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Paris, France, July 10th. 2018. Sofinnova Partners, a leading venture capital firm specialized in Life Sciences, today announced that Otsuka Holdings is acquiring its portfolio company ReCor Medical, a medical device company specialized in the treatment of hypertension. The terms of the acquisition are being withheld due to non-disclosure obligations.

ReCor Medical was created in 2009 by Sofinnova Partners, Mano Iyer – who was then entrepreneur-in-residence at Sofinnova Partners and now Chief Operating Officer of ReCor – and Professor Jacques Seguin, MD, who became a large private investor in ReCor. Prof. Seguin was previously founder and CEO of CoreValve, a past Sofinnova portfolio company and a leader in the transcatheter valve replacement space, which was sold to Medtronic. Sofinnova Partners was the sole venture capital investor in ReCor Medical and remained its largest shareholder until the sale to Otsuka.

ReCor Medical is an innovative medical device company that developed the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. ReCor recently announced positive results of its landmark RADIANCE-HTN SOLO hypertension study at EuroPCR 2018.

Antoine Papiernik, Managing Partner at Sofinnova Partners and ReCor Board Member, said: “ReCor perfectly illustrates our investment strategy: we worked hand-in-hand with Mano Iyer to create the business vision and plan for ReCor. We then founded and funded the company, and opened our network of experts, key opinion leaders and board members to help grow it. We brought trusted entrepreneurs Jay Watkins as Chairman and Andy Weiss as CEO to help guide and operate the company through to a corporate transaction to our partner Otsuka.”

Jay Watkins, Chairman of ReCor Medical said: “Sofinnova Partners remains one of few VCs willing to fund early-stage med-tech ventures targeting large and important new markets. The firm played a critical role throughout ReCor’s life, and has proven to be a reliable, value-added partner for the company. The field of renal denervation has been a complex one over the last few years with periods of euphoria and periods of doubt. Sofinnova Partners’ support remained constant throughout, helping to build a strong partnership with Otsuka and then navigate through the challenges to a very successful trade sale.”

Mano Iyer, Founder and COO of ReCor Medical added: “ReCor is a success story because Sofinnova Partners, consistent with its philosophy, saw the value of an opportunity which did not yet exist. It had the vision to create and fund the company, not only in the very beginning, but also during the critical early years. Despite the dramatic swings in the field, Sofinnova Partners’ confidence in me and in the management team was essential to keep us motivated when others lost hope. This great exit is therefore particularly sweet.”

Andrew M. Weiss, CEO of ReCor Medical adds: “I came to ReCor thanks to Antoine Papiernik’s introduction to the company. With his help, our team developed the partnership with Otsuka and was able to remain focused on value creation. The recent announcement of our positive RADIANCE-HTN SOLO study results and now the merger with Otsuka demonstrate that our teamwork with Sofinnova Partners was successful. We now have an opportunity to transform the treatment of hypertension and benefit millions of potential patients while providing a solid return for our investors. I look forward to continuing to work to make this technology a possible standard of care in hypertension treatment”.

For more information, please contact:
International: Anne Rein
Tel: +33 6 03 35 92 05
e-mail: anne.rein@strategiesimage.com
United States: Kate Barrette
Tel: +1 212 223 0561
e-mail: kbarrette@rooneyco.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 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 €1.9 billion under management. For more information: www.sofinnova.fr

About ReCor Medical, Inc.
ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,240 billion in the fiscal year ended December 2017.

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.
Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.


Toulouse, FRANCE, Ann Arbor, ETATS-UNIS, 30 août 2016 – Cerenis Therapeutics (FR0012616852 – CEREN – Eligible PEA PME), société biopharmaceutique internationale dédiée à la découverte et au développement de nouvelles thérapies HDL (« bon cholestérol ») pour le traitement des maladies cardiovasculaires et métaboliques, annonce aujourd’hui la fin du recrutement des patients dans l’étude CARAT, destinée à tester l’efficacité thérapeutique de CER-001 chez les patients à la suite d’un Syndrome Coronarien Aigu (SCA).
• CARAT est une étude de Phase II dans l’indication post syndrome coronarien aigu, destinée à maximiser l’efficacité de CER-001 à réduire la plaque d’athérome, tout en maximisant le nombre d’administrations durant la période critique suite à un premier évènement clinique.
• CER-001 est un mimétique de HDL novateur, imitant les propriétés bénéfiques de l’HDL naturel naissant (HDL pré-β)
• L’étude CARAT est une étude académique impliquant un partenariat entre plusieurs organisations de recherche, le SAHMRI (South Australian Health and Medical Research Institute) et la « Cleveland Clinic », des organismes de recherche sous contrat (InterEuropa et autres) et le sponsor pharmaceutique (Cerenis)
• Le principal paramètre clinique est la variation du pourcentage de volume d’athérome (PAV) par rapport au placebo sur une population ayant un PAV ≥30% à l’entrée de l’étude dans l’artère coronaire sélectionnée.

CARAT est une étude de phase II, menée en double aveugle et contrôlée par placebo, qui a pour objectif d’évaluer l’effet de CER-001 sur la régression de la plaque d’athérome chez les patients post-SCA, en mesurant la diminution du pourcentage du volume d’athérome (PAV) par échographie intravasculaire des coronaires (IVUS) .

Destiné à maximiser l’effet de CER-001 chez les patients, le design de l’étude consiste en une administration de la dose optimale du mimétique de HDL, à raison de 10 doses de 3 mg/kg pendant 9 semaines, soit une par semaine. L’étude, qui inclut 297 patients dans 4 pays (Australie, Hongrie, Pays-Bas et Etats-Unis). CARAT est supervisée par un comité de pilotage prestigieux et le Professeur Stephen Nicholls du centre de recherche en cardiologie du SAHMRI en est le principal investigateur.

