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16/05/2019

Oversubscribed round to bring first products powered by enzymatic DNA synthesis technology to market

Paris, May 16, 2019. Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, today announced that its portfolio company DNA Script, an industry leader in the manufacturing of synthetic nucleic acids using proprietary enzymatic technology, has raised $38.5 million in Series B financing. New shareholders LSP and BPIFrance joined the round, alongside existing shareholders Kurma Partners, Idinvest Partners, Illumina Ventures, and M Ventures (the corporate venture arm of Merck KGaA). Sofinnova Partners was the first institutional investor in DNA Script in 2016.

DNA Script is the world’s leading company in manufacturing synthetic nucleic acids using enzymatic technology. Founded in 2014 in Paris, the company aims to accelerate innovation in life sciences and technology delivering rapid, affordable, and high-quality DNA. Sixty years after the discovery of DNA, DNA Script’s revolutionary approach leverages billions of years of nature’s evolution in synthesizing DNA to enable genome scale synthesis.

The company offers a novel biochemical process for DNA and RNA synthesis, a fundamental tool used in biology research. At a recent academic conference, DNA Script presented its ability to synthesize 200nt of DNA with remarkable accuracy. This innovation may be used in numerous applications, including electronic data storage, by leveraging unprecedented capabilities of the molecule to store information. The fundraising allows DNA Script to further develop its unique enzymatic technology and nucleotide chemistry platform, and deliver the promise of same-day results.

Joško Bobanović, Partner at Sofinnova Partners, said: “We are excited that DNA Script, which we have backed from its first round of financing, was able to raise such a significant round. The company continues to deliver on its plan, and is now funded by a group of likeminded investors who support the team’s vision of creating a business that enables new applications for synthetic DNA and RNA in areas including drug discovery and development, agriculture, and industrial and food technologies.”

“Sofinnova Partners has been an excellent partner from a very early stage, just after the inception of our company,” said Thomas Ybert, CEO of DNA Script. “Since then, they have helped us on a daily basis to build DNA Script from the ground up. The team brings a strong expertise in the technology as well as one of the broadest global networks in the industry. Importantly, they also provide unconditional support and coaching to our entrepreneurs – whatever the challenge at hand,” he said.

This new funding reaffirms Sofinnova Partners’ investment strategy in the industrial biotech field, initiated in 2009. As a pioneer in this emerging and rapidly growing sector, Sofinnova Partners has a portfolio of 14 industrial biotech companies, backed through two dedicated funds: Sofinnova Green Seed Fund, which raised €22.5M in 2012, and Sofinnova IB I, which raised €125M in 2017.

About DNA Script
Founded in 2014 in Paris, DNA Script is the world’s leading company in manufacturing de novo synthetic nucleic acids using an enzymatic technology. The company aims to accelerate innovation in life sciences and technology through rapid, affordable and high-quality DNA synthesis. DNA Script’s approach leverages billions of years of natural evolution to enable genome-scale synthesis. The company’s technology has the potential to greatly accelerate the development of new therapeutics, enhanced diagnostics, sustainable chemical production, improved crops and DNA data storage.
www.dnascript.co

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, the firm brings together a team of professionals from all over Europe, the U.S. 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 €2 billion under management.
For more information: http://sofinnovapartners.com/.

Press contact for Sofinnova Partners

International
Kate Barrette
RooneyPartners LLC
kbarrette@rooneyco.com

France
Anne Rein
S&I
+ 33 6 03 35 92 05
anne.rein@strategiesimage.com

17/03/2016

Funds to support the expansion of Gecko’s biopolymers platform through clinical development and approval for multiple applications in tissue reconstruction.
Financing includes Bpifrance, and historical investors.

Paris, France, March 17, 2016 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue healing, has closed a €22.5 million financing round. This series A2 round was led by Sofinnova Partners, which becomes the largest investor in Gecko, with support from Bpifranceand existing series A investors Omnes Capital, CM-CIC Innovation and CapDecisif Management, who invested in the company in December 2013. In conjunction with the financing, Antoine Papiernik at Sofinnova Partners and Chahra Louafi at Bpifrance have joined Gecko’s Board of Directors.

Gecko was co-founded by Christophe Bancel and Bernard Gilly (both from the iBionext Network), Prof Jeff Karp (Harvard Medical School, Brigham and Women’s Hospital – Boston, MA, USA) and Prof Bob Langer (Massachusetts Institute of Technology – Cambridge, MA, USA) in late 2013 to advance a state-of-the-art polymer platform. One of its lead inventors, Dr Maria Pereira, was named a Forbes 2015 “30 under 30.” Pereira is Gecko’s Head of Research.

The funds raised will be used to further advance the development of Gecko’s first platform GB-02 for cardiovascular reconstruction and beyond. In addition, the funds will be used to leverage its fully industrialized platform in novel areas including guided tissue repair and localized drug delivery.

Gecko’s platform has demonstrated its ability to be fully industrialized, with a unique level of biocompatibility and a great potential in terms of versatility.

This platform is based on proprietary polymers with unique chemical and physical properties, including high viscosity, hydrophobicity and fast “on demand” curing for precise local delivery and in situ adhesion. Upon curing, an elastic biodegradable film is formed. The structure of the polymer is tunable, allowing customization for various applications and tissues.

Christophe Bancel, Gecko’s CEO, commented: “Our investors’ support will enable us to complete our international clinical plans in cardiovascular surgery, which, if positive, will allow us to seek our first regulatory approval within one year. In addition, the funds will be used to expand our GB-02 platform to additional applications in tissue reconstruction. We will also drive the development of our next-generation polymer GB-04, for sutureless closure.”

