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10/07/2018

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:
SOFINNOVA PARTNERS
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.
http://www.recormedical.com/

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.
http://www.otsuka.com/en/

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.
http://www.omd.otsuka.com/en/

11/08/2014

ZUG, Switzerland, Aug. 11, 2014 — Auris Medical Holding AG announced today the closing of its previously announced initial public offering of 9,400,000 of its ordinary shares at an initial public offering price of USD 6.00 per ordinary share. In addition, Auris Medical granted the underwriters a 30-day option from August 6, 2014 to purchase up to an additional 1,410,000 ordinary shares at the public offering price, less underwriting discounts. Auris’ ordinary shares were approved for listing oh the NASDAQ Global Select Market and began trading under the symbol « EARS » on August 6, 2014.

Jefferies LLC and Leerink Partners LLC acted as joint book-running managers for the offering. JMP Securities LLC and Needham & Company, LLC acted as co-managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (« SEC ») on August 5, 2014. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by emailing Prospectus_Department@Jefferies.com, or by calling (877) 547-6340Call: (877) 547-6340 or Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110 or by email at syndicate@leerink.com, or by calling (800) 808-7525Call: (800) 808-7525.

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

About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the development of treatments for acute inner ear tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic injection with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland.

Contact:
Dr. Thomas Meyer, Chairman and CEO, +41 41 729 71 94Call: +41 41 729 71 94, ear@aurismedical.com

23/07/2014

Genève, Suisse, 23 juillet 2014 – ObsEva, une société biopharmaceutique suisse dédiée au développement de médicaments innovants en médecine de la reproduction, et portant son intérêt principal sur les traitements de la menace d’accouchement prématuré et de l’infertilité, a annoncé aujourd’hui l’obtention du statut JEDI attribué par le Canton de Genève et du statut européen de SME octroyé par l’Agence européenne des médicaments.
Le statut JEDI (“Jeune Entreprise Développant des Innovations“), a été créé en 2010 par le Grand Conseil de la République et du Canton de Genève. Ce statut démontre la reconnaissance de l’activité innovante de ObsEva au sein de la région genevoise et permet d’étendre son rayonnement à toute la Suisse. “Nous sommes fiers de pouvoir contribuer au développement économique du Canton de Genève qui offre et maintient un environnement très propice à l’essor des start-up dans le domaine des sciences de la vie. Le statut JEDI permettra de faciliter les échanges avec les autorités locales.” déclare Ernest Loumaye, Directeur Général et Co-Fondateur de ObsEva.
“Genève joue un rôle primordial dans le domaine de la santé. C’est une région de petite taille et attrayante où se concentrent des acteurs des sciences de la vie, des organisations internationales, des institutions de recherche et établissements universitaires, des entreprises start-up et de grandes multinationales. Nous nous réjouissons de pouvoir accueillir ObsEva comme nouvel acteur au sein de ce noyau dynamique.” ajoute Daniel Loeffler, Directeur du Service de la Promotion Economique de Genève.
ObsEva a également annoncé aujourd’hui que l’Agence européenne des médicaments (EMA) avait confirmé le statut européen de SME (Small and Medium Enterprise) de ObsEva. Le statut de SME visant à promouvoir l’innovation et le développement de nouveaux médicaments à usage humain et vétérinaire avait été adopté par la Commission Européenne le 15 décembre 2005, par le biais de dispositions spécifiques. Les mesures incitatives liées à ce statut comprennent notamment une aide administrative, une assistance pour les procédures mais aussi diverses réductions, exonérations ou reports de frais et cotisations.

A propos de ObsEva
ObsEva SA est une société biopharmaceutique Suisse dédiée au développement de nouvelles classes de médicaments en médecine de la reproduction. ObsEva a été fondée en novembre 2012 par Ernest Loumaye MD, PhD et André Chollet PhD. Ernest Loumaye est un spécialiste en médecine de la reproduction de la femme, disposant de 20 ans d’expérience dans l’industrie biopharmaceutique. Ernest Loumaye a été le co-fondateur et CEO de PregLem SA, société biopharmaceutique dont la réussite a conduit à son acquisition en 2010 par la société Gedeon Richter. André Chollet est un spécialiste en chimie médicale et pharmaceutique avec plus de 30 ans d’expérience dans l’industrie biopharmaceutique, dont Biogen, GSK et Merck Serono. André Chollet était responsable du programme pour le traitement de la menace d’accouchement prématuré chez Serono, avant le rachat de la société par Merck KGaA.
Le portefeuille de produits de ObsEva est constitué de produits innovants, à un stade de développement clinique précoce, destinés au traitement de la menace d’accouchement prématuré et de l’infertilité, ainsi que d’autres traitements en médecine de la reproduction.
Pour en savoir plus, consultez www.obseva.com.
Pour plus d’informations, veuillez contacter le bureau du Directeur Général de ObsEva :
Delphine Renaud
Tel: +41 22 552 1550
Email: delphine.renaud@obseva.ch

18/07/2014

MINNEAPOLIS, MN, July 16, 2014 — BioAmber Inc. (NYSE: BIOA), an industrial biotechnology company producing sustainable chemicals, today announced that it has priced an underwritten registered offering of 2,800,000 shares of its common stock at a price of $12.00 per share, and granted the underwriters in the offering a 30-day option to purchase up to an additional 420,000 shares of its common stock. The gross proceeds to the Company will be $33.6 million. The offering is expected to close on July 21, 2014, subject to customary closing conditions.

Credit Suisse Securities (USA) LLC and Canaccord Genuity Inc. are acting as the bookrunning managers for the offering.