L’étude CARAT est basée sur les résultats d’études précédentes sur l’homme, notamment les données positives présentées en novembre 2015 au congrès scientifique de l’American Heart Association, pour établir si CER-001 avait un effet sur la régression de la plaque d’athérome des patients ayant subi un SCA. La dose de 3 mg/kg a été sélectionnée suite à une analyse réalisée par le Professeur Stephen Nicholls et son équipe, prenant aussi en compte les données précliniques qui confirment que davantage d’administrations de CER-001 à une faible dose est plus efficace pour faire régresser la plaque que peu d’administrations à une dose élevée.1

Le recrutement des patients dans l’étude CARAT se termine dans les délais, et les résultats sont attendus au plus tard le premier trimestre 2017. Sous réserve des résultats positifs de CARAT, une étude pivot de phase III (CALMS) devrait être ensuite lancée.

Aucun problème de sécurité ni de tolérance n’a été relevé durant l’étude CARAT qui pourrait empêcher l’étude d’être complétée à temps – des revues régulières de sécurité sont réalisées tout au long de la période d’administration par le comité indépendant de surveillance (Data Security Monitoring Board, ou DSMB), ce qui inclut le suivi des paramètres et événements cliniques durant le traitement.
• CER-001, un candidat médicament présentant un intérêt thérapeutique majeur pour les patients atteints par un SCA

Malgré les mesures de prévention secondaire, le risque persistant de récidive de la crise cardiaque pour les patients qui ont déjà eu un SCA reste très élevé et représente un important besoin médical non satisfait.

Compte tenu de ce considérable besoin médical non satisfait, CER-001, en permettant de réduire rapidement les plaques d’athérome, apporte une chance unique de réduire le risque de récidive d’événements cardiovasculaires dans les premiers mois suivant la survenance d’un SCA. CER-001, en s’ajoutant aux traitements hypolipidémiants de long terme, permettrait une baisse additionnelle du taux de mortalité et de morbidité et pourrait devenir par conséquent un nouveau standard pour le traitement des patients ayant subi un SCA.

Le Professeur Stephen Nicholls, Investigateur Principal commente : « Nous nous réjouissons d’avoir terminé le recrutement des patients dans cet étude très importante, et qu’il n’y ait eu aucun problème lié à la sécurité ou à la tolérance. Le design de l’étude CARAT repose sur les conclusions de l’étude de Phase II précédente, CHI SQUARE, qui démontrait que CER-001 à une dose de 3 mg/kg produisait une baisse statistiquement significative en PVA, un paramètre directement lié aux risques de troubles cardiovasculaires, sur des patients présentant un taux PVA ≥30%. Nous espérons que les résultats de l’étude CARAT démontreront de manière convaincante le potentiel thérapeutique clé de l’HDL infusé et offrirons plus de connaissances et de clairvoyance sur la manière dont ce produit prometteur peut offrir une option de traitement positive pour des patients post-SCA et réduire la formation de plaque d’athérome. »

Le Docteur Jean-Louis Dasseux, fondateur et CEO de Cerenis déclare : « Le recrutement du dernier patient de l’étude CARAT intervient conformément au calendrier de développement clinique, tel qu’annoncé à l’occasion de l’introduction en bourse de Cerenis. C’est avec impatience que nous attendons désormais l’obtention des résultats finaux, prévue au premier trimestre 2017, qui devraient confirmer le potentiel de notre candidat médicament pour traiter efficacement les patients atteints par un syndrome coronarien aigu et améliorer ainsi significativement leurs conditions de vie. Nous restons confiants dans le succès de CARAT, le design optimal de l’étude permettant de maximiser l’effet de CER-001 ».

Calendrier financier :
Chiffre d’affaires du 3e trimestre 2016 :
7 novembre 2016

A propos de Cerenis : www.cerenis.com
Cerenis Therapeutics Holding est une société biopharmaceutique internationale dédiée à la découverte et au développement de thérapies HDL innovantes pour le traitement des maladies cardiovasculaires et métaboliques. Le HDL est le médiateur primaire du transport retour du cholestérol (ou RLT), la seule voie métabolique par laquelle le cholestérol en excès est retiré des artères et transporté vers le foie pour élimination du corps.
Cerenis développe un portefeuille de thérapies HDL, dont des mimétiques de particules HDL pour induire la régression rapide de la plaque d’athérome chez des patients à risque tels ceux atteints de syndrome coronarien aigu et les patients souffrant de déficience en HDL, ainsi que des molécules qui augmentent le nombre de particules HDL afin de traiter les patients atteints d’athérosclérose et de maladies métaboliques associées.
Cerenis est bien positionné pour devenir un des leaders du marché des thérapies HDL avec un riche portefeuille de programmes en développement.
Depuis sa création en 2005, Cerenis est soutenu par un actionnariat historique prestigieux (Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, DAIWA Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity et Bpifrance) et a réussi son entrée en bourse sur Euronext en levant 53,4 millions d’euros en mars 2015.

A propos du CER-001
CER-001 est un complexe obtenu par bioingénierie contenant de l’apoA-I humaine recombinante, la protéine naturelle des HDL, et des phospholipides dont un chargé négativement. Sa composition a été optimisée afin d’imiter la structure et les propriétés bénéfiques des HDL naturelles naissantes, autrement connues sous la dénomination pré-bêta HDL. Son mécanisme d’action est d’augmenter l’apoA-I et le nombre de particules HDL de façon transitoire. Ceci afin de stimuler l’élimination du cholestérol et autres lipides en excès des tissus dont la paroi artérielle puis de les transporter vers le foie pour élimination via la voie métabolique appelée Transport Retour des Lipides (« Reverse Lipid Transport » ou RLT). Les précédentes études cliniques de phase II ont apporté d’importants résultats démontrant l’efficacité de CER-001 à faire régresser l’athérosclérose dans plusieurs lits vasculaires distincts chez des patients représentant l’ensemble du spectre de l’homéostasie du cholestérol. La totalité des résultats à ce jour indiquent que CER-001 effectue toutes les fonctions des pré-bêta HDL naturelles et a le potentiel de devenir sur le marché le meilleur de la classe des mimétiques de HDL.
A propos du syndrome post coronarien aigu
Environ 12% des patients post-SCA subissent une récidive cardiovasculaire dans la première année après le SCA2. Le risque de récidive est particulièrement élevé au cours des deux premiers mois suivant le premier événement, les deux tiers des récidives se produisant au cours de cette période.
Au total, la population des patients ciblés par CER-001 dans la prévention secondaire est estimée à environ 2,8 millions de patients par an pour l’Amérique du Nord et l’Europe.

