What's new?
04/04/2018

• Sofinnova Crossover Fund 1 is the largest healthcare crossover fund focused on Europe.
• With this new fund, Sofinnova Partners actively pursues the strategy to broaden its Life Sciences platform to invest across the value chain, from seed stage to late-stage companies.
• Bpifrance* and CNP Assurances acted as sponsors for the fund.

Paris, France – April 4th, 2018 — Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, announced today the launch of Sofinnova Crossover I with €275 million ($340 million), above the original first close target of €250 million. With this new fund, Sofinnova Partners goes one step further in the execution of its growth plan, aimed at expanding its coverage across the Life Sciences space with dedicated sector teams.

Pursuing a strategy Sofinnova Partners has successfully applied for decades with its early-stage focused Capital Funds, Sofinnova Crossover I will invest in the biopharmaceutical and medical device sectors. The fund will focus primarily on therapeutic and game-changing companies driven by experienced management. As a lead or cornerstone investor, the fund will seek to invest in about 15 late stage private and public companies. About 80% of the investments will be made in European companies, with the remaining 20% outside of Europe primarily in North America. A dedicated, highly experienced team of four partners will invest Sofinnova Crossover I, leveraging on Sofinnova Partners’ wider experience, track record and organizational support. This new fund attracted premier international investors, predominantly sovereign funds, insurance companies, corporations and family offices. Commitments came from Europe, including France, Italy, Denmark, Ireland, and Switzerland but also from Asian investors in China and Singapore. In addition to Bpifrance* and CNP Assurances, investors include a major Chinese biopharmaceutical company, the Danish State Investment fund, and family offices like Fidim or KCK representing leading industrial families in Europe and Asia.

Antoine Papiernik, Chairman of Sofinnova Partners, said, “With the launch of this new crossover activity, Sofinnova builds upon its unique early stage track record. Many of the companies we initially funded have become over the years large, billion-euro companies, and we have gained invaluable experience in helping them to the next level. This fund will complete our investment platform across the life-sciences value-chain, allowing us to fund companies from the seed stage to the late-stage.”

Jacques Theurillat, Partner in the crossover team at Sofinnova Partners, added: “The European healthcare market has matured with hundreds of late stage private and public companies looking for growth capital, and Sofinnova Partners, with its name, track record and experience, is particularly well positioned to identify the best European deals and transform them into global leaders.”

Triago acted as placement agent and Clifford Chance Europe LLP acted as legal counsel on Sofinnova Crossover I.

* Bpifrance directly and with the “Investment for the Future” Program, managed by the SGPI and operated by Bpifrance

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead investor in start-ups and corporate spin-offs and has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management.

16/04/2018

PARIS – April 16, 2018 – LimFlow SA, developer of innovative, peripheral endovascular technology transforming the treatment of critical limb ischemia (CLI), today announced it has secured €27 million ($33.5 million) in an oversubscribed Series C financing. The round was led by Sofinnova Partners, with continued participation from existing round B investors Bpifrance, the French sovereign investment bank, and Balestier, a Singaporean family fund. Gérard Hascöet, Venture Partner at Sofinnova Partners, and Dr. Kinam Hong, Partner of the Sofinnova Crossover I Fund, will join the company’s board of directors. The investment is the first for the newly raised Sofinnova Crossover I Fund.
Proceeds from the Series C financing will fund the company’s major strategic initiatives through the second half of 2020, including completion of a U.S. pivotal trial for the LimFlow Percutaneous Deep Vein Arterialization System (pDVA), which will be submitted to the FDA as part of the approval process, and execution of its international commercialization strategy.
Based in Paris, LimFlow was founded in late 2012 by Dr. Martin Rothman, a world-renowned interventional cardiologist, and MD Start, a European Incubator dedicated to healthcare. The company’s proprietary and CE marked technology is a novel and purely percutaneous therapy for “no-option” CLI patients when all other revascularization efforts have been exhausted and a patient is facing a major amputation.
In the past 18 months, the company has achieved a number of key milestones, including CE Mark and acceptance into the FDA Breakthrough Devices Program. Enrollment is also currently underway in both a U.S. feasibility study of the LimFlow technology (PROMISE I) and an international post-market study (PROMISE International).
“We are gratified with the support we have received from Sofinnova Partners, a leading European venture capital firm and one of the most respected and specialized global Life Sciences investors. We are equally appreciative of the continued strong commitment from our existing investors. The new funds will enable us to continue our mission to save patients from amputation, and ultimately, save lives that might otherwise be lost,” said LimFlow CEO Dan Rose.
“LimFlow is an excellent fit for our healthcare Crossover I fund, where we seek investments in companies with game-changing technologies that address important clinical unmet needs and are led by experienced and passionate management teams,” said Dr. Hong.

