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25/05/2016

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

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

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

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

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

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

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

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

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

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

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About the ReActiv8-A Trial
The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three-month endpoint after activation of stimulation and compared to baseline prior to implant. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.

About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry, and governments.
Further information can be found at www.mainstay-medical.com

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.
PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

FTI Consulting (for France)
Astrid Villette
Tel: +33 1 47 03 69 51
Email: Astrid.Villette@fticonsulting.com

Investor relations:
The Trout Group LLC
Jillian Connell Tel: +1 646 378 2956 / +1 617 309 8349
Email: jconnell@troutgroup.com

ESM Advisers:
Fergal Meegan or Barry Murphy, Davy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
Forward looking statements
This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should”, “will”, or “explore” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory applications and approvals, reimbursement arrangements, costs of sales and market penetration.
By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialization of ReActiv8, the initiation and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

16/05/2016

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

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

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

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

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

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

More information on RADIANCE-HTN can be found at:
https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3
For more information about ReCor Medical, please visit
www.recormedical.com or contact Andrew M. Weiss, President & CEO,
ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

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

28/04/2016

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

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

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

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

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

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

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

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

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

Media Contact:
Nicole Osmer
650-454-0504
nicole@nicoleosmer.com

19/04/2016

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

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

Contact : Michael KREL
mkrel@enobraq.com
+33 (0)6 31 92 53 56

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

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

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

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

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

14/04/2016

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

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

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

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

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

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

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

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

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

About RefleXion Medical
RefleXion Medical is a privately held medical device company developing the first biology-guided radiotherapy (BgRT) system for cancer treatment. By leveraging Positron Emission Tomography (PET) in a novel way, RefleXion’s patented technology will allow tumors to continuously signal their location during treatment and potentially revolutionize the practice of radiation oncology. RefleXion is backed by premier investment firms Sofinnova Partners, KCK Group, Pfizer Venture Investments and Venrock. The company has also received grant funding from the National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Program. For more information, visit www.reflexionmedical.com and follow @reflexionmed on Twitter.

RefleXion Medical Contact
press[at]reflexionmedical.com

08/04/2016

Edmond de Rothschild Investment Partners a mené le financement de série B aux côtés des investisseurs existants Sofinnova Partners et InnoBio. Large Venture a également participé à l’opération.
Les fonds serviront à mener une étude clinique confirmatoire de phase III aux États-Unis avec le médicament MD1003 dont les droits appartiennent exclusivement à Medday, chez les patients atteints de sclérose en plaques progressive.

Paris, France, le 7 avril 2016 – MedDay, une société de biotechnologie spécialisée dans le traitement des maladies neurologiques, annonce aujourd’hui une levée de fonds de 34 millions d’euros à l’occasion d’un tour de financement de série B. Edmond de Rothschild Investment Partners (EDRIP) a mené le nouveau tour d’investissement aux côtés des investisseurs historiques Sofinnova Partners et InnoBio (Bpifrance). Large Venture (Bpifrance) a également participé à l’opération.

Les nouveaux fonds permettront notamment à MedDay de conduire une étude confirmatoire de phase III aux Etats-Unis avec son principal candidat MD1003 (biotine pharmaceutique fortement dosée) chez les patients atteints de sclérose en plaques (SEP) progressive. Cette étude baptisée « SPI2 » fait suite à la réussite d’une première étude de phase III « MS-SPI » conduite en France entre 2013 et 2015. Les fonds permettront également de préparer le lancement commercial du MD1003 en Europe où le traitement est déjà disponible dans certains états membres dont la France selon la procédure d’autorisation temporaire d’utilisation. Medday poursuivra en parallèle le développement d’autres produits candidats et continuera à développer une plateforme de recherche destinée à identifier de nouvelles cibles métaboliques dans les maladies neurologiques.

