What's new?
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

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.

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/

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

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

26/04/2016

LEIDEN, Netherlands, April 25, 2016 – ProQR Therapeutics N.V. (NASDAQ:PRQR) today announced that the company will present pre-clinical data for QR-110 which is being developed for Leber’s congenital amaurosis Type 10 (LCA10) at the 2016 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, WA, May 1 – 5, 2016. QR-110 is the second molecule that will move into clinical development using ProQR’s RNA approach.
ARVO
The p.Cys998X mutation which is a cause of LCA10 is a point mutation in the CEP290 gene resulting in an activation of a cryptic splice site. QR-110 is a single-stranded, chemically modified RNA oligonucleotide designed to skip the cryptic splice site and thus result in mRNA that codes for a wild-type CEP290 protein. Following intravitreal injection in vivo, QR-110 is demonstrated to reach the outer nuclear layer of the retina, the target tissue. QR-110 is also demonstrated to increase wild-type mRNA in cells with the p.Cys998X mutation. The preclinical data will be presented on poster #1123 – B0295 on May 1st, 3:15 – 5:00pm PT. The abstract is published on the ARVO 2016 annual meeting website.
Investor and analyst event at ARVO
On May 3rd at 7:15pm PT, ProQR management invites investors and analysts to a dinner with Michael Cheetham, PhD, Professor of Molecular and Cell Biology at the Institute of Ophthalmology, University College London to discuss a novel 3-D stratified retinal organoid model for the development of therapeutics for diseases of the retina. For more information or to RSVP, please contact Ronen Abergel at rabergel@troutgroup.com.

About QR-110
QR-110 is a first-in-class oligonucleotide, designed to address the underlying cause of Leber’s congenital amaurosis Type 10 due to the p.Cys998X mutation in the CEP290 gene. The p.Cys998X mutation is a substitution of one nucleotide in the pre-mRNA that leads to aberrant splicing of the mRNA and non-functional Cep290 protein. QR-110 is designed to restore wild-type CEP290 mRNA leading to the production of wild-type CEP290 protein by binding to the mutated location in the pre-mRNA causing normal splicing of the pre-mRNA. QR-110 is intended to be administered through intravitreal injections in the eye.

About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis and Leber’s congenital amaurosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind. Since 2012.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements about QR-110 and its clinical development and therapeutic potential, and the ARVO annual meeting. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, manufacturing processes and facilities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

ProQR Therapeutics N.V.:
Sariette Witte
Investor Relations
T: +1 213 261 8891
ir@proqr.com

22/04/2016

– First drug capable of reversing disease progression in patients with progressive MS
– Extension phase data demonstrate sustained efficacy up to 2 years
– Both studies support efficacy specifically in patients with not-active progressive MS
– Best effect size ever observed in this population
– Good safety profile
Paris, France, April 21 2016 – MedDay, a biotechnology company focused on the treatment of neurological diseases, today announces full study results from the MS-SPI and MS-ON trials, including the MS-SPI extension data, which will be presented at the 2016 American Academy of Neurology Annual Meeting today.

MS-SPI and MS-ON studies tested the efficacy of MD1003, a patented pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of multiple sclerosis (MS) and particularly of the most difficult to treat “not-active progressive MS,” for which there is no approved drug.

Overall these data show the best effect size ever observed to date and confirm the good safety profile of MD1003.

Commenting on the full study results, Prof. Ayman Tourbah, Principal Investigator of the studies, CHU de Reims, Department of Neurology, France, said: “Full results of the MS-SPI study are especially remarkable. This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients. In addition, if we look at the mean Expanded Disability Scale (EDSS) change, the data compare very favourably with all previous trials that looked at the same endpoint. Almost no progression was observed in patients treated with MD1003 for 24 months and this has never been observed before. When we compare these results to other trials in progressive MS that involved more than 6000 patients overall, this is clearly the best effect size ever observed. The MS-ON trial failed to reach its primary endpoint but this is most likely due to a majority of patients with relapsing remitting MS in this trial. Indeed if we focus on patients with the progressive chronic neuropathy phenotype, they seem to have benefited from the drug in the same way as patients in the MS-SPI trial. Results from both studies are therefore consistent and point to the fact that targeting neuron and oligodendrocyte metabolism represents a promising and novel disease modifying therapy approach in progressive MS, particularly in patients with a not-active progressive disease.”

MS-SPI study results
The MS-SPI study was designed to assess the potential of MD1003 to reverse disease progression in patients with not-active progressive MS. Patients included in the study had to demonstrate disease progression of disability in the previous two years with no evidence of inflammatory activity. Patients were randomized to receive either MD1003 (n=103) or placebo (n=51) for 12 months, followed by a 12-month extension phase during which all patients received MD1003 but remained blinded as to whether they had received the active drug during the first phase. The primary endpoint was particularly challenging, and defined as the proportion of patients with either improvement of EDSS or TW25 (timed 25-foot walk) after nine months (M9) confirmed at 12 months (M12), which equates to a confirmed reversion of progression.