About LimFlow SA
LimFlow is a private, venture-backed medical device company transforming the treatment of Critical Limb Ischemia, a growing clinical need in the face of the prevalence of diabetes, heart disease and an aging population. The LimFlow Percutaneous Deep Vein Arterialization (pDVA) System is designed to bypass blocked arteries in the leg and rush oxygenated blood back into the foot. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, promotes wound healing and prevents major amputation. For more information, visit www.limflow.com.
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead investor in start-ups and corporate spin-offs and has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management For more information, please visit: www.sofinnova.fr.
CAUTION: The LimFlow technology is approved for investigational use only in the United States. The LimFlow System received the CE Mark in October 2016 and is currently available commercially in Europe. The LimFlow System has not been approved for sale in the USA, Canada, or Japan.

PRESS CONTACTS:
For LimFlow SA
Michelle McAdam, Chronic Communications Inc.
Tel: (310) 902-1274
michelle@chronic-comm.com

For Sofinnova Partners
Anne REIN
Tel: +33 (0)6 03 35 92 05
anne.rein@strategiesimage.com

11/04/2018

For its third year of operation, the Toulouse-based company EnobraQ, which specializes in biotechnology, is strengthening its development and announcing changes in its structure. It notably opens up its capital to three major research structures: INRA, INSA and CNRS and confirms a second round of fundraising in 2 years for a cumulative amount of 4.9 million euros. Sofinnova Partners, Auriga Partners, Irdinov and SuperNovaInvest are reaffirming their confidence. This financial support will make it possible to pursue development on three axes, and particularly yield improvement of certain industrial productions by up to 20%.

EnobraQ recognized by his peers.
Through this new fundraising and the entry into the capital of big names in research such as INRA, INSA and CNRS, EnobraQ is demonstrating the viability of its projects over the long term. Founded by private investors at the end of 2015, EnobraQ was one of the first startups to be accompanied by Toulouse White Biotechnology (TWB) on the development of innovative projects and one of the first to receive direct support from its supervisory bodies.

2 million euros raised to materialize breakthrough innovations
With discoveries made over the past two years, EnobraQ is currently working on a project to improve the output of industrial productions by up to 20%. Thanks to its cutting-edge research on the use of CO2, it is also developing a lactic acid production process which could thus contribute to reducing the dependency on fossil products such as oil, to save resources needed for food but also help reduce carbon footprint. Finally, the company focuses on the optimization of photosynthesis through a process demonstrating a significant improvement of the enzyme allowing the fixation of CO2. In the long run, this discovery could have a positive and lasting impact on food security worldwide

Accelerating industrialization of biotechnology processes
In its new development phase, EnobraQ aims to generalize the use of CO2 as industrial feedstock.
“Today we are entering a strategic phase of our development. Our expertise of the RuBisCO in industrial biotechnology, the most widespread protein in the world, allows us to target the nutrition, bioplastics and agri-food markets. This new fundraising and the support of three major French public research centers will enable us to expand our fields of action and lead to the implementation of sustainable processes” explains Christophe Dardel, Chief Executive Officer.

About EnobraQ
EnobraQ is a start-up created in 2015, from a pre-competitive research project supported by Toulouse White Biotechnology (TWB). Concerned with ecological and economic considerations, EnobraQ develops breakthrough technologies that use CO2 and target markets as diverse as nutrition, agri-food, cosmetics, pharmacology and bioplastics.
More information at : http://enobraq.com/
Media Contact
Agence OXYGEN – Mélissa Pontéry / Aurélie Vérin
Tél : +33 5 32 11 07 36 / melissap@oxygen-rp.com

04/04/2018

World’s Only Biology-Guided Radiation Therapy Could Help Millions More Patients Worldwide

Hayward, CA – April 4, 2018 – RefleXion Medical, a medical technology company developing the first and only biology-guided radiotherapy system (BgRT) for targeted cancer treatment, announced today it has raised more than $100 million in a Series C round of funding led by The Rise Fund, the global impact investment fund managed by TPG Growth. Also participating were T. Rowe Price Associates, Inc., Chinafocused healthcare investment firm GT Healthcare Capital Partners, and all existing investors including Sofinnova Partners, KCK Group, Venrock as well as corporate investors Pfizer Venture Investments and Johnson & Johnson Innovation – JJDC Inc.

“Radiation therapy has a long history of effectively treating cancer patients. However, current systems have significant limitations our platform addresses,” said RefleXion CEO Todd Powell. “We believe many of the 600,000 U.S. patients with metastatic cancer each year could benefit from our unique ability to accurately irradiate multiple tumors in the same session. Another 750,000 U.S. patients diagnosed annually with early stage disease may benefit from our system automatically compensating for tumor motion while precisely targeting the disease.”

During BgRT procedures, cancer patients will be injected with a PET (Positron Emission Tomography) imaging tracer that accurately identifies tumors. RefleXion’s technology then directs therapeutic x-rays at one or more targets in real time, based on the tracer signals. Using this proprietary approach, RefleXion’s platform has the potential to deliver higher doses of radiation to cancerous lesions than current systems with improved sparing of surrounding healthy tissue.