Frédéric Sedel, directeur général de MedDay, commente : « Ce nouveau tour de financement permet de sécuriser le développement international de notre principal médicament candidat. Avec les experts internationaux, nous estimons que le MD1003 constitue un traitement extrêmement prometteur pour les patients atteints de SEP progressive, une forme de la maladie particulièrement difficile à traiter aujourd’hui. L’étude SPI2 a pour objet de confirmer, auprès d’une large population de patients nord-américains, les résultats de notre étude européenne MS-SPI et de permettre l’obtention d’une autorisation commerciale aux Etats-Unis. Nous sommes fiers d’accueillir d’autres investisseurs spécialisés de renom.»

Raphaël Wisniewski, Edmond de Rothschild Investment Partners, commente : « Nous sommes heureux d’investir dans MedDay à un moment essentiel de la vie de la société aux côtés des investisseurs historiques qui continuent à apporter leur soutien. MedDay a tout pour devenir une société de biotechnologie capable de changer la donne notamment dans le domaine de la SEP progressive. En raison des résultats cliniques déjà obtenus, de la plateforme de recherche, des opportunités en cours de développement et de la force de son équipe de direction, nous sommes convaincus que MedDay apportera à brève échéance des solutions aux patients atteints de maladies neurologiques».

Au nom des investisseurs fondateurs, Rafaèle Tordjman, Managing Partner chez Sofinnova Partners, et Chahra Louafi, Directrice d’investissement senior chez Bpifrance, ajoutent : « Nous sommes ravies de participer à la seconde levée de fonds de MedDay. La société est soutenue par un groupe d’investisseurs qui partagent une vision commune : celle de créer une société solide capable de proposer aux patients des médicaments aux bénéfices exceptionnels dans des domaines où les besoins restent encore largement insatisfaits ».
Raphaël Wisniewski, Directeur Associé chez EDRIP, rejoint Rafaèle Tordjman et Chahra Louafi au conseil d’administration de MedDay.

 

À propos de MedDay
MedDay est une société de biotechnologie privée, qui développe de nouveaux médicaments ciblant le métabolisme cérébral dans le but de traiter des maladies neurologiques graves. La société a été fondée en 2011 par le Dr Frédéric Sedel (directeur général) et le Dr Guillaume Brion (directeur des opérations). Le produit le plus avancé est le MD1003 (biotine pharmaceutique à très forte dose) actuellement en phase III pour le traitement de la SEP progressive primaire et secondaire. Pour plus d’informations, rendez-vous sur le site : www.medday-pharma.com.

À propos d’Edmond de Rothschild Investment Partners
Edmond de Rothschild Investment Partners est un investisseur de référence dans l’investissement minoritaire dans des sociétés non cotées. Filiale du groupe Edmond de Rothschild basée à Paris, la société de gestion rassemble 41 collaborateurs, dont 29 professionnels de l’investissement, et gère environ 1,3 milliard d’euros. Son équipe spécialisée dans les sciences de la vie est composée de neuf professionnels qui bénéficient d’une expérience cumulée de plus de soixante ans dans les sciences de la vie et de plus de cent ans dans l’investissement non coté. L’équipe a levé plus de 450 millions d’euros à travers les différentes générations des fonds BioDiscovery, et termine actuellement l’investissement du fonds BioDiscovery 4. Depuis leur création, cette famille de fonds a investi dans 53 sociétés non cotées, dont 15 ont fait l’objet d’une cession industrielle, 14 ont été cotées sur les marchés financiers et 21 sont actives dans les portefeuilles des fonds.

Les fonds BioDiscovery, y compris BioDiscovery 4, sont des fonds professionnels de capital investissement bénéficiant d’une procédure allégée. A ce titre, ils ne sont pas soumis à l’agrément de l’Autorité des Marchés Financiers et peuvent adopter des règles d’investissement dérogatoires. Plus d’informations sont disponibles sur le site www.edrip.fr

