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16/05/2019

Oversubscribed round to bring first products powered by enzymatic DNA synthesis technology to market

Paris, May 16, 2019. Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, today announced that its portfolio company DNA Script, an industry leader in the manufacturing of synthetic nucleic acids using proprietary enzymatic technology, has raised $38.5 million in Series B financing. New shareholders LSP and BPIFrance joined the round, alongside existing shareholders Kurma Partners, Idinvest Partners, Illumina Ventures, and M Ventures (the corporate venture arm of Merck KGaA). Sofinnova Partners was the first institutional investor in DNA Script in 2016.

DNA Script is the world’s leading company in manufacturing synthetic nucleic acids using enzymatic technology. Founded in 2014 in Paris, the company aims to accelerate innovation in life sciences and technology delivering rapid, affordable, and high-quality DNA. Sixty years after the discovery of DNA, DNA Script’s revolutionary approach leverages billions of years of nature’s evolution in synthesizing DNA to enable genome scale synthesis.

The company offers a novel biochemical process for DNA and RNA synthesis, a fundamental tool used in biology research. At a recent academic conference, DNA Script presented its ability to synthesize 200nt of DNA with remarkable accuracy. This innovation may be used in numerous applications, including electronic data storage, by leveraging unprecedented capabilities of the molecule to store information. The fundraising allows DNA Script to further develop its unique enzymatic technology and nucleotide chemistry platform, and deliver the promise of same-day results.

Joško Bobanović, Partner at Sofinnova Partners, said: “We are excited that DNA Script, which we have backed from its first round of financing, was able to raise such a significant round. The company continues to deliver on its plan, and is now funded by a group of likeminded investors who support the team’s vision of creating a business that enables new applications for synthetic DNA and RNA in areas including drug discovery and development, agriculture, and industrial and food technologies.”

“Sofinnova Partners has been an excellent partner from a very early stage, just after the inception of our company,” said Thomas Ybert, CEO of DNA Script. “Since then, they have helped us on a daily basis to build DNA Script from the ground up. The team brings a strong expertise in the technology as well as one of the broadest global networks in the industry. Importantly, they also provide unconditional support and coaching to our entrepreneurs – whatever the challenge at hand,” he said.

This new funding reaffirms Sofinnova Partners’ investment strategy in the industrial biotech field, initiated in 2009. As a pioneer in this emerging and rapidly growing sector, Sofinnova Partners has a portfolio of 14 industrial biotech companies, backed through two dedicated funds: Sofinnova Green Seed Fund, which raised €22.5M in 2012, and Sofinnova IB I, which raised €125M in 2017.

About DNA Script
Founded in 2014 in Paris, DNA Script is the world’s leading company in manufacturing de novo synthetic nucleic acids using an enzymatic technology. The company aims to accelerate innovation in life sciences and technology through rapid, affordable and high-quality DNA synthesis. DNA Script’s approach leverages billions of years of natural evolution to enable genome-scale synthesis. The company’s technology has the potential to greatly accelerate the development of new therapeutics, enhanced diagnostics, sustainable chemical production, improved crops and DNA data storage.
www.dnascript.co

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, the firm brings together a team of professionals from all over Europe, the U.S. and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor in seed, start-ups, corporate spin-offs and late stage companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2 billion under management.
For more information: http://sofinnovapartners.com/.

Press contact for Sofinnova Partners

International
Kate Barrette
RooneyPartners LLC
kbarrette@rooneyco.com

France
Anne Rein
S&I
+ 33 6 03 35 92 05
anne.rein@strategiesimage.com

17/02/2016

Targets Sustainable Bio-based Chemicals Market

London, Ontario – 17 February 2016 – Comet Biorefining, Inc. has announced the location of its commercial scale biomass derived sugar facility in the TransAlta Energy Park in Sarnia, Ontario. The 60 million pounds per year plant will come online in 2018 producing dextrose sugar from locally sourced corn stover and wheat straw. Corn stover consists of residues left in the field after harvest including stalks, leaves, husks and cobs.

Using its proprietary patented process, Comet converts non-food agricultural and forest residues into high-purity dextrose sugars that will be transformed into bio-based products including organic acids, amino acids and bioplastics. These low-carbon bio-based products replace traditional petroleum-based materials, reduce greenhouse gas emissions and help contribute to Canada’s efforts on climate change. Comet dextrose is cost and performance competitive with commercial dextrose sugars, the benchmark raw material for today’s biochemical production.

Comet chose to locate in Sarnia by working together with Bioindustrial Innovation Canada (BIC), the Ontario Federation of Agriculture (OFA) and an Ontario farmers’ cooperative on a project to attract sustainable technology providers to the region and to meet increasing demand from chemical suppliers and consumers for low-carbon products.