Antoine Papiernik, Managing Partner at Sofinnova Partners, added: “We are thrilled to be involved with Gecko Biomedical, a company which combines all the key features we are looking for when investing in a company: a very strong management team and a world-class platform technology with a multitude of possible paradigm-shifting applications.”

 

About Gecko
Gecko Biomedical is a privately owned medical device company based in Paris, France that is dedicated to the rapid development and commercialization of a unique biopolymers platform.
Gecko’s first product (GB-02) is an innovative polymer for tissue healing, targeting cardiovascular reconstruction as an initial indication. The structure of GB-02 is tunable, allowing customization for various applications and tissues. Gecko’s biopolymers platform is fully industrialized and highly versatile, with potential novel applications in other fields of tissue reconstruction, such as guided tissue repair and localized drug delivery.
Gecko’s platform is based on proprietary biopolymers with unique chemical and physical properties, including high viscosity, hydrophobicity and fast “on demand” curing for precise local delivery and in situ adhesion.
The Company’s technologies are derived from world-class research and intellectual property from the laboratories of Pr Robert Langer (MIT) and Pr Jeff Karp (Brigham and Women’s Hospital), who co-founded the company in 2013, alongside Christophe Bancel and Bernard Gilly from the iBionext Network. For more information, please visit: www.geckobiomedical.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr

About Bpifrance
Bpifrance, a subsidiary of the Caisse des Dépôts and the French State, a trusted partner for entrepreneurs, supports companies from start-up to their listing on the stock market, through credit, guarantees and equity. Bpifrance also provides support services and enhanced support for innovation, external growth and export in partnership with Business France and Coface. Bpifrance offers companies a funding continuum for each key stage of their development together with services adapted to different regional needs. Through its 42 regional offices (90% of decisions are taken in region), Bpifrance represents a true financially competitive service for entrepreneurs. Bpifrance acts in support of public policies implemented by the State and the Regional authorities to meet three objectives: support business growth; prepare for future competitiveness; contribute to the development of an ecosystem favourable to entrepreneurship. With Bpifrance, companies have a powerful, close and efficient partner to meet all their needs for funding, innovation and investment. For more information go to: www.bpifrance.fr – Follow us on Twitter: @bpifrance

About CM-CIC Innovation
CM-CIC Innovation is a subsidiary of CM-CIC Investissement, the Crédit Mutuel – CIC group’s investment and merchant bank division. With more than 2.6 billion Euros worth of equity under management and over 600 portfolio companies, CM-CIC Investissement is a key player in capital investment in France, backed by its own equity resources. CM-CIC Innovation is specialized in investment and support for high-potential growth companies, with strong technology expertise, in the first stages of their development. It finances firms positioned on sectors such as life sciences, information technology, industrial innovations or environment. For more information go to: www.cmcic-investissement.com

About Omnes Capital
Omnes Capital is a major player in private equity and infrastructure. With €2.1 billion in assets under management, Omnes capital provides companies with the capital needed to finance their growth and with key expertise in a number of areas: Buyout & Growth Capital, Private Debt, Venture Capital, Renewable Energy, Co-Investment, Secondary Funds of Funds. Omnes Capital was a subsidiary of Crédit Agricole until March 2012. The firm is now owned by its employees. Omnes Capital is a signatory to the United Nations Principles for Responsible Investment (PRI). For more information go to: www.omnescapital.com

About CapDecisif Management
CapDecisif Management is an investment management company approved by the AMF (French Financial Markets Authority). Our team currently manages €110m over five different funds amongst which FPCI CapDecisif 3, G1J IdF and Regional Co-Investment Funds (FRCI). CapDecisif Management focuses on venture capital startups and invests mainly in upstream, innovative companies with high-growth potential, and which are located primarily in the Paris region. CapDecisif 3 is supported by the French National Seed Fund, managed by Bpifrance investment within the framework of the “Investissements d’Avenir”, and Paris Region. For more information go to: www.cap-decisif.com

 

PRESS CONTACTS
For Gecko
Christophe BANCEL Tel: +33 1 76 21 72 28 cbancel@geckobiomedical.com
Twitter: @geckobiomedical
For Sofinnova Partners
Anne REIN Tel: +33 6 03 35 92 05 anne.rein@strategiesimage.com

For Bpifrance
Nathalie POLICE Tél : + 33 1 41 79 95 26 nathalie.police@bpifrance.fr

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

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

09/03/2016

Burntisland, Scotland, March 10th 2016. CelluComp, a sustainable materials company, announces the closing of a £3.7 Million funding round. The funding was lead by FPCI CapAgro Innovation, with follow-on investments from Sofinnova Partners, and Scottish Enterprise through its investment arm, the Scottish Investment Bank (SIB), as well as a syndicate of angel investors.

CelluComp uses a proprietary technology to extract nano-cellulose fibres from the waste streams of root vegetables to produce a unique product called Curran®. Curran® provides a high performing, environmentally-sound and economically-viable solution for reinforcement and rheology (thickening) in multiple industries, such as paints & coatings, paper, food, home and personal care, concrete, oil drilling and composites. To-date, CelluComp has focused its attention on the coatings and paper industries. Unlike competing solutions from wood, Curran® is able to reach attractive cost targets thus enabling mass-market applications. CelluComp built its first production facility in Scotland in 2015 and plans further capacity and commercial expansion in the near future. CelluComp has benefited from its existing partnerships and will continue to work with partners to expand capacity and commercial reach.

Christian Kemp-Griffin, CEO of CelluComp, commented: “Along with founders David Hepworth and Eric Whale I am extremely pleased to have raised this round of financing with such important partners. This investment not only gives the company the needed funds to build our production capacity and commercial development but also brings a combined level of expertise and professionalism that will allow the company to accelerate its success. ”

Jean-Baptiste Cuisinier, Chairman of CapAgro, the first venture capital fund in France to be dedicated to innovation in agriculture, food and renewable chemistry and energies, expressed how pleased he was to invest in such a dynamic young company that not only showed terrific promise but also provided economic and environmental solutions for the agricultural sector.