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

À propos d’InnoBio (Bpifrance)
La banque d’investissement publique, Bpifrance, est le résultat de la fusion des organismes professionnels de financement et d’investissement OSEO, FSI, CDC Entreprises et FSI Régions. Elle a été établie en vertu du droit français le 31 décembre 2012. Elle compte deux actionnaires : l’État français et la Caisse des Dépôts. Bpifrance a pour objectif de soutenir des entreprises (PME, sociétés de moyenne capitalisation et grandes entreprises ayant une importance stratégique dans l’économie française), depuis leur phase initiale de capitalisation jusqu’à leur introduction en bourse. Elle offre un accès au crédit, aux garanties et au financement par émission d’actions. Bpifrance offre également une assistance et des services de soutien avancés dans les domaines de l’innovation, de l’exportation et de la croissance externe. Elle fait office d’interlocuteur unique pour les besoins en financement et en investissement des entrepreneurs de chaque région. InnoBio est un fonds de capital-risque de 173 millions d’euros dirigé par Bpifrance, qui investit également dans ce fonds. Sanofi, GSK, Roche, Novartis, Pfizer, Lilly, Ipsen, Takeda et Boeringer-Ingelheim comptent parmi ses autres investisseurs. L’objectif principal de ce fonds est de réaliser des investissements en actions dans des entreprises innovantes proposant des technologies, des produits et des services dans le domaine des soins de santé. Pour plus d’informations, rendez-vous sur le site : www.bpifrance.fr

À propos de Large Venture (Bpifrance)
Doté de 600 M€, Large Venture a vocation à investir dans les sociétés innovantes en hypercroissance ayant de forts besoins capitalistiques. Il accompagne les entreprises des secteurs prioritaires de la santé, du numérique et de l’environnement dans l’accélération de leur développement commercial, leur déploiement à l’international ou l’industrialisation de leur technologie. Large Venture investit au capital de sociétés déjà financées par des VCs ou ayant déjà un chiffre d’affaires significatif et a pour objectif de favoriser l’émergence de champions français, futurs leaders mondiaux de leurs marchés. Large Venture est un investisseur minoritaire ayant la capacité de soutenir ses participations sur le long terme.

À propos de la SEP progressive
La SEP est la maladie neurologique handicapante la plus fréquente chez l’adulte jeune, les premiers symptômes se manifestant généralement entre 20 et 40 ans. Dans la majorité (85 %) des cas, les patients connaissent une phase initiale de troubles neurologiques évoluant par poussées, dite forme récurrente-rémittente (SEP-RR), qui se transforme généralement avec le temps en forme secondairement progressive de la maladie (SEP-SP). Lorsque la SEP entre dans la phase progressive, les patients présentent une aggravation lente de leur handicap neurologique. La SEP progressive primaire (SEP-PP) caractérisée par une progression dès le début de la maladie est moins fréquente et ne touche que 10 à 15 % des patients. La SEP progressive qu’elle soit secondaire ou primaire (SEP-PS ou SEP-PP) peut être subdivisée en SEP progressive « active » ou « non active », selon qu’il existe ou non une activité inflammatoire surajoutée (poussées ou nouvelles lésions IRM). Les traitement actuels, immunosuppresseurs et immunomodulateurs, permettent de réduire la fréquence des poussées et le nombre de lésions détectables en IRM. Ces médicaments sont surtout efficaces dans la SEP-RR et, à moindre degré, dans le sous-groupe de patients atteints d’une SEP progressive active. A l’inverse, il n’existe pas de médicament ciblant la SEP progressive « non active » qui constitue la population la plus difficile à traiter.

À propos de MD1003
Le MD1003 est une biotine de grade pharmaceutique très fortement dosée qui a déjà démontré son efficacité chez les patients souffrant d’une sclérose en plaques progressive. Le MD1003 a un mécanisme d’action susceptible d’agir sur deux cibles associées à la SEP progressive : (1) il active les acétyl-CoA carboxylases (ACC1 et ACC2), des enzymes impliquées dans la synthèse des acides gras à longue chaîne nécessaires à la synthèse de la myéline ; et (2) il active des enzymes impliquées dans le fonctionnement du cycle de Krebs, principale voie de production énergétique indispensable au fonctionnement des axones démyélinisés et ce afin d’éviter la dégénérescence axonale. Les résultats de deux études de phase III, MS-SPI et MS-ON, ont déjà démontré la capacité unique de ce médicament à inverser l’évolution de la maladie chez certains patient, en plus de réduire le taux de progression global de la maladie. Les effets ont plus spécifiquement été observés sur les formes progressives « non actives » de la maladie, pour lesquelles aucun médicament n’a encore démontré d’efficacité. Ce médicament est déjà disponible dans certains pays européens et notamment en France sous autorisation temporaire d’utilisation.