Andrew Richard, CEO of Comet said, “Construction of this first-of-akind plant represents a key step towards the large-scale commercialization of our cellulosic sugar business. It highlights the important role our technology plays in the value chain, helping to drive the bioeconomy and reduce greenhouse gas emissions.”
“Comet’s cellulosic sugar technology was one of the clean sustainable technologies recommended, with the best fit for the region and an excellent opportunity to accelerate the growth of the ioeconomy in rural Ontario”, noted Dr. Murray McLaughlin, Executive Director, BIC.

“Establishing new uses for agricultural residues in the bio-based chemical supply chain leads to sustainable farms and new markets. Both outcomes are primary goals of the OFA, and this project does just that,” said Don McCabe, OFA’s President.

Media Contact
Kathryn Sheridan
Sustainability Consult
ks@sustainabilityconsult.com
Europe: +32 496 116198
North America: (202) 470 3239

About Comet Biorefining
Comet Biorefining is a leading provider of sustainable, high-quality, cost-competitive cellulosic dextrose technology for applications in renewable biochemicals and biofuels. Comet Biorefining operates a demonstration scale plant in Rotondella, Italy and is constructing a60 million pounds per year commercial sugar plant to come online in 2018. The company plans to build, own and operate its own plants and will strategically license its technology to select partners on a worldwide basis to meet the growing demand for bio-based products.
For more information, visit http://www.cometbiorefining.com.

17/02/2016

Targets Sustainable Bio-based Chemicals Market

London, Ontario – 17 February 2016 – Comet Biorefining, Inc. has announced the location of its commercial scale biomass derived sugar facility in the TransAlta Energy Park in Sarnia, Ontario. The 60 million pounds per year plant will come online in 2018 producing dextrose sugar from locally sourced corn stover and wheat straw. Corn stover consists of residues left in the field after harvest including stalks, leaves, husks and cobs.

Using its proprietary patented process, Comet converts non-food agricultural and forest residues into high-purity dextrose sugars that will be transformed into bio-based products including organic acids, amino acids and bioplastics. These low-carbon bio-based products replace traditional petroleum-based materials, reduce greenhouse gas emissions and help contribute to Canada’s efforts on climate change. Comet dextrose is cost and performance competitive with commercial dextrose sugars, the benchmark raw material for today’s biochemical production.

Comet chose to locate in Sarnia by working together with Bioindustrial Innovation Canada (BIC), the Ontario Federation of Agriculture (OFA) and an Ontario farmers’ cooperative on a project to attract sustainable technology providers to the region and to meet increasing demand from chemical suppliers and consumers for low-carbon products.

Andrew Richard, CEO of Comet said, “Construction of this first-of-akind plant represents a key step towards the large-scale commercialization of our cellulosic sugar business. It highlights the important role our technology plays in the value chain, helping to drive the bioeconomy and reduce greenhouse gas emissions.”
“Comet’s cellulosic sugar technology was one of the clean sustainable technologies recommended, with the best fit for the region and an excellent opportunity to accelerate the growth of the ioeconomy in rural Ontario”, noted Dr. Murray McLaughlin, Executive Director, BIC.

“Establishing new uses for agricultural residues in the bio-based chemical supply chain leads to sustainable farms and new markets. Both outcomes are primary goals of the OFA, and this project does just that,” said Don McCabe, OFA’s President.

Media Contact
Kathryn Sheridan
Sustainability Consult
ks@sustainabilityconsult.com
Europe: +32 496 116198
North America: (202) 470 3239

About Comet Biorefining
Comet Biorefining is a leading provider of sustainable, high-quality, cost-competitive cellulosic dextrose technology for applications in renewable biochemicals and biofuels. Comet Biorefining operates a demonstration scale plant in Rotondella, Italy and is constructing a60 million pounds per year commercial sugar plant to come online in 2018. The company plans to build, own and operate its own plants and will strategically license its technology to select partners on a worldwide basis to meet the growing demand for bio-based products.
For more information, visit http://www.cometbiorefining.com.

03/02/2016

Paris, France – February 3rd. 2016 — Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, today announced that portfolio company ENYO Pharma, a biotech company specialized in the treatment of acute and chronic viral infections such as hepatitis B, raised €22 M in a Series A financing. As leading and seed investor, Sofinnova Partners led the fundraising and brought together an international investors’ syndicate composed of Morningside Ventures and Bpifrance, through its Innobio fund.

The deal was completed just one year after Sofinnova Partners’ initial seed investment, and follows upon ENYO Pharma’s recent successes: the firm licensed several patents and created a unique technology platform for the treatment of viral pathologies, one of healthcare’s fastest growing sector.

ENYO Pharma was created in 2014 by Patrice André and Vincent Lotteau, two Inserm scientists based in Lyon (France). The CEO and co-founder, Jacky Vonderscher, PhD, is a highly experienced industry veteran with a successful history of developing novel therapeutics, in particular for Roche and Novartis (i.e. Sandimmum Neoral®, Myfortic® Certican®, Afinitor®).

