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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/

10/09/2014

Geneva, Switzerland, 10 September 2014 – ObsEva, a Swiss-based, specialty biopharmaceutical company dedicated to the development and commercialisation of innovative drugs for women’s reproductive medicine, announced today the appointment of Ben T.G. Tan as Vice President Commercial & Business Development.
Ben brings to ObsEva over 25 years of business development, licensing and strategic marketing experience in clinical-stage biotechnology and pharmaceutical companies.
“I am delighted that Ben is joining ObsEva, as his experience will be invaluable for further expanding and optimising ObsEva’s product pipeline to address unmet medical needs and to create the highest value for all our stakeholders ” stated Ernest Loumaye, CEO and Co-Founder of ObsEva.
Ben joins ObsEva from Evolva SA, where he successfully divested its lead Phase 2 asset as part of Evolva’s strategic shift away from pharmaceutical development and towards ingredients for health, wellness and nutrition. As Head of Business Development & Licensing at Speedel AG (2001-2008), Ben in-licensed preclinical and clinical assets and contributed to Speedel’s IPO in September 2005. After Speedel’s acquisition by Novartis Pharma AG for CHF 1 billion in 2008, he joined Novartis as Global Program Strategic Marketing Director and led the commercialisation activities for an antiplatelet drug. Prior to Speedel, Ben was Head of Global Licensing at Organon NV, a leader in Women’s Health Care.
Ben began his pharmaceutical industry career at Roche Netherlands as a sales representative for hospital products and progressed to become Head of Medical Marketing, in which role he successfully launched Neupogen (filgrastim) in a co-promotion with Amgen Europe, before moving to Roche HQ in Basel as Global Business Leader for various Phase 3 assets in co-development with Sigma-Tau and Genentech.
Ben holds an MS (cum laude) in Medical Biology from the Vrije Universiteit Amsterdam.

About ObsEva
ObsEva SA is a Swiss-based, specialty biopharmaceutical company dedicated to the development and
commercialisation of innovative drugs for women’s reproductive medicine. ObsEva was founded in
November 2012, by Ernest Loumaye MD, PhD and André Chollet PhD. Ernest Loumaye is a specialist
in female reproductive medicine with 20 years of experience in the biopharmaceutical industry.
Ernest Loumaye was previously Co-Founder and CEO of PregLem SA, a successful biopharmaceutical
company which was acquired by Gedeon Richter in 2010. André Chollet is specialist in medicinal and
pharmaceutical chemistry with more than 30 years of experience in various positions in the
biopharmaceutical industry, including in Biogen, GSK and Merck Serono. André Chollet was
responsible for the preterm labor program at Serono before the acquisition of the company by Merck
KGaA.
ObsEva’s founding assets are innovative products at early stages of clinical development addressing
preterm labor and infertility treatment as well as additional indications in reproductive medicine.

For more information, please visit www.obseva.com.
For further information, please contact ObsEva CEO Office:
Delphine Renaud
Tel: +41 22 552 1550
Email: delphine.renaud@obseva.ch

09/09/2014

Patent Underpins FX006 Formulation Technology and Provides Intellectual Property Protection Into 2031