“The RefleXion system is the first and only one to have a patient’s tumors guide their own treatment and destruction,” said Samuel Mazin, PhD, Founder and CTO of RefleXion. “Our goal is to eliminate disease throughout the body with solo treatments or in concert with immunotherapy and other advanced cancer drugs. We believe this could help reduce the more than 13 million global cancer deaths projected to occur in 2030 by the World Health Organization.”

Additionally, RefleXion’s technology has been shown to simplify and automate many elements of the radiotherapy treatment process. An immediate benefit could be increasing access to care in underserved areas suffering from shortages of trained technicians and qualified support staff.

“This compelling new technology has the potential to dramatically improve the health and lifespans of metastatic cancer patients around the world,” said Matthew Hobart, Partner at TPG Growth. “Investing in companies like RefleXion is core to The Rise Fund’s mission of building high-performing businesses that also create positive social impact. We’re excited to work with the team at RefleXion to help them scale the business and create a new category in cancer care.”

About RefleXion Medical
RefleXion Medical is a privately held medical device company developing the first biology-guided radiotherapy (BgRT) system for cancer treatment. By leveraging Positron Emission Tomography (PET) in a novel way, RefleXion’s patented technology will allow tumors to continuously signal their location during treatment and potentially revolutionize radiotherapy. RefleXion is backed by premier investment firms Sofinnova Partners, KCK Group, Pfizer Venture Investments, Venrock and Johnson & Johnson Innovation, JJDC Inc. The company has also received grant funding from the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Program. For more information, visit www.reflexion.com and follow @reflexionmed on Twitter.

About TPG Growth
TPG Growth is the middle market and growth equity investment platform of TPG, the global private investment firm. With more than $13 billion of assets under management, TPG Growth targets investments in a broad range of industries and geographies. TPG Growth has the deep sector knowledge, operational resources, and global experience to drive value creation, and help companies reach their full potential. The firm is backed by the resources of TPG, which has more than $73 billion of assets under management. For more information, visit www.tpg.com.

About The Rise Fund
The Rise Fund is the world’s largest global fund committed to achieving measurable, positive social and environmental outcomes alongside outsized financial returns—referred to as “complete returns.” The Rise Fund is managed by TPG Growth, the global growth equity and middle market buyout platform of alternative asset firm TPG. TPG Growth Founder and Managing Partner Bill McGlashan, U2 lead singer Bono, a well-known activist and a special partner with TPG Growth, and Jeff Skoll, a global entrepreneur, film producer, and impact investor, co-founded The Rise Fund. They were joined by a group of influential thought leaders with a deep personal and professional commitment to driving social and environmental progress, who came together to form the Founders Board. The Rise Fund’s objectives align with the U.N.’s Sustainable Development Goals. The Rise Fund invests in education, energy, food and agriculture, financial services, growth infrastructure, healthcare, and technology, media, and telecommunications companies that deliver complete returns. For more information, visit therisefund.com.

Contacts:
RefleXion Medical
Kevin Knight
214-732-9392
kknightpr@gmail.com

The Rise Fund
Frank Thomas
212 601 4711
Fthomas@therisefund.com

04/04/2018

• Sofinnova Crossover Fund 1 is the largest healthcare crossover fund focused on Europe.
• With this new fund, Sofinnova Partners actively pursues the strategy to broaden its Life Sciences platform to invest across the value chain, from seed stage to late-stage companies.
• Bpifrance* and CNP Assurances acted as sponsors for the fund.

Paris, France – April 4th, 2018 — Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, announced today the launch of Sofinnova Crossover I with €275 million ($340 million), above the original first close target of €250 million. With this new fund, Sofinnova Partners goes one step further in the execution of its growth plan, aimed at expanding its coverage across the Life Sciences space with dedicated sector teams.

Pursuing a strategy Sofinnova Partners has successfully applied for decades with its early-stage focused Capital Funds, Sofinnova Crossover I will invest in the biopharmaceutical and medical device sectors. The fund will focus primarily on therapeutic and game-changing companies driven by experienced management. As a lead or cornerstone investor, the fund will seek to invest in about 15 late stage private and public companies. About 80% of the investments will be made in European companies, with the remaining 20% outside of Europe primarily in North America. A dedicated, highly experienced team of four partners will invest Sofinnova Crossover I, leveraging on Sofinnova Partners’ wider experience, track record and organizational support. This new fund attracted premier international investors, predominantly sovereign funds, insurance companies, corporations and family offices. Commitments came from Europe, including France, Italy, Denmark, Ireland, and Switzerland but also from Asian investors in China and Singapore. In addition to Bpifrance* and CNP Assurances, investors include a major Chinese biopharmaceutical company, the Danish State Investment fund, and family offices like Fidim or KCK representing leading industrial families in Europe and Asia.

Antoine Papiernik, Chairman of Sofinnova Partners, said, “With the launch of this new crossover activity, Sofinnova builds upon its unique early stage track record. Many of the companies we initially funded have become over the years large, billion-euro companies, and we have gained invaluable experience in helping them to the next level. This fund will complete our investment platform across the life-sciences value-chain, allowing us to fund companies from the seed stage to the late-stage.”