Joško Bobanović, Partner at Sofinnova Partners, added: “Since our initial investment CelluComp has progressed significantly and surpassed our expectations. With existing production capacity, the company is ready to develop interesting markets and prepare for the next phase of growth. We look forward to continue supporting the team in the future.”

Kerry Sharp, Head of the Scottish Investment Bank, said “Scottish Enterprise has worked with CelluComp since the beginning, and we are pleased to see the company expanding globally and attracting further international investment. Last year CelluComp established Scotland’s first bio-based production facility, and this new round of investment will help support the expansion of the company’s manufacturing facilities in line with the ambition of Scotland’s National Plan for Industrial Biotechnology. We look forward to working with CelluComp as it continues to develop.”

For further details, please contact:
Christian Kemp-Griffin Tel: + 33 (0)6 82 83 00 32, e-mail: ckgriffin@cellucomp.com

Notes to Editors:

CelluComp is Scottish-based materials Start-up Company that manufactures and markets sustainable products produced from the waste streams of the food industry. CelluComp launched its business in 2004 with the research and development of Curran®, a material derived from nano-cellulose of sugar beets. Curran® provides multiple solutions for many industries such as paints & coatings, paper, food, concrete, home & personal care, oil drilling and composites. CelluComp’s vision is to activate change in the way the world uses materials by creating Material Change for Good.
More information is available at.www.cellucomp.com

CapAgro is supported by eight leading industrial groups and financial institutions that are closely involved in the development of agriculture, the food industry and green chemistry. Created in September 2014, the venture capital firm focuses on projects related to sustainable farming, quality and nutrition in the food industry and biomass conversion. With nearly €60 million of funds under management, CapAgro is already supporting 11 innovative companies mostly in Europe.

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 Europe’s key entrepreneurs in the Life Sciences industry. With €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. www.sofinnova.fr

The Scottish Investment Bank (SIB) is the investment arm of Scotland’s main economic development agency, Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise. It manages a suite of co- investment funds including the Scottish Co-investment Fund and the Scottish Venture Fund, which are partly funded by the European Regional Development Fund (ERDF), Renewable Energy Investment Fund and the Scottish Recycling Fund. SIB is the cornerstone investor in the privately managed Scottish Loan Fund, managed by Maven Capital Partners and an investor in Epidarex Capital’s life sciences fund. Our investment funds support Scotland’s SME funding market to ensure businesses with growth and export potential have adequate access to growth capital. We also provide a team of Financial Readiness specialists to help companies prepare for new investment and access appropriate finance.
www.scottish-enterprise.com/sib

24/02/2016

A major step forward in bionic vision for patients with retinitis pigmentosa1452269936_pixium_004

Paris, France – February 24, 2016 – Pixium Vision (FR0011950641 – PIX) a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, announces today the first implant and successful activation of IRIS® II, the only epi-retinal implant with 150 electrodes, intended for patients who have lost sight as a result of retinitis pigmentosa (RP).
The first human implant of IRIS® II was successfully performed in January, by Professor Michel Weber, Head of Ophthalmology at the University Hospital of Nantes, France. This is part of Pixium Vision’s ongoing clinical trial to assess the safety and performance of IRIS® II as a treatment to compensate for blindness by providing a form of bionic vision and enabling greater autonomy for patients.
Professor Weber commented: “This first implant was successfully completed for the 58 year old retinitis pigmentosa patient. With the implant design and its smart retinal fixation, the procedure is close to the surgical techniques familiar to the retinal surgeons.” Pr. Weber added: “After many years in darkness, the patient was activated and reported first perception of light. Per clinical protocol, the patient will now enter training to learn how to interpret the light signals.”

The implant activation and first light perception provide tangible evidence of visual perception. It precedes the normal rehabilitation process where, per protocol, the patient learns to interpret the bionic vision.
Dr Yannick Le Mer, a pioneer in retinal implant surgery at the Fondation Ophtalmologique Rothschild in Paris (a centre of excellence for ophthalmic surgery participating in the study with Hôpital des QuinzeVingts) added: “The new IRIS®II implant represents a major step forward for patients with retinitis pigmentosa: the intervention is relatively quick thanks to the design of the implant and it is now equipped with 150 electrodes, close to three time more than currently available. Epi-retinal approach is currently the less invasive and most optimal solution to allow retinitis pigmentosa patients to emerge from darkness.”
Khalid Ishaque, CEO of Pixium Vision, said: “The first implant and activation of IRIS® II, with its innovative features, is an exciting and major advance in the field of bionic vision development, interfacing the eye and the brain. Pixium Vision is dedicated to conceive, develop and bring meaningful bionic vision innovations to surgeons, enabling them to treat patients who have lost sight.” Up to 10 patients will be included in the ongoing clinical trial in several specialized centres in Europe. In December 2015, Pixium Vision filed for CE mark. Subject to CE mark approval, IRIS® II should be commercially available around mid-2016.

IRIS® II incorporates innovative characteristics:
– A smart bio-inspired camera that is intended to function like the human eye: the sensor does not take a sequence of video frames, essentially composed of redundant information, but continuously captures the changes in a visual scene with its time independent pixels;
– An epi-retinal implant with 150 electrodes, almost three times more electrodes than available today;
– An explantable design: the electrode array is secured on the retinal surface by a patented support system that allows explantation, minimizing risk of retinal damage and permitting potential for upgrade to newer therapy options.
Earlier in the year, Pixium Vision also announced promising pre-clinical safety data1 for its next generation PRIMA implant, a miniaturized wireless sub-retinal implant in preparation for the first in human feasibility study later this year.