À propos de l’étude MS-SPI
L’étude MS-SPI est une étude randomisée 2:1, en double insu, contrôlée contre placebo menée chez des patients atteints d’une SEP progressive non active. La durée du traitement était de 12 mois, suivi d’une phase d’extension de 12 mois au cours de laquelle le placebo a été remplacé par le traitement actif. Le critère d’évaluation principal de l’étude a été défini comme la proportion de patients ayant présenté une amélioration à neuf mois (M9), avec une confirmation de l’amélioration à 12 mois (M12). Le critère principal a été atteint (p = 0,0051). La variation moyenne du score EDSS (score de handicap) entre M0 et M12 a diminué dans le groupe MD1003 (-0,03) alors qu’il s’est aggravé dans le groupe placebo (+0,13, p = 0,014). L’Impression clinique globale évaluée par le clinicien (CGI) et par le patient (SGI), après 12 mois de traitement, était significativement meilleure dans le groupe MD1003 que dans le groupe placebo (p < 0,0001 et p = 0,0094, respectivement).

Pour plus d’informations, veuillez contacter :

MedDay Pharmaceuticals
Email : contact@medday-pharma.com

Consilium Strategic Communications
Mary-Jane Elliott, Jonathan Birt, Laura Thornton
Tél : +44 (0)20 3709 5700
Email : medday@consilium-comms.com

07/04/2016

Palo Alto, CA, USA and Amsterdam, The Netherlands, 7 April 2016  – ReCor Medical announced today the enrollment of the first subjects in the FDA IDE-approved RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise® Renal Denervation System on blood pressure in patients with hypertension.

RADIANCE-HTN is a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: the SOLO cohort will evaluate subjects with essential hypertension on two or fewer antihypertensive medications, and the TRIO cohort will evaluate subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.
The first TRIO patient was enrolled at the Erasmus University Medical Center in Rotterdam, the Netherlands by Dr. Joost Daemen. “We are excited to have enrolled the first patient in this very important study,” commented Dr. Daemen. “We have significant experience using the Paradise System and believe that the RADIANCE-HTN study is well designed to demonstrate the System’s treatment effect. If RADIANCEHTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus.”
The first SOLO patient was enrolled at Sutter Health, Sacramento, CA, USA by Dr. Pei-Hsiu Huang. “The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment,” added Dr. Huang. “We are excited to be part of this important study and by the possibility that RADIANCE-HTN could demonstrate the efficacy of renal denervation with the Paradise System, and open a path to new treatment options for our hypertension patients.”
RADIANCE-HTN is approved to enroll 292 subjects at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands.

More information on RADIANCE-HTN can be found at:
https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3

About ReCor Medical, Inc.
ReCor Medical is a private, venture-backed, medical device company that designs and manufactures 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 3 clinical trials, and has been used in over 200 patients.

For more information about ReCor Medical, please visit
www.recormedical.com or contact Andrew M. Weiss, President & CEO,
ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.

04/04/2016

• Positive data from Zilretta Phase 2b and Phase 3 clinical trials demonstrate consistent efficacy across both studies with substantial and persistent pain relief
• In the Phase 3 trial Zilretta, in contrast to immediate-release triamcinolone acetonide (TCA), exceeds American Academy of Orthopedic Surgeons (AAOS) criteria for clinically important effects on pain and function
• Safety data from these studies are comparable to placebo and immediate-release TCA
• CONFERENCE CALL TODAY APRIL 4, 2016 AT 9:00 A.M. EDT

BURLINGTON, Mass., April 04, 2016 – Results from two Flexion Therapeutics, Inc. (Nasdaq:FLXN) sponsored pivotal clinical trials showed that its lead drug candidate Zilretta (also known as FX006) provided sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, presented the results at the OARSI 2016 World Congress in Amsterdam in a podium presentation that is available at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.

