New medium-sized companies need to come to the fore, and this is the reason of being of clusters like i-Care. There is much potential for development in the thousand or so French companies working in medical devices.

BF: What are the challenges for the years ahead?E.B.: The main challenge is financing innovation and streamlining reimbursements for medical procedures. If we expect to boost the me-dical technology sector, we’ll have to further develop research and help hospitals invest in innovation and purchase new technology. Our industry players are developing real high-level capabilities, what we need to do now is ensure this is leveraged effectively.

BF: What do you want to achieve with events like Medica?E.B.: It’s quite a unique opportunity to reconnect with all the suppliers of medical devices, meet with the main sub-contractors and find new ones. i-Care Cluster uses the event as a way to reach out to similar organizations in Germany and Switzerland, thus helping to strengthen our region’s foothold in the market and to enhance our European and international visibility.

“OUR INDUSTRY PLAYERS ARE DEVELOPING REAL HIGH-LEVEL CAPABILITIES”Emmanuel Blanc heads i-Care Cluster, an initiative to federate and support all health technology businesses that design, manufacture and commercialize medical devices and solutions based on health information technology. Here he delivers his expert insight into how the region is positioning itself in this cutting-edge sector.

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BIOTECHFINANCES • 2015-2016 3

Special Issue • Medical Devices Lyon Metropolis 2015-2016 COMPANY TESTIMONIALS

Following on from Europe and the US, Lyon-based start-up Eye Tech Care is now targeting China.

Founded in 2008 and managed by CEO Dietrich Wolf, the young company deve-lops and markets EyeOP1®, an innovative

solution for treating glaucoma with focused ultrasound. Reaching out to the Chinese market is fairly unusual for French start-ups which mostly target the US. “But we think we can create value faster in China, and with less investment,” Wolf says.“With 28% of the world’s patients, many of whom have advanced glaucoma requiring surgery, China repre-sents a key market for glaucoma treatment. Our easy-to-use tech-nology offers an ideal alternative,” Wolf points out. Putting forward these argu-ments, Eye Tech Care has entered the approval process of the China Food and Drug Admi-nistration (CFDA) for its EyeOP1® system. In Europe, an extension of the CE marking has been granted to the system’s new version which is more user-friendly and comes with optimized settings.These advancements mean the company can expand its business operations beyond France and Europe where its markets

typically were before. After raising €4.5 M in early 2015, the start-up which recorded earnings of €650,000 for 2014, is once again looking to attract higher levels of funding including from abroad by the end of the year. The CEO explains, “This is to step up our sales and marketing drive for the brand and to better prepare for

product licensing in China and the US.” This inter-national develop-ment isn’t however overshadowing its operations in France and the Lyon area. The company conti-nues to work closely alongside inves-tors and suppliers, research teams (Inserm) and clinical

partners (Lyon and Grenoble hospitals). “Membership of the Lyonbiopôle brings a strong impetus to what we are about,” Wolf adds. “On top of that, we have gained interesting insights from a business to meet with Chinese practio-ners and to pave the way for our operations in their country.”

Eye Tech Care sets sights on ChinaDietrich Wolf, CEO

“With 28% of the world’s patients, China represents a key market for

glaucoma treatment.”

Sofradim Production has been controlled by the giant Medtronic ever since the latter took over Covidien of

which Sofradim had been a subsidiary. With 85,000 employees, the global leader in medical devices has a $27 M turnover. “Cross- fert i l izat ing Medtronic’s techno-logies with those we excel at may well deliver success for the future,” affirms Michel Thérin, pre-sident of Sofradim Production, who employs 280 people, a third of which work on product development.To boost company growth, he is current-ly looking to obtain clearance in Europe over the coming months for an inno-vative product, a resorbable hemosta-tic gauze. An investment of €15 M has been made to mass produce this product

which helps stop bleeding during surgical operations mainly on the spleen, liver and kidneys. This is a major diversification for a company otherwise known for its parietal reinforcement implants range. Now Sofra-dim is hoping to establish itself in the hemos-tasis market. Valued at €8 B, it has a 5- 10%

annual growth rate.This innovation came about through a patent and a technology deve-loped by CNRS. Michel Thérin is particularly keen on collaborative work with research labs of technical and engineering schools in Lyon and Saint-Etienne and with the CEA in Grenoble. He

is mindful of the partnerships he can set up with hospital teams which possess “top-class technical facilities”. He also stresses how he reaches out to local

businesses and service providers, especially in the field of materials characterization, in order to actively involve them in these endea-vors despite a possible slowdown in momentum due to having more stakeholders on-board.