Jacques Theurillat, Partner in the crossover team at Sofinnova Partners, added: “The European healthcare market has matured with hundreds of late stage private and public companies looking for growth capital, and Sofinnova Partners, with its name, track record and experience, is particularly well positioned to identify the best European deals and transform them into global leaders.”

Triago acted as placement agent and Clifford Chance Europe LLP acted as legal counsel on Sofinnova Crossover I.

* Bpifrance directly and with the “Investment for the Future” Program, managed by the SGPI and operated by Bpifrance

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead investor in start-ups and corporate spin-offs and has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management.

28/03/2018

This financing allows for the execution of the company’s clinical and regulatory market access program

Paris, France, March 23. 2018 – SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners.

Based in Paris, SafeHeal develops an innovative digestive anastomosis protection device, called Colovac, designed to reduce complications and obviate the need for ostomies for colectomy patients. This technology consists of a minimally invasive and fully reversible implant that remains in place until the body’s natural healing and tissue repair processes are complete, for approximately two weeks, after which it is removed. SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the USA, representing an initial market greater than 1 billion €.

Funds raised will allow to execute SafeHeal’s clinical and regulatory market access program, followed by a focused commercial launch. The company has already begun a CE mark study and has successfully tested the device on seven patients. Attesting of its disruptive potential, SafeHeal is laureate of the Worldwide Innovation Challenge 2015 edition.

SafeHeal was founded in 2015 by MD Start, a medtech accelerator founded by Sofinnova Partners in 2008 and specialized in building companies focusing on large, unaddressed clinical needs and significant market opportunities. Prior to leading this Series A financing round, Sofinnova Partners participated to SafeHeal’s seed funding, together with MD Start.

“This investment enables us to execute our aggressive clinical and regulatory strategy, launch commercial operations once CE mark will be received and also continue investing in our R&D. We are currently recruiting patients in our First-in-Human clinical trial in France and are planning to extend the enrollment to hospitals in Germany, the UK and the US”, said Karl Blohm, CEO of SafeHeal.

“SafeHeal is a great example of the high impact therapies we are focusing on” said Anne Osdoit, Partner at MD Start and co-founder of SafeHeal, “We are thrilled to see SafeHeal maturing into its next development phase. This financing round allows them to engage in the transformation from incubation status to commercial operations”.

“We are excited to invest in SafeHeal and believe that their endoluminal bypass sheath is the most innovative disruption in the protection of colorectal anastomosis”, said Antoine Papiernik, Managing Partner at Sofinnova Partners, “This investment also demonstrates the power of our strategy allowing us to be present from incubation, with MD Start building companies from the ground up, to much larger rounds of funding to create potential worldwide leaders in their space”.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.6 billion under management. For more information, please visit: www.sofinnova.fr

About MD Start
MD Start is a European-based accelerator, a team of entrepreneurs and a fund brought together under the same efficient 3-in-1 accelerator structure, dedicated bringing to the market innovative medical devices based on inventions originating from the clinical environment. MD Start incepts, finances, incubates and manages start-up companies developing revolutionary therapeutic solutions and aiming to become international medtech leaders.

About SafeHeal
Safeheal is an early-stage medical device company based in Paris and created in 2015. The company develops Colovac, a device invented by a French digestive surgeon, Charam Khosrovani, to avoid the need for diverting ostomy in patients undergoing colectomy. The device is a flexible bypass sheath intended to reduce any contact of fecal content with the colorectal anastomotic site, following colorectal surgery (open or laparoscopic). It is anchored upstream to the anastomosis using a stent combined with an innovative vacuum-based mechanism. Colovac is seamless, minimally invasive and fully reversible. Once in place, the implant covers the colon down to the anus. It remains in place until the body’s natural healing and tissue repair processes are complete (approximately two weeks), after which it is removed during an endoscopic procedure, without the need for a second surgical intervention. This enables patients to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. SafeHeal was cofounded by MD Start and Sofinnova Partners. It is laureate of the Worldwide Innovation Challenge (2015 edition).

For more information, please contact:

SOFINNOVA PARTNERS
Anne Rein
Tel: +33 6 03 35 92 05
e-mail: anne.rein@strategiesimage.com

SafeHeal SAS
Website : www.safeheal.com
e-mail: contact@safeheal.com

06/03/2018

• Micropep Technologies, developing a non-GMO new generation of bioherbicides and biostimulants, is the third investment of the Sofinnova IB I fund dedicated to industrial biotech

• Sofinnova IB I, which recently closed at €125M, is the largest European fund dedicated to sustainable transition of the chemical industry.

Paris, March 6th 2018 – Sofinnova Partners, a leading European venture capital firm specialized in life sciences, today announces that Micropep Technologies, a biotech company focused on biological alternatives to agrochemicals, raised €4M. Sofinnova Partners becomes the company’s leading shareholder, next to IRDInov and Toulouse Tech Transfer. Sofinnova Partners invested with its recently closed €125M fund dedicated to the sustainable transition of the chemical industry, Sofinnova IB I, which is the largest European fund dedicated to this fast growing new area.