Net proceeds, after underwriting discounts and commissions and other estimated fees and expenses payable by BioAmber will be approximately $31.1 million.

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

The securities described above are being offered by BioAmber pursuant to a shelf registration statement on Form S-3 (No. 333-196470) including a base prospectus. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement related to the offering was filed with the Securities and Exchange Commission (the « SEC ») on July 15, 2014 and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered, when available, may also be obtained by contacting: Credit Suisse Securities (USA) LLC by mail at One Madison Avenue, New York, New York 10010, Attention: Prospectus Department, or by calling toll free (800) 221-1037, or by emailing newyork.prospectus@credit-suisse.com; and Canaccord Genuity Inc. by mail at 99 High Street, 12th Floor, Boston, MA 02110, Attention: Syndicate Department, or by calling (617) 371-3900.

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

About BioAmber Inc.
BioAmber (NYSE: BIOA) is an industrial biotechnology company producing sustainable chemicals. Its proprietary technology platform combines industrial biotechnology and chemical catalysis to convert renewable feedstock into sustainable chemicals for use in a wide variety of everyday products including plastics, resins, food additives and personal care products.

BioAmber Inc. Safe Harbor Statement
This communication contains « forward-looking statements » within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about BioAmber Inc. (« BioAmber »), including but not limited to: statements about BioAmber’s expected funding sources of the planned Sarnia, Ontario plant and other planned manufacturing facilities and the expected timing of the completion of construction and the start of commercial operations at each of these facilities; the joint venture with Mitsui & Co. Ltd.; the take-or-pay agreement with Vinmar International Ltd. related to bio-based 1,4 butanediol and bio-based succinic acid; the take-or-pay agreement with PTT MCC Biochem Company Limited related to bio-succinic acid from the planned Sarnia, Ontario plant; the expected applications of BioAmber’s products and the sizes of addressable markets; the ability to gain market acceptance for bio-succinic acid, its derivatives and other building block chemicals; the benefits of BioAmber’s transition from E. coli bacteria to yeast; the ability to commence commercial sales and execute on the commercial expansion plan, including the timing and volume of future production and sales; the expected cost-competitiveness and relative performance attributes of the bio-succinic acid and the products derived from it; the ability to cost-effectively produce and commercialize bio-succinic acid, its derivatives and other building block chemicals; customer qualification, approval and acceptance of BioAmber’s products; the ability to maintain and advance strategic partnerships and collaborations and the expected benefits and accessible markets related to those partnerships and collaborations; the impact of the recent off-take agreements on BioAmber’s business with its customers, BioAmber’s distributors and its current and future equity partners; the ability to economically obtain feedstock and other inputs; the achievement of advances in BioAmber’s technology platform; the ability to obtain and maintain intellectual property protection for BioAmber’s products and processes and not infringe on others’ rights; government regulatory and industry certification approvals for facilities and products; government policymaking and incentives relating to bio-chemicals. For additional disclosure regarding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC including, the « Risk Factors » section of BioAmber’s most recent filings and in the prospectus supplement for this offering. You should consider these factors in evaluating the forward-looking statements included in this presentation and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and BioAmber undertakes no obligation to update such statements as a result of new information.

BioAmber Investor Contact

Michael Rice
LifeSci Advisors, LLC
1350 Avenue of the Americas 28th Floor
New York, NY 10019
646-597-6979
mrice@lifesciadvisors.com

11/07/2014

PRINCETON, N.J. and PARIS – July 9, 2014 – STENTYS (FR0010949404 — STNT), a medical technology company commercializing the world’s first and only Self-Apposing® stent to treat acute myocardial infarction (AMI), today announced its first distribution contracts in South America.
STENTYS has established distributor agreements in Argentina, Chile and Colombia. These contracts represent the first step in STENTYS’ strategy to expand its commercial presence into the Latin American coronary stent market, which is estimated to be worth over $200 million.

STENTYS intends to extend its coverage to other countries in this region, notably Brazil, Mexico and Venezuela, by the end of 2015.

Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS, commented: “After recent expansion into the Middle East in 2013 and Southeast Asia at the beginning of this year, entering into new distributor relationships in South America clearly indicates the successful execution of our worldwide growth strategy. The ramp up in these high-potential emerging markets will be further supported next year by the commercialization of the Sirolimus-eluting stent, which should obtain CE Marking during the second half of 2014.”

• Upcoming financial publication
STENTYS expects to publish its revenues for the first half of 2014 on July 24, 2014, after market.
About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent is expected to receive CE Mark in H2 2014.
About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS’s Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low one year mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents.
More information is available at www.stentys.com

This press release contains forward looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, including with respect to a pre-market approval for the Company’s BMS, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 “Risk Factors” of the Company’s 2011 Registration Document (document de référence) filed with the Autorité des marchés financiers in France on August 27, 2013 under number R.13-040 as such section may be updated from time to time.

STENTYS
Stanislas Piot
CFO
Tel.: +33 (0)1 44 53 99 42
stan.p@stentys.com
Europe: NewCap.
Financial communication / IR Europe
Dusan Oresansky / Pierre Laurent
Tel.: +33 (0)1 44 71 94 93
stentys@newcap.fr
US: MacDougall Biomedical Communications
Charles Liles, Tel.: 781 235 3060
Christine Labaree or Hunter Marshall, Tel.: +1 650 339 7533
stentys@macbiocom.com

STENTYS is listed on Compartment B of Euronext Paris
ISIN: FR0010949404 – Ticker: STNT

02/07/2014

• Une étape importante dans la constitution du dossier de marquage CE d’IRIS®, premier des systèmes de restauration de la vision développés par la société

Paris, 2 juillet 2014 7h30 – Pixium Vision (FR0011950641 – PIX), société qui développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome, annonce avoir reçu la certification ISO 13485:2012. Les champs d’application de cette certification couvrent la conception, le développement, la fabrication et la distribution des SRV IRIS® et PRIMA.