Based on a radically new therapeutic approach of infectious diseases, ENYO Pharma’s technology does not target the constituents of the virus, like most existing antivirals do, but targets the infected individual’s cellular functions which are central in the virus replication. By disrupting the interactions between viral and human proteins, the technology impedes virus’ activation. The paradigm shift that ENYO Pharma’s platform introduces for viral diseases opens new perspectives for therapy beyond infectious diseases. Funds raised will be used to accelerate the deployment of ENYO Pharma’s programs, and launch Phase 1 clinical trials for its lead compound which focuses on hepatitis B. In addition, the firm develops a second program which focuses on influenza.

Rafaèle Tordjman, M.D., PhD, Managing Partner at Sofinnova Partner says: « ENYO Pharma perfectly illustrates Sofinnova Partners’ strategy which targets disruptive technologies combined with outstanding managers: we have developed strong ties with Jacky Vonderscher who sits on the Board of Sofinnova Partners’ portfolio company ObsEva. His vision and talent are key assets to carry out ENYO Pharma’s potential, and after the success of the seed investment phase, we are thrilled to continue backing the team”.

Jacky Vonderscher, PhD, CEO of ENYO Pharma, continues: « With over 350 million people chronically infected with the hepatitis B virus awaiting treatment, ENYO Pharma answers a huge medical need. Sofinnova Partners played a key role in the success of the fundraising, and our investors’ support will allow us to develop our technology and bring patients radically novels solutions ».
About Sofinnova Partners – www.sofinnova.fr
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 more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management.

03/02/2016

Paris, France – 3 février 2016 — Sofinnova Partners, un leader du capital risque en Europe spécialisé dans les sciences de la vie, annonce avoir mené la levée de fonds d’ENYO Pharma, une société spécialisée dans le traitement des infections virales aiguës et chroniques, telles que l’hépatite B. La société de biotechnologie lève 22 M€ pour sa Série A. En tant que principal actionnaire ayant financé l’amorçage, Sofinnova Partners a mené l’opération et réuni un syndicat international d’investisseurs composé de Morningside Ventures et Bpifrance, à travers son fonds Innobio.

Cet investissement intervient un an après le financement d’amorçage que Sofinnova Partners a réalisé et s’inscrit dans le prolongement d’avancées majeures : la société a licencié plusieurs brevets et développé une plateforme technologique unique dans le traitement des pathologies virales, un secteur émergent en très forte croissance.

ENYO Pharma a été créée en 2014 par Patrice André et Vincent Lotteau, deux chercheurs de l’Inserm à Lyon. La société est dirigée et cofondée par Jacky Vonderscher, PhD, CEO, qui bénéficie d’un parcours internationalement reconnu dans l’industrie pharmaceutique, et se distingue pour avoir développé et mis sur le marché avec succès plusieurs molécules innovantes pour le compte notamment de Roche et Novartis (i.e. Sandimmum Neoral®, Myfortic® Certican®, Afinitor®). Unique et novatrice dans le domaine des maladies infectieuses, l’approche d’ENYO Pharma consiste à cibler non pas les constituants du virus, comme le font la plupart des antiviraux actuels, mais les fonctions cellulaires de l’individu infecté, nécessaires à la réplication virale. Les antiviraux que développe la société perturbent les interactions entre les protéines virales et humaines, et par ce biais empêchent le virus d’agir. Introduisant un véritable changement de paradigme dans le traitement des pathologies virales, la plateforme d’ENYO Pharma permet d’envisager des perspectives thérapeutiques au-delà même du domaine des maladies infectieuses. Les fonds levés serviront à accélérer le déploiement du programme phare centré sur le traitement de l’hépatite B et démarrer les études cliniques de Phase 1 courant 2016. Le deuxième programme qu’ENYO Pharma développe cible le traitement de la grippe.

Rafaèle Tordjman M.D., PhD, Managing Partner de Sofinnova Partners, déclare : « ENYO Pharma illustre parfaitement la stratégie de Sofinnova Partners qui mise sur l’association d’une innovation de rupture et d’un management d’exception : nous connaissons bien Jacky Vonderscher, qui siège au Conseil d’administration d’ObsEva, une autre société de notre portefeuille. Sa vision et son talent sont de véritables atouts pour concrétiser le potentiel d’ENYO Pharma et, après le succès de la phase d’amorçage, sommes ravis de continuer à les accompagner ».

Jacky Vonderscher, PhD, Président d’ENYO Pharma, poursuit : « Avec plus de 350 millions d’individus dans le monde chroniquement infectés par le virus de l’hépatite B en attente de traitement, ENYO Pharma répond à un besoin essentiel. Sofinnova Partners a joué un rôle déterminant dans le succès de la levée de fonds ; le soutien de nos investisseurs va nous permettre de développer notre technologie et d’apporter aux patients une nouvelle génération d’antiviraux ».
A propos de Sofinnova Partners – www.sofinnova.fr
Sofinnova Partners est un des leaders du capital risque en Europe spécialisé dans les sciences de la vie. Basée à Paris, l’équipe est composée de 12 professionnels de l’investissement issus d’Europe, des Etats Unis et de Chine. La société investit dans les technologies de changement de paradigme aux côtés d’entrepreneurs visionnaires. Sofinnova Partners intervient en priorité dans les start up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Depuis plus de 40 ans, la société a accompagné plus de 500 entreprises à travers le monde devenues des leaders sur leur marché. Sofinnova Partners gère aujourd’hui 1,5 milliard d’euros.