After Agrosavfe, which focuses on biological molecules to replace chemical fungicides and insecticides, Micropep is Sofinnova IB1’s second investment in Ag-Biotech, and third overall. Sofinnova Partners has been investing in industrial biotech since 2009 and today has a portfolio of 11 companies, in Europe and North America, at different stages of maturity. They range from companies at proof of concept, such as Enobraq in Toulouse (France) developing micro-organisms using C02 as source of carbon, all the way to commercial stage like Avantium in Amsterdam (The Netherlands) developing a brand-new type of plastic using renewable raw material.

Micropep, founded in 2016 in Toulouse, focuses on bioherbicides and biostimulants. The company uses plants’ natural molecules, called “micro-peptides”, to temporarily control expression of their genes and regulate plant growth but leaving their DNA intact. The company currently works on four development programs: germination, flowering, growth, and weed control. The proceeds of the financing will be used to strengthen its technology platform, further its R&D programs to proof of concept, and initiate its commercial growth with a strong international focus.

Denis Lucquin, Managing Partner at Sofinnova Partners, says: “We are thrilled to back Micropep. This young company has all the necessary features we look for: a breakthrough technology with a strong commercial and environmental impact and clear business objectives driven by visionary entrepreneurs.”

Thomas Laurent, Micropep’s CEO and co-Founder, continues: “Sofinnova Partners’ support represents a major step for Micropep’s development. Their expert knowledge combined with an unparalleled international network, validates the work we accomplished so far and represents a strong advantage for our growth and our ambition to revolutionize agriculture “.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.6 billion under management. For more information, please visit: www.sofinnova.fr

About Sofinnova IB 1
Sofinnova IB 1 is Sofinnova Partners’ first fund dedicated to industrial biotechnologies, with a focus on start-ups in Europe and North America and more specifically on the sustainable transition of the chemical industry. With €125M in capital, financed by institutional investors and industrial players, the Fund plans to invest in about ten companies. These companies, in their early stage, focus on the replacement of fossil carbon by a renewable one and cover the entire chemical industry, from agrichemicals to polymers and specialty chemicals.