Bernard Gilly, Président Directeur Général et co-fondateur de Pixium Vision, déclare : « Nous sommes heureux qu’un organisme de référence atteste de la fiabilité de notre système de management de la qualité. Avec l’obtention de la certification ISO 13485, Pixium Vision a franchi une étape importante du parcours menant à la demande de marquage CE pour IRIS®. Nous poursuivons le développement de nos SRV et nos activités de pré-commercialisation, conformément à notre feuille de route.»

Dans le cadre de sa politique d’excellence, Pixium Vision a mis en place un système de management de la qualité afin de s’assurer que l’ensemble des produits soient inspectés et testés par un personnel qualifié à chaque étape du processus de fabrication. L’organisme notifié international DEKRA a ainsi constaté et validé le respect du système qualité et des exigences réglementaires, la maîtrise des procédés spéciaux et l’analyse du risque sur l’ensemble de la chaine de valeur des produits.

Contacts

Pixium Vision
Pierre Kemula, CFO
contact@pixium-vision.com
+33 1 76 21 47 30

Relations Investisseurs / Relations Presse
Citigate Dewe Rogerson
Lucie Larguier – Laurence Bault (Paris)
Mark Swallow – David Dible (Londres)
pixium-vision@citigatedr.co.uk / pixium-vision@citigate.fr
+33 1 53 32 84 78 / +44 20 7282 2948

Relations Presse Hors investisseurs
NewcapMedia
Annie-Florence Loyer – Nadège Le Lezec
afloyer@newcap.fr /nlelezec@newcap.fr


A propos de la norme ISO 13485

ISO 13485 est une norme établie pour mesurer la qualité des instruments et équipements médicaux ainsi que celle des technologies médicales. Cette norme définit les exigences relatives aux systèmes de management de la qualité et des systèmes d’assurance qualité liées à la conception, le développement, la production, l’installation et l’entretien de dispositifs médicaux. Cette norme peut être utilisée en interne ou par des tiers, notamment les organismes de certification, pour tester la capacité d’une organisation à répondre aux exigences réglementaires ainsi qu’à celles de ses clients.
A propos de Pixium Vision (www.pixium-vision.com)

Pixium Vision développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les SRV de Pixium Vision sont des systèmes composés de plusieurs éléments de haute technologie associés à une intervention chirurgicale et à une période de rééducation. Ils visent à offrir à terme aux patients une vision aussi proche que possible de la normale.

Le SRV IRIS® est actuellement en phase d’essais cliniques dans plusieurs centres en Europe. Les patients supportent bien leur implant à ce jour et des améliorations de la perception visuelle des patients aveugles sont observées. Les résultats de ces études seront utilisés pour déposer une demande de marquage CE. Sous réserve d’obtention du marquage CE, la commercialisation d’IRIS devrait débuter en 2015.

Pixium Vision développe également PRIMA, un implant sous-rétinien, qui est actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.

01/07/2014

Dublin – Ireland, 30th June 2014 – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it has received authorization from the Belgian Federal Agency for Medicines and Health Products to expand the clinical trial of ReActiv8 (ReActiv8-A), its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain, to include clinical trial sites in Belgium. Enrolment of subjects is commencing in these additional sites. The added sites also participated in the European Feasibility Study, results of which were presented in mid-2013.
Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8. We are pleased to now add Belgium to our clinical trial which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”
The ReActiv8-A clinical trial started in Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain who have few other treatment options.

About Mainstay
Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.
The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that 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 spine stability, allowing the body to recover from CLBP.
People with debilitating 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 spinal 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 economies.
Further information can be found at www.mainstay-medical.com

Press Release
Media queries to:

Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com
Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com
Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:
Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / 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” or “will”, or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory 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 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 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, 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, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

24/06/2014

10-12 December 2014
Four Seasons, Prague, Czech Republic

Veleslavínova 1098/2a
110 00 Praha 1-Staré Mesto
Czech Republic

bohemian_summit2014

This invitation-only conference for senior executives from medical device companies in Europe, provides a private and exclusive setting for networking and partnering. The agenda will include high-level panel discussions with keynotes from industry and academic leaders, as well as social networking events.

Who Attends?
Attendance to the Bohemian Medical Device Summit is by invitation only. Invitations are limited to CEOs and senior executives from medical technology companies and senior executives with responsibility for R&D, Licensing, M&A and Business Development from major medical device manufacturers. The conference is NOT open to service providers, such as CROs, data support, consultancy companies, banks, law firms, VCs, or funding companies.

http://www.bohemiansummit.com/

18/06/2014

La société lève 34,5 millions d’euros (46,7 millions d’US dollars) sur Euronext Paris, avec l’exercice intégral de la clause d’extension

Ce document ne constitue pas une offre de vente des actions de PIXIUM VISION aux Etats-Unis ni dans aucun autre pays. Les actions de PIXIUM VISION ne pourront être vendues aux Etats-Unis en l’absence d’enregistrement ou de dispense d’enregistrement au titre du U.S. Securities Act de 1933, tel que modifié. PIXIUM VISION n’envisage pas d’enregistrer l’offre mentionnée dans le présent document ou une partie de cette offre aux Etats-Unis ni d’effectuer une quelconque offre publique d’actions aux Etats-Unis.
Ne pas distribuer directement ou indirectement aux Etats-Unis, au Canada, en Australie ou au Japon

Paris, 17 juin 2014 – Pixium Vision, société qui développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome, annonce le succès de son introduction en bourse sur le marché réglementé d’Euronext à Paris (Euronext Paris), avec une levée de 34,5 millions d’euros. Le Conseil d’Administration du 17 juin 2014 a décidé l’exercice intégral de la clause d’extension. Pixium Vision va ainsi émettre 4 166 666 actions nouvelles au prix de 8,28 euros par action. Sur la base du prix de l’offre, la capitalisation boursière de la société ressort à 100,4 millions d’euros.