02/02/2016

Development of Novel DUB Inhibitors from Innovative Drug Platform

Woodford Patient Capital Trust joins existing syndicate supporting transition to clinical development

                                                                               

CAMBRIDGE, UK – 2 February 2016 MISSION Therapeutics, a drug discovery and development company focused on selectively targeting deubiquitylating enzymes to treat cancer, neurodegenerative and other diseases, today announced it has raised £60 million. The financing was jointly led by Imperial Innovations Businesses LLP (“Innovations”) and new investor Woodford Patient Capital Trust Plc (“WPCT”), with follow-on investment from existing shareholders Sofinnova Partners, SR One, Roche Venture Fund and Pfizer Venture Investments.

The £60 million will enable MISSION to maximize the potential of its world leading DUB platform and advance a series of first-in-class small molecule drugs candidates targeting specific DUBs into clinical development.

Anker Lundemose, Chief Executive Officer, MISSION Therapeutics commented:MISSION Therapeutics has attracted one of the highest profile investor syndicates in Europe. We welcome WPCT and thank our existing investors for their continued support. This is strong endorsement of our unique discovery platform and will enable us to maximize the potential of multiple lead compounds for diverse therapeutic indications. 2016 will see us progress our advanced programs into regulatory preclinical development and deepen our pipeline, from a position of increased financial strength.”

Rob Woodman, Director of Healthcare Ventures, Imperial Innovations added: “We believe MISSION’s world-class DUB platform has the potential to deliver innovative treatments in indications of high unmet need including neurodegenerative diseases and cancer. The investor group are pleased to support the creative management team in realising the full potential of the ground-breaking discovery chemistry as MISSION enters its next, clinically-centred stage of growth.”

DUBs are involved in multiple cellular processes, including DNA damage and cell proliferation, and the inhibition of these enzymes has considerable potential for the generation of novel drugs for treating cancer and other unmet medical needs, including neurodegenerative disease, muscle wasting and infectious disease. Despite significant efforts within the pharmaceutical sector, there is a lack of DUB inhibitors in clinical development.

 

CONTACT:

MISSION Therapeutics Ltd

Anker Lundemose MD PhD

Chief Executive Officer

Tel +44 1223 497199

 

Hume Brophy

Mary Clark, Eva Haas, Hollie Vile

Email: missiontherapeutics@humebrophy.com

Tel: +44 207 862 6390

 

NOTES TO EDITORS:

About MISSION Therapeutics

MISSION Therapeutics was founded in 2011 to commercialise expert research into the ubiquitin pathway for the treatment of cancers and non-malignant disease. It has built a world-leading platform for the discovery and development of first-in-class, small molecule drugs that selectively target deubiquitylating enzymes (DUBs) – an emerging, and hitherto intractable, drug class that is attracting significant commercial interest as the potential ‘Next Kinase Area’.

DUBs are involved in multiple cellular processes, including DNA damage and cell proliferation, and the inhibition of these enzymes has considerable potential for the generation of novel drugs for treating cancer and other unmet medical needs, including neurodegenerative disease, muscle wasting and infectious disease. Despite significant efforts within the pharmaceutical sector, there is a lack of DUB inhibitors in clinical development.

MISSION’s leadership team has a wealth of international, commercial and scientific experience and the company has strong links with key academic and research centers including Cancer Research UK laboratories and the Gurdon Institute, University of Cambridge. Professor Steve Jackson at Cancer Research UK laboratories and the Gurdon Institute, University of Cambridge is the scientific founder of MISSION and is the Chief Scientific Officer of the Company.

The Company has to date received £27 million in venture capital from a blue chip syndicate comprising institutional (Sofinnova Partners, Imperial Innovations) and corporate (SR One, Roche Venture Fund and Pfizer) investors and is based at the Babraham Research Campus, south of Cambridge.

 

About Woodford Patient Capital Trust

WPCT is the £800 million investment trust launched in April 2015 by Woodford Investment Management LLP (“Woodford”). The trust invests mainly in early-stage and early-growth companies but also has exposure to some blue-chip companies. Woodford is a fast-growing asset management company built on a founding philosophy of transparency and simplicity. Launched in May 2014, the company has more than £14bn assets under management. Further information can be found at https://woodfordfunds.com

18/01/2016

Montreal, Canada, January 15, 2016. BioAmber Inc. (NYSE: BIOA), a leader in renewable materials, today announced that it has priced an underwritten public offering of 2,600,000 shares of its common stock at a price of $5.00 per share. The gross proceeds to the Company will be $13.0 million. The offering is expected to close on January 21, 2016, subject to customary closing conditions.

Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, is acting as the sole bookrunning manager for the offering. Raymond James & Associates, Inc. is acting as co-manager for the offering.

Net proceeds, after underwriting discounts and commissions and other estimated fees and expenses payable by BioAmber will be approximately $11.8 million.

BioAmber intends to use the net proceeds of the offering for working capital and other general corporate purposes.

The securities described above are being offered by BioAmber pursuant to a shelf registration statement on Form S-3 (No. 333-196470) including a base prospectus, which was declared effective by the Securities and Exchange Commission (the “SEC”) on July 9, 2014. The securities may be offered only by means of a prospectus. The prospectus and the preliminary prospectus supplement related to the offering have been filed with the SEC and are available on the SEC’s website located at www.sec.gov and may also be obtained by contacting Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, at placements@hcwco.com. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered, when available, will be available on the SEC’s website and may also be obtained by contacting Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, at placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About BioAmber
BioAmber (NYSE: BIOA) is a renewable materials company. Its innovative technology platform combines biotechnology and catalysis to convert renewable feedstock into building block materials that are used in a wide variety of everyday products including plastics, paints, textiles, food additives and personal care products. For more information visit www.bio-amber.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about BioAmber, including but not limited to statements with respect to BioAmber’s plans to consummate its proposed public offering. BioAmber may use words such as “expect,” “anticipate,” “project,” “intend,” “plan,” “aim,” “believe,” “seek,” ” estimate,” “can,” “focus,” “will,” and “may” and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, whether or not BioAmber will be able to raise capital, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering, BioAmber’s business and financial condition, and the impact of general economic, industry or political conditions in the United States or internationally. For additional disclosure regarding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC, including the “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2014 and in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, and under the heading “Risk Factors” of the prospectus supplement for this offering. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and BioAmber undertakes no obligation to update such statements as a result of new information.

About Rodman & Renshaw
Rodman & Renshaw, a unit of H.C. Wainwright & Co., is an investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private growth companies across multiple sectors and regions.

Contact:
Rodman & Renshaw
430 Park Avenue, 4th Floor
New York, New York 10022
212-356-0500
info@rodm.com

18/12/2015

IRIS® II, un système de restauration de la vision unique, doté d’une caméra neuromorphique intelligente et d’un implant de 150 électrodes, explantable et évolutif

Paris, France – le 14 décembre 2015 – Pixium Vision (FR0011950641 – PIX), société qui développe des systèmes de vision bionique innovants pour permettre aux patients ayant perdu la vue de vivre de façon plus autonome, annonce aujourd’hui avoir reçu l’autorisation de l’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) pour démarrer une étude clinique chez des patients devenus aveugles d’une rétinite pigmentaire avec le Système de Restauration de la Vision (SRV) IRIS® II, doté d’un implant épi-rétinien unique de 150 électrodes, explantable et évolutif.
Cette autorisation s’inscrit dans le prolongement de l’étude clinique menée par la Société avec IRIS® I, SRV équipé d’un implant épi-rétinien de 49 électrodes. Conformément à sa stratégie, Pixium Vision vise à proposer aux patients la meilleure option thérapeutique.
Pour Khalid Ishaque, Directeur Général de Pixium Vision, « Cette autorisation réglementaire constitue une étape majeure dans le développement de la gamme IRIS®. Après l’expérience clinique d’IRIS® I en stimulation épi-rétinienne, nous nous tournons maintenant vers l’avenir avec un système doté de presque 3 fois plus d’électrodes que le produit concurrent.» Khalid Ishaque ajoute : « C’est en travaillant en parallèle sur le développement du dispositif ET de ses algorithmes, que nous souhaitons proposer les meilleurs systèmes de Restauration de la Vision aux patients.»
Sous réserve d’obtention du marquage CE, le lancement commercial d’IRIS® II devrait débuter lors du premier semestre de 2016.
Le SRV IRIS® II est doté d’une technologie avancée et différenciée. Ses principales caractéristiques sont :
– Une caméra neuromorphique intelligente qui fonctionne comme l’oeil humain : le capteur ne prend pas de clichés mais visualise, à chaque instant avec ses pixels indépendants, l’ensemble des évènements nouveaux ;
– Un implant épi-rétinien équipé de 150 électrodes, qui permet des combinaisons de stimulation rétinienne plus nombreuses et plus pertinentes ;
– Cet implant est conçu pour être explantable : les électrodes sont maintenues en contact avec la surface de la rétine par un système de support breveté qui permet l’explantation sans dégrader la rétine et ainsi le remplacement ou l’upgrade du système.
Au-delà de la technologie, le design du SRV IRIS® II a été entièrement repensé pour mieux répondre aux attentes des patients et faciliter l’adoption de la technologie. Dans ce cadre, le système a été récompensé par le Prix Janus de la Santé 2015 et l’Etoile de l’Observeur du Design 2016.

