Mainstay Medical Achieves Quality System Certification

Certification is an important step towards the commercialisation of ReActiv8

Dublin, Ireland – Mainstay Medical International plc (“Mainstay” or the “Company”) announces that its Quality Management System has been evaluated and found to be in compliance with the international quality standards ISO 13485:2003 and EN ISO 13485:2012. These international standards provide an accepted international framework for meeting medical device quality standards and compliance certification is an important step towards CE Mark and the commercialisation of ReActiv8. This certification granted by the Company’s Notified Body, BSI Group-Medical Devices, covers the operational activities for developing and bringing to market implantable stimulation systems in the area of pain management.

Mainstay is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We are delighted that all the hard work of the Mainstay team was recognized with the ISO 13485 certification after passing the audits of our Quality Management System at all our facilities in Ireland, Australia and USA without any major observations. This is a testament to the quality and experience of the individuals in the team that made this happen, and an important step towards the commercialization of ReActiv8.”

The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. In the “full quality assurance” conformity route the Company has chosen, the EU Active Implantable Medical Device Directive requires an evaluation of the Company’s Quality Management System as a prerequisite to obtaining CE Mark. By achieving ISO 13485 certification, Mainstay has met this requirement.

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites continue to enrol subjects. The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with CLBP who have few other treatment options.

About Mainstay

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

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Innocoll AG Announces Third Quarter 2014 Financial and Operating Results

ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced financial and operating results for the three months and nine months ending September 30, 2014.

"This is our first quarterly report as a public company," said Michael Myers, Ph.D., Chairperson of the Management Board and Chief Executive Officer of Innocoll. "The successful completion of our IPO in July has provided us with funds that have enabled us to advance our clinical development programs for our key pipeline products, XaraColl® for the treatment of post-operative pain, Cogenzia® for the adjuvant treatment of diabetic foot infections, and CollaGUARD®, our collagen membrane barrier for the prevention of post-surgical adhesions. We have significant momentum now and look forward to keeping you updated on the progress of our clinical development programs over the coming quarters."

Summary of Year-to-Date 2014 Highlights

Financial Highlights

• Innocoll received net proceeds of approximately $52.7 million, net of underwriting discounts and commissions and offering expenses, from the issuance and sale of approximately 6.7 million American Depository Shares (ADSs) in its initial public offering, including shares issued upon the partial exercise of the underwriters' over-allotment option.
• On July 25, 2014, Innocoll's ADSs began trading on the NASDAQ Global Market under the symbol "INNL".
• Year to date product sales revenue of €3.7 million was up by 38% compared to the corresponding period last year.
• As of September 30, 2014 cash and cash equivalents were €47.3 million ($60.0 million).

Clinical Highlight

• In July, we initiated a pivotal study comparing the pharmacokinetics and safety of XaraColl our implantable bioresorbable collagen sponge at doses of 200mg and 300mg to a standard bupivacaine solution. Once the data from this study becomes available, which is currently anticipated to be in the first quarter of 2015, we plan to initiate our Phase 3 efficacy program in post-operative pain in the United States.
• On October 27th, we submitted a document to the FDA for Cogenzia for our planned clinical trials in patients with moderate to severe diabetic foot ulcer infections requesting approval for certain improvements to the Phase 3 clinical protocols and for reconfirmation of all of the key understandings that were agreed upon with the FDA in the Special Protocol Assessment (SPA). The agency has informed Innocoll that written feedback to this document will be sent within 30 days of its submission, following which the Phase 3 program for Cogenzia is expected to be initiated.
• We developed a clinical protocol and obtained approval to run a CollaGUARD pilot study in patients undergoing intrauterine adhesiolysis via operative hysteroscopy. This study, which will be conducted in the Netherlands and will commence recruiting patients this month, is being run to generate data that will be used to finalize our pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support commercialization of CollaGUARD in countries where the product is already approved. Innocoll will plan on holding a Pre-IDE meeting with FDA once the pilot study results are available.

Regulatory and Commercial Highlights

• During the quarter, Cogenzia received marketing approval in Canada, Russia, Argentina and Mexico. Cogenzia is now approved in six countries and has also been filed for approval in India and Australia.
• CollaGUARD was approved in Argentina bringing the total number of country approvals to 46 countries in Europe, Asia and emerging markets. The first shipment of product was made to our partner Takeda in preparation for their planned launch of CollaGUARD in Russia. Takeda also filed for approval for CollaGUARD in Ukraine, Belarus, and Kazakhstan this year.
• The RegenePro dental product line was launched in the U.S. by Biomet 3i LLC during the quarter.

Organizational Highlights

• Earlier this year, Innocoll strengthened its supervisory board with the appointment of Jonathan Symonds CBE as Chairman, former CFO of Novartis and AstraZeneca, David Brennan, former CEO of AstraZeneca, Shumeet Banerji, former senior executive at Booz Allen Hamilton and member of the board of directors of Hewlett-Packard, and the pending appointment, subject to shareholder approval, of Joseph Wiley, of Sofinnova Ventures.

Three Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: Innocoll reported a net profit attributable to ordinary shareholders of €2.0 million, or €1.57 per share ($0.15 per ADS), for the three months ended September 30, 2014, compared to a profit of €13.0 million, or €336.13 per share, for the three months ended September 30, 2013.

Non-GAAP diluted profit excluding stock-based compensation and certain non-cash finance or other income was €0.3 million or €0.20 per share ($0.02 per ADS), for the three months ended September 30, 2014, compared to a loss of €0.8 million, or €1.04 per share, for the three months ended September 30, 2013.

Weighted average shares outstanding increased from 0.04 million during the three months ended September 30, 2013 to 1.25 million during the three months ended September 30, 2014, respectively, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuances in 2014.

Revenues: Revenues were €1.1 million for the three months ended September 30, 2014 as compared to €0.6 million for the three months ended September 30, 2013 an increase of 82%. This increase was primarily due to an increase in sales by Jazz Pharmaceuticals of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, the first shipment of our adhesion barrier CollaGUARD to our partner Takeda in connection with the product's launch in Russia, and Biomet 3i's launch of RegenePro, our product to treat dental wounds in the US.

General and Administrative (G&A) Expenses: G&A expenses were €2.6 million for the three months ended September 30, 2014 as compared to €1.0 million for the three months ended September 30, 2013. G&A expenses in the three months ended September 30, 2014 included €1.2 million in non-cash charges for stock-based compensation compared to €0.0 of such charges in the three months ended September 30, 2013.