BURLINGTON, Mass., Sept. 9, 2014 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Patent and Trademark Office has issued a composition of matter patent (No. 8828440), entitled « Corticosteroids for the Treatment of Joint Pain, » which provides coverage for FX006, the company’s lead clinical product candidate. FX006 is a novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA). The patent describes and claims an injectable formulation comprised of controlled or sustained-release microparticles that contain TCA in a poly(lactic-co-glycolic) acid co-polymer (PLGA) matrix.
« The issuance of this patent marks an important milestone for Flexion as it directly protects our lead product, FX006, for a prolonged period of time and provides a critical foundation for its eventual commercialization, » said Michael Clayman, M.D., President and CEO. « Based on the available clinical data to date, we are enthusiastic about the prospect of FX006 playing an important role in the treatment of patients with osteoarthritis (OA) of the knee. This patent, together with last week’s announcement on the planned start of our pivotal Phase 3 clinical trial for FX006 a year ahead of schedule, brings us closer to realizing the potential of this novel therapy. »
FX006 is designed to provide prolonged pain relief for the treatment of OA of the knee, while potentially avoiding untoward systemic effects associated with immediate-release steroids. Last year Flexion announced the results of a Phase 2b OA dose-ranging trial that demonstrated that FX006 provided superior pain relief compared to the standard of care IA immediate-release steroid. Flexion also recently announced positive topline clinical trial results from a Phase 2a synovial fluid pharmacokinetic (PK) trial of FX006, which demonstrated, for the first time, that a single IA injection of FX006 can provide therapeutic concentrations of FX006 in joint fluid for at least 12 weeks. A pivotal Phase 2b confirmatory clinical trial for FX006 is currently enrolling patients and topline data are expected in the first half of 2015. Based on a recent meeting with the U.S. Food and Drug Administration (FDA) to review the clinical development program for FX006, Flexion earlier this month announced plans to accelerate the initiation of a pivotal Phase 3 clinical trial for FX006 to late 2014 and expects to complete the trial by the second half of 2015. The Phase 3 trial will be an international, multi-center, randomized, blinded, single-dose study in 462 patients with OA of the knee. It will have three separate arms that include a 40 mg dose of FX006, placebo, and a 40 mg dose of TCA. The primary objective of the trial will be to provide the second pivotal efficacy dataset against placebo for an NDA submission. In addition, the trial will provide a key comparative dataset against the current standard of care, immediate-release TCA, and could potentially support a commercial advantage in the launch of the drug.

About Flexion Therapeutics
Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company’s lead program, FX006, is an intra-articular sustained-release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including statements relating to the future of Flexion, its ongoing development of its product candidates, the potential duration and impact of patent protection for FX006, anticipated clinical and other milestones (including the timing of such milestones), and potential role of FX006 in the treatment of patients with OA of the knee are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics, whether the company’s patents will be held valid and enforceable, the fact that Flexion relies on third parties to manufacture and conduct the clinical trials of its product candidates, which could delay or limit their future development or regulatory approval, the possibility that future trial results may not be consistent with past results, the fact that Flexion will require additional capital, including prior to completing Phase 3 development of, filing for regulatory approval for, or commercializing, FX006 or any of its other product candidates and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to it, and other risks and uncertainties described in Flexion’s filings with the Securities and Exchange Commission (SEC), including under the heading « Risk Factors » in Flexion’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. You are encouraged to read Flexion’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and Flexion undertakes no obligation to update or revise any of the statements.

CONTACT: Media Contact
Jamie Lacey-Moreira
PressComm PR, LLC
T: 410-299-3310
jamielacey@presscommpr.com

Corporate Contact
Lisa Davidson, MBA
Vice President, Finance and Administration
Flexion Therapeutics, Inc.
T: 781-305-7765
ldavidson@flexiontherapeutics.com

Source: Flexion Therapeutics, Inc.

03/09/2014

Paris. September 2. 2014. Sofinnova Partners, a Paris-based life science venture capital firm, reinforces its investment team with the appointment of Henrijette Richter as Partner.

Henrijette has over ten years of investing experience in venture capital. For the past seven years she was an Investment Director at Novo Seeds, part of Novo A/S (Denmark), which she co-established. Henrijette holds a combined PhD and Industrial Scientist degree in Molecular Biology from the University of Copenhagen, and did her postdoctoral fellowship at MIT Center for Cancer Research, Cambridge. She has invested and serves on the Board of several biotech companies such as Affinicon, Orphazyme, EpiTherapeutics, Avilex Pharma, and Lysogene.

Henrijette Richter says: “I am delighted to join Sofinnova Partners’ experienced and talented team. We have worked together in the past through co-investments, and share a common vision, to back strong entrepreneurs and help them successfully bring ground-breaking innovations to market”.
Denis Lucquin, Managing Partner at Sofinnova Partners says: “Henrijette is a great addition to our team and we are extremely pleased to welcome her. Henrijette has a solid investment experience in our field, a remarkable scientific background, and a very strong network, in particular in Scandinavia, an important territory for our strategy”.

About Sofinnova Partners
Sofinnova Partners is an independent venture capital firm based in Paris, France. For more than 40 years, the firm has backed nearly 500 companies at different stages of their development – pure creations, spin-offs, as well as turnaround situations – and worked alongside key entrepreneurs in the Life Sciences industry around the globe. With over €1.3 billion of funds under management, Sofinnova Partners has created market leaders with its experienced team and hands-on approach in building portfolio companies through to exit.

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/