Medtronic-Covidien diversifies into hemostatic gauzesMichel Thérin, VP R&D of Medtronic-Covidien (Trévoux R&D innovation center)

THE INDUSTRIOUS WINNING STRATEGY OF LYON METROPOLIS

“Cross-fertilizating Medtronic’s

technologies with those we excel at may well deliver success

for the future.”

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4 BIOTECHFINANCES • 2015-2016

Special Issue • Medical Devices Lyon Metropolis 2015-2016COMPANY TESTIMONIALS

In October 2016, Medi-crea will be relocating from La Rochelle, on France’s Atlantic coast, to Van-

cia in the Lyon region, thus bringing together its head office, production units and R&D teams. “We are investing €16 M in the move which will be decisive for our future.” Explains Denys Sournac, CEO of this company with a 100 staff which has been listed on En-terNext since 2006. “By converging on one site, we will be able to optimize our industrial capability, continue to innovate, and integrally manage most of our production.”The company pumps €2.5 M into R&D every year. But for the CEO, what inspires engineers to develop ground-breaking products such as the Pass LP is how production processes are managed and knowing what surgeons need.Since 2010 Medicrea has been develo-ping a range of surgeon-friendly implants. These products consist of custom-made

rods, and more recently, 3D interverte-bral cages. “This has come about through our Unid platform concept,” Sournac states. “In order to provide patient-specific treatment while catering for the needs of surgeons, we use special design software alongside specific machining or printing processes. The beauty of Unid lies in its ability to go beyond our conventional

products.”The 3D printing project is still in its experimental stage and pending approval. A 3D titan printer has required €1.3 M worth of investment already. In 2013, some 400

patients had surgeries using these perso-nalized rods in France and the US. These rods represent 10% in turnover which has increased five-fold since 2009 bringing it up to €23.9 M in 2014 of which 60% has been generated in the US. “The US market remains a priority for us.” the CEO adds. “This is why we are looking to be more visible to investors over there and highlighting the benefits of our patient-

specific process. We know that American surgeons value this approach very much.”

Medicrea invents patient-specific implantsDenys Sournac, CEO

Ten years after it was founded, Biom’Up has pulled off one of the year’s most amazing feats when it

managed to secure €31.3 M. Specializing in resorbable, collagen-based biomate-rials, the company boasts an unblemished track record. Also driving them forward

is a comprehensive local ecosystem that saw their development, from being incu-bated at Crealys all the way to their initial funding round. The spin-off from the National Institute for Applied Sciences of Lyon certainly has what it takes to become one of the global market leaders.And this poten-tial has been pic-ked up by life science investors’ radars. In its recent financing round-table, Bpifrance Large Venture, European in-vestment com-pany Gimv and the Danish foundation Lundbeckfond Ventures put up €18.3 M alongside its long-standing shareholders InnoBio, SHAM, ACG management which topped up with €12 M. Lastly, a further €1 M was brought in by the management team led by CEO Etienne Binant.“We now have the resources and partners needed to position ourselves in the he-

mostasis market, a segment worth $2 B,” Binant explains. The proceeds of the financing round will be used primarily to finance a large clinical study of a new hemostatic product – Hemoblast – which is able to stop light to moderate bleeding during surgery in less than six minutes

maximum. The study was cleared by the Food and Drug Admi-nistration (FDA) in August and involves 400 patients main-ly from the US. If successful, the product could be commercia-lized by late 2016 with large-scale manufactu-

ring in a new factory set up by Biom’Up, starting in 2017. Parallel to this, the start-up from Lyon is continuing to market another product, an anti-adhesion collagen membrane for surgery. This solid foundation has enabled the company to employ some 50 people and record a turnover of €4 M for 2015, up 30% on the previous year.

Biom’Up, a gem in Lyon’s ecosystem Etienne Binant, CEO

“We now have the resources needed to position ourselves

in this market, a segment worth more

than €2 B.”

“The US market remains a priority

for us.”

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BIOTECHFINANCES • 2015-2016 5