Excluding such charges for stock-based compensation, G&A expenses for the three months ended September 30, 2014 were €1.4 million as compared to €1.0 million for the three months ended September 30, 2013. We expect increases in G&A going forward as we build out our infrastructure to support our clinical programs and commercialization.

Research and Development (R&D) Expenses: R&D expenses were €0.9 million for the three months ended September 30, 2014 as compared to €0.2 million for the three months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl. Going forward, we expect R&D expenses to increase significantly as we advance our clinical trial programs.

Operating Losses: Operating losses in the three months ended September 30, 2014 and 2013 were €3.6 million and €1.5 million, respectively. Excluding stock-based compensation, adjusted operating losses in the three months ended September 30, 2014 were €2.4 million. The difference between the €2.4 million adjusted operating losses and the €0.3 million non-GAAP diluted profit set out above was primarily due to foreign exchange gains of €2.7 million during the three months ended September 30, 2014.

Finance and Other Income: Finance and other income was €5.6 million for the three months ended September 30, 2014 as compared to €14.5 million for the three months ended September 30, 2013. Finance and other income or expense items were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the third quarter of 2014, as well as foreign exchange gains in each quarter.

Although Innocoll options issued to investors are settled in stock and are included in our authorized capital, under IFRS accounting rules, they will continue to be valued on a quarterly basis, which is likely to result in significant non-cash finance expense or income going forward.

Proceeds from Investment, Cash Position: In the second and third quarters of 2014 the company received total net proceeds from the issuance of shares of €52.1 million ($69.9 million), consisting of €12.4 million ($17.2 million) net proceeds of pre-IPO equity issuance and €39.7 million ($52.7 million) net proceeds from the IPO.

As of September 30, 2014, cash, cash equivalents, and short-term investments totalled €47.3 million ($60.0 million), which is expected to be sufficient to fund our clinical programs and operational expenses through the first half of 2016.

Nine Month 2014 Financial Results

Net Profit/(Loss) Available to Ordinary Shareholders: For the nine months ended September 30, 2014 net loss attributable to ordinary shareholders was €16.4 million or €33.36 per share ($3.19 per ADS), compared to a profit of €6.7 million, or €142.70 per share, for the nine months ended September 30, 2013.

Non-GAAP diluted loss excluding stock-based compensation and certain non-cash finance and other income was €7.2 million or €14.70 per share ($1.41 per ADS), for the nine months ended September 30, 2014, compared to a loss of €4.4 million, or €6.00 per share, for the nine months ended September 30, 2013.

Weighted average shares outstanding increased from 0.05 million during the nine months ended September 30, 2013, to 0.49 million during the nine months ended September 30, 2014, primarily as a result of the conversion of preference shares into ordinary shares and pre-IPO and IPO equity issuance in 2014.

Revenues: Revenues for the nine months ended September 30, 2014 were 38% higher at €3.7 million, compared to €2.7 million for nine months ended September 30, 2013. This increase was primarily due to an increase in sales of CollatampG, CollaGUARD and RegenePro as described above.

General and Administrative (G&A) Expenses: G&A expenses were €7.4 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. G&A expenses in the nine months ended September 30, 2014 included €2.8 million in non-cash charges for stock-based compensation, compared to €0.0 of such charges in the corresponding period in 2013.

Excluding such charges for stock-based compensation, G&A expenses were €4.6 million for the nine months ended September 30, 2014 as compared to €2.9 million for the nine months ended September 30, 2013. The increase in G&A was primarily due to accounting, legal and consulting professional fees, insurance costs and investor relations costs related to becoming a public company.

Research and Development (R&D) Expenses: R&D expenses were €2.0 million for the nine months ended September 2014 as compared to €1.2 million for the nine months ended September 30, 2013. The increase was primarily due to the commencement of our pharmacokinetics and safety study of XaraColl.

Operating Losses: Operating losses in the nine months ended September 30, 2014 and 2013 were €9.7 million and €4.4 million respectively. Excluding stock-based compensation, operating losses in the nine months ended September 30, 2014 were €6.9 million.

Finance and Other Income/(Expense): Finance and other income was an expense of €6.6 million for the nine months ended September 30, 2014 as compared to income of €11.2 million for the nine months ended September 30, 2013. Finance and other income or expense items in each period were non-cash items arising out of the re-domicile of our parent company to Germany during the third quarter of 2013, and changes in the value of liabilities associated with options issued to pre-IPO investors outstanding during the second and third quarter of 2014, as well as foreign exchange gains in each period.

For further financial information for the period ending September 30, 2014, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, exchanged at a rate of €1.2687 per euro, the exchange rate as of September 30, 2014.

Conference Call

Innocoll management will host a conference call today at 10 a.m. EST to discuss third quarter 2014 financial results and provide a business update.

To participate in the conference call, please dial 877-407-4018 (domestic) or 201-689-8471 (international) and ask for the "Innocoll third quarter financial results conference call." A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.innocollinc.com

An archived webcast recording and telephone replay will be available on the Innocoll website beginning approximately two hours after the call. To access the telephone replay, please dial 877-870-5176 for domestic callers or 858-384-5517 for international callers and enter the conference code: 13594801. The telephone replay will be available until midnight EST on November 16.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® in Phase 3 development for the treatment of post-operative pain; Cogenzia® in Phase 3 for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD (Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of the Company's products are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany.

For more information, please visit www.innocollinc.com.

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Mainstay Medical - Interim Management Statement

Continued progress towards commercialisation of ReActiv8®

Dublin – Ireland, 6 November 2014 – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) is issuing this Interim Management Statement covering the period from 1 July 2014 to today’s date.

Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. The Company is focused on the development and commercialisation of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.

Business Update

We continue to make progress in the ReActiv8-A clinical trial, with subjects being recruited the UK, Belgium, and Australia, (see http://clinicaltrials.gov/show/NCT01985230). The ReActiv8-A clinical trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. The Company currently expects that data from 40 subjects could be sufficient to apply for a CE Mark. We are pleased to report that over 25 subjects have been implanted as part of the ReActiv8-A clinical trial to date.