Following the presentation Professor Conaghan said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”
“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”

The Phase 3 trial was a randomized, double-blind, placebo-controlled, active-comparator trial that enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single intra-articular injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by the weekly mean of the average daily pain (ADP) score. The secondary objectives of the study assessed the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in additional pre-specified measures.

Phase 3 study data from the OARSI podium presentation and from additional company analyses are summarized below and posted to the Flexion website at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.
In the Phase 3 study, Zilretta:
• Met its primary endpoint at week 12, demonstrating highly significant (p < 0.0001, 2-sided) and clinically meaningful pain relief against placebo as measured by the weekly mean of the ADP score.
• Achieved statistically significant pain relief against placebo as measured by the weekly mean of the ADP score at weeks 1 through 16 and demonstrated, on average, an approximately 50 percent reduction in pain from baseline over weeks 1 through 12.
• Achieved numerically superior pain relief against immediate-release TCA at weeks 2 through 12 as measured by the weekly mean of the ADP score, but did not achieve statistical significance in that measure.
• Achieved statistical significance against placebo and immediate-release TCA at each time point through 12 weeks on WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
• Demonstrated in a pre-specified subset analysis of patients with unilateral knee pain (35 percent of subjects in the study), substantially magnified effects in the weekly mean of the ADP score, WOMAC A, B and C and KOOS quality of life and significantly enhanced separation from placebo and immediate-release TCA in all of these measures.
• Demonstrated reduced rescue medicine consumption compared with placebo and immediate-release TCA.

The Phase 3 data were also evaluated for clinical relevance by applying established AAOS criteria. In its 2013 publication, “Evidence-Based Guideline: Treatment of Osteoarthritis of the Knee,” the AAOS comprehensively reviewed the available literature on existing treatments and determined a minimal relative improvement in WOMAC A, B and C measures that would be meaningful to patients. This is referred to as the Minimal Clinically Important Improvement (MCII). The Phase 3 data show that Zilretta exceeds the MCII in WOMAC A, B and C and thus demonstrates a clinically important effect, whereas immediate-release TCA in this study does not.
The Phase 2b trial enrolled 310 participants in a multi-center, randomized, double-blind study, in which the participants received an injection of either 40 mg or 20 mg of FX006, or a placebo (saline). The 40 mg arm of Zilretta, compared to placebo, demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of Zilretta also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042).
Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.

Conference Call
Flexion’s management will host a conference call today at 9:00 a.m. EDT. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 84943960. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee
OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.
Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta
Zilretta is being investigated as the first intra-articular (IA) sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.
To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, 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, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading « Risk Factors » in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Relations Contact
David Carey
Lazar Partners LTD
T: 212-867-1768
dcarey@lazarpartners.com

Media Relations Contact
Mariann Caprino
TogoRun
T : 917.242.1087
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com

17/03/2016

Une levée de fonds pour soutenir l’expansion de la plateforme de bio-polymères de Gecko Biomedical à travers le développement clinique et l’approbation de mise sur le marché pour de nombreuses applications dans la reconstruction des tissus.
L’opération a réuni un syndicat d’investisseurs qui, aux côtés de Sofinnova Partners, comprend Bpifrance et les investisseurs historiques.

Paris, France, 17 mars, 2016 – Gecko Biomedical (“Gecko”), une société de dispositifs médicaux développant des polymères innovants permettant de refermer des plaies, vient de lever €22,5 millions. Ce tour de financement de série A2 a été mené par Sofinnova Partners, qui devient le premier actionnaire, avec le soutien de Bpifrance, et les investisseurs historiques qui avaient investi dans l’entreprise en décembre 2013, Omnes Capital, CM-CIC Innovation et CapDecisif Management. En parallèle de cette levée de fonds, Antoine Papiernik de Sofinnova Partners et Chahra Louafi de Bpifrance deviennent membres du Conseil d’Administration.