Contacts :
Jean-Louis Dasseux
05 62 24 09 49

Relations investisseurs
Emmanuel Huynh / Louis-Victor Delouvrier
01 44 71 98 53


MONTREAL, Aug. 30, 2016 – BioAmber Inc. (NYSE: BIOA) announced today that its joint venture with Mitsui & Co. has achieved the final operational milestone set out in a CAD$20 million commercial loan that the joint venture drew down in 2015. BioAmber Sarnia demonstrated performance levels validating commercial operation, as defined in its loan agreement with Comerica Bank, Export Development Canada (EDC) and Farm Credit Canada (FCC).
The performance indicators for the Sarnia manufacturing facility included the overall efficiency of BioAmber’s proprietary biotechnology in fermentation, the plant’s throughput and output in continuous operation, and the quality of the final product. This milestone is further evidence that the Sarnia plant is operating well, as recently disclosed in BioAmber’s Q2 2016 operating results.
BioAmber Sarnia has also demonstrated the performance targets that Sustainable Development Technology Canada (SDTC) had originally set for the project. These include targets related to greenhouse gas emissions and financial performance. SDTC has completed its third-party validation of Sarnia’s performance and approved the final grant payment of CAD$1.45 million to BioAmber.
« Our lenders had set out rigorous performance criteria for the Sarnia facility and achieving these milestones is independent validation of how well our plant is operating, » said Fabrice Orecchioni, BioAmber’s Chief Operating Officer. « Our facility is the world’s largest succinic acid plant and our variable costs are competitive with petro-succinic acid at current oil prices. With Sarnia up and running, BioAmber has established itself as a global leader in renewable chemicals, » he added.

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, which are subject to substantial risks, uncertainties and assumptions. These statements often include words such as « believe, » « expect, » « anticipate, » « intend, » « plan, » « estimate, » « seek, » « will, » « may » or similar expressions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur and the timing of events and circumstances and actual results could differ materially from those projected in the forward- looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For additional disclosure reg arding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC including, the « Risk Factors » section of BioAmber’s most recent Annual Report on Form 10-K and the recent quarterly reports on Form 10-Q.

SOURCE BioAmber Inc.


Novo A/S and Sofinnova Partners are leading this latest financing round
NEW YORK, New York ― June 15, 2016 ― Rgenix, a cancer therapeutics company developing first-in-class drugs targeting novel cancer pathways, announced a $33 million Series B financing led by Novo A/S and Sofinnova Partners, with participation from existing investors including Partnership Fund for New York City, Alexandria Venture Investments, and Conegliano Ventures LP. The financing will support clinical development of Rgenix’s lead drug candidates, RGX-104 and RGX-202, as well as further development of its therapeutics pipeline.
“We are thrilled to have attracted top-tier investors to advance development of our novel cancer therapeutics,” said Masoud Tavazoie, M.D. Ph.D., Chief Executive Officer and co-founder of Rgenix. “This financing validates the potential of our lead immunotherapy RGX-104, which will be entering clinical trials this fall, and also demonstrates the strength of our discovery platform, developed in the laboratory of Rgenix co-founder Dr. Sohail Tavazoie at The Rockefeller University. The funding will enable our team to deliver an innovative therapy to cancer patients while simultaneously pushing forward our pipeline of other novel drug candidates.”
Antoine Papiernik, Managing Partner at Sofinnova Partners, commented: “We are very excited to back such a high quality team at Rgenix. We also believe that RGX-104 could revolutionize treatment to cancer patients that today lack effective therapies.”
Despite recent advances in cancer therapy, most patients will eventually succumb to their disease due to drug resistance and immune evasion. RGX-104 is a small molecule that reverses immune evasion and drug resistance by targeting immunosuppressive cells in the tumor microenvironment via a novel pathway, resulting in strong anti-tumor activity in several drug-resistant cancer types in pre-clinical models, both as a single agent and in combination with approved immunotherapies such as PD-1 inhibitors. The target of RGX-104 was discovered using Rgenix’s miRNA platform that has yielded several new cancer targets across multiple prevalent cancer types.
“We are excited to support Rgenix’s novel approach to treating cancers of high unmet need,” said Nilesh Kumar, Senior Principal of Novo Ventures*. “Rgenix has an exciting platform founded on strong science from The Rockefeller University; the lead program is a first in class opportunity addressing a key mechanism in tumor immunosuppression in various cancer types.”
In connection with the financing, Nilesh Kumar of Novo Ventures and Antoine Papiernik of Sofinnova Partners will join the Rgenix Board of Directors together with existing members, including Executive Chairman Eric Rowinsky, M.D., Masoud Tavazoie, M.D. Ph.D., Nancy Chang, Ph.D., and Saeed Tavazoie, Ph.D.

About Rgenix
Rgenix is a privately-held cancer therapeutics company focused on the discovery and development of novel cancer drugs that target key pathways in cancer progression. Using a miRNA based target discovery platform developed by Rgenix scientific co-founders at The Rockefeller University, the company is developing several first-in-class drug candidates to treat cancers of high unmet need. The company brings together distinguished scientific founders and a leadership team with a seasoned Board comprised of experienced drug developers. The company is funded by leading biotechnology investors, including Novo A/S, Sofinnova Partners, and Alexandria Venture Investments. For more information, please visit www.rgenix.com.