Special Issue • Medical Devices Lyon Metropolis 2015-2016

Still quick on the draw after almost a hundred and seventy years of ope-rations, the Saint-Etienne-

based business is keeping pace with the times while remaining true to itself. It has shifted from traditio-nal textile products like the dressings used by WWI sol-diers, to technical products (medical and sports orthosis), while expanding into the broader realm of high value-ad-ded medical devices. Today the family business, led by Eli-sabeth Ducottet, has gone digital and partnered with a start-up to develop connected therapeutic soles. The aim is first to design a gauge to test the pressure of the foot arches, and then to develop a device to track and alert people who suffer from neuropathy. As part of Thuasne’s drive for open innovation, the partnership with the start-up – FeetMe –

embraces the digital revolution dear to Elisabeth Ducottet. The medical textile industry went through a modernization process which brought about automated looms; it certainly doesn’t want to miss out now on the galaxy 3.0. “We need

to take this digital revolution further in order to produce medical devices with more functiona-lity - offering greater accuracy, connec-tivity, and flow of information,” insists Thuasne’s CEO, who is delighted with the brainstor-ming going on in the Auvergne-Rhône-Alpes region, home

to a number of technical institutes and research labs such as the CEA. Thuasne is working especially closely with Ecole des Mines in Saint-Etienne. The school has set up a biomechanics lab which is a welcome development for pushing ahead with new products. Other key enablers in the region include the

innovation cluster Techtera, of which Thuasne is a member, and French Tech with the “design à Saint-Etienne” label and which also has a hand in transforming our medical devices.

Thuasne taking its digital revolution to new heights with connected soles Elisabeth Ducottet, CEO

“We need to take this digital revolution

further in order to produce medical devices with more

functionality.”

Since it was founded in 1979, high-tech medical company Edap TMS has been based in Vaulx-en-

Velin near Lyon. “We integrate dif-ferent technologies and the Lyon area is great for that,” says Emmanuel Blanc,

development director. “With 80% of our sub-contractors in and around the city we have solutions at our very doorstep.” As president of the regional i-Care Cluster, Emmanuel Blanc also appreciates “the outlook brought in by connections with other industry players.”Right from the start, Edap TMS has grown through its close ties with resear-chers from Inserm (LabTau*) and with physicians from Hospices Civils de Lyon. Their colla-boration has enabled them to come up with a method for treating urolithia-sis using extracorporeal shock wave lithotripsy, and another for prostate cancer using high intensity focused ultrasound (HIFU). By marketing these products to hospi-tals, 80% of which are abroad (8 subsi-diaries and offices), Edap TMS now has a 150-strong staff and has seen its reve-

nues go up from €24 M to €30 M. “We lose money every year,” explains Emma-nuel Blanc, “due to 10% to 12% of our turnover being fed into R&D. We have started seeing a reversal in the model whereby medical technology required less clinical development expenditure than pharmacy: we have invested €100 M for

the HIFU technology.”However, the out-look for Edap TMS is bright. LabTau is exploring how to apply HIFU technologies to treat liver cancer, in conjunction with anti-cancer center Léon-Bérard in Lyon. “Fur-thermore, Edap TMS

has now managed to obtain clearance from the FDA in the US for its product,” states Emmanuel Blanc, who is delighted. Japan, the only other country where approval is pending, is likely to follow suit.(*) Laboratory of Therapeutic Applications of Ultrasound

Edap TMS focuses on partnership in innovationEmmanuel Blanc, Development Director

“We have invested € 100M

for the HIFU technology.”

COMPANY TESTIMONIALS

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6 BIOTECHFINANCES • 2015-2016

Special Issue • Medical Devices Lyon Metropolis 2015-2016FEATURED ARTICLE

Spanning fields such as infectology, nanotechnologies, specialized textiles and more. The Auvergne-Rhône-Alpes region brings together 15% of the French sector’s businesses. These include big names like: Sanofi Pasteur, Merial, bioMérieux, Genzyme Polyclonals, Fresenius, Mylan, Thuasne, Gibaud, Sigvaris, Covidien (recently taken over by Medtronic), Roche Diagnostics, Eurofins Optimed, Endocontrol...“Further to this solid regional foothold, we have a mature network of small and medium-sized businesses and innovative start-ups,” Agostino-Etchetto points out. These young innovators are attracting foreign investors like Biom’Up has (specialized in collagen-based medical devices) when it managed to secure nearly €32 M through the Gimv and Lundbeckfond Ventures funds. Another example is Amoeba (green biocide), which was incubated by Crealys in 2010. It was listed on Euronext in the summer of 2015 and since then it has seen its share price increased by... 210%!