In July 2014, the Company submitted an information package about ReActiv8 and the proposed US clinical trial to the US Food and Drug Administration (‘FDA’) under an Investigational Device Exemption (‘IDE’). We met with the FDA in September 2014 and obtained feedback and guidance. We currently anticipate making a submission to start the proposed US clinical trial under an IDE to the FDA in the first quarter of 2015.

Financial Update

There have been no significant changes in the financial position of the group since publication of the Half Year Results for the period ended 30 June 2014. Expenditure relating to clinical trial activities, ongoing research and development and general and administrative expenses is in line with expectations. The Company had $21.4 million cash on hand as at 30 September 2014.

Outlook

Mainstay looks forward to continuing progress with the ReActiv8-A clinical trial as it works towards obtaining CE Mark and commencing the commercialisation of ReActiv8.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating CLBP. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting, Dublin Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Jeanne Bariller, FTI Consulting, Paris
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Acorda Therapeutics Completes Acquisition of Civitas Therapeutics

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it has completed its acquisition of Civitas Therapeutics and obtained global rights to CVT-301, a Phase 3 treatment candidate for OFF episodes of Parkinson’s disease. The acquisition also included rights to the proprietary ARCUS® pulmonary delivery technology, and a manufacturing facility with commercial-scale capabilities based in Chelsea, MA. Under the terms of the acquisition agreement, Acorda paid $525 million in cash to acquire Civitas.

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders.

Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS), as demonstrated by an increase in walking speed. The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda is currently developing seven clinical-stage therapies and one preclinical stage therapy. This pipeline addresses a range of disorders including chronic post-stroke walking deficits, Parkinson’s disease, epilepsy, neuropathic pain, stroke, peripheral nerve damage, spinal cord injury, and heart failure.

For more information, please visit the Company’s website at: www.acorda.com.

Genable Technologies Ltd Moving GT038 Into Full Development

Dublin - The Genable team recently attended a Pre-IND meeting with the Food and Drug Administration (FDA) in Washington USA, to discuss the development of GT038 for the treatment of Rhodopsin linked autosomal dominant retinitis pigmentosa (Rho-AdRP). It was a very informative meeting during which the FDA provided feedback and advice on the preclinical and clinical development plans for GT038.

Dr Jason Loveridge Genable CEO commented “ Following a very informative and useful meeting with the US medicines regulatory authority, the FDA, we are delighted to confirm that GT038 has now moved from research to development. The FDA’s input taken together with advice from our Medical Advisory Board and most importantly Genable’s close links with patient groups increases the probability that we can progress GT038 into the clinic and subsequently provide benefit for RP patients.

Background Information

Genable Technologies Ltd. is a privately held Irish bio-pharmaceutical company developing new gene medicines to treat autosomal dominant genetic diseases based on the pioneering work of Professor Jane Farrar, Dr Paul Kenna & Professor Peter Humphries at the Smurfit Institute for Genetics in Trinity College Dublin, Ireland. Genable has received significant financial backing to date from venture capital companies including, Fountain Healthcare Partners, Delta Partners and the patient-led research charities, Fighting Blindness Ireland and Foundation Fighting Blindness Clinical Research Institute.

Genable's approach is innovative and unique, utilising well-established, clinically safe & effective AAV vectors to obtain expression of RNA interference (RNAi) molecules, which suppress the expression of both copies of the disease gene, normal and faulty and a replacement gene which is genetically modified and is refractory to suppression but still encodes a normal wild-type protein. The combination of suppression and replacement overcomes the significant hurdle in dominant disease of mutation variability by eliminating the need to target specific mutations and is applicable to a wide range of disorders

Genable's lead product, GT038, is designed for the treatment of patients with rhodopsin linked autosomal dominant retinitis pigmentosa (Rho-adRP), a debilitating, progressive form of inherited blindness resulting from a diverse array of mutations in the RHO gene. Genable's technology is protected by a broad suite of granted patents and patent applications in the USA, EU and worldwide.

This sub-type of adRP affects approximately 1 in 30,000 people and represents an already identified and potentially treatable population of around 30,000 patients in the US and Europe. Genable will employ the same approach to develop other gene medicines for a number of other sub-types of adRP. The company has received Orphan Drug Designation for GT038 in both the EU and US.

Agreements were executed in 2014 with Spark Therapeutics for the supply of GLP & GMP grade GT038 for the completion of preclinical development as well as the clinical trial programme.

For further information please contact jloveridge@genable.net

Neuravi Introduces Collaborative Clot Research Initiative at ESMINT Conference in September

Advancing Stroke Therapy through The Science of Clot

Galway, Ireland — Neuravi, a developer of innovative stroke therapy, announced today that it will introduce the Neuravi Thromboembolic Initiative (NTI) during a series of workshops on “The Science of Clot” at the upcoming European Society of Minimally Invasive Neurological Therapy (ESMINT) conference in Nice. The NTI brings together Neuravi engineers with clinicians and researchers from leading international institutions in an effort to deepen the understanding of the mechanical properties of clot and occlusion dynamics, with the goal of improving the physician’s ability to restore flow in acute ischemic stroke.

The ESMINT conference gathers leaders in minimally invasive neurological therapy from across Europe. “One of the goals of ESMINT is to advance the practice of neuro-intervention through the support of research, education and training,” observed Prof. Laurent Pierot, President ESMINT Congress. “Currently, there is a growing interest in identifying different clots and in understanding how different clot characteristics may impact treatment in acute ischemic stroke. The NTI workshops will help in these efforts.”

The NTI workshops will feature a presentation by Dr. Anastasios Mpotsaris, Uniklinik Köln, as well as interactive hands-on sessions with engineers exploring clot characterization, the dynamics of occlusion formation and clot-device interactions and any potential implications for revascularization. Physicians may sign up to attend the sessions being held September 4-6 by registering via email at clot@neuravi.com.

“The NTI represents Neuravi’s commitment to advance the treatment of stroke by investing and collaborating in research to unravel the science of stroke occlusion,” stated Eamon Brady, CEO of Neuravi. “We are excited to have this opportunity to both share and learn with the neurointerventional community during these interactive workshops.”

Civitas Therapeutics Files Registration Statement for Proposed Initial Public Offering

Chelsea, Mass., - Civitas Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not been determined.

J.P. Morgan Securities LLC and BofA Merrill Lynch will act as joint book-running managers for the offering. Cowen and Company, LLC and Oppenheimer & Co. Inc. will act as co-managers.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling (866) 803-9204; and from BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attention: Prospectus Department, or by emailing dg.prospectus_requests@baml.com.