25/01/2018
Paris, 24 January 2018 – Gecko Biomedical (“Gecko”) has been granted a total of €6 million in funding under the Investments for the Future program (PIA) for its project proposal entitled “PIAVE” [Projets Industriels d’Avenir (Promising Industrial Projects)], which is piloted by the General Secretariate for Investment (SGPI) and operated by Bpifrance. This funding is a contribution towards the industrialization and development of innovative solutions in the area of tissue reconstruction, and the peripheral nerve in particular.
Gecko is a medical device company developing an exclusive platform of polymers allowing for tissue reconstruction. These synthetic polymers, which are biocompatible, bioresorbable, and activated by a specific type of light, can be applied onto internal tissues during surgical procedures (acting like an adhesive, a barrier or a filler product, depending on the type of surgery). They are also 3D-printable, allowing for the production of flexible, bioresorbable and very high-resolution implants.
This funding will provide support for the industrialization of Gecko’s polymers platform, as well as for the development of a new, innovative program that will enable the reconstruction of peripheral nerves, without sutures, using 3D-printed micro-conducts secured by one of the company’s exclusive adhesives.
A 1,150 m2 manufacturing site, powered by 100% green electricity, is currently under construction in Roncq (in the Hauts-de-France Region) and will feature four clean rooms (totalling 300 m2 ) and an analytical laboratory extending over 140 m2.
Christophe Bancel, CEO of Gecko Biomedical, said: “This funding will allow us to speed up our industrialization process and equip ourselves with a globally unique manufacturing site. Cutting-edge processes will be performed on this site to produce all our liquid polymers in individual, sterile conditions, ready for use by surgeons. We also intend to speed up a second phase in our strategy through the industrial and clinical development of our 3D printing platform for flexible, bioresorbable and high-resolution implants, by leveraging our polymers as a biomedical resin, as well as by optimising state-of-the-art 3D printing techniques”.
Marie Zwarg, the Area Leader for Healthcare within the management team for Bpifrance’s Industrial Sectors, added that: “Bpifrance has supported Gecko Biomedical since its creation. We are delighted to contribute to furthering the development of its top-level technological platform with multiple applications, while also contributing to its industrialization in France”.
About Gecko Biomedical
Gecko Biomedical is a privately owned medical device company based in Paris, France that is dedicated to the rapid development and commercialization of a unique biopolymer platform to address various unmet clinical needs.
The company’s platform is based on a proprietary polymer family with unique properties including superior biocompatibility, tunable bioresorbability, and adjustable tissue adherence. Furthermore, the polymer hydrophobicity, high viscosity and controlled “on demand” curing enables a unique and controlled delivery to targeted tissues or the creation of scaffolds.
Gecko Biomedical’s first product, SETALUMTM Sealant, is an innovative polymer dedicated for tissue reconstruction. It is targeted to vascular reconstruction as an initial indication. Its structure is tunable, allowing customization for various applications and tissue types. The polymer is part of a biopolymer platform family that is fully industrialized and highly versatile, with potential novel applications in other fields of tissue reconstruction such as guided tissue repair, and the field of localized drug delivery.
The Company’s technology is based on world-class research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women’s Hospital), who co-founded the company in 2013, alongside Christophe Bancel and Bernard Gilly from the iBionext Network. For more information, please visit: www.geckobiomedical.com. Twitter: @geckobiomedical
About the Investments for the Future program
The Investments for the Future program (PIA) benefits from 57 million euros and is piloted by the General Secretariate for Investment. It was established by the government to fund innovative and promising investments in France. Six national priorities have thus been identified to allow France to increase its potential for growth and employment:
• higher education, research and training,
• research development and transfer to the economic sphere,
• sustainable development,
• industry and SMEs,
• the digital economy,
• health and biotechnology.
Find out more on investments for the future: http://www.gouvernement.fr/secretariat-general-pour-linvestissement-sgpi
Twitter: @SGPI_avenir
Bpifrance | PRESS RELEASE | 24 JANUARY 2018 | 3
About PIAVE
PIAVE’s call for projects is directed at projects that fit within the new 9-solution approach of the New Face of Industry in France (Nouvelle France industrielle).
It covers two types of projects:
• R&D and industrialization work,
• work aimed at reinforcing competitiveness within strategic French sectors.
These projects must benefit several small and medium enterprises (SMEs), or independent mid-cap companies (MCCs), and must show a concrete and significant benefit to the sector and its structuring. They must also entail industrial activity, and must prove, on fruition, to be autonomous with regard to public support.
In order to be eligible, these projects must involve a program entailing a minimum spend of 3 million euros, as well as a remit entailing prospects for business and for employment:
• fulfilling one or more solutions for the New Face of Industry in France, particularly with regard to the implementation of a road map approved by the 9 solutions piloting committee. In this event, the project must be handled by a company, irrespective of its size. This company may involve other companies, laboratories or research establishments within a consortium;
• fulfilling the objectives of one of the strategic sector committees; the project may alternatively be supported by a structure that brings together a number of companies, or by an entity which represents companies in the sector (such as a professional federation, a special interest group or an association…).
A budget of 305 million euros will be allocated to the “Promising Industrial Projects” (“PIAVE”) initiative, by way of state assistance (involving subsidies and refundable advance payments).
About Bpifrance
Bpifrance funds companies, at every stage of their growth, through loans, guarantees and equity. Bpifrance supports them in their innovation projects, as well as supporting them internationally. Bpifrance also now ensures their export activity through a broad range of products. Also on offer to entrepreneurs are advisory services, universities, networking and acceleration programs designed for start-ups, SMEs and mid-cap companies.
Thanks to Bpifrance and its 48 regional sites, entrepreneurs benefit from a close point of contact, which is dedicated to them and effectively supports them in facing their challenges.
More information here: www.Bpifrance.fr – http://investissementsdavenir.bpifrance.fr/ – Follow us on Twitter:
@Bpifrance – @BpifrancePresse
Press Office contacts:
Gecko
Europe
Brice Epry
Telephone: +33 1 76 21 72 28
info@geckobiomedical.com
United States
Marion Janic
Telephone: +1-212-223-4017
mjanic@rooneyco.com
Bpifrance
Nicolas Jehly
Telephone: +33 1 41 79 95 12
nicolas.jehly@bpifrance.fr