About the IRIS® II clinical study:
Study title: “Compensation for Blindness with the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)”
https://clinicaltrials.gov/ct2/show/NCT02670980?term=Compensation+for+Blindness+with+the+Intelligent+R etinal+Implant+System+%28IRIS+V2%29+in+Patients+With+Retinal+Dystrophy+%28IRIS+2%29&rank=1
The IRIS® II clinical trial is a multi-centric, open label, non-randomized prospective European study to assess safety and performance of the IRIS® II bionic vision system as treatment to compensate for blindness, providing a form of perception for blind persons and enabling them greater autonomy and quality of living. Up to 10 patients suffering from retinitis pigmentosa, Cone-Rod dystrophy, choroideremia will be included and followed for a minimum of 18 months and an additional 18 months, subject to patient agreement. Clinical trials are currently underway in 7 centers below. Additional centers are being opened in United Kingdom and Spain.

– Hôpital des Quinze-Vingts et la Fondation
Ophtalmologique Rothschild, Paris (France)
Contact: Dr Saddek Mohand-Said
28, Rue de Charenton, 75012 Paris, France
Tel: +33 1 40 02 14 04

– Klinik und Poliklinik für Augenheilkunde Hamburg –
Eppendorf (Germany)
Contact: Dr. Matthias Keserü
Martinistraße 52, 20246 Hamburg, Germany
Tel: +49 40 7410 18878

– CHU de Nantes Clinique Ophtalmologique (France)
Contact: Prof. Michel Weber
1 Place Alexis Ricordeau, 44000 Nantes, France
Tel : +33 2 40 08 36 22

– Dept. of Ophthalmology, University of Bonn (Germany)
Contact: Prof. Dr. Frank G. Holz, Prof. Peter Charbel Issa
Ernst-Abbe -Str. 2, 53127 Bonn, Germany
Tel: +49 228 287 1564 7

– CHU Nimes, Service Ophtalmologie (France)
Contact: Dr. Gérard Dupeyron
Place du Pr. Robert Debré, 30029 Nimes Cedex 9, France
Tel : +33 4 66 68 32 71

– Universitäts Klinikum Klinik für Augenheilkunde
Freiburg (Germany)
Contact: Prof. Hansjürgen Agostini
Kilianstrasse 5, 79106 Freiburg, Germany
Phone: +49 761 270 40060

– Augenklinik der Medizinischen Universtaet Graz
(Austria)
Contact: Prof. Michaela Velikay – Parel
Auenbruggerplatz 4, 8036 Graz, Austria
Tel: +43 316 385 3817
About Pixium Vision (www.pixium-vision.com)
Pixium Vision’s Mission is to create a world of bionic vision for those who have lost their sight enabling them to regain partial perception and greater autonomy and improved quality of daily living. Pixium Vision is the only company today developing in parallel 2 innovative bionic retinal implant systems, which incorporate active implantable prostheses intended to treat and compensate for blindness resulting from the degeneration of retinal photoreceptor cells. The Company harnesses the rapid advances in neuroscience, neuromorphic visual processing, microelectronics / nanoelectronics, optoelectronics, neurobiology and intelligent software algorithms.
These bionic systems are intended for blind people whose optic nerve remains functional. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period. European Clinical trials are currently underway with IRIS®, the company’s first bionic vision system. Patients have tolerated their implants well so far and improvements in visual perception have been observed. Pixium Vision has filed IRIS’s CE mark dossier at the end of 2015 and expects CE mark approval by mid-2016.
Pixium Vision is, in parallel, also developing PRIMA, a sub retinal miniaturized wireless implant platform currently in preclinical studies. The Company plans to begin clinical trials with PRIMA in Europe in 2016.
The company is EN ISO 13485 certified.
Pixium Vision maintains close collaborations with academic and research partnerships spanning across the prestigious Vision Institute in Paris, the Hansen Experimental Physics Laboratory at Stanford University, as well as several global scientific, medical, clinical, and technology experts, resulting also in strong intellectual property portfolio.
Pixium Vision is listed on Euronext (Compartiment C) in Paris.
ISIN: FR0011950641; Mnemo: PIX
IRIS® is a trademark of Pixium-Vision SA

Contacts

Pixium Vision
Pierre Kemula, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
@PixiumVision
Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Daphné Boccara – dboccara@newcap.fr
+33 1 44 71 94 93

Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 “Risk Factors” of the company’s Registration Document filed with the AMF under number R15- 069 on September 23, 2015 which can be found on the websites of the AMF – AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).

24/02/2016

Une avancée majeure pour la vision bionique chez les patients atteints de rétinite pigmentaire1452269936_pixium_004