About Civitas Therapeutics

Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUS™ technology, with an initial focus on treating debilitating OFF episodes in patients with Parkinson’s disease.

Contact:

Stephanie Gillis
Civitas Therapeutics, Inc.
617-660-4121
sgillis@civitastherapeutics.com

Civitas Therapeutics Secures $55 Million in Series C Financing

Proceeds to support Phase 3 clinical trial for CVT-301 Parkinson’s disease program and pipeline expansion

CHELSEA, Mass.– Civitas Therapeutics, Inc., a privately-held biopharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced the successful completion of a $55 million Series C financing. The financing round included new investors Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures, with participation from all existing investors, including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, and Wellington Management Company, LLP.

“The proceeds from this financing will be used towards the upcoming Phase 3 clinical trials for our lead candidate, CVT-301, an inhaled formulation of levodopa (L-dopa) being developed for rapid and reliable relief from debilitating motor fluctuations, known as OFF episodes, associated with Parkinson’s disease (PD), as well as for additional, early stage pipeline development programs,” said Mark Iwicki, President and Chief Executive Officer of Civitas Therapeutics. Civitas intends to initiate the pivotal Phase 3 clinical trial in early 2015, and expects data to be reported in 2016.

About CVT-301

CVT-301 is being developed as a self-administered, adjunctive, as needed, inhaled L-dopa therapy for OFF episodes, providing rapid delivery of L-dopa to the brain to be used in conjunction with a PD patient’s individually optimized oral L-dopa regimen. CVT-301 leverages Civitas’ proprietary ARCUS™ technology which enables the delivery of a precise dose to the lung to potentially enable rapid and predictable L-dopa absorption through a reusable, pocket-size, breath-actuated inhaler.

CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s Disease and OFF Episodes

Over one million people in the US and between seven and ten million people worldwide suffer from PD. PD is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement. The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream leading to the unreliable control of symptoms resulting in the emergence of OFF episodes. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients today.

About ARCUS™ Technology

Our proprietary ARCUS technology, the basis of CVT-301, allows for the consistent and precise delivery of large quantities of drug per inhalation in a simple, patient-friendly, breath-actuated inhaler. The technology delivers a consistent dose to the lung every time across a wide range of patient inhalation flow rates. The technology has been used to successfully deliver more than one million doses to patients in clinical trials. We have a robust patent portfolio relating to CVT-301 and our ARCUS technology which covers, among other things, important aspects of the formulated drug product, the inhaler, the method of delivery of drug and the manufacturing processes for CVT-301.

About Civitas Therapeutics

Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUS™ technology, with an initial focus on treating OFF episodes in patients with Parkinson’s disease. Civitas is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, Wellington Management Company, LLP, Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures.

For additional information contact:

Stephanie Gillis
Civitas Therapeutics
617-660-4121
sgillis@civitastherapeutics.com

Innocoll AG Announces Closing of Initial Public Offering

ATHLONE, Ireland, - Innocoll AG (Nasdaq:INNL) (the "Company"), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced the closing of its public offering of 6,500,000 American Depositary Shares ("ADSs"), each representing 1/13.25 ordinary shares, at a public offering price of $9.00 per ADS. As part of the public offering, Sofinnova Venture Partners VIII, L.P., or Sofinnova, purchased an aggregate of 1,666,667 ADSs at the public offering price. Sofinnova will have a right to nominate one member to the Company's supervisory board. All of the ADSs were offered by the Company. The Company's ADSs are listed on The NASDAQ Global Market under the symbol "INNL." In addition, the Company has granted the underwriters an option until August 23, 2014 to purchase up to an additional 975,000 ADSs at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

The Company received total net proceeds from the public offering of approximately $51.5 million after deducting underwriting discounts and commissions and offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for the following purposes: (i) developing XaraColl, Cogenzia and CollaGUARD, (ii) expanding its manufacturing infrastructure, and (iii) general corporate purposes.

Piper Jaffray & Co. and Stifel acted as joint book-running managers for the public offering. JMP Securities acted as lead manager for the public offering. The offering of these securities was made only by means of a prospectus, copies of which can be obtained from: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at prospectus@pjc.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, or by telephone at (415) 364-2720 or by email at syndicateops@stifel.com.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on July 24, 2014. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the offered securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals. All of the Company's products are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Denise Carter
Executive Vice President Business Development
and Corporate Affairs
T: (215) 765-0149

Lisa Wilson
In-Site Communications, Inc.
Investor Relations
T: (212) 452-2793

Mainstay Medical Announces Pre-IDE Submission for ReActiv8® to FDA

Mainstay Medical continues progress towards the commercialisation of ReActiv8.

Dublin, Ireland – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it has submitted a Pre-Investigational Device Exemption (‘IDE’) information package to the US Food and Drug Administration (‘FDA’ or the ‘Agency’) for ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain.

Under the Pre-IDE Submission Program of the FDA, Mainstay can request feedback from the Agency on its planned ReActiv8 IDE submission. The FDA states that “Receiving and incorporating FDA feedback on various elements of a future IDE submission, such as the proposed study design or statistical analysis plan, can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval.” 1

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “The pre-IDE submission to the FDA is a significant step on the path to regulatory approval and commercialization of ReActiv8. We will consider the FDA’s feedback in our planned IDE submission. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”

Clinical trials with ReActiv8 are ongoing in Europe and Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain who have few other treatment options.

- End -

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

1 Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff. Guidance for Industry and Food and Drug Administration Staff. Document issued on: February 18, 2014.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Mainstay Medical Announces Expansion of Clinical Trial of ReActiv8® for People with Chronic Low Back Pain to Belgium

Dublin, Ireland, – Mainstay Medical International plc (Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE) announces that it has received authorization from the Belgian Federal Agency for Medicines and Health Products to expand the clinical trial of ReActiv8 (ReActiv8-A), its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain, to include clinical trial sites in Belgium. Enrolment of subjects is commencing in these additional sites. The added sites also participated in the European Feasibility Study, results of which were presented in mid-2013.

Mr. Peter Crosby, Mainstay’s Chief Executive Officer, noted “We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8. We are pleased to now add Belgium to our clinical trial which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain.”

The ReActiv8-A clinical trial started in Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain who have few other treatment options.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

About Chronic Low Back Pain

One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from CLBP.