General Secretariate for Investment
Vincent Deshayes
Telephone: +33 1 42 75 64 29
vincent.deshayes@pm.gouv.fr
05/01/2018
The feasibility clinical study is designed to evaluate PRIMA sub-retinal implant in patients with Atrophic Dry Age-related Macular Degeneration
Paris, France. January 4, 2018 – 7.00 AM CET – Pixium Vision (FR0011950641 – PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announced today that it has received the approval from the US Food and Drug Administration (FDA) to begin the clinical feasibility study for PRIMA, Pixium Vision’s new-generation miniaturized wireless photovoltaic sub-retinal implant, in patients with Atrophic Dry Age-related Macular Degeneration (AMD).
“This first approval in the US will allow Pixium Vision to commence a feasibility study of the PRIMA device and follows a thorough review by the FDA. It also highlights the FDA’s recognition of PRIMA’s innovative potential to address the significant unmet need to treat Atrophic Dry-AMD,” said Khalid Ishaque, Chief Executive Officer of Pixium Vision “Atrophic Dry-AMD is a major cause of irreversible loss1 of the vision which affects approximately 4 million people and for whom there is currently no proven therapeutic solution. Alongside the ongoing clinical trial in France, the feasibility study in the United States marks a significant milestone for Pixium Vision with the mission to create a world of bionic vision for those who have lost their sight.”
The clinical feasibility study of PRIMA implant, to be conducted at the University of Pittsburgh Medical Center, will recruit up to five patients with vision loss that results from Atrophic Dry Age-related Macular Degeneration. The primary endpoint is restoration of visual perception as well as safety at a 12-month follow-up with a longer-term follow-up duration of 36 months. Pixium Vision expects to start the US study in the first half of 2018.
Contacts
Pixium Vision
Didier Laurens, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
@PixiumVision
Media Relations
France: Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Léa Jacquin – ljacquin@newcap.fr
+33 1 44 71 94 94
Media Relations International: Image Box PR
Neil Hunter
neil@imageboxpr.co.uk
Tel +44 (0)20 8943 4685
ABOUT PRIMA
PRIMA is a miniaturized new generation implant totally wireless. The PRIMA implant is a micro photovoltaic chip of 2×2 millimeters and 30 microns thick, and is equipped with 378 electrodes. Implanted under the retina via a less invasive surgical procedure, the implant converts pulsed near infra-red light signal received from the external glasses with an integrated mini-camera into electrical signals transmitted to the brain via the optic nerve. PRIMA is designed to treat retinal dystrophies, particularly aiming to treat initially advanced atrophic dry-AMD, the most prevalent form of Age-related Macular Degeneration, thanks to miniaturization and aimed to preserve patient’s residual peripheral vision. Prima is also intended to be evaluated at a later stage for treatment of vision loss from Retinitis Pigmentosa.
ABOUT PIXIUM VISION
Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period. Following the CE mark for its first bionic retinal implant systems, IRIS®II, Pixium Vision is now conducting a clinical study in Human with PRIMA, its next generation sub-retinal miniaturized photovoltaic wireless implant system, for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, Moorfields Eye Hospital in London, and Institute of Ocular Microsurgery (IMO) in Barcelona. Pixium Vision is EN ISO 13485 certified and labeled “Entreprise Innovante” by Bpifrance
For more information, please visit: www.pixium-vision.com;
And follow us on: @PixiumVision; www.facebook.com/pixiumvision
www.linkedin.com/company/pixium-vision
Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 “Risk Factors” of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF – AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA
Pixium Vision is listed on Euronext Paris (Compartment C). Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
Pixium Vision is included in the Euronext CAC All Shares index
Euronext ticker: PIX – ISIN: FR0011950641 – Reuters: PIX.PA – Bloomberg: PIX:FP
19/12/2017
Ecolab Inc., the global leader in water, hygiene and energy technologies and services has acquired a minority stake in Metgen OY. As part of the acquisition, Ecolab will be granted exclusive distribution rights globally for Metgen OY’s pulp and paper portfolio, as well as its wastewater enzyme portfolio. This business supplies differentiated custom blended enzymatic solutions to maximize biomass performance for various industries.
MetGen, headquartered in Kaarina, Finland, designs novel enzymatic solutions to improve energy efficiency and speed of processes in industries such as Pulp and Paper, Biofuels and Biochemicals.
“We are glad to welcome Ecolab as an investor in MetGen. Our business goals are fully aligned with Ecolab’s objective to support customers to achieve the best solutions in water technologies for the pulp and paper sector. MetGen is excited to work together with the Ecolab team to accelerate market growth through the global introduction of innovative, sustainable enzymatic solutions in various business segments,” said Alex Michine, CEO of MetGen.
The investment provides Ecolab with access to innovative custom enzymes to help producers improve machine efficiency, water and energy savings, product quality and profitability. The terms of the transaction were not disclosed.
“We are excited to work with MetGen and implement their innovative products into our offerings to enhance Ecolab’s ability to provide value-added solutions for our customers in the Pulp and Paper Industry,” said Jerome Charton, senior vice president and general manager, Nalco Water global paper, Ecolab’s water management business.
For more information, please contact:
Alex Michine, CEO, MetGen Oy, +358 40 543 3740
skype: alexmichine
www.metgen.com
MetGen Rakentajantie 26, 20780, Kaarina
WWW.METGEN.COM Phone: 02 237 7077
info@metgen.com
MetGen Oy
Rakentajantie 26,
20780 Kaarina
info@metgen.com
About MetGen Oy
MetGen designs and markets novel enzymatic solutions for the most challenging of industrial conditions to address our customer’s specific challenges. MetGen’s enzymes – MetZyme® – are industrial, highly-active, natural catalysts that accelerate chemical reactions and company uses advances in genetic engineering and microbiology to adapt enzymes to harsh industrial conditions and to handle a variety of lignocellulosic substrates. MetGen aims to be a widely recognized supplier of industrial enzymes, significantly contributing to the economics and sustainability of process industries such as pulp & paper, biofuels and biochemicals. MetGen’s competitive advantage is in tailoring or adapting enzymes to meet customer’s specific needs. www.metgen.com
About Ecolab
A trusted partner at more than one million customer locations, Ecolab (ECL) is the global leader in water, hygiene and energy technologies and services that protect people and vital resources. With 2016 sales of $13 billion and 48,000 associates, Ecolab delivers comprehensive solutions and on-site service to promote safe food, maintain clean environments, optimize water and energy use, and improve operational efficiencies for customers in the food, healthcare, energy, hospitality and industrial markets in more than 170 countries around the world. Follow us on Twitter @ecolab, Facebook at facebook.com/ecolab, LinkedIn at Ecolab or Instagram at Ecolab Inc.
11/12/2017