Pixium Vision (Paris:PIX) (FR0011950641 – PIX), société qui développe des systèmes de vision bionique innovants pour permettre aux patients ayant perdu la vue de vivre de façon plus autonome, annonce aujourd’hui la première implantation et le succès de l’activation d’IRIS® II, seul implant épi-rétinien équipé de 150 électrodes, destiné à des patients devenus aveugles d’une rétinite pigmentaire.
La première implantation mondiale d’IRIS® II a été réalisée avec succès en janvier à Nantes, par le Pr. Weber, chef du service d’ophtalmologie du CHU de Nantes. Elle s’inscrit dans le cadre de l’étude clinique menée par Pixium Vision, qui vise à démontrer la sécurité et les performances d’IRIS® II comme traitement pour compenser la cécité et fournir une vision bionique aux personnes aveugles afin de leur rendre une plus grande autonomie.
Pour le Pr. Weber, « Cette première mondiale, réalisée chez un patient de 58 ans s’est dérouléeavec succès. La conception de l’implant ainsi que sa fixation sur la rétine, rendent la procédure chirurgicale aisée, similaire au protocole habituellement observé par les chirurgiens rétiniens.» Pr. Weber a ajouté: “Après des années dans le noir, le patient a été activé. Il a déclaré percevoir des premiers signaux lumineux. En accord avec le protocole clinique, le patient va maintenant commencer sa rééducation pour apprendre à interpréter ces signaux lumineux.”
L’activation de l’implant et les premières perceptions lumineuses sont un premier témoignage tangible de perception visuelle. Elles précèdent la rééducation qui, en accord avec le protocole clinique, permet au patient d’apprendre à interpréter la vision bionique.
Dr. Yannick Le Mer, pionnier de la chirurgie des implants rétiniens à la Fondation Ophtalmologique Rothschild à Paris (un centre d’excellence de chirurgie ophtalmique qui participe à l’étude clinique avec l’Hôpital des Quinze-Vingts) a ajouté : « Le nouvel implant IRIS® II constitue une avancée majeure pour les patients atteints de rétinite pigmentaire : sa conception rend l’intervention chirurgicale relativement rapide et il est maintenant équipé de 150 électrodes soit presque trois fois plus que celui actuellement disponible. L’approche épi-rétinienne est aujourd’hui la solution la moins invasive et la plus optimale pour permettre aux patients atteints de rétinite pigmentaire de sortir de l’obscurité.»
Pour Khalid Ishaque, Directeur Général de Pixium Vision, « Avec ses fonctionnalités innovantes, la première implantation et activation d’IRIS® II représente un progrès important et passionnant dans le domaine du développement de la vision bionique,interface de l’œil et du cerveau. Pixium Vision se consacre à la conception et au développement de la vision bionique pour apporter des innovations significatives aux chirurgiens pour traiterles patients ayant perdu la vue. »
Jusqu’à 10 patients seront implantés dans plusieurs centres spécialisés en Europe. En décembre 2015, Pixium Vision a déposé un dossier de marquage CE. Sous réserve de son obtention, le lancement commercial d’IRIS® II devrait débuter vers mi- 2016.
IRIS® II intègre des caractéristiques innovantes :
• Une caméra bio-inspirée intelligente reproduisant le fonctionnement de l’œil humain : le capteur ne prend pas de clichés successifs, composés principalement d’informations redondantes, mais visualise à chaque instant avec ses pixels asynchrones, l’ensemble des évènements nouveaux ;
• Un implant épi-rétinien équipé de 150 électrodes, soit presque trois fois que ce qu’il se fait actuellement ;
• Un implant conçu pour être explantable : les électrodes sont maintenues en contact avec la surface de la rétine par un système de support breveté qui permet l’explantation sans dégrader la rétine et ainsi le remplacement ou l’upgrade du système.
Plus tôt cette année, Pixium Vision a aussi annoncé des données précliniques de sécurité prometteuses pour son implant de prochaine génération, PRIMA, un implant sous rétinien miniaturisé, sans fil dont l’étude de faisabilité chez l’homme devrait débuter avant la fin de l’année.

A propos de l’étude clinique d’IRIS® II
Titre de l’étude : « Compensation de la cécité à l’aide du système d’implant rétinien intelligent (IRIS 2) chez des patients atteints de dystrophie rétinienne »
https://clinicaltrials.gov/ct2/show/NCT02670980?term=Compensation+for+Blindness+with+the+Intelligent+Retinal+Implant+System+%28IRIS+V2%29+in+Patients+With+Retinal+Dystrophy+%28IRIS+2%29&rank=1
L’essai clinique IRIS® II est multicentrique, européen prospectif, ouvert et non randomisé visant à évaluer l’innocuité et la performance du système comme traitement pour compenser la cécité et fournir des perceptions visuelles aux personnes aveugles pour leur rendre une plus grande autonomie et une meilleure qualité de vie.
Jusqu’à 10 patients souffrant de rétinite pigmentaire, de dystrophie des cônes et de bâtonnets, ou encore de Choroïdérémie seront implantés dans le cadre de cette étude et seront suivis sur une durée minimale de 18 mois et maximale de 36 mois si le patient choisit de continuer sur une durée de 18 mois de suivi supplémentaire.
Les essais cliniques sont actuellement en cours dans les 7 centres ci-dessous. Des centres supplémentaires sont en cours d’ouverture en Grande Bretagne et en Espagne.
• Hôpital des Quinze-Vingts et la Fondation
Ophtalmologique Rothschild à Paris (France)
Contact: Dr. Saddek Mohand-Said
28, Rue de Charenton, 75012 Paris, France
Tel: +33 1 40 02 14 04
• Klinik und Poliklinik für Augenheilkunde Hamburg –
Eppendorf (Allemagne)
Contact: Dr. Matthias Keserü
Martinistraße 52, 20246 Hamburg, Allemagne
Tel: +49 40 7410 18878
• CHU de Nantes Clinique Ophtalmologique (France)
Contact: Prof. Michel Weber
1 Place Alexis Ricordeau, 44000 Nantes, France
Tel : +33 2 40 08 36 22
• Dept. of Ophthalmology, University of Bonn
(Allemagne)
Contact: Prof. Dr. Frank G. Holz, Prof. Peter Charbel Issa
Ernst-Abbe -Str. 2, 53127 Bonn, Allemagne
Tel: +49 228 287 1564 7
• CHU Nimes, Service Ophtalmologie (France)
Contact: Dr. Gérard Dupeyron
Place du Pr. Robert Debré, 30029 Nimes Cedex 9, France
Tel : +33 4 66 68 32 71
• Universitäts Klinikum Klinik für Augenheilkunde
Freiburg (Allemagne)
Contact: Prof. Hansjürgen Agostini
Kilianstrasse 5, 79106 Freiburg, Allemagne
Phone: +49 761 270 40060
• Augenklinik der Medizinischen Universtaet Graz
(Autriche)
Contact: Prof. Michaela Velikay – Parel
Auenbruggerplatz 4, 8036 Graz, Autriche
Tel: +43 316 385 3817