About Novo A/S
Novo A/S, a private Danish limited liability company fully owned by the Novo Nordisk Foundation, is the holding company in the Novo Group, a family of independent companies wholly owned by the Novo Nordisk Foundation. Novo A/S is responsible for managing the Foundation’s assets, which are currently valued at more than $53 billion.
Besides being the major shareholder in the Novo Group companies, Novo A/S provides seed and venture capital to development stage companies and takes significant ownership positions in well-established companies within life science, as well as manages a broad portfolio of financial assets. Their teams of scientific and commercial experts actively support their portfolio of projects and companies, and manage a range of financial investments. For further information, visit www.novo.dk.
* Novo Ventures (US) Inc. is a separate legal entity that provides consultancy services to Novo A/S, mainly within the areas of identifying, analyzing and negotiating various investment opportunities among life science and biotech companies in the US as well as certain follow-up activities related thereto, such as board memberships, financial control and reporting efforts.

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. For more information, please visit: www.sofinnova.fr.

Media Contact:
Marion Janic


Vienna, Austria, 16 June 2016 – Hookipa Biotech AG, a company pioneering a new class of immunotherapies and vaccines, today announces the appointment of Mr. Jörn Aldag as CEO.

Mr. Aldag brings significant leadership experience and sector knowledge to Hookipa from leading immunotherapy companies including uniQure, Molecular Partners and Unum Therapeutics. In particular, he has an impressive track record of building companies based on unique technology platforms, and bringing them to public markets in order to access the depth of capital needed to develop clinical stage assets. Alongside his CEO role at Hookipa Mr. Aldag will remain Chairman of Molecular Partners and on the board of Unum Therapeutics, both of which are developing next-gen immuno-oncology therapies.

Prior to his appointment as CEO of Hookipa, Mr Aldag was CEO of Nasdaq-listed uniQure N.V, a company pioneering adeno-associated virus based gene therapy. Under his leadership uniQure received the first ever approval of a gene therapy product by the European Medicines Agency, built a broad pipeline of gene therapy products across several disease areas, obtained approximately $200 m through its NASDAQ-listing and follow-on, and closed a multi-billion $ collaboration in cardiovascular gene therapy. Previous experience includes President and CEO of Evotec AG (1997-2008). In his position at Evotec AG, he designed many alliances with leading pharma companies, listed the Company on the Frankfurt Stock Exchange and Nasdaq and managed the acquisition of LSE-listed Oxford Asymmetry and Nasdaq-listed Renovis Inc. Mr. Aldag holds business degrees from the European Business School and Harvard Business School (AMP).

Mr. Aldag replaces Dr. Katherine Cohen, who joined the Company in 2011 and led its development from early science to clinical stage. As CEO, Dr. Cohen successfully secured €27 million in funding for the Company through Series A and Series B financing rounds, as well as raising an additional €11 million in non-dilutive funds.

Commenting on his new role, Mr. Aldag said, “Hookipa’s Vaxwave® technology platform has tremendous application in both infectious disease and in oncology, and I applaud what Katherine and the team have built to bring this vaccine technology to the next level. The Company is at a very exciting time of its development. Our lead program, HB-101 against Cytomegalovirus, having completed pre-clinical testing and GMP manufacturing, is poised to start a Phase 1 trial in Q3 2016 and our Human Papillomavirus immunotherapy candidate is entering pre-clinical testing.”

Dr. Cohen commented, “It has been a tremendous experience to lead Hookipa and bring the Company to what it is today. I look forward to seeing further success of the Company under Jörn’s leadership.“

“On behalf of the Board, the team and our highly supportive investors I would like to thank Katherine for her contribution to the Company. I am delighted to welcome Jörn Aldag as CEO, to lead the Company through the next stage of its development. Given his experience and track record, I am confident that he will enable Hookipa to realise the tremendous potential of its technology in both oncology and infectious disease.” Chairman John Lambert said.


About Hookipa Biotech
Hookipa Biotech is an immunotherapy company developing next-generation cancer immune-therapeutics and vaccines using novel, proprietary arenavirus vector platforms. Hookipa has raised €11 million in non-dilutive funds and €27 million equity investment from internationally renowned venture capital investors including Sofinnova Partners, Forbion Capital Partners, Boehringer Ingelheim Venture Fund, Takeda Ventures and BioMedPartners. Additional information on Hookipa is available at www.hookipabiotech.com.

About Vaxwave®
Hookipa’s broadly enabling Vaxwave® technology platform is based on replication-defective lymphocytic choriomeningitis virus vectors that allow induction of strong humoral and cellular immune responses to viral, bacterial and tumor antigens. Strong therapeutic efficacy data have been generated in various pre-clinical models. One of the most distinguishing features of this vector platform is its homologous prime-boosting capacity, and Vaxwave® based immunotherapy can be applied repeatedly to boost the immune system and generate potent CD8+ T cell responses against targeted antigens. Vaxwave® is patent-protected by issued patents and patent applications worldwide.

Issued for and on behalf Hookipa Biotech AG by Instinctif Partners.

For further information please contact:
At the Company
Jörn Aldag
Chief Executive Officer
Hookipa Biotech AG
Helmut-Qualtinger-Gasse 2
1030 Vienna

Media enquiries
Sue Charles/ Daniel Gooch/ Alex Bannister
Instinctif Partners
+44 (0)20 7866 7905


Le prestigieux hôpital ophtalmologique Moorfields de Londres intègre l’essai clinique d’IRIS® II, un système de vision bionique doté d’une caméra bio-inspirée et d’un implant épi-rétinien explantable de 150 électrodes

Paris, France – le 31 mai 2016 – 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’autorité réglementaire du Royaume-Uni (MHRA) pour démarrer une étude clinique chez des patients devenus aveugles d’une rétinite pigmentaire (RP) avec le système bionique IRIS® II, doté d’un implant épi-rétinien explantable de 150 électrodes.