A MULTIDISCIPLINARY APPROACH

“Apart from this strong industrial presence, the region’s key strength lies in its public-private ecosystem,” explains Stéphane

Avril, a researcher at Centre Ingénierie and Santé de Mines Saint-Etienne specia-lizing in treatments for aortic aneurysm. This innovation-driven ecosystem is home to France’s largest number of researchers in biomedical engineering, which repre-sents some 2,000 masterminds across the whole region working away at disruptive solutions and technologies. “Auvergne-Rhône-Alpes ranks second in the country for the number of scientific publications produced, just behind the greater Paris area. We carry a strong reputation,” says Avril who, this year, was awarded a grant for his project Biolochanics developed in partnership with Yale University in the US. This grant comes after an earlier one awarded to his colleague Pierre Badel last December, and together they total €3.5 M over five years. The new “made in Saint-Etienne” treatment is expected to substantially reduce the number of the 30,000 deaths recorded every year in Europe due to enlarged aorta. This broader program for aneurysms and aging of tissues brings together 14 regional partners including Saint-Etienne University Hospital, Ecole Centrale Lyon and Hospice Civils de Lyon. “The region assembles a number of biological, engineering and medical faculties that all

work hand in hand. In fact a networked skills base along with a multidisciplinary, and cooperative approach to the private sector constitute a major feature of the Auvergne-Rhône-Alpes region,” adds Thierry Hoc, a researcher at Ecole Centrale Lyon. This seen, for example, by the imminent opening of an industrial department, at Mines Saint-Etienne school, in medical textiles fully financed by the firm Thuasne.

AUVERGNE-RHÔNE-ALPES, A UNIQUE PUBLIC/PRIVATE ECOSYSTEM FOR MEDICAL DEVICES IN FRANCEIs Auvergne-Rhône-Alpes a region of excellence for medical devices? “It is certainly a global benchmark for medical innovation,” says Florence Agostino-Etchetto, head of the Lyonbiopôle innovation cluster, a key driver of the region’s healthcare sector “a result of all the ongoing work done in the economy, policymaking and academic research”.

Florence Agostino-Etchetto

Over 300 businesses operate in the main medical technology sectors in Lyon. They include: Becton Dickinson, bioMérieux, Depuy France, Edap TMS, Saphir medical, Floréane, Medical Implants Group, Praxim, Micro Vitae, Medicrea, Biom’up, Fresenius, Medtronic, Tornier, Allergan, Groupe Lépine, Stryker, Tekka, Gambro, Baxter, Fresenius, Aguettant, Roche, GE Healthcare, Animascope, Voxcan, Gibaud, Sigvaris, Thuasne, La-boratoire Tetra, Biomet.

MAIN SECTORS AND KEY FIGURES FOR MEDICAL TECHNOLOGIESSurgery 2,600 jobs 54 businesses ; dialysis 2,800 jobs 48 busi-nesses ; medical imaging 600 jobs ; medical textiles 2,600 jobs 27 businesses ; diagnostics 18 businesses

ENVIRONMENT AND SCIENTIFIC EXPERTISELYON METROPOLIS: infectology, biotechnology and medical devices.The Lyon Metropolis area has become the European leader in

vaccines for humans and animals, bacteriological diagnostics and licensing systems. It is also Europe’s number one hub for manufac-turing vaccines and France’s second largest employer in life sciences.

GRENOBLE: biotechnology and structural biologyBetween Lyon and Grenoble, “There has been a long love-hate tradition,” says Patrick Boisseau of CEA-Leti, “but the rivalry is a thing of the past”. Today Grenoble is known for its capabilities in biology, chemistry, IT, nanotechnologies and physics thanks to its research powerhouses: CEA, Université Joseph Fournier and Grenoble INP.

SAINT-ETIENNE METROPOLIS: medical technologiesSaint-Etienne and the Loire department account for a third of the Auvergne-Rhône-Alpes region’s potential in medical technology, especially orthopedic implants, medical and sports textiles, home-help and biotechnology.

Sources: DIRECCTE / Région Rhône-Alpes

Driving forces in Lyon’s medical devices ecosystem

6 BIOTECHFINANCES • 2015-2016

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BIOTECHFINANCES • 2015-2016 7

Special Issue • Medical Devices Lyon Metropolis 2015-2016 FEATURED ARTICLE

These crossovers uniting labs and busi-nesses are even more prominent in Grenoble which is known in the region for nanotechnologies and assisted surgery. “Here, all research projects have to partner with industry,” says Patrick Boisseau, head of the nanomedicine program at CEA- Leti lab which has a 250 research staff working on health technology programs. “Every year we have at least 150 contracts underway with major clients, start-ups and even our own spin-offs’.

A DIVERSIFIED INDUSTRY

The extensive support system available to innovators is another key asset of the region. The regional network includes clusters, incubators, and expert hot spots which all come together to deliver value and contribute to the 2014-2020 regional innovation strategy under which life sciences and nanotechs feature among the region’s seven hi-tech target sectors. However, there are issues that the regional ecosystem needs to address in order to enhance its image for foreign investors. “The region’s healthcare/health techno-logy sector is a high-value economic driver, but it needs to become easier to navi-gate,” states Bertrand Bergue of ARDI, the region’s agency for development and innovation. “Some of the top funders from outside the region would like to invest, and so we are working to reassure them about how the region can offer a safe and suppor-tive environment for their endeavors.”