Gecko a été créé en 2013 par Christophe Bancel, Bernard Gilly (tous deux membres du réseau iBionext), Prof. Jeff Karp (Harvard Medical School, Brigham and Women’s Hospital – Boston, MA, USA) et Prof. Bob Langer (Massachusetts Institut de Technology – Cambridge, MA, USA), avec le soutien du Dr. Maria Pereira, une figure internationale sélectionnée en 2015 par le magazine Forbes pour faire partie des “30 personnalités de moins de 30 ans” du secteur de la santé, qui a co-inventé la technologie et est actuellement Responsable de la Recherche chez Gecko.

Les fonds permettront d’accélérer le développement de la première plateforme de polymères, GB-02, spécialisée dans le domaine de la reconstruction cardiovasculaire, mais aussi d’autres tissus. Capitalisant sur la technologie, les fonds serviront également à déployer la plateforme sur d’autres indications, comme la reconstruction guidée de tissus et la libération localisée de médicaments.

La plateforme de Gecko est désormais complètement industrialisée, avec un niveau unique de biocompatibilité et un très large potentiel d’applications différentes. S’appuyant sur des polymères propriétaires, la technologie présente des caractéristiques chimiques et physiques uniques : une forte viscosité, des propriétés hydrophobes et une capacité à polymériser rapidement à la demande lorsque le chirurgien le décide. Une fois polymérisé, le composé forme un film élastique et biodégradable. Ces polymères peuvent être modifiés afin de faire varier leurs propriétés et donc permettre un grand nombre d’applications.

Christophe Bancel CEO de Gecko déclare : « Le soutien de nos investisseurs nous permettra de réaliser notre plan de développement clinique à l’international en chirurgie cardiovasculaire, en vue de faire les demandes d’autorisation pour notre premier produit d’ici un an. De plus, les fonds serviront à développer le polymère GB-02 sur d’autres indications en reconstruction de tissus. Nous travaillons également à la prochaine génération de polymères, GB-04, destinée à certaines procédures chirurgicales sans suture ».

Antoine Papiernik, Managing Partner chez Sofinnova Partners, ajoute : « Nous sommes heureux de travailler avec Gecko Biomedical, une société qui combine toutes les qualités que nous recherchons dans les entreprises dans lesquelles nous investissons : une solide équipe de management, et une plateforme technologique de très haut niveau, permettant des applications de rupture dans un large domaine ».
A propos de Gecko
Gecko Biomedical est une société de dispositifs médicaux privée basée à Paris, France, dédiée au développement rapide et à la commercialisation d’une plate-forme unique de biopolymères. Le premier produit de Gecko (GB02) est un polymère innovant ciblant la cicatrisation tissulaire, avec une première indication dans la reconstruction cardiovasculaire. La structure de GB02 est réglable, ce qui permet la personnalisation de ses propriétés pour diverses applications et tissus. La plate-forme de biopolymères de Gecko est entièrement industrialisée et très polyvalente, avec des applications potentielles dans d’autres domaines de la reconstruction tissulaire, tels que la réparation tissulaire guidée et un système de délivrance localisée de médicaments. La plate-forme Gecko est construite autour de biopolymères propriétaires ayant des propriétés physiques uniques. Ils sont hautement visqueux, hydrophobes, et proposent une polymérisation chimique rapide et «à la demande» permettant une délivrance localisée et une adhérence in situ. Les technologies de Gecko sont issues des travaux de recherche et de la propriété intellectuelle des laboratoires du Pr. Robert Langer (MIT) and Pr. Jeff Karp (Brigham and Women’s Hospital), qui ont co-fondé la société en 2013, aux côtés de Christophe Bancel et Bernard Gilly du réseau iBionext. Pour plus d’informations : www.geckobiomedical.com