L’hôpital ophtalmologique Moorfields de Londres, rejoint le réseau des centres d’excellences en France, en Allemagne et en Autriche, impliqués dans l’essai clinique d’IRIS II. Le prestigieux hôpital Moorfields de Londres est le plus ancien centre d’excellence ophtalmologique d’Europe pour l’enseignement, la recherche académique et la recherche clinique. L’ajout de nouveaux centres cliniques en Europe permet de sensibiliser un plus grand nombre de patients, de leur donner l’opportunité de participer à l’essai clinique, et ouvre la voie à la future commercialisation du système de vision bionique.
Parallèlement, Pixium Vision a initié en décembre dernier le processus de demande d’approbation de marquage CE, sur la base de l’expérience clinique d’IRIS. Sous réserve de l’obtention du marquage CE, la commercialisation devrait débuter vers mi-2016.

Mahi Muqit, PhD FRCOphth, Consultant Ophtalmologiste et Chirurgien Vitréorétinien, à l’hôpital Moorfields principal investigateur de l’étude clinique au Royaume-Uni, a déclaré : « Nous sommes ravis de participer à l’essai clinique d’IRIS® II et d’être le premier site actif au Royaume Uni. Les patients souffrant de rétinite pigmentaire peuvent désormais bénéficier d’un implant rétinien de dernière génération qui peut potentiellement leur offrir un meilleur bénéfice visuel. Ce nouvel essai clinique est essentiel pour évaluer les dernières technologies et proposer aux patients un système de vision bionique différencié et évolutif. Nous sommes ravis de collaborer avec Pixium Vision pour développer de nouvelles solutions pour les dystrophies rétiniennes que sont la Rétinite Pigmentaire et la DMLA. »

Pour Khalid Ishaque, Directeur Général de Pixium Vision, « L’approbation de cette étude clinique par le Royaume-Uni renforce notre confiance dans IRIS® II, notre premier système de vision bionique. » Khalid Ishaque, a ajouté : «Aujourd’hui, Pixium Vision est la seule société à développer un système d’implant épi rétinien pour la rétinite pigmentaire, et un implant sous-rétinien photovoltaïque, sans fil, pour les patients atteints de DMLA. Nous sommes fiers d’initier cette collaboration au Royaume-Uni avec le très prestigieux hôpital ophtalmologique Moorfields de Londres. »

IRIS® II intègre des caractéristiques innovantes :
– Une caméra bio-inspirée reproduisant le fonctionnement de l’oeil humain : le capteur ne prend pas de clichés successifs, composés principalement d’informations redondantes, mais visualise à chaque instant avec ses pixels asynchrones, l’ensemble des évènements nouveaux ;
– Un implant épi-rétinien équipé de 150 électrodes, soit presque trois fois qu’actuellement ;
– Un implant 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.

A propos de « Moorfield Eye Hospital »
« Moorfields Eye Hospital NHS Foundation Trust » est l’un des meilleurs hôpitaux ophtalmologiques au monde pour les traitements, les soins cliniques, la recherche et l’enseignement. Nous excellons dans les soins ophtalmologiques depuis plus de 200 ans et nous continuons d’être à l’avant-garde des nouvelles avancées et des nouveaux développements. Nous sommes partie intégrante de l’un des premiers centres académiques en science de la vie du Royaume Uni, partenaires de l’UCL, et membre de l’un des premiers réseaux de santé. En 2004, nous avons été l’une des premières organisations à devenir une « NHS foundation trust ». Pour plus d’informations, rendez-vous sur www.moorfields.nhs.uk .

A propos de l’étude clinique d’IRIS® II
Titre de l’étude : « Compensation de la cécité à l’aide du système d’implant rétinien intelligent (IRIS 2) chez des patients atteints de dystrophie rétinienne » https://www.clinicaltrials.gov Ref: NCT02670980
L’essai clinique IRIS® II est multicentrique européen prospectif, ouvert et non randomisé visant à évaluer l’innocuité et la performance du système 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.
Les essais cliniques sont actuellement en cours dans plusieurs centres européens :

A propos de Pixium Vision ( www.pixium-vision.com ; @PixiumVision ; www.facebook.com/pixiumvision)
Pixium Vision développe des systèmes de vision bionique innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les systèmes 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 système 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 a déposé le dossier de Marquage CE à la fin 2015 et anticipe l’obtention du marquage CE vers mi-2016.
Pixium Vision développe également PRIMA, un implant sous-rétinien miniaturisé, sans fil, 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 EN ISO 13485.
Pixium Vision travaille en étroite collaboration avec des partenaires académiques de renommée mondiale tels que l’Institut de la Vision à Paris et le Laboratoire de physique expérimentale Hansen à l’Université Stanford.
Pixium Vision est coté sur Euronext (Compartiment C) à Paris.
ISIN: FR0011950641 ; Mnemo: PIX
IRIS® est une marque déposée de Pixium-Vision SA

Pixium Vision
Pierre Kemula, CFO
+33 1 76 21 47 68
Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr


ReActiv8® is the only approved implantable neurostimulation system addressing cause, not just symptoms, of chronic low back pain

Dublin – Ireland, 25 May 2016 – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), today announced that it has received CE Mark approval for ReActiv8®, its innovative and proprietary implantable neurostimulation system to treat disabling chronic low back pain. CE Marking enables commercialization of ReActiv8 in Europe.

The CE Mark approval is based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options.1

“CE Marking is a pivotal milestone for Mainstay. Our team has been working tirelessly towards making ReActiv8 commercially available to physicians and their patients,” Peter Crosby, CEO of Mainstay, commented. “We believe ReActiv8 has the potential to change the lives of millions of people who currently have limited treatment options for their chronic low back pain.”