Jason Hannon, CEO, to host business update call

Dublin – Ireland, 11 December 2017 – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces a positive outcome of the Interim Analysis in its U.S. Pivotal ReActiv8-B Study (the “Study”), comprising a definitive size and an estimated completion date.
Key updates relative to the Study (and its design) are as follows:
• The Study utilizes an adaptive trial design, inclusive of an Interim Analysis, to determine the definitive size of the Study of up to 232 patients in the pivotal cohort. With this adaptive design, Mainstay commenced the Study with a sample size of 128 patients pending the Interim Analysis;
• The independent Data Monitoring Committee (“DMC”) has completed the Interim Analysis, which is based on data from the first 58 patients in the pivotal cohort to complete the primary endpoint. The DMC has recommended continuation of the Study with a definitive size of 168 evaluable patients. The ultimate number of patients in the Study will be slightly higher than 168 due to the nature of the enrollment process;
• The DMC also reported that they have observed no safety concerns in the Study; and
• The Study is expected to be fully enrolled by the end of the second quarter of 2018, and the Company expects to announce full data readout towards the end of 2018.
133 patients have been implanted in the pivotal cohort in the Study to date and clinical study sites have continued to implant patients pending the outcome of the Interim Analysis.
The Study is intended to gather data in support of an application for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the U.S..
Richard Rauck MD, President and Founder, Carolinas Pain Institute, Medical Director for The Center for Clinical Research, Pain Fellowship Director at Wake Forest University School of Medicine and Chairman of the DMC said: “The outcome of the Interim Analysis has validated the adaptive Study design agreed with the FDA, which provided for a sample size of up to 232 patients in the pivotal cohort. By following this course, we have been able to determine an appropriate sample size for the Study. We also reviewed the safety data and I am pleased to report there are no safety concerns in the Study thus far.”
Jason Hannon, CEO, said: “We are pleased to now have a definitive enrollment goal for the Study, which compares favorably in total size to other neuromodulation studies. We will now push forward to the data collection point in a highly efficient manner, and I am confident we will complete the Study in the coming months and announce the full data readout towards the end of 2018.”

Press Release
Chris Gilligan MD, Chief, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical School, and Principal Investigator for the ReActiv8-B Study said: “The treatment of Chronic Low Back Pain is a significant challenge around the world with many patients experiencing disabling effects for large portions of their lives. These patients can be left with few treatment options. I’m proud to be part of a clinical study that is analyzing whether we can use ReActiv8 to help patients truly restore their muscle function and thereby reduce the effects of chronic pain, rather than rely on short term analgesics such as opioids. I look forward to the compilation of the data.”
Investor Conference Call and Business Update
Jason Hannon will host an investor conference call to discuss this positive news and will also provide a broader business update at 16:00 GMT (11:00 EST) on 11 December 2017 in English.
Dial-ins for the call are outlined below:
Europe: +44 203 139 4830
Ireland: +353 1 696 8154
USA: +1 718 873 9077
Participant PIN: 65178331#

In addition to the update on the Interim Analysis, the business update will include the following developments:
• The Company continues to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites. Four centers in Germany and Ireland have implanted patients with ReActiv8 to date, and several additional sites have been trained. We have begun recruiting an experienced sales team of direct Mainstay employees. The team currently consists of eight people, located in key regions in Germany and one person in Ireland.
• Mainstay is planning to add to its investment in commercial infrastructure to expand commercialization in Europe and in preparation for commercialization in other markets including Australia and the U.S. We will be building a market development team of clinical experts to drive market penetration, identify the right physician partners, help educate the market about Reactiv8, and support implants.
• We will also increase our investment in the training of physicians; the education of referring physicians regarding the potential of ReActiv8; and in the collection and dissemination of clinical data regarding the expanding use of ReActiv8.
• Cash on hand at 30 November 2017 was $12.7 million. The Company on an ongoing basis explores potential financing opportunities to fund the business.

Press Release
This announcement contains inside information within the meaning of the EU Market Abuse Regulation 596/2014

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and its ordinary shares are admitted to trading on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-B Study
The ReActiv8-B Study is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). In summary, this means that eligible subjects will have baseline data collected and then following verification that the enrollment criteria are met, ReActiv8 will be implanted. At the 14-day post implant follow up visit, half the patients will be randomized to receive appropriately programmed stimulation (the treatment arm), and half will be randomized to receive sham stimulation/minimal stimulation (the control arm) .The ReActiv8-B Study is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA.

About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.
Further information can be found at www.mainstay-medical.com
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com

NewCap (for France
Julie Coulot
Tél. : +33 1 44 71 20 40
Email: jcoulot@newcap.fr
AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel: +49 2102 1485368
Email: abo@andreasbohne.com

Press Release
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Forward looking statements
This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.
By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8®, the progress and success of the ReActiv8-B Clinical Study, the ability to raise additional capital to fund the Company’s business and the cost of such capital, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.