The primary endpoint was met (p=0.0051) with 12.6% of patients in the MD1003 arm showing a confirmed reversion of progression at M9 (confirmed at M12), compared to none (0%) in the placebo arm. During the 12-month extension phase, patients initially on MD1003 exhibited sustained improvement compared to baseline, with 13.2% of patients showing improvement at M18 (confirmed at M24) and 15.4% of patients showing improvement at M24. When patients in the placebo group were switched to MD1003 for the extension phase, the proportion of responders reached 7.1% at M18 (confirmed at M24) and 11.9% at M24, demonstrating that treatment with MD1003 reversed progression in some patients switched to MD1003.

The primary judgement criterion was supported by the mean change of EDSS from baseline in the overall population. The mean EDSS decreased between M0 and M12 in the MD1003 group (-0.03) compared to progression in the placebo group (+0.13, p=0.014). During the extension phase, the values remained relatively constant compared to baseline in patients maintained on MD1003 (from -0.03 to 0.04 at M24), indicating sustained efficacy, whereas patients initially on placebo stopped progressing on EDSS once switched to MD1003 (from +0.13 at M12 to +0.15 at M24, compared to baseline).

The efficacy demonstrated on EDSS was also supported by the mean clinical global impression of change scale (CGI) which was worse at M12 in the placebo group compared to the MD1003 group (p<0.0001). It remained constant in the extension phase for patients initially on MD1003 and improved after patients were switched from placebo to MD1003. As a result no difference was observed between the two groups at the end of the extension phase (p=0.92).

MS-ON study results
The MS-ON study was designed to investigate whether MD1003 could accelerate recovery following incomplete remission of an acute relapse and/or specifically improve patients with progressive disability. For this purpose, the study enrolled patients with fixed visual loss (≥6 months) following an acute optic neuritis in the previous three years (non-progressive chronic optic neuropathy, n=62) together with MS patients showing progressive visual loss assessed at two different visits in the previous three years (progressive optic neuropathy, n=31). The placebo-controlled phase was 24 weeks (65 patients received MD1003 and 28 received a placebo) followed by a 24-week extension phase during which all patients (n=92) received MD1003. The primary endpoint was the mean change from baseline in 100% contrast visual acuity (VA) at 24 weeks of the selected eye (defined as the eye with the worst visual acuity and acute or progressive worsening within the three years prior to inclusion).

Final results showed that, overall, patients who received MD1003 improved slightly more than patients who received the placebo (average of 3.1 letters in the MD1003 arm versus 1.8 letters in the placebo arm). However the difference did not reach statistical significance. Patients in both the MD1003 and placebo groups continued to improve during the extension phase (mean of 4.25 letters in the initial MD1003 arm versus 4.0 letters in the placebo arm switched to MD1003).
Prospectively defined subgroup analyses identified that only patients with progressive ON may benefit from MD1003, while no effect was observed in the largest subgroup of patients with non-progressive ON following a relapse. During the placebo-controlled phase, patients in the progressive chronic ON subgroup who received MD1003 improved by a mean of 2.75 letters, while patients who received the placebo worsened by a mean of -1.45 letters. During the 24-week extension phase, patients who were given MD1003 continued to improve (to a mean of 4.55 letters) while those who were initially on placebo stopped worsening after they were switched to the active drug (mean of -1.2 letters at 48 weeks).

Safety
Findings from both MS-SPI and MS-ON trials show that, overall, MD1003 is well tolerated. The incidence of adverse events was similar across the two groups in both studies. In some patients, abnormal laboratory data indicated that MD1003 could affect the results of immunoassays which use biotinylated antibodies and substrates.

Commenting on the full study results, Prof. Bruce Cree, UCSF, USA, principal investigator in the upcoming US study with MD1003, commented: “Taken together, these studies are very promising and provide hope for a condition that has thus far been largely intractable using treatments targeting neuro-inflammation. That the extension study from the SPI trial showed an apparent durability of effect suggests that high dose biotin may have disease modifying properties in addition to its proposed role in enhancing energy metabolism. Furthermore, the positive impact of high dose biotin points to a new line of inquiry in understanding the pathophysiology of progressive MS.”