Bernard Gilly, Président Directeur Général et fondateur de Pixium Vision, déclare : « Le succès de notre introduction en bourse témoigne de la confiance des investisseurs dans la stratégie de Pixium Vision. Nous sommes convaincus que Pixium Vision, fort des technologies complémentaires d’IRIS® et de PRIMA, est dans une position unique pour devenir un leader mondial des systèmes de restauration de la vision et ainsi permettre aux personnes ayant perdu la vue de vivre en plus grande autonomie.»

Les fonds levés dans le cadre de cette introduction en bourse vont permettre à Pixium Vision de poursuivre sa stratégie et notamment de financer le développement clinique et le lancement commercial d’IRIS® en Europe et aux Etats-Unis, ainsi que le développement clinique et l’obtention des autorisations règlementaires de mise sur le marché en Europe du système PRIMA.

L’offre a bénéficié d’une demande importante d’investisseurs de qualité, français et internationaux, et de la participation notable des investisseurs personnes physiques en France. Parmi ces investisseurs de qualité, Bpifrance Participations est entré au capital de Pixium Vision à hauteur de 8,07% (en supposant l’option de surallocation totalement exercée) représentant un investissement de 8,5 millions d’euros. Par ailleurs, les actionnaires historiques de la société – les fonds Sofinnova, Abingworth, Omnes Capital, Innobio et Seventure – ont confirmé leur volonté de participer fortement au développement de Pixium Vision en portant leurs souscriptions à 8,5 millions d’euros. Bpifrance Participations devient, aux côtés des actionnaires historiques, qui ont ainsi renouvelé leur confiance, un actionnaire de référence de la société.

A cette occasion, Bpifrance Participations, les fonds historiques, le Président Directeur Général et le Directeur Général Délégué ont signé un pacte d’actionnaires afin notamment d’octroyer un poste d’administrateur à Bpifrance Participations et de prendre des engagements de conservations réciproques de leurs titres dans la société, en vue de conférer une stabilité propice au développement des activités de Pixium Vision.

Les actions de Pixium Vision seront cotées sur Euronext Paris sous le code ISIN FR0011950641 et le mnémonique PIX. Les premiers échanges auront lieu le 18 juin 2014 (sous forme de promesses) et la date de règlement-livraison est prévue le 20 juin 2014.

Caractéristiques générales de l’offre (hors option de surallocation)
• Prix final de l’offre : 8,28 euros par action
• 4 166 666 actions nouvelles émises incluant l’exercice complet de la clause d’extension
• Capitalisation boursière de 100,4 millions d’euros, sur la base d’un nombre total de 12 131 220 actions, d’une valeur de 8,28 euros par action
• L’Offre a pris la forme d’une offre à prix ouvert auprès du public en France et d’un placement global principalement auprès d’investisseurs institutionnels en France et hors de France, à l’exception notamment des Etats-Unis
• Placement global : 3 658 347 actions allouées aux investisseurs institutionnels, soit 87,80% du nombre total d’actions émises, dont 1 030 001 actions souscrites par les actionnaires actuels (Sofinnova, Abingworth, Omnes Capital, Innobio, et Seventure) et 1 030 000 actions souscrites par Bpifrance Participations
• Offre au public : 508 319 actions ont été allouées aux investisseurs individuels, soit 12,20% de l’offre
• Option de surallocation : jusqu’à 624 999 actions nouvelles pourront être émises, en cas d’exercice, en une seule fois à tout moment, en tout ou partie, de l’option de surallocation au plus tard le 17 juillet 2014 (inclus). Le produit brut global de l’opération pourrait atteindre 39,7 millions d’euros avec l’exercice intégral de l’option de surallocation
Société Générale, agissant en qualité d’agent stabilisateur, ou tout établissement agissant pour son compte, pourra, sans y être tenu, et avec faculté d’y mettre fin à tout moment, pendant une période de 30 jours à compter de la date de fixation du prix de l’Offre, soit, selon le calendrier indicatif, du 18 juin au 17 juillet 2014 intervenir aux fins de stabilisation du marché des actions Pixium Vision, dans le respect de la législation et de la réglementation applicables et notamment du Règlement (CE) n°2273/2003 de la Commission du 22 décembre 2003. Les interventions réalisées au titre de ces activités visent à soutenir le prix de marché des actions Pixium Vision et sont susceptibles d’affecter leur cours.

