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22/09/2016

– Company establishes top-tier investor base consisting of MPM Capital, Sofinnova Partners, Wellington Partners and Merck Ventures


Martinsried / Munich, Germany, September 22, 2016
— iOmx Therapeutics AG (iOmx), a biopharmaceutical company developing cancer therapeutics based on novel immune checkpoint targets, today announced the closing of a Series A financing round totaling EUR 40 million. MPM Capital and Sofinnova Partners co-led the round, and were joined by Wellington Partners and Merck Ventures.

iOmx focuses on the development of first-in-class cancer therapeutics addressing next-generation immune checkpoints. By systematically screening human tumor cells, the company has already identified a number of new targets and analyzed their mode of action. The proceeds of the financing round will be used to advance several proprietary product candidates up to initial clinical proof-of-concept.

iOmx was founded based on work from the laboratory of oncology expert and co-founder Philipp Beckhove, previously at the German Cancer Research Center, Heidelberg, and now at the RCI Regensburg Center for Interventional Immunology. The company’s innovative screening platform was developed by co-founder Nisit Khandelwal, SVP of Research. Additional co-founders include highly experienced biotech executives and internationally renowned cancer specialists Patrick Baeuerle, Elmar Maier (CBO), and Sebastian Meier-Ewert (CEO).

« The development of checkpoint inhibitors represents a major advance in the treatment of certain cancers. However, despite some truly transformative successes, to date only a minority of patients benefit from existing treatment options. We aim to bring the advances in immuno-oncology to a greater proportion of cancer patients, » said Sebastian Meier-Ewert, CEO of iOmx. « Therefore, we are proud to have attracted such an outstanding international investor base. The round was significantly oversubscribed, highlighting the expectation that immune checkpoint-based cancer therapeutics have great potential for changing the oncology landscape – and iOmx is excellently positioned to play a leading role in this field. »

« We are thrilled to back iOmx, together with such a high profile investor syndicate. The company combines all the key features we are looking for when investing: an exceptional management team, world class science, and a market breaking technology platform that has the potential to build a strong pipeline of proprietary and more efficacious cancer therapeutics, » said Henrijette Richter, Chairwoman of iOmx´ Board of Directors and Partner at Sofinnova Partners.


About iOmx Therapeutics
iOmx (www.iomx.de) focuses on the development of first-in-class cancer therapeutics addressing novel immune checkpoints on cancer cells. The company’s proprietary platform systematically screens tumor cells for specific immune checkpoint modulators, which allow targeting the tumor´s immune resistance mechanisms. iOmx is building a pipeline of promising cancer immunotherapeutics based on novel, proprietary targets with a known mode of action. Founded in March 2016 based on the work of its scientific founders Philipp Beckhove and Nisit Khandelwal conducted at the German Cancer Research Center, the company has raised EUR 40 million in early July 2016 from MPM Capital (both its BV2014 and UBS Oncology Impact Funds), Sofinnova Partners, Wellington Partners and Merck Ventures and is based in Martinsried / Munich, Germany.

About MPM Capital
MPM Capital (http://www.mpmcapital.com) is an early-stage life sciences venture investing firm that works to identify and build companies that seek to cure major diseases by translating scientific innovations into positive clinical outcomes. MPM’s portfolio of companies aims to revolutionize the face of medicine across multiple areas including cancer, diabetes, obesity, pain, eHealth and more. With its experienced and dedicated team of operating executives, and medical and scientific advisory board, MPM is powering novel medical breakthroughs that transform patient lives.

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.

About Merck Ventures
Merck Ventures is the strategic, corporate venture capital arm of Merck. Its mandate is to invest in innovative technologies and products with the potential to significantly impact Merck‘s core business areas. From our headquarters in Amsterdam and offices in the US and Israel we invest globally in transformational ideas driven by great entrepreneurs. Merck Ventures takes an active role in its portfolio companies and teams up with entrepreneurs and co-investors to translate innovation towards commercial success. Merck Ventures has a significant focus on early-stage investing and company creation including the creation of spin-offs to leverage Merck‘s science and technology base.