EUROPEAN COMPETITION

Another challenge facing the birthplace of French medical devices and life sciences is the commercialization of certain innova-tions. It’s a challenge for France and other countries, as it is for regions developing medical devices such as Auvergne-Rhône-Alpes, says Gérald Comtet, manager of the regional i-Care Cluster focused on health technology. We perform well in design, safety and clinical applications, but our healthcare system, and those of other countries, don’t have budgets adapted to financing new devices. In other words, innovators or would-be innovators can sometimes be put off by the lack of funding. “Sooner or later, businesses at the seed stage will have to seek funding,” states Nathalie Cohet, entrepreneur advisor at Pulsalys, an accelerator combining the competencies of Lyon Science Transfer and Crealys for the Lyon/Saint-Etienne area. “The public sector and especially local and regional policy-makers are playing their part by providing support schemes, and the private sector has to build on this.” The FIRA – the Rhône-Alpes Innovation Fund – exemplifies

this public sector involvement. Worth €68.8 M, the fund was set up a few weeks ago to support innovative businesses in the region. Behind the new measure are three different sources of capital: Bpifrance, the European Regional Development Fund (ERDF) and the Rhône-Alpes Regional Government. Beneficiaries will be able to receive loans as business capital. “Secu-ring high levels of non-dilutive capital is challenging for our region’s innovative start-ups whose cash flow is crucial to their business success,” explains Marie-Adeline Peix, who is in charge of managing Bpifrance’s regional partnerships. “As part of Bpifrance, our role is to streamline support schemes and ensure they deliver tailored solutions for both young and mature businesses and for all types of projects at all stages of development.”

BETWEEN €50,000 AND €1 M

The FIRA will be invested over a 5-year period, thus coinciding with the European Union’s financing timeline. Through the scheme, interest-free loans of between €50,000 and €1 M will be allocated to around 500 businesses for a maximum period of 8 years. It’s good news for biotech but also for businesses operating in the medical devices market as they won’t have to justify their turnover to apply. “To be eligible, an applicant must first have a concrete innova-tion project, be located in the Rhône-Alpes region, and possess equity or quasi equity. That’s it.” concludes Peix. “Although it’s better to have at least three years’ worth of financial statements to apply for FIRA loans, we do have the discretion to finance younger projects by spin-offs from established groups, entrepreneurs who we have already supported in the past, or high-potential R&D initiatives.”By implementing this measure, the national bank and the Rhône-Alpes Regional Government hope to build innovation capacity in new areas and advance the commercialization of new generation products. “Our priority will go to the high-potential sectors within the Region that have been identified under the Regional Innova-tion Strategy » Peix points out. A welcome feature for entrepreneurs is that there are no collective selection rounds for FIRA aid; instead projects will be selected on an ongoing basis according to whether they meet the criteria set out. Investors are already looking ahead to a possible FIRA 2 whose scope is being defined as France’s regions boundaries are being redrawn to some extent.The overall objective of the Auvergne-Rhône-Alpes region is to keep pace with the front-running regions at a time when powerful hubs are emerging throughout Europe.“Today’s competition comes from regio-nal hubs such as Baden-Württemberg or

Catalonia,” Patrick Boisseau explains. There is also the Genève-Lausanne corridor which is attracting scores of high-level researchers from around the world. “Rhône-Alpes has a lot going for it as well as the potential to rank among the best,” Boisseau goes on. “With ARDI, we are putting together a plan to show Europe our human and material capabilities. Our long-term challenge is to enhance our appeal in order to keep up with the competition.”

Rhône-Alpes: healthcare industry in figures

183projects approved between 2005 and 2015 by Lyonbiopôle cluster, worth €870 M in funding including €390 M from public sector schemes.

150laboratories across the region with 9,000 researchers including 2,000 working in infectology (50% public sector), and 4,000 in nanotechnologies of which 300 specialize in healthcare applications (CEA, LETI...) in Grenoble.

2Academic Research Communities dealing with healthcare, disability, quality of life and aging. They develop partnerships between industry and academia to finance and manage research projects.

In addition :• 80,000 jobs in healthcare including:• 30,000 in medical devices sector• 800 businesses in medical technology• 2 WHO centers/1 laboratory BSL4

Jean Mérieux• 2nd largest university hospital in France with

Hospice Civils de Lyon (staff of 22,000)• 40 hospitals• Over 15,000 life sciences students

and 150 research graduates per year.

Sources: MIPRA 2013/2014 / Lyonbiopôle, Aderly.

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