A propos de Pixium Vision (www.pixium-vision.com, @PixiumVision)
Pixium Vision développe des systèmes de vision bionique innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les systèmes de Pixium Vision sont des systèmes composés de plusieurs éléments de haute technologie associés à une intervention chirurgicale et à une période de rééducation. Ils visent à offrir à terme aux patients une vision aussi proche que possible de la normale.
Le système IRIS® est actuellement en phase d’essais cliniques dans plusieurs centres en Europe. Les patients supportent bien leur implant à ce jour et des améliorations de la perception visuelle des patients aveugles sont observées. La société a déposé le dossier de Marquage CE à la fin 2015 et anticipe l’obtention du marquage CE vers mi-2016.
Pixium Vision développe également PRIMA, un implant sous-rétinien miniaturisé, sans fil, qui est actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.
La société est certifiée EN ISO 13485.
Pixium Vision travaille en étroite collaboration avec des partenaires académiques de renommée mondiale tels que l’Institut de la Vision à Paris et le Laboratoire de physique expérimentale Hansen à l’Université Stanford.
Pixium Vision est coté sur Euronext (Compartiment C) à Paris.
ISIN: FR0011950641 ; Mnemo: PIX
IRIS® est une marque déposée de Pixium-Vision SA

Avertissement :
Le présent communiqué contient de manière implicite ou expresse certaines déclarations prospectives relatives à Pixium Vision et à son activité. Ces déclarations dépendent de certains risques connus ou non, d’incertitudes, ainsi que d’autres facteurs, qui pourraient conduire à ce que les résultats réels, les conditions financières, les performances ou réalisations de Pixium Vision diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés ou sous-entendus dans ces déclarations prospectives.
Pixium Vision émet ce communiqué à la présente date et ne s’engage pas à mettre à jour les déclarations prospectives qui y sont contenues, que ce soit par suite de nouvelles informations, événements futurs ou autres.
Pour une description des risques et incertitudes de nature à entraîner une différence entre les résultats réels, les conditions financières, les performances ou les réalisations de Pixium Vision et ceux contenus dans les déclarations prospectives, veuillez-vous référer au chapitre 4 « Facteurs de risques » du document de référence de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro R15-069 le 23 septembre 2015, lequel peut être consulté sur les sites de l’Autorité des marchés – AMF (www.amf-france.org) et de Pixium Vision (www.pixium-vision.com).

Contacts
Pixium Vision
Pierre Kemula, +33 1 76 21 47 68
CFO
investors@pixium-vision.com
@PixiumVision
ou
Relations Presse
Newcap Media
Annie-Florence Loyer, +33 1 44 71 00 12 / +33 6 88 20 35 59

23/02/2016

US FDA Approves ReCor Medical Investigational Device Exemption for the RADIANCE-HTN Clinical Trial to Study Treatment Effect of Paradise® Renal Denervation System in Patients with Hypertension
PALO ALTO, Calif. and AMSTERDAM, Feb. 22, 2016 – ReCor Medical announced today that it has received FDA IDE approval for the 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: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.

RADIANCE-HTN will be led by two Co-Primary Investigators (Co-PIs): Professor Michel Azizi, MD PhD (Georges Pompidou Hospital, Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women’s Hospital, Boston, MA). The study is approved to enroll 292 patients at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands. Initial patient enrollment is anticipated in the first quarter of 2016.

Professor Azizi, Co-PI and lead author of the landmark DENER-HTN study, commented; “Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The RADIANCE-HTN trial design will allow us to evaluate the efficacy of the Paradise System in a broad population of hypertensive patients across the hypertension spectrum.”

“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” added Co-PI Dr. Mauri. “We believe that the Paradise System, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events. RADIANCE-HTN’s blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”

Leslie Coleman, DVM, ReCor Vice President of Regulatory and Medical Affairs commented; “We believe that our innovative trial design, evaluating patients both off and on a standard antihypertensive drug regimen, will provide unique insights into the blood pressure effect of our Paradise System.”

“FDA IDE approval of the RADIANCE-HTN trial positions ReCor as one of the few companies in the field who are investing in randomized, blinded and sham-controlled studies with the co-leadership from the hypertension and interventional physician communities,” commented ReCor CEO Andrew M. Weiss. “We believe that this physician partnership is essential for the future establishment of RDN as a standard of care for the treatment of hypertension.”

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 option for 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.

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.

SOURCE ReCor Medical

RELATED LINKS
http://www.recormedical.com

23/02/2016

US FDA Approves ReCor Medical Investigational Device Exemption for the RADIANCE-HTN Clinical Trial to Study Treatment Effect of Paradise® Renal Denervation System in Patients with Hypertension
PALO ALTO, Calif. and AMSTERDAM, Feb. 22, 2016 – ReCor Medical announced today that it has received FDA IDE approval for the 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: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.

RADIANCE-HTN will be led by two Co-Primary Investigators (Co-PIs): Professor Michel Azizi, MD PhD (Georges Pompidou Hospital, Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women’s Hospital, Boston, MA). The study is approved to enroll 292 patients at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands. Initial patient enrollment is anticipated in the first quarter of 2016.

Professor Azizi, Co-PI and lead author of the landmark DENER-HTN study, commented; “Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The RADIANCE-HTN trial design will allow us to evaluate the efficacy of the Paradise System in a broad population of hypertensive patients across the hypertension spectrum.”