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

A propos de Bpifrance
Bpifrance, filiale de la Caisse des Dépôts et de l’État, partenaire de confiance des entrepreneurs, accompagne les entreprises, de l’amorçage jusqu’à la cotation en bourse, en crédit, en garantie et en fonds propres. Bpifrance assure, en outre, des services d’accompagnement et de soutien renforcé à l’innovation, à la croissance externe et à l’export, en partenariat avec Ubifrance et Coface. Bpifrance propose aux entreprises un continuum de financements à chaque étape clé de leur développement et une offre adaptée aux spécificités régionales. Fort de 42 implantations régionales (90 % des décisions prises en région), Bpifrance constitue un outil de compétitivité économique au service des entrepreneurs. Bpifrance agit en appui des politiques publiques conduites par l’État et par les Régions pour répondre à trois objectifs : accompagner la croissance des PME, préparer la compétitivité de demain et contribuer au développement d’un écosystème favorable à l’entrepreneuriat. Avec Bpifrance, les entreprises bénéficient d’un interlocuteur puissant, proche et efficace, pour répondre à l’ensemble de leurs besoins de financement, d’innovation et d’investissement. Plus d’informations sur : www.bpifrance.fr – Suivez-nous sur Twitter : @bpifrance
A propos de CM-CIC Innovation
CM-CIC INNOVATION est une filiale de CM-CIC Investissement spécialisée dans les investissements capital-risque. Son objectif est d’investir dans des entreprises développant des technologies prometteuses. CM-CIC INNOVATION choisit des entreprises avec un fort potentiel de croissance sur des secteurs dynamiques comme les technologies de l’information, les télécommunications, l’électronique, les sciences de la vie, les nouveaux matériaux ou encore l’environnement.
La politique de CM-CIC INNOVATION est de fournir un appui en fonds propres à long terme à des startups innovantes pour rationaliser leurs chances de succès. Pour plus d’informations : www.cmcic-investissement.com

A propos de Omnes Capital
Omnes Capital est un acteur majeur du capital investissement et de l’investissement en infrastructure. Avec 2,1 milliards d’euros sous gestion, Omnes Capital apporte aux entreprises les fonds propres nécessaires à leur développement à travers ses expertises de référence : Capital Développement & Transmission, Dette Privée, Capital Risque, Energies Renouvelables, Co-Investissement, Fonds de fonds secondaire. Omnes Capital était une filiale de Crédit Agricole S.A. jusqu’en mars 2012. La société est aujourd’hui détenue par ses salariés. Omnes Capital est signataire des Principes pour l’Investissement Responsable des Nations Unies (PRI). Pour plus d’informations : www.omnescapital.com

A propos de CapDecisif Management
CapDecisif Management est une société de gestion agréée par l’AMF. Avec 110M€ actuellement sous gestion au travers de cinq fonds, dont le FPCI CapDecisif 3, G1J IdF et le Fonds Régional de Co-Investissement (FRCI). CapDecisif Management se concentre sur l’investissement en capital-risque dans les sociétés innovantes à fort potentiel principalement en Région Ile-de-France. CapDecisif Management intervient dans tous les champs de l’innovation tels que : les télécommunications, les technologies de l’information / logiciels, les sciences du vivant, l’énergie et l’environnement. Le FPCI CapDecisif 3 est notamment soutenu par le Fonds National d’Amorçage (FNA), géré par BPI France, pour le compte de l’Etat dans le cadre du Programme d’Investissements d’Avenir (PIA) et la Région Ile De France. Pour plus d’informations : www.cap-decisif.com

 

CONTACTS PRESSE
Pour Gecko
Christophe BANCEL Tel: +33 1 76 21 72 28 cbancel@geckobiomedical.com
twitter : @geckobiomedical
Pour Sofinnova Partners

15/03/2016

– Production and marketing of furandicarboxylic acid (FDCA) based on renewable resources, the main new building block for polyethylenefuranoate (PEF)
– Further development and licensing of Avantium’s production processes for FDCA and PEF at industrial scale
– Intention to build a reference plant for FDCA with an annual capacity of up to 50,000 tons at BASF’s Verbund site in Antwerp, Belgium

Ludwigshafen, Germany, and Amsterdam, Netherlands – March 15, 2016 – BASF and Avantium today announced that they have signed a letter of intent and entered into exclusive negotiations to establish a joint venture (JV) for the production and marketing of furandicarboxylic acid (FDCA), as well as marketing of polyethylenefuranoate (PEF), based on this new chemical building block. FDCA is produced from renewable resources.