Calendrier indicatif (résumé)
18 juin 2014 Premiers échanges sur Euronext Paris sous la forme de promesses d’actions (jusqu’au 20 juin 2014 inclus)
20 juin 2014 Règlement et livraison des actions (OPO et Placement Global)
23 juin 2014 Début des négociations des actions de la Société sur Euronext Paris
17 juillet 2014 Date limite d’exercice de l’option de surallocation
Fin de la période de stabilisation éventuelle

Codes de l’action Pixium Vision
• Nom de la société : Pixium Vision
• Libellé : « Pixium Vision » (et sous le libellé « Pixium promesses » pour les promesses d’actions qui seront négociées du 18 juin 2014 au 20 juin 2014 (inclus)
• ISIN : FR0011950641
• Mnémonique : PIX
• Compartiment : C
• Secteur : 4535 – Medical Equipment (classification ICB)

Investissement de Bpifrance Participations / Répartition du capital post Offre
• Innobio (actionnaire historique de la société dont la société de gestion est Bpifrance Investissement) et Bpifrance Participations sont considérés agir de concert conformément à l’article L. 233-10 du Code de commerce.
• Postérieurement à l’Offre et en supposant l’option de surallocation totalement exercée, la répartition du capital social sera la suivante :
Actionnaires Nombre d’actions % du capital et des droits de vote
Fondateurs (hors Bernard Gilly) 512 997 4,02%
Bernard Gilly (mandataire social/PDG) 130 881 1,03%
Fonds Sofinnova 2 967 529 23,26%
Abingworth 2 086 720 16,36%
Fonds Omnes 1 466 794 11,50%
Fonds Seventure 155 872 1,22%
Autres investisseurs financiers 74 419 0,58%
Sous total investisseurs financiers (hors concert) 6 751 334 52,92%
Fonds Innobio 1 599 334 12,54%
Bpi France Participations 1 030 000 8,07%
Sous total concert 2 629 334 20,61%
Actions issues des rompus post regroupement 9 0,00%
Flottant 2 731 664 21,41%
Total 12 756 219[1] 100,00%

Mise à disposition du prospectus
Des exemplaires du prospectus visé par l’Autorité des marchés financiers (l’« AMF ») le 2 juin 2014 sous le numéro 14-257, composé d’un document de base enregistré le 12 mai 2014 sous le numéro l.14-030 et de la note d’opération (incluant le résumé du prospectus), sont disponibles sans frais et sur simple demande au siège social de Pixium Vision – 13 rue Moreau – 75012 PARIS. Le prospectus peut être consulté sur les sites de l’Autorité des marchés – AMF (www.amf-france.org) et de Pixium Vision (www.pixium-vision.com).

Facteurs de risques
L’attention du public est attirée sur le chapitre 4 « Facteurs de risques » du document de base et sur le chapitre 2 « Facteurs de risques liés à l’Offre » de la note d’opération, et en particulier sur le fait qu’à ce jour, les produits sont en cours de développement, que la Société ne réalise pas de chiffre d’affaires et n’est pas en mesure de verser de dividende.

Contacts

Pixium Vision
Khalid Ishaque, CEO
Bernard Gilly, Executive Chairman
Pierre Kemula, CFO
+33 1 76 21 47 30

Investor Relations / Press Relations
Citigate Dewe Rogerson
Mark Swallow – David Dible (London)
Lucie Larguier – Laurence Bault (Paris)
pixium-vision@citigatedr.co.uk / pixium-vision@citigate.fr
+44 20 7282 2948 / +33 1 53 32 84 78

Relations Presse Hors investisseurs
NewcapMedia
Annie-Florence Loyer – Nadège Le Lezec
afloyer@newcap.fr /nlelezec@newcap.fr

A propos de Pixium Vision
Pixium Vision développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les SRV de Pixium Vision s’appuient sur les dernières évolutions de la microélectronique, de l’optronique et des logiciels et permettent d’envisager une solution thérapeutique visant à offrir à terme aux patients une vision aussi proche que possible de la normale.

Pixium Vision développe deux systèmes de restauration de la vision :
• IRIS® : actuellement en phase d’essais cliniques dans plusieurs centres en Europe. Les résultats de ces études seront utilisés pour déposer une demande de marquage CE. La commercialisation d’IRIS devrait débuter en 2015, sous réserve d’obtention du marquage CE. Pixium Vision continuera à améliorer les performances d’IRIS® pour les patients, notamment par le développement de nouveaux algorithmes et logiciels.
• PRIMA : actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.
Créée en 2011 à Paris, Pixium Vision résulte des efforts de recherche combinés de l’Institut de la Vision et de l’Université Pierre et Marie Curie à Paris (UPMC) ainsi que du travail collaboratif de plusieurs équipes européennes et américaines de recherche de haut niveau. Pixium Vision est soutenu par un groupe d’investisseurs européens, incluant Sofinnova Partners, Omnes Capital, Bpifrance (par l’intermédiaire d’Innobio), Abingworth, et Seventure.
Pixium Vision est coté sur Euronext à Paris (ISIN: FR0011950641 ; Mnemo: PIX).

Pour en savoir plus, consultez www.pixium-vision.com

IRIS® est une marque déposée de Pixium-Visium SA

Avertissement :
Le présent communiqué et les informations qu’il contient ne constituent pas, ni ne sauraient être interprétés comme une offre au public ou une invitation de vente ou de souscription, ou la sollicitation de tout ordre ou invitation d’achat ou de souscription d’actions PIXIUM VISION dans un quelconque pays. La diffusion de ce communiqué dans certains pays peut constituer une violation des dispositions légales en vigueur. Les personnes en possession du communiqué doivent donc s’informer des éventuelles restrictions locales et s’y conformer.

En particulier, le présent communiqué ne constitue pas une offre de vente de valeurs mobilières ou une quelconque sollicitation d’offre d’achat ou de souscription de valeurs mobilières aux Etats-Unis. Les actions, ou toute autre valeur mobilière, de PIXIUM VISION ne peuvent être offertes ou vendues aux Etats-Unis qu’à la suite d’un enregistrement en vertu du U.S. Securities Act de 1933, tel que modifié (« U.S. Securities Act de 1933 »), ou dans le cadre d’une exemption à cette obligation d’enregistrement. Les actions de PIXIUM VISION n’ont pas été et ne seront pas enregistrées au titre du U.S. Securities Act de 1933, et PIXIUM VISION n’a pas l’intention de procéder à une quelconque offre au public de ses actions ou valeurs mobilières aux Etats-Unis.