ReActiv8 is indicated as an adjunct to medical management of chronic low back pain for relief of pain in adults who have attempted at least medical management and physical therapy. During patient-controlled treatment sessions, ReActiv8 stimulation causes repetitive contractions of the key stabilizing muscles in the back to support recovery from chronic low back pain and related symptoms.

Dr. Robert Pflugmacher, orthopedic surgeon at the University Hospital in Bonn, Germany said “We see several new chronic low back pain patients every week who are not indicated for surgery and who meet the indications for ReActiv8. Rather than sending them home untreated, we now have an exciting new option we can offer them. As orthopedic surgeons, ReActiv8 meets our objective of addressing the underlying functional causes of chronic low back pain, and the straightforward implant procedure utilizes skills and techniques familiar to us.”

Mainstay will initially focus its sales and marketing efforts for ReActiv8 on Germany. The launch will primarily target hospitals with a multi-disciplinary approach to back pain and a large patient population. The Company has a direct sales force which is supported by its team of experienced field clinical specialists. As Mainstay gains experience and momentum, the Company will consider expanding to additional customers and countries.

“ReActiv8 is an innovative use of neurostimulation for the treatment of chronic low back pain and the clinical data from the ReActiv8-A trial are compelling,” said Dr. Stefan Schu, neurosurgeon and neurostimulation expert at the Sana Hospital in Duisburg, Germany. “Neurosurgeons in Germany have a track record of embracing important innovations and we are looking forward to offering ReActiv8 to patients who until now were facing the prospect of disabling chronic low back pain for the rest of their lives.”

Mainstay will conduct a Post Market Clinical Follow-up to gather additional long term data. In the US, subject to the availability of sufficient financial resources, the Company plans to launch the ReActiv8-B clinical trial in support of an application for Premarket Approval (PMA) which is required for commercialization in the United States.

CE Marking
CE Marking allows companies to legally market and distribute products within the European Market, and declares the product complies with all applicable European Directives and Regulations. For Active Implantable Medical Devices (AIMDs) like ReActiv8, CE Marking is granted by a Notified Body after review of the design dossier and other information for conformity to the AIMD Directive. Following CE Marking, a product can be sold in the EEA, and certain other countries.

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, Australia and Germany, 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 recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize 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

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, Mary-Jane Elliott, 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 1 663 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
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 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.


ReCor Medical Announces Collaboration and Investment with Otsuka Holdings for Asian Commercialization and Clinical Studies in the US and Europe

Palo Alto, CA, USA and Amsterdam, The Netherlands, 16 May 2016 – ReCor Medical (“ReCor”) announced today the signing of a development and commercialization agreement, together with an additional investment, with Otsuka Holdings (“Otsuka Holdings”), a global healthcare group headquartered in Tokyo, Japan. As part of the agreement, Otsuka Holdings obtained exclusive rights to commercialization of the ReCor Paradise® ultrasound-based renal denervation system for Japan, China, Korea and other Asian countries. Otsuka Holding’s investment will be used to further ReCor’s clinical studies in the US and Europe. Under the commercialization agreement, Otsuka will have exclusive rights to conduct clinical trials, regulatory activities and sales and marketing functions for commercialization of the ReCor Paradise technology for renal denervation in Asia. Otsuka’s initial focus will be to conduct a clinical trial of the Paradise System in Japan to demonstrate its potential benefit in patients with treatment-resistant hyper ension.

ReCor plans to use the Otsuka funding to advance its IDE-approved RADIANCE-HTN study for evaluation of the Paradise System in patients with hypertension in the US and EU. The study recently began enrolling at sites in the United States, The Netherlands, and the UK, and additional sites are planned for France and Germany.

Tatsuo Higuchi, President and Representative Director of Otsuka Holdings, said, “We are excited to commercialize ReCor’s unique ultrasound-based renal denervation technology in Asia. This collaboration demonstrates Otsuka’s strategy of leveraging our expertise in select disease areas for the development of medical device-based solutions with the potential to address medical needs that cannot be met by pharmaceutical treatment alone.”

Andrew M. Weiss, President & CEO of ReCor, commented: “We highly value Otsuka’s development and marketing capabilities in Asia – one of the most important potential markets for our Paradise technology. Otsuka has been one of our most important investors since leading our Series D financing, joining Sofinnova Partners and RICA Universal in funding ReCor. This latest investment is designed to fund our RADIANCE-HTN study, which we hope will demonstrate the blood-pressure lowering effect of the Paradise System in patients with hypertension.”

About ReCor Medical, Inc.
ReCor Medical is a private medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN) called the Paradise System®. RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. ReCor has initiated enrollment in its RADIANCE-HTN study, en IDEapproved, randomized, sham-controlled trial to demonstrate the efficacy of the Paradise System in patients with hypertension. RADIANCE-HTN is being conducted in approximately 35 centers in the United States, Netherlands, UK, France and Germany.

More information on RADIANCE-HTN can be found at:
For more information about ReCor Medical, please visit
www.recormedical.com or contact Andrew M. Weiss, President & CEO,
ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

About Otsuka Holdings Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of approximately JPY1,445 billion in the fiscal year ended December 2015. Under its corporate philosophy, “Otsuka – people creating new products for better health worldwide”, the Otsuka Group conducts research, development, manufacturing and marketing of innovative products that are uniquely positioned to provide advanced therapy, improve quality of life and support a healthy lifestyle.
Additional information can be found on http://www.otsuka.com/en/


Fremont, Calif. and London, April 27, 2016 — Shockwave Medical, a pioneer in the treatment of calcified vascular disease, today announced positive clinical results from the pooled DISRUPT PAD Study, a single-arm, two-phase multicenter study evaluating the safety and performance of Lithoplasty® System to treat peripheral artery disease, at the 38th Annual Charing Cross 2016 Symposium in London.