About Wellington Partners
Wellington Partners is among the most successful pan-European Venture Capital firms. With more than € 800 million under management and offices in Munich, London and Zurich, Wellington Partners invests in start-up companies throughout Europe that have the potential to become global leaders in the areas of life sciences, digital media and resource efficiency. Since 1998, Wellington Partners has invested in more than 100 companies, including publicly listed firms like 4SC, Actelion, Evolva, Genticel, Oxford Immunotec, Supersonic Imagine, Wavelight (acquired by Alcon) and Xing as well as privately held companies like AyoxxA, Definiens (acquired by Medimmune), Endostim, Grandis (acquired by Novartis), G-Therapeutics, Imevax, immatics, Immobilienscout24 (acquired by Deutsche Telekom), invendo medical, MPM Medical, MTM Laboratories (acquired by Roche), NEUWAY Pharma, Oxagen/Atopix, Quanta, Rigontec, Sapiens (acquired by Medtronic), Sensimed, Symetis, Spotify and Themis. For further information, please visit www.wellington-partners.com.

Contact & Media Inquiries

akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

21/09/2016

Minneapolis, September 21, 2016. BioAmber Inc. (NYSE:BIOA) is pleased to announce an important milestone in its application for a $360 million loan guarantee from the U.S. Department of Energy (U.S. DOE). This loan guarantee is in connection with the Company’s goal of securing non-dilutive funding for its proposed second manufacturing facility that would be located in the United States.

The U.S. DOE’s Loan Program Office (LPO) administers a four phase process under the Title XVII Innovative Clean Energy Projects loan guarantee program. This program finances innovative renewable energy and efficient energy projects. BioAmber successfully completed the first two phases of the process and was selected for the next phase in which it will engage the LPO in the negotiation of terms and conditions of the potential loan guarantee, and work with the LPO to validate the engineering, environmental, market and financial information that BioAmber submitted in the previous phases.

BioAmber’s proposed second facility will be over six times the size of its existing Sarnia plant, with annual capacity of 70,000 tons of bio-based 1,4-butanediol (BDO), 24,000 tons of bio-based tetrahydrofuran (THF) and 60,000 tons of bio-based succinic acid. Using ten year average feedstock and chemical pricing, and the same performance targets as the Sarnia plant, this facility is forecast to generate annual sales of over $350 million and $150 million of EBITDA at full capacity.

Jean-Francois Huc, BioAmber’s CEO stated: “Our first commercial plant in Sarnia is ramping up to full capacity and performance is on track. Securing funding for our second facility would be the cornerstone of our next phase of growth, where we will have expanded our product line to include bio-BDO and bio-THF and in so doing, become a world leader in renewable chemicals.”

For more information on the DOE Title XVII program’s application process, visit: http://energy.gov/lpo/title-xvii-application-process.

About The Department of Energy’s Loan Programs Office
The Department of Energy’s Loan Programs Office (LPO) supports a large, diverse portfolio of more than $30 billion in loans, loan guarantees, and commitments, supporting more than 30 closed and committed projects. This portfolio is helping to advance the nation’s all-of-the-above energy strategy through projects including the first nuclear power plant to begin construction in the U.S. in the last three decades, one of the world’s largest wind farms, several of the world’s largest solar generation and thermal energy storage systems, and more than a dozen new or retooled auto manufacturing plants across the country.

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 we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. F or 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 » section of BioAmber’s most recent Annual Report on Form 10-K and the recent quarterly reports on Form 10-Q.

BioAmber Investor Contact

Mike Hartmann
Executive VP
Tel (514) 844 8000 ext 120
mike.hartmann@bio-amber.com

14/09/2016

The Company Will Develop New Medicines to Selectively Potentiate and Expand Regulatory T Cells

CAMBRIDGE, MA. and SAN FRANCISCO, CA. September 14, 2016 – Delinia, a new company developing novel therapeutics that rebalance the immune system to treat serious and life-threatening autoimmune diseases, announced today that it has closed a $35 million Series A investment. The round was co-led by Sofinnova Partners and Atlas Venture. Delinia’s lead program is a targeted regulatory T cell (Treg) therapy, with the potential to selectively treat immune disorders without broadly suppressing a patient’s immune system. Delinia plans to use the capital raised through this financing to advance the lead program though clinical proof-of-concept.