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spinal surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on economies.

Further information can be found at www.mainstay-medical.com

Media queries to:

Jonathan Neilan, FTI Consulting Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

ESM Advisers:

Fergal Meegan / Barry Murphy, Davy
Tel: +353 1 6796363
Email: fergal.meegan@davy.ie / barry.murphy2@davy.ie

Forward looking statements

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should” or “will”, or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

Chrono Therapeutics, Inventor of Wearable “Smart” Smoking Cessation Technology, Secures $32 Million in Series A Financing

Syndicate includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures

HAYWARD, Calif – Chrono Therapeutics , a pioneer in digital drug products, announced today the close of a $32 million Series A financing round, led by Canaan Partners and5AM Ventures . Additional participants in the financing were Fountain Healthcare Partners , Mayo Clinic andGE Ventures . The funds will be used to complete product development and clinical studies for the company’s SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation. As part of the financing, Wende Hutton, general partner with Canaan Partners, Jim Young of 5AM Ventures and Aidan King of Fountain will join Chrono’s board of directors.

“Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support,” said Alan Levy, Ph.D., CEO of Chrono. “We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult.”

Smoking kills more than 400,000 Americans each year, and is responsible for approximately one in five deaths in the US. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control , and 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns; SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop digital support program, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

“We have developed a unique approach to the very difficult problem of helping smokers quit their life-threatening habits,” noted Chrono founder Guy DiPierro. “We believe that the blend of a well understood active drug compound in nicotine with a programmable, wearable delivery system that takes into account a person’s habits as well as physiological patterns that each contribute to cravings has the potential to help more smokers quit once and for all.”

Leslie Bottorff, Managing Director of Healthcare at GE Ventures added, “Chrono Therapeutics is paving the way for personal monitoring in healthcare through the creation of the SmartStop integrated digital solution. Their technology is only just beginning, and GE Ventures looks forward to working together to transform disease management.”

“Over the past 20 years, I have had the privilege of backing Alan Levy as CEO in the founding of three life sciences companies,” stated Wende Hutton. “Alan brings an exceptional track record of success in drug/device combination therapies to Chrono.”

Mainstay Announces the Partial Exercise of the Over-Allotment Option, Increasing the Gross Proceeds of the Offer to Approximately €18.8M

Mainstay Announces the Partial Exercise of the Over-Allotment Option, Increasing the Gross Proceeds of the Offer to Approximately €18.8M

Not for distribution, directly or indirectly, in the United States of America, Canada, Australia and Japan

Mainstay Medical International plc (“Mainstay”) (Paris:MSTY) announces that, in connection with its initial public offering on the regulated market of Euronext Paris and on the Enterprise Securities Market of the Irish Stock Exchange, the Over-allotment Option granted to Kempen & Co and Société Générale, in their role as Joint Global Coordinators and Joint Bookrunners, was partially exercised on 28 May 2014. The partial exercise of the Over-allotment Option resulted in the allotment and issue by Mainstay to Société Générale as Stabilising Manager of 38,264 new Ordinary Shares at the Offer Price of €21.15 per share, giving additional gross proceeds of approximately €0.8m. As a result, the total number of Ordinary Shares allotted and issued by Mainstay in connection with the Offer amounted to 889,439 new Ordinary Shares, increasing the total gross proceeds of the Offer to approximately €18.8m.

Application has been made for listing and admission to trading of the 38,264 new Ordinary Shares on Euronext Paris and on the ESM. It is expected that listing and admission to trading of the 38,264 new Ordinary Shares on Euronext Paris will take place at 9.00 am CET on 30 May 2014 and on the ESM will take place at 8.00 am (Dublin time) on 4 June 2014.

Total Voting Rights

In conformity with Regulation 20 of the Transparency (Directive 2004/109/EC) Regulations 2007 of Ireland, Mainstay confirms that, as at 29 May 2014, the issued share capital of Mainstay consists of 4,294,141 Ordinary Shares (which carry voting rights) and 40,000 deferred shares of €1 each (which do not carry voting rights). Therefore, the figure that may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Mainstay under the Transparency (Directive 2004/109/EC) Regulations 2007 of Ireland and the Transparency Rules of the Central Bank of Ireland is 4,294,141.

In accordance, with the provisions of Article 631-10 of the Règlement général of the French Autorité des marchés financiers, Société Générale, acting as Stabilising Manager, declares that:

It has conducted stabilization transactions on Mainstay’s Ordinary Shares (IE00BJYS1G50);

The stabilization period started on 29 April, 2014;

The stabilization period closed on 28 May, 2014.

Pricing information is set forth below:

Date                  Low price              High price

29/04/2014       20.900                  21.150

30/04/2014       20.800                  21.150

02/05/2014       21.150                  21.150

05/05/2014       20.930                  21.150

06/05/2014       21.150                  21.150

07/05/2014       20.930                  21.150

08/05/2014       20.800                  21.150

09/05/2014       21.150                  21.150

12/05/2014       21.150                  21.150

13/05/2014       20.910                  21.150

14/05/2014       21.140                  21.140

15/05/2014       21.140                  21.140

16/05/2014       20.800                  21.140

FOR FURTHER DETAILS, CONTACT:

Joint Global Coordinators and Joint Bookrunners
Kempen & Co N.V.
Beethovenstraat 300
1077 WZ Amsterdam
The Netherlands

Société Générale
Tour Société Générale
17, Cours Valmy,
92972 Paris La Défense Cedex
France

Prospectus Adviser, ESM Adviser and Co-Lead Manager
Davy
Davy House
49 Dawson Street
Dublin 2, Ireland

Media & Investor Relations Adviser

FTI Consulting (Dublin)
10 Merrion Square
Dublin 2, Ireland
+353 1 663 3600 or mainstay@fticonsulting.com
Eilish Joyce/Jonathan Neilan

FTI Consulting (Paris)
5, Rue Scribe
Paris, 75009, France
+33 1 47 03 68 63 or mainstay@fticonsulting.com
Jeanne Bariller

DISCLAIMERS

This document does not constitute and shall not be considered as constituting a public offer, an offer to purchase or as an intention to solicit the interest of the public for a public offering of securities.

The information in this announcement is for background purposes only and does not purport to be accurate, full or complete. It is given at the date of its publication (unless otherwise marked) and is subject to updating, revision and amendment and no reliance may be placed for any purpose on it.