Le présent communiqué constitue une communication à caractère promotionnel et non pas un prospectus au sens de la Directive 2003/71/CE du Parlement européen et du Conseil du 4 novembre 2003 telle que modifiée, notamment par la Directive 2010/73/UE du Parlement européen et du Conseil du 24 novembre 2010, et telle que transposée dans chacun des Etats membres de l’Espace économique européen (la « Directive Prospectus »).

S’agissant des Etats membres de l’Espace Economique Européen, ayant transposé la Directive Prospectus, aucune action n’a été entreprise et ne sera entreprise à l’effet de permettre une offre au public des valeurs mobilières objet de ce communiqué nécessitant la publication par PIXIUM VISION d’un prospectus dans l’un ou l’autre des Etats membres autre que la France. En conséquence, les actions PIXIUM VISION ne peuvent être offertes et ne seront offertes dans aucun des Etats membres autre que la France, sauf conformément aux dérogations prévues par l’article 3(2) de la Directive Prospectus, si elles ont été transposées dans cet Etat membre ou dans les autres cas ne nécessitant pas la publication par PIXIUM VISION d’un prospectus au titre de l’article 3 de la Directive Prospectus et/ou des règlementations applicables dans cet Etat membre.

S’agissant du Royaume-Uni, ce communiqué s’adresse uniquement aux personnes qui : (i) sont des professionnels en matière d’investissements au sens de l’article 19(5) du Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (tel qu’actuellement en vigueur, ci-après le « Financial Promotion Order »), (ii) sont visées à l’article 49(2) (a) à (d) (« high net worth companies, unincorporated associations etc. ») du Financial Promotion Order, (iii) sont en dehors du Royaume-Uni, ou (iv) sont des personnes à qui une invitation ou une incitation à s’engager dans des activités d’investissement (au sens de la section 21 du Financial Services and Markets Act 2000) dans le cadre de l’émission ou de la cession de toutes valeurs mobilières peut être légalement communiquée, directement ou indirectement (toutes ces personnes étant dénommées ensemble, les « Personnes Habilitées »). Le présent communiqué est destiné uniquement aux Personnes Habilitées et ne peut être utilisé par aucune personne autre qu’une Personne Habilitée. Tout investissement ou activité d’investissement auquel se rapporte le présent communiqué est accessible uniquement aux Personnes Habilitées et ne peut être réalisé que par les Personnes Habilitées.

Le prospectus et le présent communiqué contiennent des déclarations prospectives. Aucune garantie ne peut être donnée quant à la réalisation de ces déclarations prospectives qui sont soumises à des risques tels que, notamment, ceux décrits dans le document de base de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro I. 14-030 le 12 mai 2014, et à l’évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels PIXIUM VISION est présente.

05/06/2014

June 5, 2014, Amsterdam, today AVANTIUM announced that it has closed a financing round of €36 million ($50 million) from a consortium of iconic strategic players. This unique consortium consists of Swire Pacific, The Coca-Cola Company, DANONE, ALPLA, and existing shareholders. With this capital raise the new investors affirm their commitment to advancing PEF, Avantium’s next generation packaging material. Proceeds will be used to complete the industrial validation of PEF and finalize the engineering & design of the first commercial scale plant. As part of its strategy to use responsibly sourced plant based materials for PEF production, Avantium will validate the use of 2nd generation feedstock.
Follow on investments were made by existing shareholders Sofinnova Partners, Capricorn Venture Partners, ING Corporate Investments, Aescap Venture, Navitas Capital, Aster Capital and De Hoge Dennen Capital.
Tom van Aken, CEO Avantium stated: “Closing this financing round with Swire, The Coca-Cola Company, Danone, ALPLA and our existing investors underpins their commitment to making PEF bottles a commercial success. PEF is a 100% biobased plastic with superior performance compared to today’s packaging materials and represents a tremendous market opportunity. Our proprietary YXY technology to make PEF has been proven at pilot plant scale as we are now moving to commercial deployment. “
Philippe Lacamp, Swire Pacific’s Head of Sustainable Development said, “We are excited to invest in Avantium, which has an impressive track record in developing breakthrough technology. This investment aligns with our sustainable development strategy to build and develop a portfolio of promising early stage sustainable technologies to reach commercial scale. The technology that Avantium supplies represents a pathway to the next generation of bio-based packaging materials, and has huge potential application for our existing bottling businesses.”
Yu Shi, Director Next Generation Materials and Sustainability Research at The Coca-Cola Company comments, “By advancing smart technology, we believe performance and sustainability can go hand-in-hand to make a world of difference for consumers, the environment and our business. Avantium’s breakthrough technology continues to offer a promising pathway for supporting both our efforts to commercialize renewable, plant-based plastics and develop unique properties for packaging to drive new growth. We are pleased to further expand our existing partnership with Avantium through this latest investment.”

PRESS RELEASE
Frederic Jouin, Director of Danone Research Packaging Center comments: « We participate in this venture as we believe in the future of bio-based plastics for our packaging, with a potential significant reduction in carbon footprint and enhanced barrier properties compared to PET. With this investment, we re-affirm our will to launch a 100% bio-based bottle not in direct competition with food and 100% recyclable and our wish to accelerate this launch on the market. »
Jan van der Eijk, Chairman of the Avantium Supervisory Board, adds; “It is a remarkable milestone in the biobased chemicals industry that large brand owners, such as The Coca-Cola Company and DANONE jointly invest for the first time in a company like Avantium. Together with the investment of Swire and ALPLA, it is clear to us that the market is willing to back winning technologies, such as PEF”.