“We are excited to advance what we believe is a new paradigm for the treatment of patients with severe autoimmune disease,” said Saurabh Saha MD PhD, President and CEO of Delinia and a Venture Partner with Atlas Venture. “Rarely does a company have the opportunity to develop a therapy with a unique combination of compelling biology, novel mechanism of action, and clinical validation of the target.” Prior to joining Delinia, Dr. Saha was Chief Medical Officer at Synlogic, and before that he was President, Chief Scientific Officer, and a member of the Board of Directors at BioMed Valley Discoveries. In addition to his broad experience in biotechnology, Dr. Saha was the global head of the New Indications Discovery Unit at Novartis, a position he took after his time at McKinsey & Company.

Delinia’s novel protein therapeutic platform is built on technology created by co-founder and Chief Scientific Officer, Jeffrey Greve PhD. This platform specifically targets, activates, and augments the levels of Tregs, a cell type that naturally exists in the body and whose role is to regulate the inflammatory response of other cells. Delinia’s approach aims to restore healthy immune regulation rather than broadly suppress the immune system. The currently available drugs used to treat autoimmune diseases cause broad immunosuppression that often leads to both short- and long-term toxicities.

Delinia has assembled a Scientific Advisory Board (SAB) comprised of experts in the fields of immunology, Treg biology, and autoimmune disease. The SAB is Chaired by Delinia co-founder Michael Rosenblum MD PhD, who serves as Assistant Professor of Dermatology at the UCSF School of Medicine. The SAB also includes Abul Abbas MD, Distinguished Professor of Pathology and Chair of Pathology at the UCSF School of Medicine; Christophe Benoist MD PhD, Grove-Rasmussen Professor of Microbiology and Immunology at Harvard Medical School; Jerome Ritz MD, Professor of Medicine at Harvard Medical School and the Dana-Farber Cancer Institute, and Executive Director of the Connell O’Reilly Cell Manipulation and Gene Transfer Laboratory; and David Wofsy MD, Professor of Medicine and Microbiology/Immunology at the UCSF School of Medicine.

Delinia’s board of Directors is Chaired by Jeffrey Tong PhD, Entrepreneur in Residence at Third Rock Ventures. In addition, Henrijette Richter PhD, Partner at Sofinnova Partners, and David Grayzel MD, Partner at Atlas Venture are founding board members. The board will be joined by President and CEO Saurabh Saha MD PhD.

About Delinia
Delinia was founded to discover and develop novel therapeutics for the treatment of autoimmune and inflammatory diseases. Delinia’s lead program is a molecule that selectively potentiates and expands regulatory T cells (Tregs), the powerful immune cells that are critical to maintaining self-tolerance and immune system homeostasis. Delinia’s scientific founders and experienced executive leaders are working to advance the company’s initial programs to the clinic. Delinia is headquartered in Cambridge, Massachusetts with research operations in San Francisco, California. To learn more, please visit www.deliniabio.com.
About Atlas Venture
Atlas Venture is a biotech-focused, early-stage venture capital firm that creates and invests in life sciences startup companies in the U.S. Atlas is based in Cambridge, Massachusetts. Since 1993, Atlas has invested in over 150 early stage life sciences companies. For more information, visit www.atlasventure.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 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
Paul Kidwell
paulkidwell@comcast.net
(617) 680-1088

30/08/2016

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 :
Cerenis
Jean-Louis Dasseux
CEO
info@cerenis.com
05 62 24 09 49

NewCap
Relations investisseurs
Emmanuel Huynh / Louis-Victor Delouvrier
cerenis@newcap.eu
01 44 71 98 53

30/08/2016

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.

27/06/2016

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:
RooneyPartners
Marion Janic
212.223.4017
mjanic@rooneyco.com

17/06/2016

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
Austria

Office@Hookipabiotech.com
Media enquiries
Sue Charles/ Daniel Gooch/ Alex Bannister
Instinctif Partners
+44 (0)20 7866 7905
hookipa@instinctif.com

01/06/2016

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 :
http://www.pixium-vision.com/fr/essai_clinique/participating-centers

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

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

25/05/2016

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.

16/05/2016

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:
https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3
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/