The prospectus (the "Prospectus") of Mainstay Medical International Plc (the "Company") was approved on 9 April 2014 by The Central Bank of Ireland, the Irish competent authority, and notified to the French Autorité des Marchés Financiers ("AMF") for passporting in connection with the Company’s application for listing its ordinary shares on Euronext Paris and the Enterprise Securities Market operated by the Irish Stock Exchange, and the public offering of its ordinary shares in France. The Prospectus and the French translation of the summary are available on the Company’s website at www.mainstay-medical.com; the French translation of the summary is also available on the AMF's website at www.amf-france.org. The Company draws the attention of the public in France to Part 2 "Risk Factors" of the Prospectus and their summary in the French translation of the Prospectus summary. These risks may have a material adverse effect on the Company and its subsidiaries, their business, financial condition, results of operations or growth prospects as well as on the market price of Mainstay Medical International’s ordinary shares on Euronext Paris and the ESM.

No reliance may or should be placed by any person for any purposes whatsoever on the information contained in this announcement or on its completeness, accuracy or fairness.

The distribution of this document in certain countries may be subject to specific regulations. Persons who come into possession of this press release must inform themselves of and comply with these restrictions.

In particular:

This document does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of securities in the United States of America (the "United States"), or in any other jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of the United States or any such jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. The Company has not registered, and does not intend to register, any portion of any offering of its securities in the United States, and does not intend to conduct a public offering of any of its securities in the United States.

This announcement includes statements that are, or may be deemed to be, forward looking statements. These forward looking statements can be identified by the use of forward looking terminology, including the terms “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “projects”, “should” or “will”, or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward looking statements include all matters that are not historical facts. They appear throughout this announcement and include, but are not limited to, statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, the Company’s results of operations, financial position, prospects, financing strategies, expectations for product design and development, regulatory approvals, reimbursement arrangements, costs of sales and market penetration.

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, currency fluctuations, changes in its business strategy, political and economic uncertainty and other factors to be disclosed in the Prospectus. The forward-looking statements therein speak only at the date of this announcement.

Media & Investor Relations Adviser

FTI Consulting (Dublin)
Eilish Joyce/Jonathan Neilan, +353 1 663 3600
mainstay@fticonsulting.com

or

FTI Consulting (Paris)
Jeanne Bariller, +33 1 47 03 68 63
mainstay@fticonsulting.com

Palyon Medical and CORE Manufacturing Announce Strategic Partnership

Valencia, CA - Palyon Medical Corporation and CORE Manufacturing LLC have entered into a strategic partnership for the manufacturing of Palyon’s line of implantable drug delivery pumps.

Palyon, a developmental stage company, has a pump portfolio that includes programmable devices for maximum clinical flexibility and constant flow devices for lower cost steady drug delivery. CORE is an ISO 13485, ISO 9001 and FDA approved manufacturer of implantable devices. Under this new partnership, CORE Manufacturing will provide manufacturing services, procurement coordination and dual quality control oversight, greatly reducing Palyon’s time to market introduction.

“CORE brings a level of clinical manufacturing experience that will greatly streamline our process and allow our researchers and engineers to focus on developing the next generation of devices, such as an implantable insulin pump,” said Michael Sember, Palyon CEO. “Having CORE’s production facility in such close proximity to us will allow for enhanced efficiency, reduced manufacturing coordination costs and speed our path to market.”

Palyon’s inventive implantable infusion pump platform will offer highly accurate drug delivery rates and incorporate unique safety features including the only sensor-based feedback flow control, refill error detection capability, a non-motorized pumping mechanism that is less susceptible to wear and tear, catheter occlusion detection and a highly favorable MRI profile.

"CORE Manufacturing is honored to partner with Palyon. CORE is uniquely qualified to develop and manufacture the lineup of Palyon’s active implantable devices. This partnership will allow both companies to leverage their core competencies," said Joel Hirsch, President of CORE Manufacturing.

About Palyon

Palyon Medical Corporation, headquartered in Southern California, is a privately held medical device company focused on creating innovative treatment systems to alleviate symptoms of chronic pain, spasticity, diseases of the central nervous system and chronic metabolic diseases. Palyon’s mission is to provide the market with the broadest range of implantable infusion devices that offer an unparalleled feature set to address a broad range of unmet medical needs. For more information visit www.palyonmedical.com.

About CORE Manufacturing, LLC

Located in Valencia, CA, CORE Manufacturing is an ISO 13485, ISO 9001, and FDA approved manufacturer of implantable, minimally invasive, and peripheral medical devices. Capabilities include: rapid-turn prototyping, full turnkey device-level assembly, sterilization and testing.

Media Contact:

Palyon Medical Corp: Michael Sember msember@palyoncorp.com, (661) 705-5601

CORE Manufacturing LLC: Joel Hirsch jhirsch@core-manufacturing.com, (661) 621-6200

Civitas Therapeutics Announces Positive Phase 2b Results for CVT-301, Inhaled Levodopa for the Treatment of Parkinson’s Disease

- CVT-301 shown to rapidly treat debilitating OFF episodes associated with Parkinson’s disease -

- Met primary endpoint with clinically important and statistically-significant reduction in average UPDRS III motor score versus placebo -

- Phase 2 study results to be presented at American Academy of Neurology 2014 Annual Meeting -

Chelsea, MA -  Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced positive results from a Phase 2b clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa). Study results from Phase 2 studies will be presented at the 66th Annual American Academy of Neurology Meeting on April 29, 2014 at 2:30pm ET in Philadelphia, PA.

“We are extremely pleased that we met our primary endpoints in our Phase 2b trial with statistical significance, demonstrating that CVT-301 was safe and well tolerated and provides patients with a rapid, clinically important improvement in motor function. CVT-301 provided onset of action by 10 minutes with durable effects lasting for at least 60 minutes,” said Mark Iwicki, President and CEO of Civitas. “CVT-301 is being developed to address a significant unmet need facing Parkinson’s disease patients today, and these results, particularly the efficacy and ease-of-use seen in the outpatient setting, give us confidence that CVT-301 can have a transformative impact on the daily lives of patients.”