About Avantium – www.avantium.com/financing
Avantium is a leading technology company specialized in the area of advanced high-throughput R&D. The company develops and commercializes YXY – the brand name for its cost competitive technology platform to catalytically convert plant based materials into biobased chemicals and bioplastics like PEF. PEF is a novel 100% biobased polyester with enhanced barrier, thermal and mechanical properties over existing packaging materials. These properties enable new packaging innovations to make lighter, thinner, smaller and stronger bottles, to extend product shelf life and to provide supply chain benefits. Combined with the 50-70% reduction in carbon footprint, PEF fulfils key criteria to become the next generation biobased plastic for bottles, film and fibers.
Today Avantium is supplying its technology development partners with PEF manufactured from material produced at its pilot plant in Geleen, The Netherlands. Avantium is planning its first commercial scale plant (50,000ton), which is projected to be operational in 2017 to enable the full commercial launch of the first PEF bottles to consumers.
Note for the editorial team, not for publication
http://www.avantium.com/
For more information about Avantium, please contact Dominique Levant: Tel: +31 (0)20 586 0132,
Email: info@avantium.com

About Swire Pacific Limited
http://www.swirepacific.com/en/global/home.php
For more information about Swire, please contact Cindy Cheung: Tel: +852 2840 8091,
Email: cindycheung@jsshk.com

About The Coca-Cola Company
http://www.coca-colacompany.com/our-company/
PRESS RELEASE
For more information about The Coca-Cola Company, please contact Kerry Tressler: Tel: +1 404 676 3676, Email: ketressler@coca-cola.com

About Danone
http://www.danone.com/en/
For more information about Danone, please contact Stéphanie Spira: Tel: +33 6 99 19 13 57,
Email: Stephanie.SPIRA@danone.com

About ALPLA
http://www.alpla.com/en
For more information about ALPLA, please contact Sabrina Ortner: Tel: +43 (5574) 602 – 241,
Email: Sabrina.ortner@alpla.com

04/06/2014

• CER-001 proven to enhance Reverse Lipid Transport, facilitating elimination of cholesterol from the body
• Statistically significant reduction in carotid artery Mean Vessel Wall Area in two distinct clinical populations, as measured by Magnetic Resonance Imaging
• CER-001 complementary to LDL-c-lowering treatment and may represent a new chronic therapy on top of standard of care for patients with Familial Hypercholesterolemia and Familial Primary Hypoalphalipoproteinemia
• CER-001 well tolerated

TOULOUSE, France and ANN ARBOR, Michigan, 30 May 2014 – Cerenis Therapeutics, the biopharmaceutical company, today announced that two of its Phase II studies, SAMBA and MODE (Modifying Orphan Disease Evaluation), with CER-001, an engineered human apoA-Icontaining pre-ß HDL mimetic, met their primary clinical endpoints in patients with Familial Primary Hypoalphalipoproteinemia (FPHA) and Homozygous Familial Hypercholesterolemia (HoFH), respectively.

Data are being presented at the Late Breaker Session at the European Atherosclerosis Society (EAS) Meetings in Madrid, Spain on June 2, 2014.
For the EAS Interactive Programme and link to the abstracts, please visit: www.eas.kenes.com.

SAMBA clinical trial: Proof-of-Mechanism data will be presented at the EAS from the SAMBA Phase II efficacy and safety trial in patients with Familial Primary Hypoalphalipoproteinemia (FPHA), a rare syndrome of severe HDL deficiency caused by mutations in the genes responsible for HDL synthesis /maturation and characterized by accelerated atherosclerosis.

This pharmacokinetic/pharmacodynamic trial, conducted by Principal Investigator, Erik S.G. Stroes, MD, PhD of the Department of Vascular Medicine at the Academic Medical Center (AMC) in Amsterdam, The Netherlands, enrolled 7 FPHA patients in an open-label single-arm active-treatment study and assessed the efficacy of infused CER-001 engineered human apoAI- containing pre-ß HDL particles in reconstituting the endogenous Reverse Lipid Transport in individuals who have defects in the natural HDL pathway and facilitate elimination of cholesterol from the body.

The data from patients receiving CER-001 treatment on top of optimized standard of care LDL-clowering therapy showed that CER-001 performed the four steps of the Reverse Lipid Transport pathway: CER-001 increased cholesterol mobilization and esterification in the HDL fraction, and one month of treatment with 9 doses of CER-001 resulted in a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI). CER-001 was well-tolerated.

Specific data from the study will be presented on Monday June 2, 2014 at 3:45pm in Madrid.
Dr. Stroes commented, « The results of this study support the future use of CER-001 for chronic administration aiming to reduce the elevated cardiovascular risk in low HDL patients with a high unmet clinical need. »

MODE clinical trial:
Cerenis also reported that data from the MODE (Modifying Orphan Drug Evaluation) trial, a Phase II efficacy and safety study in patients with Homozygous Familial Hypercholesterolemia(HoFH), a rare disease of markedly elevated LDL-cholesterol (bad cholesterol) levels caused by genetic defects in the LDL-receptor pathway and characterized by premature atherosclerosis. Data will also be presented as a late-breaking clinical trial at the EAS.