The JV will use the YXY process® developed by Avantium in its laboratories in Amsterdam and pilot plant in Geleen, Netherlands, for the production of FDCA. It is intended to further develop this process as well as to construct a reference plant for the production of FDCA with an annual capacity of up to 50,000 metric tons per year at BASF’s Verbund site in Antwerp, Belgium. The aim is to build up world-leading positions in FDCA and PEF, and subsequently license the technology for industrial scale application.

FDCA and PEF: New materials enabling improved food packaging films and plastic bottles
FDCA is the essential chemical building block for the production of PEF. Compared to conventional plastics, PEF is characterized by improved barrier properties for gases like carbon dioxide and oxygen. This can lead to longer shelf life of packaged products. Due to its higher mechanical strength, thinner PEF packaging can be produced, thus a lower amount of packaging material is necessary. Therefore PEF is particularly suitable for the production of certain food and beverage packaging, for example films and plastic bottles. After use, PEF can be recycled.

“With the planned joint venture, we want to combine Avantium’s specific production technology and application know-how for FDCA and PEF with the strengths of BASF,” said Dr. Stefan Blank, President of BASF’s Intermediates division. “Of particular importance is our expertise in market development and large-scale production as an established and reliable chemical company in the business of intermediates and polymers,” Blank added.

“The contemplated joint venture with BASF is a major milestone in the development and commercialization of this game-changing technology. Partnering with the number one chemical company in the world, provides us with access to the capabilities that are required to bring this technology to industrialization,” said Tom van Aken, Chief Executive Officer of Avantium. “The joint venture will further strengthen the global technology and establish the market leadership for FDCA and PEF. With BASF, we plan to start production of FDCA to enable the first commercial launch of this exciting bio-based material and to further develop and grow the market to its full potential,” van Aken continued.

About Avantium
Avantium is a leading chemical technology company and a forerunner in renewable chemistry. Together with its partners around the world, Avantium develops efficient processes and sustainable products made from biobased materials. Avantium offers a breeding ground for revolutionary renewable chemistry solutions. From invention to commercially viable production processes. One of Avantium’s many success stories is YXY technology®, with which they created PEF: a completely new, high-quality plastic made from plant-based industrial sugars. PEF is 100% recyclable. It therefore offers a cost-effective solution to make anything from a wide range of plastic bottles and packaging to fibers. YXY is the most advanced technology, but Avantium is also working on a host of other ground-breaking projects and is providing advanced catalysis research services and systems to the leading chemical and petrochemical companies. Avantium’s offices and headquarters are based in Amsterdam, the Netherlands. Further information at www.avantium.com

About BASF Intermediates
The BASF Group’s Intermediates division develops, produces and markets a comprehensive portfolio of about 700 intermediates around the world. Its most important product groups include amines, diols, polyalcohols, acids and specialties. Intermediates are used for example as starting materials for coatings, plastics, pharmaceuticals, textiles, detergents and crop protectants. Innovative intermediates
from BASF help to improve both the properties of final products and the efficiency of production processes. The ISO 9001 certified Intermediates division operates plants at production sites in Europe, Asia and North America. Around the globe, the division generated sales to third parties of about €2.8 billion in 2015. Further information at www.intermediates.basf.com

About BASF
At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. The approximately 112,000 employees in the BASF Group work on contributing to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into five segments: Chemicals, Performance Products, Functional Materials & Solutions, Agricultural Solutions and Oil & Gas. BASF generated sales of more than €70 billion in 2015. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information at www.basf.com

Media contacts:
BASF SE
Klaus-Peter Rieser
Intermediates Division
Phone: +49 621 60 95138
E-mail: klaus-peter.rieser@basf.com

Avantium
Alex de Vries
Phone: +31 20 586 0132
Mobile: + 31 651 11 9205
E-mail: alex.de.vries@msl.nl