CVT-301 is being developed as an adjunctive, as-needed therapy to provide rapid and reliable relief from intermittent debilitating motor fluctuations, known as OFF episodes, suffered by Parkinson’s disease patients. OFF episodes, which result from the unpredictable nature of oral baseline therapies, affect over half of all patients on an oral L-dopa treatment regimen and are considered to be one of the most important issues facing Parkinson’s disease patients today.

“OFF episodes are debilitating events for Parkinson’s disease patients. A rapid and reliable therapy that can address these episodes would be a major advancement in treatment," said Dr. Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson's Research, which provided supportive funding for the study. “These results suggest that CVT-301 could have a transformative impact on patients’ lives,” said Dr. Sherer. “As supporters of this program from its early days, we are pleased with its performance thus far and look forward to continued success in Phase 3 trials.”

The Phase 2b study was designed to assess the on-demand use of CVT-301 in Parkinson’s disease patients experiencing motor fluctuations over a one-month period. The trial evaluated the efficacy, safety and tolerability of two doses of CVT-301. Motor responses were evaluated during regularly- scheduled clinical visits using the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III). In addition, efficacy was also evaluated during out-patient use with commonly used diary-based outcomes measures.

The primary endpoint was successfully met with CVT-301 achieving a clinically important and statistically significant reduction in average UPDRS III motor score versus placebo at time points ranging from 10 to 60 minutes post-administration (p < 0.001). Furthermore, clinically important and statistically significant improvements in UPDRS III were seen at every time point including 10 minutes, the earliest time point tested, for both tested doses.

Over the course of the study, patients self-administered CVT-301 as-needed to treat approximately 4,500 OFF episodes, at an average of approximately 2 treatments per day. With self-administration during at-home use, CVT-301 use was not associated with any increase in either non-troublesome or troublesome dyskinesia. All doses of CVT-301 were safe and well-tolerated, and the CVT-301 inhaler was also shown to be easily utilized by Parkinson’s disease patients in the OFF state.

“Patients today live with the reality that their oral medications could fail them at any moment,” said Dr. Karl Kieburtz, the Robert J. Joynt Professor of Neurology, University of Rochester, president of Clintrex LLC and a member of the Civitas Scientific Advisory Board. “By providing rapid onset and reliable relief using levodopa, the standard of care and backbone of patients’ therapy, in a simple patient-friendly device, CVT-301 has the potential to usher in a new paradigm in the treatment of Parkinson’s disease.”

Trial Design

The Phase 2b trial (CVT-301-003) was a randomized, double-blind, placebo-controlled, multicenter study of inhaled CVT-301 or placebo for the treatment of up to 3 OFF episodes per day in Parkinson’s disease subjects experiencing intermittent OFF episodes. The 86 patients treated in this study underwent an initial screen and run-in period of 2-4 weeks during which baseline motor assessments, measured using the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III), as well as other baseline efficacy and safety/pulmonary function assessments, were conducted. Following this phase, patients were randomized to receive CVT-301 or inhaled placebo in a double-blinded fashion. During the first 2 weeks of treatment, patients self-administered an inhaled levodopa dose of approximately 35 mg or placebo. During the final 2 treatment weeks, patients were dose-escalated to an inhaled levodopa dose of approximately 50 mg or placebo. In-office assessments of UPDRS III were performed at week 1, week 2 and week 4. The primary endpoint was defined as the mean change from pre-dose in average UPDRS III score (10-60 minutes post dose) after 4 weeks of treatment. Patients were also instructed to complete a Parkinson’s disease diary for three days prior to the office visits, recording daily OFF time and ON time without and with dyskinesias, as well as a daily treatment log. Safety parameters measured included pulmonary function, ECGs and vital signs (blood pressure, heart rate and orthostatic blood pressure).

About CVT-301

CVT-301 is being developed as a self-administered, as needed, inhaled L-dopa therapy for OFF episodes, providing rapid delivery of L-dopa to the brain without altering a patient’s individually optimized oral L-dopa regimen. Oral L-dopa, used for chronic symptom management, is administered to maintain dopamine levels in the brain above the therapeutic threshold; however, the reliability of oral L-dopa formulations is significantly compromised by delayed and unpredictable absorption and excessive variability in drug concentrations in the bloodstream inherent to the oral delivery route. L-dopa remains widely recognized as the most efficacious treatment for Parkinson’s disease symptoms in spite of this intrinsic unreliability, which results in OFF episodes. CVT-301 is being developed as an adjunct as- needed therapy to standard oral L-dopa therapy to address OFF episodes as they emerge and enable patients to reliably manage their symptoms.

CVT-301 leverages Civitas’ proprietary ARCUSTM technology to optimally deliver a precise dose to the lung for rapid and predictable L-dopa absorption. The ARCUSTM platform is uniquely able to deliver the necessary L-dopa dose with the required precision in a convenient, non-invasive manner. A Phase 1 study in healthy volunteers showed that CVT-301 rapidly achieved target L-dopa plasma levels with a pharmacokinetic (PK) profile supportive of its therapeutic potential. The Phase 2a double-blind, placebo-controlled dose finding study (CVT-301-002) confirmed the PK profile in patients, produced rapid and durable improvement in motor function when administered to patients in the OFF state, and was generally safe and well-tolerated at all doses tested. Civitas has recently completed a successful Phase 2b study to evaluate the efficacy and safety of CVT-301 in treating emergent OFF episodes during one month of continued use. CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s Disease

Over one million people in the US and over seven million people worldwide suffer from Parkinson’s disease, a neurodegenerative disorder caused by the diminished production of dopamine, resulting in progressive impairment of motor function including tremors at rest, rigidity and impaired movement. Even when treated with the current standard of care, the majority of Parkinson’s patients continue to experience OFF periods. These unpredictable OFF episodes reduce patients’ ability to lead productive, independent lives and are recognized by patients, care givers and healthcare professionals as one of the most troubling and debilitating issues associated with the disease.

About ARCUSTM Technology

The ARCUSTM inhalation technology delivers a reliable and consistent drug dose with a compact, breath-actuated inhaler. The ARCUSTM platform uses a proprietary dry powder and inhaler combination that is unique in its ability to deliver a large, precise dose independent of inspiratory flow rate from a simple, easy-to-use device suitable for convenient self-administration. The technology has successfully delivered more than one million doses to patients incorporating active agents ranging from small molecules to large proteins and has been scaled up to accommodate a commercial product launch.

About Civitas Therapeutics

Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, with an initial focus on treating debilitating OFF episodes in patients with Parkinson’s disease. Civitas is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital and RA Capital.