A propos de Pixium Vision (www.pixium-vision.com, @PixiumVision)
Pixium Vision développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les SRV de Pixium Vision sont des systèmes composés de plusieurs éléments de haute technologie associés à une intervention chirurgicale et à une période de rééducation. Ils visent à offrir à terme aux patients une vision aussi proche que possible de la normale.
Le SRV IRIS® est actuellement en phase d’essais cliniques dans plusieurs centres en Europe. Les patients supportent bien leur implant à ce jour et des améliorations de la perception visuelle des patients aveugles sont observées. La société prévoit de déposer le dossier de Marquage CE avant la fin de 2015. Sous réserve d’obtention du marquage CE, la commercialisation d’IRIS devrait débuter lors du premier semestre de 2016.
Pixium Vision développe également PRIMA, un implant sous-rétinien, qui est actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.
La société est certifiée ISO 13485.
Pixium Vision est coté sur Euronext (Compartiment C) à Paris.
ISIN: FR0011950641 ; Mnemo: PIX
IRIS® est une marque déposée de Pixium-Vision SA

A propos de l’étude clinique
L’essai clinique IRIS® II est multicentrique européen prospectif, ouvert et non randomisé visant à évaluer l’innocuité et la performance du Système de Restauration de la Vision IRIS® II comme traitement pour compenser la cécité et fournir des perceptions visuelles aux personnes aveugles pour leur rendre une plus grande autonomie et une meilleure qualité de vie.
Jusqu’à 10 patients souffrant de rétinite pigmentaire, de dystrophie des cônes et de bâtonnets, ou encore de Choroïdérémie seront implantés dans le cadre de cette étude et seront suivis sur une durée minimale de 18 mois et maximale de 36 mois si le patient choisit de continuer sur une durée de 18 mois de suivi supplémentaire.

Contacts
Pixium Vision
Pierre Kemula, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
@PixiumVision

Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Daphné Boccara – dboccara@newcap.fr
+33 1 44 71 94 93

Avertissement :
Le présent communiqué contient de manière implicite ou expresse certaines déclarations prospectives relatives à Pixium Vision et à son activité. Ces déclarations dépendent de certains risques connus ou non, d’incertitudes, ainsi que d’autres facteurs, qui pourraient conduire à ce que les résultats réels, les conditions financières, les performances ou réalisations de Pixium Vision diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés ou sous-entendus dans ces déclarations prospectives.
Pixium Vision émet ce communiqué à la présente date et ne s’engage pas à mettre à jour les déclarations prospectives qui y sont contenues, que ce soit par suite de nouvelles informations, événements futurs ou autres.
Pour une description des risques et incertitudes de nature à entraîner une différence entre les résultats réels, les conditions financières, les performances ou les réalisations de Pixium Vision et ceux contenus dans les déclarations prospectives, veuillez-vous référer au chapitre 4 « Facteurs de risques » du document de référence de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro R15-069 le 23 septembre 2015, lequel peut être consulté sur les sites de l’Autorité des marchés – AMF (www.amf-france.org) et de Pixium Vision (www.pixium-vision.com).

08/12/2015

Paris, France – December 8th, 2015 — Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, announced today the close of Sofinnova Capital VIII at €300 million, above the initial fund target of €250 million. Following the raise of its previous fund at €240m in 2012, this new fund brings the total amount under management at Sofinnova Partners to €1.5 billion ($1.6 Bn).
Pursuing the strategy it has consistently applied over the years, Sofinnova Capital VIII will invest in the healthcare industry and more specifically in the biopharmaceutical and medical device sectors. Sofinnova Partners will seek to invest as a founding and lead investor in start-ups and corporate spin-offs, and focus on therapeutic “paradigm shifting” technologies and products alongside visionary entrepreneurs. Sofinnova Capital VIII will invest about two thirds of its funds in European companies, and one third outside of Europe primarily in North America. This fund will leverage Sofinnova Partners’ experienced international team. Based in Paris, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China.
This new fund attracted premier international investors, predominantly pension funds, funds of funds, family offices and insurance companies. Commitments came in majority from Europe, including France, Italy, Sweden, Norway, Switzerland, Belgium and Luxembourg, but also from leading North American investors in the US and Canada.
Antoine Papiernik, Managing Partner at Sofinnova Partners, said, “Our experienced team, stable strategy and exit track record resonated well with investors, hence the success and speed of our fundraising for this fund. Over the last three years, we completed 10 remarkable exits in the portfolio for a total enterprise value of almost 3 billion euros.”
Rafaèle Tordjman, Managing Partner at Sofinnova Partners, added: “We are honored by our investors’ support, which will allow us to transform entrepreneurs’ vision into successful businesses, and help bring life saving innovations to the medical community and patients.”
Triago acted as placement agent and Clifford Chance LLP acted as legal counsel on Sofinnova Capital VIII,.