 

About progressive MS
MS is the most common disabling neurological disease among young adults, with first symptoms typically manifesting between 20 and 40 years of age. In the majority (85%) of cases, patients experience an initial phase of relapsing-remitting neurological dysfunction (RRMS), which typically evolves into a secondary progressive disease at a later point in the clinical course (SPMS). Once MS is in the progressive phase, individuals experience a gradual worsening of neurological disability. Primary progressive MS (PPMS) characterized by disease progression from onset affects 10–15% of MS patients. Progressive disease (either SPMS or PPMS) can be further divided into active or not-active progressive disease based on the existence or not of superimposed inflammatory activity. Immunosuppressive and immunomodulatory drugs have been shown to decrease the frequency of relapses and CNS lesions in relapsing remitting MS. These drugs may also delay progression in the subgroup of patients with active progressive MS. However, there is currently no drug targeting non-active progressive MS, which represents the larger and most difficult to treat population.

In relapsing MS, lymphocytes and monocytes of the peripheral adaptive immune system infiltrate perivascular brain and spinal cord tissue causing focal inflammation that can be identified on imaging as acute contrast enhancing lesions. The histopathological hallmark of these lesions is injury to oligodendroglia cells that wrap axons in myelin, the cell membrane that enhances electrical resistance and allows saltatory conduction through the nervous system. Axons themselves are typically relatively spared. In contrast, progressive MS is mainly associated with progressive axonal degeneration, chronic demyelination and, usually, little or no inflammation. It is considered that axonal degeneration results from energy failure caused by chronic demyelination and mitochondrial dysfunction.

About MD1003
MD1003 is a patented, highly dosed pharmaceutical grade biotin that has already shown efficacy in patients with progressive multiple sclerosis. MD1003 has a unique mode of action which potentially acts on two targets related to progressive MS: (1) it activates the Krebs cycle, the main route for energy production that protects against axonal degeneration and (2) it potentially activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin repair. The drug is already commercialized in some European countries under early-access programs.
About MedDay
MedDay is a privately held biotechnology company developing new drugs targeting brain metabolism for neurodegenerative diseases. The company was founded in 2011 by Frédéric Sedel, MD, PhD (Chief Executive Officer); and Guillaume Brion, MD (Chief Operating Officer). The Company’s most advanced pipeline candidate is MD1003 for the treatment of primary and secondary progressive multiple sclerosis. For more information, please see: www.medday-pharma.com.

References
Sedel, et al. Mult Scler Relat Disord. 2015 Mar;4(2):159-69
Sedel, et al. Neuropharmacology. 2015 Sep 5. doi: 10.1016/j.neuropharm.2015.08.028.
Peyro Saint Paul L et al. Expert Opin Drug Metab Toxicol. 2016 Mar;12(3):327-44

For more information, please contact:

MedDay Pharmaceuticals
Email: contact@medday-pharma.com

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

19/04/2016

Buy recommendation with a target price of 18.8 euros per share*

Toulouse, FRANCE, Ann Arbor, UNITED STATES, April 18, 2016 – Cerenis Therapeutics (FR0012616852- CEREN), an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies (“good cholesterol”) for treating cardiovascular and metabolic diseases, today announces the publication of an initiation of coverage report by PORTZAMPARC, with a target price of 18.8 euros per share*.

* This information does not constitute an offer to sell or subscribe or a solicitation to purchase or subscribe for securities in France, Europe, the United States or any other jurisdiction. The delivery of a service for financial analyses production and diffusion has been concluded between Cerenis Therapeutics and Portzamparc Société de bourse.

About Cerenis Therapeutics: www.cerenis.com
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies for the treatment of cardiovascular and metabolic diseases. HDL is the primary mediator of the reverse lipid transport, or RLT, the only natural pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body.
Cerenis is developing a portfolio of HDL therapies, including HDL mimetics for the rapid regression of atherosclerotic plaque in high-risk patients such as post-ACS patients and patients with HDL deficiency, and drugs which increase HDL for patients with low number of HDL particles to treat atherosclerosis and associated metabolic diseases.
Cerenis is well positioned to become one of the leaders in the HDL therapeutic market, with a broad portfolio of programs being developed.
Since its inception in 2005, the company has been funded by top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance (Fund for Strategic Investment) and last March successfully completed an IPO on Euronext raising €53.4m.

About CER-001:
CER-001 is an engineered complex of recombinant human apoA-I, the major structural protein of HDL, and phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL. Its mechanism of action is to increase apoA-I and the number of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to transport them to the liver for elimination through a process called Reverse Lipid Transport. Previous Phase II studies have provided important data demonstrating the efficacy of CER-001 in regressing atherosclerosis in several distinct vascular beds in patients representing the entire spectrum of cholesterol homeostasis. The totality of the data to date indicates that CER-001 performs all of the functions of natural pre-beta HDL particles and has the potential to be the best-in-class HDL mimetic in the market.