Results from 95 patients with calcified vascular stenosis of the superficial femoral artery (SFA) and popliteal artery enrolled at eight sites were presented by principal investigator Thomas Zeller, M.D., head of the Department of Angiology at Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.

Acute procedure results on the entire cohort and interim follow up results for the DISRUPT PAD pooled study are in line with the DISRUPT PAD I findings presented at the Charing Cross Symposium last year and continue to demonstrate that the Lithoplasty Technology provides successful and safe treatment of patients with calcified peripheral artery disease, a difficult-totreat population. Primary efficacy results demonstrated 100% acute success, defined as ability to achieve less than 50% residual stenosis using Lithoplasty with or without adjunctive angioplasty. Importantly, an average residual stenosis of 24%, with no difference in the ability to dilate lesions between moderate (44%) and severely (55%) calcified lesions, was noted. Stent utilization due to a flow limiting dissection following Lithoplasty was limited to 1% (1/95 patients) with no stents placed for efficacy reasons. Thirty-day patency assessed by duplex ultrasound was 100% with interim six-month follow-up demonstrating patency of 81%.

“The results we have seen with the Lithoplasty System show consistent procedural success, high acute gain, minimal vessel injury, and remarkably low use of implants,” Dr. Zeller said. “We also continue to see sustained functional improvement through six months with consistent effectiveness across all subgroups. These results are very encouraging.”

Arterial calcification is increasingly common with an aging population as cardiovascular disease has become a chronic condition due to improved disease management, preventive care, and lifestyle changes. Traditional devices and techniques for treating occlusive calcified lesions generate suboptimal and unpredictable outcomes often leading to significant soft tissue damage requiring additional treatment. The most advanced of these devices targets only superficial calcium, leaving deep calcium unaffected, frequently resulting in poor lesion dilation. Lithoplasty is a novel technology utilizing integrated lithotripsy emitters that generate mechanical pulse waves to disrupt both superficial and deep calcium normalizing vessel wall compliance prior to low-pressure balloon dilatation.

« The positive results of the DISRUPT PAD program reinforce our belief that the Lithoplasty System is uniquely suited to address substantial unmet needs in the treatment of patients with peripheral, coronary and heart valve disease, using a balloon-based approach that is inherently familiar to physicians,” said Shockwave Medical CEO and co-founder Daniel Hawkins.

“We are very pleased with the success the Lithoplasty System has demonstrated in treating calcified peripheral vascular disease,” said Todd Brinton, M.D., clinical associate professor of Medicine at Stanford and co-founder of Shockwave Medical. “The pooled DISRUPT PAD results support our goal of changing the paradigm in the treatment of advanced cardiovascular disease.”

About Shockwave Medical’s Lithoplasty® System
Lithoplasty technology integrates the calcium-disrupting power of lithotripsy with the familiarity and simplicity of balloon-based interventional devices. Built on a traditional balloon catheter platform, Lithoplasty Devices use the intermittent pulsatile mechanical energy of lithotripsy to disrupt both superficial and deep calcium while minimizing soft tissue injury and an integrated balloon to dilate lesions at low pressures, restoring blood flow.
Shockwave Medical has received CE Mark for use of the Lithoplasty System in the treatment of peripheral vascular disease. Clinical work has also been conducted in coronary vessels and aortic valves. The Lithoplasty System is not available for sale in the United States.
To view an animation of the Lithoplasty System visit http://shockwavemedical.com/.

About Shockwave Medical
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty® Technology for the treatment of calcium in peripheral and coronary vascular disease and heart valve disease. Delivered on a standard balloon catheter platform, Lithoplasty Technology combines the calcium disrupting power of lithotripsy with the familiarity and simplicity of a balloon in a single enabling device. For more information visit www.shockwavemedical.com.

Media Contact:
Nicole Osmer


Toulouse, 19 avril 2016. EnobraQ, une entreprise de biotechnologies développant des procédés de fermentations industrielles à partir de CO2, vient de finaliser un premier tour de financement de 2,9 million d’euros mené par Auriga Partners et Sofinnova Partners. IRDInov et CEA investissement ont aussi participé à ce tour d’amorçage. Les fonds levés permettront à la société de développer son programme de recherche visant à obtenir une preuve de concept avancée d’ici fin 2017.
Créée fin 2015 par Sofinnova Partners, suite à un projet de recherche du démonstrateur Toulouse White Biotechnology, EnobraQ développe un procédé fermentaire utilisant du CO2 comme source de carbone pour la production de précurseurs de synthèses organiques et de polymérisation. Dans un contexte où les solutions technologiques sont attendues pour lutter contre le réchauffement climatique et trouver des substituts au pétrole, l’approche d’EnobraQ est révolutionnaire. Grâce un procédé biologique de capture du CO2 par des levures, sa technologie vise à réduire un des principaux gaz à effet de serre en l’utilisant comme source de carbone renouvelable. Elle apporte une réponse unique et innovante pour réduire la menace et saisir l’opportunité : nourrir des levures issues de sa technologie avec du CO2 et de l’hydrogène décarbonné pour opérer des synthèses chimiques sur mesure à une taille industrielle.

«Le succès de ce financement marque une étape importante ; c’est un grand honneur et une grande satisfaction d’avoir pu convaincre plusieurs fonds d’amorçage prestigieux de nous aider dans notre développement prospectif » commente Leopold Demiddeleer, Président d’EnobraQ. «Alors que la société est à un stade de développement encore très amont, et donc très risqué, nos investisseurs ont été convaincus par l’exceptionnel potentiel de la société » ajoute-t-il.

Contact : Michael KREL
+33 (0)6 31 92 53 56

À propos d’EnobraQ
EnobraQ est une société de biotechnologie qui développe des procédés fermentaires utilisant le dioxyde de carbone comme matière première pour apporter des alternatives biosourcées aux molécules d’origine fossile et particulièrement pétrolière. La société a été fondée en 2015 à la suite d’un projet précompétitif au sein du démonstrateur Toulouse White Biotech.