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 more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management.

08/12/2015

Paris, France – 8 Décembre 2015. Sofinnova Partners, un leader du capital risque en Europe spécialisé dans les sciences de la vie, annonce avoir levé 300 millions d’euros pour son fonds Sofinnova Capital VIII dédié à la santé, soit un montant supérieur à l’objectif initial de 250 millions d’euros. Le fonds précédent, levé en 2012, était de 240 millions d’euros. Le total d’actifs géré par Sofinnova Partners atteint désormais plus de 1,5 milliard d’euros.
Avec la même stratégie d’investissement déployée par Sofinnova Partners depuis des années, ce fonds investira dans le secteur de la santé, et plus spécifiquement dans la biopharmacie et l’instrumentation médicale. Aux côtés d’entrepreneurs visionnaires, le fonds ciblera des technologies de rupture permettant des innovations thérapeutiques. Sofinnova Partners investira, de façon prioritaire, dans les start-up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Environ les deux tiers du fonds Sofinnova Capital VIII seront investis en Europe, et un tiers hors d’Europe, principalement en Amérique du Nord. Ce fonds s’appuiera sur une équipe expérimentée et internationale. Basée à Paris, elle réunit douze professionnels de l’investissement venus d’Europe, des Etats Unis et de Chine.
Sofinnova Capital VIII a su attirer un pool d’investisseurs institutionnels de premier plan au niveau mondial, en particulier des compagnies d’assurance, des fonds de fonds, des family offices et des fonds de pension. La majorité des fonds levés viennent d’Europe, notamment de France, d’Italie, de Suède, de Norvège, de Suisse, de Belgique et du Luxembourg, mais aussi des Etats-Unis et du Canada.
Antoine Papiernik, Managing Partner chez Sofinnova Partners, déclare: “La qualité du track record de Sofinnova Partners, la constance de notre stratégie et l’expérience de notre équipe ont été déterminantes dans le succès de cette levée de fonds. Les trois dernières années ont été particulièrement actives: nous avons réalisé 10 sorties pour une valeur d’entreprise totale de presque 3 milliards d’euros ».
Rafaèle Tordjman, Managing Partner chez Sofinnova Partners, ajoute: “Nous sommes fiers du soutien que nous témoignent nos investisseurs, qui par leur confiance vont nous permettre de transformer l’ambition d’entrepreneurs visionnaires, et ainsi mettre sur le marché des innovations capables de transformer la vie de la communauté médicale et des patients”.
Sur ce fonds Sofinnova Capital VIII, Triago a agi en tant qu’agent de placement et Clifford Chance Europe LLP en tant que conseil juridique.

A propos de Sofinnova Partners
Sofinnova Partners est un des leaders du capital risque en Europe spécialisé dans les sciences de la vie. Basée à Paris, l’équipe est composée de 12 professionnels de l’investissement issus d’Europe, des Etats Unis et de Chine. La société investit dans les technologies de changement de paradigme aux côtés d’entrepreneurs visionnaires. Sofinnova Partners intervient en priorité dans les start up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Depuis plus de 40 ans, la société a accompagné plus de 500 entreprises à travers le monde devenues des leaders sur leur marché. Sofinnova Partners gère aujourd’hui 1,5 milliard d’euros.

04/12/2015

Additional data confirm clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options

Dublin – Ireland, 4 December 2015 – Mainstay Medical International plc (Mainstay or the Company, listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (CLBP), today announced additional results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial to gather data for a submission for CE Marking for ReActiv8. The additional results are consistent with those released on 31 August, 2015 and continue to show clinically important, statistically significant and lasting improvement in pain, disability and quality of life in this clinically challenging population.

NOTE: Results in this release have been updated including data from 13 subjects who had not yet reached the 180 day follow-up at the time of the August press release. A full description of the ReActiv8-A Trial and updated results are provided in an addendum to this release.
ReActiv8 is for treatment of people who suffer from CLBP, have attempted most or all available treatment options, and are not candidates for back surgery or spinal cord stimulation. The ReActiv8-A Trial population was relatively young (mean age 43.9 years) and had a long history of low back pain (mean 13.8 years). All of the subjects had attempted physical therapy, and 70% were taking opioids for back pain. The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have reached the 90 day follow up and 45 have reached the 180 day follow up.
Results highlights:

? Clinical performance of ReActiv8 at 90 days compared to baseline for all subjects is:
o 63% with clinically important improvement in back pain defined as =2 point reduction on the 0-10 Numerical Rating Scale (NRS) for low back pain1 measured on the day.
o 57% responder rate for pain: A responder is defined as a subject with a clinically important improvement in mean of prior 7 days NRS with no clinically significant increase in medications taken for low back pain.
o 57% with a clinically important improvement2 in disability on the Oswestry Disability Index (ODI).
o 67% with a clinically important improvement3 in quality of life on the EQ-5D scale.
? Clinical performance at 90 days is even better for the group of subjects who do not receive financial compensation for being out of work due to their back pain. For those 32 subjects the results are:
o 72% with clinically important improvement in low back pain NRS on the day.
o 69% responder rate for pain.
o 63% with clinically important improvement in ODI.
o 69% with a clinically important improvement in EQ-5D.
? Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days (n=45). Paired data for all subjects at 90 and 180 days respectively are:
o 63% and 58% with clinically important improvement in low back pain NRS on the day.
o 57% and 60% with clinically important improvement in ODI.
o 67% and 73% with clinically important improvement in EQ-5D.
o 61% and 67% reported >50% Percent Pain Relief.
? Adverse Events (AEs) incidence and type were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs and no serious AEs related to the device, therapy or procedure.
? The observed lead migration incidence (<1%) demonstrates that the ReActiv8 lead mitigates the risk of lead migration identified with commercially available neurostimulation leads in the earlier Feasibility Trial.
? In the August press release, the Company announced a modification of the implant technique with different lead routing developed to mitigate the risk of breaks of the wires inside the lead, which had been observed in the ReActiv8-A Trial. Experience to date with the first 14 subjects implanted with the modified approach (new implants and revisions) are encouraging.
T
he Company announced on 2 November, 2015 that a submission for CE Marking was made.
Subjects continue to be enrolled in the ReActiv8-A Trial to gather additional data on performance and safety which the Company plans to incorporate into the Post Market Clinical Follow Up. To date there have been 6 additional subjects implanted in the ReActiv8-A Trial.

– ReActiv8-A Trial Results Below –
Addendum: ReActiv8-A Trial Description and Results
Subjects were enrolled in the ReActiv8-A Trial if they continued to experience disabling CLBP despite at least 90 days of medical management, which included at least physical therapy and drugs (most subjects had attempted many other treatments including chiropractic, massage, and acupuncture). In addition, subjects had no identifiable spine pathology that could be the clear cause of their CLBP, had no prior spine surgery, and were not candidates for spine surgery or spinal cord stimulation. Back pain was assessed using a Numerical Rating Scale (NRS) in which subjects were asked to grade their low back pain from 0 (no pain) to 10 (worst imaginable pain). Subjects were instructed to not change their medications for low back pain until after the 90 day end point.
Subjects were implanted with ReActiv8 in a short surgical procedure. After approximately 14 days, subjects began stimulation sessions with ReActiv8 for 30 minutes each morning and evening, and outcome data collection is at 90 days, 180 days and annually thereafter.

Baseline Characteristics & Outcomes available in pdf attached

Adverse Events
Adverse events are adjudicated by an independent Clinical Events Committee. As of the most recent adjudication in November, there were 67 reported AEs related to the device, therapy or procedure. There were three Serious Adverse Events (SAEs), none of which were related to the device, therapy or procedure. There were no unanticipated AEs or unanticipated device related AEs. The AE incidence and type were comparable to AEs in clinical trials reported for other neurostimulation devices.
6 See, for example, https://clinicalTrials.gov/show/NCT01609972 and https://clinicalTrials.gov/show/NCT01923285
7 Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., … Witter, J. (2010). Research design considerations for confirmatory chronic pain clinical Trials: IMMPACT recommendations. Pain, 149(2), 177–93.

Lead Related Events
To date, the ReActiv8 lead has shown only one instance of lead migration (dislodgement) out of 134 implanted leads (including those implanted in revision procedures) for a lead migration incidence of less than 1%. These results demonstrate that the ReActiv8 lead mitigates the risk of lead migration identified with commercially available neurostimulation leads in the earlier Feasibility Trial.
In the August press release, the Company announced a modification of the implant technique with different lead routing developed to mitigate the risk of breaks of the wires inside the lead, which had been observed in the ReActiv8-A Trial. Experience to date with the first 14 subjects implanted with the modified approach (new implants and revisions) are encouraging.

Summary
These results demonstrate that for a population of people with long term Chronic Low Back Pain and limited treatment options, treatment with ReActiv8 delivers clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life.
PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Matthew Neal, Hendrik Thys,
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
FTI Consulting (for Ireland)
Jonathan Neilan, Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

FTI Consulting (for France)
Astrid Villette,
Tel: +33 1 47 03 69 51
Email: Astrid.Villette@fticonsulting.com
Investor relations:
The Trout Group LLC
Jillian Connell, Tel: +1 646 378 2956 / +1 617 309 8349
Email: jconnell@troutgroup.com
ESM Advisers:
Fergal Meegan or Barry Murphy, Davy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable 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 and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).
About the ReActiv8-A Trial
The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three month endpoint after activation of stimulation and compared to baseline prior to implant. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the lower 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 utilisation put a significant burden on individuals, families, communities, industry, and governments.
Further information can be found at www.mainstay-medical.com
ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world.
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

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” or “will”, 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 Company’s ability to obtain CE Marking for ReActiv8®, the initiation and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, 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.