“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” added Co-PI Dr. Mauri. “We believe that the Paradise System, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events. RADIANCE-HTN’s blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”

Leslie Coleman, DVM, ReCor Vice President of Regulatory and Medical Affairs commented; “We believe that our innovative trial design, evaluating patients both off and on a standard antihypertensive drug regimen, will provide unique insights into the blood pressure effect of our Paradise System.”

“FDA IDE approval of the RADIANCE-HTN trial positions ReCor as one of the few companies in the field who are investing in randomized, blinded and sham-controlled studies with the co-leadership from the hypertension and interventional physician communities,” commented ReCor CEO Andrew M. Weiss. “We believe that this physician partnership is essential for the future establishment of RDN as a standard of care for the treatment of hypertension.”

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 option for 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.

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.

SOURCE ReCor Medical

RELATED LINKS
http://www.recormedical.com

18/02/2016

Company Announces Licensing Agreement with AstraZeneca

Boston, MA, [February 17th. 2016] — Corvidia Therapeutics, a biotechnology company focused on the development of precision cardiovascular therapies, announced today that it has raised $26 million in a Series A financing, co-led by seed-investor Sofinnova Partners, and Apple Tree Partners.
Concurrent with the financing, Corvidia has licensed a clinical stage compound from AstraZeneca to develop and commercialize as its lead therapeutic (COR-001). Funds from the Series A financing will be used to progress COR-001 into Phase I/II clinical trials during 2016, as well as to advance the company’s preclinical pipeline.
Corvidia was co-founded by serial entrepreneur and Chief Executive Officer, Michael Davidson, M.D. Dr. Davidson, a recognized expert in the field of cardiology, previously served as Chief Medical Officer of Sofinnova-backed Omthera Pharmaceuticals, and was instrumental in the successful acquisition of that company by AstraZeneca in 2013 for $443 million. Joining Dr. Davidson at Corvidia are Co-founders Rahul Kakkar M.D. and Matt Devalaraja, Ph.D., both of whom previously worked in AstraZeneca’s Emerging Innovations Unit, where they developed the science behind genome-guided cardiovascular therapies. Ram Aiyar Ph.D., MBA, an Entrepreneur-in-Residence at the National Institutes of Health and BioHealth Innovation, completes Corvidia’s founding team.
Commenting on today’s news, Dr. Davidson stated, “Our ability to complete this significant Series A financing with such high-quality investors is a testament to the promise of our technology and expertise of our management team, positioning Corvidia as a leader in the field of precision medicine as applied to cardiovascular diseases. With these funds, we aim to drive each of our assets through clinical trials and validate our precision medicine approach.”
Graziano Seghezzi, Partner at Sofinnova Partners, and Corvidia’s board member commented, “Given Omthera’s success, we were strongly in favor of teaming up once again with Dr. Davidson. The seed funding that Sofinnova Partners provided allowed for Corvidia’s inception, for the pipeline crafting and for the eventual structuring of the Series A. We are pleased to continue to support Corvidia and this latest financing represents a major step for the future advancement of novel, cardiovascular therapeutics.”
Seth Harrison, M.D., Managing Partner of Apple Tree Partners, noted, “In our years of start-up investing we have not seen a better team than the group that Michael Davidson has
assembled from AstraZeneca and the NIH. We are thrilled to be able to support Corvidia with our capital resources and company building experience, and look forward to working with Sofinnova Partners, AstraZeneca, and management to create the first great precision cardiovascular medicine company “
COR-001, a monoclonal antibody initially developed by MedImmune, AstraZeneca’s global biologics research and development arm, was previously in a Phase 1 study for a different indication. It was repurposed by AstraZeneca’s Emerging Innovations Unit, Scientific Partnering and Alliances (SP&A), prior to licensing to Corvidia. “This is another example of the strong entrepreneurial culture within AstraZeneca, where we push the boundaries of science to explore new therapeutic uses for our compounds. We will continue to divest or out-license assets where we believe it will help accelerate the development of new medicines.” said Kumar Srinivasan, Vice President, SP&A, Innovative Medicines Unit, AstraZeneca.
In conjunction with the financing, Seth Harrison and Adrien Lemoine, Executive Director, Corporate Development for AstraZeneca, will join Graziano Seghezzi and Michael Davidson on Corvidia’s Board of Directors.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr

About Apple Tree Partners
Apple Tree Partners (ATP) is a venture capital firm that invests in pharmaceuticals, biotech, medtech, and healthcare services. Founded in 1999, with a history of well-known successes,
ATP closed its current capital pool of $1.5 billion in 2012 and is actively funding healthcare innovation. ATP starts companies, or invests in existing companies, with commitments as high as $250 million. The firm is headquartered in New York City, with satellite offices in Princeton, NJ, Cambridge, MA, and Los Altos, CA. For more information, please visit: www.appletreepartners.com

About Corvidia Therapeutics
Based in Boston, MA, Corvidia is a biotechnology company pioneering the next generation of cardiovascular therapies. Leveraging functional genomics, the company’s founding team has decoded previously unrecognized genetic susceptibilities within general cardiovascular populations. Corvidia’s pipeline programs precisely identify patients with unique sensitivity to specific biologic pathways, potentially allowing for the rapid development of therapies targeting those pathways. For more information, please visit: www.corvidiatx.com

PRESS CONTACTS
For Corvidia Therapeutics
Media Contact: Paula Schwartz, pschwartz@rxir.com, Tel: +1 917-322-2216
Contact: Ram Aiyar, ram@corvidiatx.com

For Apple Tree Partners
Contact : Aaron Kantoff, aaron@appletreepartners.com

For Sofinnova Partners
Media Contact : Anne REIN, anne.rein@strategiesimage.com, Tel: +33 (0)6 03 35 92 05