About CER-209:
CER-209 is the first drug candidate in the category of oral P2Y13 receptor agonists. The P2Y13 receptor is a member of the P2Y receptor family, a well-known receptor family including the P2Y12 receptor which is the target of successful drugs such as the anti-thrombotic agent Clopidogrel (Plavix®). In preclinical studies CER-209 promotes HDL recognition by the liver and increase the activity of Reverse Lipid Transport (RLT), and thus has an impact on atherosclerosis regression. Because of the favorable metabolic effects observed in the liver, CER-209 may also offer a new mechanism for the treatment of non-alcoholic steatohepatitis (NASH).

Contacts:
Cerenis
Jean-Louis Dasseux
CEO
info@cerenis.com
Tel: +33 (0)5 62 24 09 49

NewCap
Investors relations
Emmanuel Huynh / Louis-Victor Delouvrier
cerenis@newcap.eu
Tel: +33 (0)1 44 71 98 53

Media relations
Nicolas Merigeau
cerenis@newcap.eu
Tel: +33 (0)1 44 71 94 98

19/04/2016

Amsterdam, April 19th, 2016 – Today Avantium, an innovative chemical technology company and leader in renewable chemistry, announced that it has closed a financing round of €20 million. The investments are made by PMV, an independent investment company for Flanders, FPIM, a Belgian Federal Holding and Investment Company, and Avantium’s existing shareholders.

The funds will be used to commercialize the YXY technology for producing 100% biobased packaging material PEF (polyethylenefuranoate), a next generation plastic with superior performance. This roll out includes the construction of a ‘reference plant’, the world’s first commercial plant to produce FDCA (furandicarboxylic acid). This reference plant with a capacity of up to 50,000 metric tons per year will be built at the BASF’s Verbund site in Antwerp, Belgium.
On March 15 this year, Avantium and BASF announced that they signed a letter of intent to establish a joint venture for the production and marketing of the renewable chemical building block FDCA, as well as marketing of PEF. The joint venture will use the YXY process technology developed by Avantium to solidify its world-leading positions in FDCA and PEF, and subsequently license the YXY technology for industrial scale applications.
Tom van Aken, CEO Avantium: “We are in an exciting period where all pieces of the strategy are coming together and major milestones are achieved. Today, we proudly announce the successful closing of our financing round, and we are honored that PMV and FPIM strengthen our shareholder base. Belgium is very important to us, since we plan to build the reference plant at the chemical cluster of BASF in Antwerp. Through the joint venture that we are setting up with BASF, we aim to rapidly deploy of the YXY technology and be the technology and market leader in FDCA and PEF.”

Roald Borré, Head of Equity Investments at PMV, commented: “Our team is very proud to be part of this great story. At PMV we are all about creating value for all stakeholders involved by building sustainable companies. Avantium made it in 2015 to the Global Cleantech List, a list of the top 100 private clean technology companies, and this for the sixth year in a row. Thereby joining other companies in our portfolio on the list like Kebony and FRX Polymers. FDCA and PEF are without any doubt innovations with an incredible impact on the environment and thus society. We are very committed to supporting companies that bring innovation, sustainability, a solid business plan and a great team together. For us Avantium clearly is one of these companies.”
Philippe Muyters, Flemish minister for Work, Economy and Innovation: “As a government we are proud that this investment is taking place in Antwerp, which confirms Flanders as a leading region for investments in chemistry and innovation. The government has put everything in place to convince this promising company to invest in Flanders. We are glad that today they announce their financial closing and the new reference plant in Antwerp.”

About PMV
PMV NV is a Flemish investment company, financing promising entrepreneurs from conception through to the internationalization of their business, investing in large infrastructure projects. To this end, PMV always works with market actors acting as consortium partners. PMV has a particular focus on the sustainable economic development of Flanders, with demonstrable added value for both economy and society. (www.pmv.eu)
The Flemish economic landscape is changing rapidly. Revolutions in production techniques, ICT, globalization, ecology and energy require new, adapted industrial policy. To maintain our competitive edge under these circumstances, the Flemish government and PMV have set up a unique investment fund: TINA. This acronym refers to the much needed ‘Transformation, Innovation and Acceleration’ of Flanders’ industrial fabric. TINA is a market-driven investment fund managed by PMV, activating 200 million euros in risk capital. This funding reinforces innovation, unlocks its strategic potential and accelerates commercialization.
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 the YXY technology to produce 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 solutions to fibers. YXY is the most advanced technology, and 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 http://www.avantium.com/.

MEDIA CONTACTS
Avantium:
Dominique Levant
Marketing & Communications Officer Avantium
Tel.: +31 (0)20 586 01 32
Email: dominique.levant@avantium.com

PMV:
Ben Jehaes
Communications Manager PMV
Tel.: +32 (0)2 274 63 06
Email: ben.jehaes@pmv.eu