À 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.
Pour plus d’informations : www.sofinnova.fr
Contact : Anne Rein, anne.rein@strategiesimage.com

À propos d’AURIGA IV Bioseeds :
AURIGA IV Bioseeds est un fonds d’amorçage, doté de plus de 40M€, soutenu par la Banque Publique d’Investissement et le Fonds Européen d’Investissement. Le fonds soutient des sociétés technologiques développées à partir des connaissances et du savoir-faire en Infectiologie et en Microbiologie. AURIGA IV Bioseeds est géré par AURIGA Partners, société de gestion indépendante de capital innovation technologique, basée 18 avenue Matignon 75008 Paris et
enregistrée au code du commerce sous le numéro RCS 419 156 351. AURIGA Partners investit en fonds propres dans des projets technologiques innovants à fort potentiel.
Contact : Franck Lescure, Partner AURIGA Partners – lescure@aurigapartners.com

À propose de IRDInov :
IRDInov, géré par IRDI Gestion, est un fonds d’amorçage dédié au financement de sociétés innovantes en phase d’amorçage ou de démarrage. La stratégie d’investissement de ce fonds est centrée sur les projets de spin off d’entreprises issues des organismes de recherche publique ou privée dans tous les secteurs d’activité innovants (agro-industrie, aérospatial, santé, informatique, télécoms, chimie, énergie, environnement…), sur un espace géographique composé de l’Aquitaine, de Midi-Pyrénées et du Limousin.
http://www.irdi.fr | Contact : Jean-Michel Petit, Directeur Général d’IRDInov – jean-michel.petit@irdi.fr

À propos de CEA Investissement
Créée en 1999, CEA Investissement se consacre au financement d’entreprises de haute technologie. Ses investissements s’appuient sur deux fonds : le Fonds « Amorçage Technologique Investissement” (ATI) (dont les souscripteurs sont BPI France au travers du Fonds National d’Amorçage, EDF, SAFRAN et BIOMERIEUX et le CEA) et le Fonds Stratégique CEA intervenant à tout type de stade de développement au capital de sociétés partenaires du CEA. Depuis sa création, CEA Investissement a financé le démarrage de plus de 50 start-up.
L’investissement dans ENOBRAQ a été réalisé avec le fonds ATI.
www.cea-investissement.com/ Contact : Celia Hart, Directeur d’Investissement Sciences du Vivant, celia.hart@cea.fr


Financing Will Support Commercialization of the First Biology-Guided Radiotherapy System for Targeted, Personalized Cancer Treatment

HAYWARD, Calif., April 14, 2016 – RefleXion Medical, a medical equipment company developing the first biology-guided radiotherapy system for targeted, personalized cancer treatment, announced today that it has closed a $46 million Series B round of funding. The financing was led by new investor KCK Group, a family investment fund. Also participating in the round were existing investors Pfizer Venture Investments, Venrock and Sofinnova Partners, RefleXion’s largest shareholder.

In conjunction with the financing, Nael Kassar and Greg Garfield from KCK Group will join the RefleXion Board of Directors. Current Board members include Antoine Papiernik, Bill Burkoth, Colin Cahill, Dr. Fred Moll, Jay Watkins, Dr. Samuel Mazin and Akshay Nanduri.

“KCK is extremely excited to partner with RefleXion, and is committed to seeing their technology transform care for patients suffering from cancer,” said Greg Garfield, Head -Medical Technologies Division at KCK Group.

Radiotherapy is a non-invasive cancer treatment procedure, often used in conjunction with medical and surgical oncology therapies. In the United States, approximately 1 million patients receive some form of radiotherapy every year. RefleXion’s biology-guided radiotherapy system (BgRT) could redefine the category by utilizing both anatomic (Computed Tomography) and functional (Positron Emission Tomography) imaging data to guide personalized radiotherapy. Delivering targeted treatment based on the patient’s individual biology, PET-CT guided radiotherapy has the potential to deliver a higher dose of therapeutic radiation to cancerous lesions while sparing surrounding healthy tissue.

“In just two years, the RefleXion team has mitigated the core technical risks in developing a disruptive biology-guided radiotherapy system,” said Dr. Samuel Mazin, Co-Founder/President of RefleXion and inventor of the company’s core technology. “PET has been an effective tool to help diagnose and stage cancer using a radiotracer to map the higher metabolic activity of cancerous lesions. With this metabolic map, we could track multiple tumors in real time and precisely deliver targeted therapy based on that patient’s individual biology.”

In addition to the potential of improving treatment efficacy for primary lesions and tracking of multiple tumors, the RefleXion biology-guided radiotherapy system may also enable several compelling applications of precision medicine. This may include the use of novel PET tracers to adapt treatment based on relevant biological tumor characteristics such as tumor hypoxia, cellular proliferation, DNA synthesis and genetic markers.

Proceeds from the Series B financing will be allocated towards expanding RefleXion’s Engineering, Regulatory and Commercial organizations. “On behalf of the company and existing investors, I would like to welcome KCK Group as we work together to advance cancer care in a significant way. This major financing, along with the collective support, vision and guidance of Sofinnova Partners, Pfizer and Venrock, will allow the Company to achieve the development and regulatory milestones preceding a commercial launch of this paradigm-changing technology,” said Jay Watkins, Chairman of RefleXion.

About KCK Group
KCK is a family investment fund that invests in a diverse set of industries, including medical technologies.

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 the practice of radiation oncology. RefleXion is backed by premier investment firms Sofinnova Partners, KCK Group, Pfizer Venture Investments and Venrock. The company has also received grant funding from the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Program. For more information, visit www.reflexionmedical.com and follow @reflexionmed on Twitter.

RefleXion Medical Contact