18/02/2016

La société annonce un accord de licence avec AstraZeneca
Boston (Etats Unis, MA), 17 février 2016 — Corvidia Therapeutics, une société de biotechnologie spécialisée dans le développement de thérapies cardiovasculaires personnalisées, annonce avoir levé 26 M$ (23 M€) lors d’un financement de série A co-mené par Sofinnova Partners, investisseur depuis l’amorçage, et Apple Tree Partners.
Parallèlement au financement, Corvidia a signé un accord de licence avec AstraZeneca, plc pour développer et commercialiser sa molécule phare, COR-001, actuellement en phase préclinique. Les fonds levés vont permettre de démarrer les études cliniques de Phase I/II courant 2016 sur COR-001 et d’accélérer le déploiement des programmes pour les autres molécules de la société en phase précliniques.
Corvidia a été co-fondée par Dr. Michael Davidson, M.D., un serial entrepreneur et expert reconnu dans le domaine de la cardiologie. Dr. Michael Davidson était précédemment Directeur médical d’Omthera Pharmaceutical, une société de biotechnologie financée par Sofinnova Partners, et rachetée par AstraZeneca en 2013 pour $443 million. Les autres co-fondateurs de Corvidia sont Rahul Kakkar M.D. et Matt Devalaraja, Ph.D., qui ont développé au sein de l’unité Innovations émergentes d’AstraZeneca la technologie à la base de la thérapie génie cardiovasculaire de Corvidia, ainsi que Ram Aiyar Ph.D., MBA, entrepreneur en résidence à l’Institut national de l’innovation en santé et biosanté.
Dr. Davidson déclare “La réalisation d’un financement de série A, porté par des investisseurs d’une telle qualité, est un gage de confiance pour la technologie et le talent de notre équipe, qui place Corvidia en position de leader dans le domaine de la médicine personnalisée appliquée aux maladies cardiovasculaires. Avec ces fonds, nous pourrons déployer les essais cliniques sur nos molécules en vue de valider notre approche en matière de médecine de précision”.
Graziano Seghezzi, Partner chez Sofinnova Partners, et membre du Conseil d’administration de Corvidia commente : “A la suite du succès d’Omthera’s, nous étions très motivés à l’idée de nous associer de nouveau avec Dr. Davidson. Le financement d’amorçage de Sofinnova Partners a permis de créer la société, mettre en place le pipeline de molécules, et dernièrement constituer ce financement de série A. Nous sommes ravis de continuer à soutenir Corvidia avec ce financement qui représente une étape majeure pour le développement de nouvelles thérapies cardiovasculaires.”
Seth Harrison, Managing Partner d’Apple Tree Partners, poursuit, “ Nous avons rarement vu une équipe aussi talentueuse que celle qu’a réuni Michael Davidson autour du spin off d’AstraZeneca. Nous sommes enchantés de pouvoir soutenir Corvidia avec notre investissement et notre expérience en matière de développement d’entreprise, et sommes ravis de travailler avec Sofinnova Partners, AstraZeneca, et l’équipe de management pour créer la première grande entreprise dédiée à la médecine de précision cardiovasculaire ».
La molécule COR-001 est un anticorps monoclone pour lequel une étude Phase 1 a déjà été réalisée dans le cadre d’une autre indication thérapeutique, et que l’équipe issue d’AstraZeneca a réorienté vers des indications cardiovasculaires, avant de la licencier à Corvidia. “C’est une illustration de la très forte culture entrepreneuriale d’AstraZeneca, qui pousse les limites de la science pour explorer des nouvelles thérapies à partir de nos produits existants. Nous allons continuer à licencier les actifs pour lesquels nous pensons qu’ils peuvent accélérer le développement de nouvelles thérapies”, précise Kumar Srinivasan, Vice-Président, Partenariats scientifiques et alliances, AstraZeneca.
Seth Harrison et Adrien Lemoine, Directeur exécutif Corporate Development d’AstraZeneca, ont rejoint Graziano Seghezzi et Michael Davidson au Conseil d’administration de Corvidia.

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’information : www.sofinnova.com

A propos d’Apple Tree Partners
Apple Tree Partners (ATP) est une société de capital-risque spécialisée dans la pharmacie, la biotech, medtech, et services de santé. Créée en 1999, avec une histoire marquée par de nombreux succès, la société a finalisé un fonds de 1.5 milliard de dollars en 2012 et finance activement l’innovation dans la santé. Apple Tree investit jusqu’à 250 M$ dans des entreprises qui démarrent ou déjà existantes. Apple Tree est basée à New York City (New York), avec des bureaux à Princeton (New Jersey), Cambridge (Massachusetts) et Los Altos (Californie). Pour plus d’information : www.appletreepartners.com

A propos de Corvidia Therapeutics
Basée à Boston (Etats Unis, MA), Corvidia est une société de biotechnologie spécialisée dans les thérapies cardiovasculaires de nouvelles génération. S’appuyant sur la génomie fonctionnelle, la société a décodé une prédisposition génétique inconnue au sein des populations cardiovasculaires. Les molécules du pipeline de Corvidia sont destinées à des patients ayant une sensibilité à certaines voies biologiques particulières, et potentiellement permettront le développement rapide de thérapies ciblant ces voies biologiques. Pour plus d’information : www.corvidiatx.com

CONTACTS PRESSE
Pour Corvidia Therapeutics
Media: Paula Schwartz, pschwartz@rxir.com, Tel: +1 917-322-2216
Corporate: Ram Aiyar, raiyar@corvidiatx.com, Tel: +1 267-273-9999

Pour Apple Tree Partners
Media: Aaron Kantoff, aaron@appletreepartners.com

Pour Sofinnova Partners
Anne REIN, anne.rein@strategiesimage.com, Tel: +33 6 03 35 92 05