The open-label single-arm active-treatment study in 23 patients with homozygous FH met the prespecified primary clinical endpoint in the modified Intention to Treat population, demonstrating a statistically significant reduction in carotid artery Mean Vessel Wall Area, asmeasured by Magnetic Resonance Imaging (3T-MRI), after 6-months of bi-weekly CER-001 treatment on top of optimized LDL-c-lowering therapy, including apheresis. CER-001 was welltolerated. Specific data from the study will be presented on Monday June 2, 2014 at 4:00pm in Madrid. Dr. Kees Hovingh, the Principal Investigator of the MODE study, commented, « These data indicate that HDL therapy is complementary to LDL-c-lowering treatment and may represent a new therapy for addressing the unmet medical need in FH patients. » John F. Paolini, MD, PhD, FACC, Chief Medical Officer of Cerenis, said, “CER-001 has been shown to offer an important benefit for patients suffering from accelerated cardiovascular disease caused by genetic defects at both ends f the spectrum of cholesterol homeostasis.
The demonstrated safety profile observed in all studies performed thus far supports the use of CER-001 for chronic treatment in both these rare patient populations.”
Jean-Louis Dasseux, PhD, MBA, and CEO of Cerenis, concluded: “In all preclinical and clinical studies to date, CER-001 has been shown to perform the functions of natural HDL and the steps of the Reverse Lipid Transport Pathway leading to elimination of cholesterol from the body with a high degree of potency. The clinical benefit observed in these genetically challenged patients is further evidence supporting HDL therapy in the broader treatment of atherosclerosis. We are committed to continuing the development of CER-001 in these important rare disease clinical indications.”

NOTES TO EDITORS
About Cerenis Therapeutics
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of novel HDL therapies for the treatment of cardiovascular and metabolic diseases. HDL is the primary facilitator of the reverse lipid transport, or RLT, pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body. Cerenis is developing a portfolio of HDL therapies, including HDL mimetics for the rapid regression of atherosclerotic plaque in high-risk patients, and drugs which increase HDL for patients with low HDL. Cerenis is well-positioned to become the leader in the HDL therapeutic market with a broad portfolio of programs in development. Since its inception in 2005, the company raised €117 M in equity with top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and the FSI (Fund for Strategic Investment). €10,7M was also provided by OSEO, the French agency for innovation, to support the development of CER-001.

About CER-001
CER-001 is an engineered complex of recombinant human apoA-I, the major structural protein of HDL, and charged phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL. Its mechanism of action is to increase apoA-I and the number of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to transport them to the liver for elimination through a process called Reverse Lipid Transport.

Familial Primary Hypoalphalipoproteinemia (FPHA)
Hypoalphalipoproteinemia (“low HDL”), as a general term, has historically been defined clinically as an HDL-cholesterol (HDL-C) less than 40 mg/dL (1.0 mmol/L) in men, and less than 50 mg/dL (1.3 mmol/L) in women. A number of etiologies, often metabolic, can underlie a reduced circulating level of cholesterol in the HDL fraction, for example diabetes, Metabolic Syndrome, obesity, and lack of physical activity (thus called secondary hypoalphalipoproteinemia). In a very small percentage of the population, particularly amongst the patients with the very lowest HDL-C values, there are patients who have a genetic defect (thus called primary hypoalphalipoproteinemia) affecting either the constituent components of the pre-ß particle, the process of pre-ß particle synthesis, the steps leading to maturation into an alpha HDL particle, or the rates of catabolism – any of which alone or in combination can then result in an inherited condition of very low circulating HDL particle number. Familial Primary Hypoalphalipopr teinemia (FPHA) includes patients with a range of individual mutations across the key genes involved in HDL particle production or maturation (apoA-I, ABCA1, LCAT) which are individually extremely rare (prevalence less than one in one million births in the homozygous form) but in both homozygous and heterozygous forms can act in an autosomal dominant manner to cause low apoA-I levels and low HDL particle numbers through either decreased production or increased clearance and premature destruction of HDL particles and ultimately result in accelerated atherosclerosis from a single final common pathophysiology of impaired Reverse Lipid Transport (RLT) and accumulation of cholesterol throughout the body, in particular, the vasculature. FPHA patients are at high risk of cardiovascular disease as a consequence of having inherited a virtually absent endogenous RLT system. Because of the specific characteristics and very limited available therapeutic approaches, FPHA remains an unmet medical need and a life-threatening condition.

Familial Hypercholesterolemia (FH)
Familial hypercholesterolemia (FH) is characterized by high cholesterol levels, specifically very high lowdensity lipoprotein (LDL) levels and early cardiovascular disease. Many patients have mutations in the LDLR gene that encodes the LDL receptor protein, which normally removes LDL from the circulation, or apolipoprotein B (ApoB), which is the part of LDL that binds with the receptor; mutations in other genes are rare. In homozygous familial hypercholesterolemia (HoFH), serum LDL-C levels may be elevated sixfold. Patients develop severe aortic stenosis and coronary heart disease by age 20 and normally do not respond adequately to drug or diet modification therapy. Although the existing therapies, including statins, cholesterol absorption inhibitors, and LDL apheresis, can significantly reduce circulating LDL-C, nevertheless, LDL-C still remains higher than that recommended by current treatment guidelines, and these patients continue to have cardiovascular events of MI, stroke, and death at an elevated rate. The prevalence of homozygous FH is approximately one in one million births.

For further information, please contact:
Cerenis Therapeutics:
Jean-Louis Dasseux, President and CEO
John F. Paolini, CMO
Tel: +33 5 62 24 09 49
info@cerenis.com

Instinctif Partners
Melanie Toyne-Sewell
Tel: +44 20 7457 2029
cerenis@instinctif.com