For additional information contact:

Stephanie Gillis Civitas Therapeutics
sgillis@civitastherapeutics.com

Mainstay Medical International Plc: Announcement of Offer Price and Number of Issued Ordinary Shares on Admission To Euronext Paris and ESM

Further to the announcement on 9 April, 2014 of its intention to raise funds through an initial public offering, Mainstay Medical International plc (“Mainstay” or the “Company”) announces the successful pricing of its initial public offering of new ordinary shares by way of a public offering in France and of an international private placement to institutional investors (the “Offer”), the number of new ordinary shares comprised in the offer and the timing for admission of its existing and new ordinary shares (“Ordinary Shares”) to trading on the regulated market of Euronext Paris and on the Enterprise Securities Market (“ESM”) of the Irish Stock Exchange.

Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. Mainstay is focused on the development of ReActiv8®, an innovative implantable medical device designed to treat people with Chronic Low Back Pain (CLBP).

HIGHLIGHTS

• The Offer comprises 851,175 new Ordinary Shares representing gross proceeds of an amount of €18.0 million, excluding any Ordinary Shares that may be issued under the Over-allotment Option.
• The Offer price has been set at €21.15 per new Ordinary Share (“Offer Price”).
• The size of the Offer may be increased by up to 45,953 new Ordinary Shares issued in the case of exercise, in part or in full, of the Over-allotment Option within 30 days after the Offer Price is made public.
• On commencement of unconditional dealings, the Company will have a market capitalisation, based on the Offer Price, of approximately €90.0 million.
• The gross proceeds will be used to conduct clinical trials, initially in Australia and then additionally in Europe, to submit an application for CE mark approval and for general corporate purposes.
• Retail investors who applied for Ordinary Shares under the retail offer have been allocated 16,783 Ordinary Shares, corresponding to €0.4 million, or 2.0% of the new Ordinary Shares.
• Institutional investors who applied for Ordinary Shares under the institutional private placement have been allocated 834,392 Ordinary Shares, corresponding to €17.6 million, or 98.0% of the new Ordinary Shares. Of the Ordinary Shares allocated to institutional investors, 355,791 Ordinary Shares were allocated to US Qualified Institutional Buyers (QIBs), corresponding to €7.5 million, or 41.8% of the new Ordinary Shares.
• Mainstay’s major institutional shareholders (Sofinnova Partners, Fountain Healthcare Partners, Medtronic, Inc., Capricorn Venture Partners and Seventure Partners Managed Funds) invested €8 million in the Offer. David Brabazon, a director of Mainstay, invested €0.1 million in the Offer.
• Following commencement of unconditional dealings:
  • Existing shareholders will hold 83.3% of the Ordinary Shares; and
  • Directors will hold 14.1% of the Ordinary Shares.
• Conditional dealings in the Ordinary Shares on Euronext Paris (under the “if and when issued” product line: MAINSTAY AIW) and the ESM are expected to commence at 9:00 a.m. (CET) on 29 April 2014.
• Settlement and delivery is expected to occur on 2 May 2014, with unconditional dealings in Ordinary Shares on the ESM expected to start at 9:00 a.m. (CET) on 2 May 2014 and on 5 May 2014 on Euronext Paris.

Dr Oern Stuge, Chairman, said:

“The successful initial public offering marks a major milestone in the company’s progress and we are now ready to move on to the next stage of our development as a listed company. We are very pleased that our IPO has been so well received by institutional and retail investors, who have recognised that Mainstay’s unique and innovative approach to the treatment of debilitating CLBP not only addresses an important clinical need, but moreover creates an interesting investment opportunity. We have recently commenced clinical trials of ReActiv8 and we continue to diligently execute our plans to obtain regulatory approval and subsequent commercialisation.”

Further Information

• Kempen & Co and Société Générale Corporate & Investment Banking are acting as Joint Bookrunners in connection with the Offer. Davy is acting as Prospectus adviser, ESM adviser and Co-Lead Manager.
• This Pricing Statement relating to the Offer will be made available on the Company’s website at www.mainstay-medical.com.
• Capitalised terms used but not defined herein shall have the meaning given to those terms in the Prospectus.

OFFER STATISTICS

Price (per Ordinary Share) €21.15

Number of Ordinary Shares that will be in issue immediately prior to the commencement of unconditional dealings 3,404,702

Number of Ordinary Shares issued in the Offer (1) 851,175

Maximum number of Ordinary Shares that may be issued under the Over- allotment Option 45,953

Estimated gross proceeds of the Offer receivable by the Company (2) €18.0 million

Estimated net proceeds of the Offer receivable by the Company (2) €14.5 million

Market Capitalisation of the Company at the Offer Price on the commencement of unconditional dealings €90.0 million

Euronext / ESM ticker MSTY

ISIN Code IE00BJYS1G50

(1) The Extension Clause was not exercised, and assuming no exercise of the Over-allotment Option.

(2) Assumes no exercise of the Over-allotment Option.

About Mainstay Medical

Mainstay Medical is an Irish medical device company that is developing an innovative implantable neurostimulation device, ReActiv8, for people with debilitating Chronic Low Back Pain.

Mainstay is headquartered in Dublin, Ireland and has subsidiaries in the Australia and the United States. Mainstay is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (USA), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).

Chronic Low Back Pain

Chronic Low Back Pain is generally defined as Low Back Pain where the pain persists for more than three months. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments. The Company estimates that in approximately 7% of all cases of Low Back Pain, the pain persists for more than three months.

About ReActiv8

ReActiv8 represents a new approach to the treatment of Chronic Low Back Pain. ReActiv8 is an implantable neurostimulation device which applies electrical stimulation to nerves that supply one of the key stabilising muscles in the back, the lumbar multifidus muscle. The hypothesis on which ReActiv8 is based is that electrical stimulation of the nerve that innervates the lumbar multifidus muscle to cause contraction of the muscle can help reactivate the muscle control system, thereby leading to improved spine stability and a reduction in the effects of CLBP.

Further information is available at www.mainstay-medical.com

Mainstay Medical Announces Intention To Launch Initial Public Offering And List On Euronext Paris And On The Enterprise Securities Market Of Irish Stock Exchange

Mainstay Medical International plc (“Mainstay”), a medical device company that is developing innovative therapies for people with debilitating Chronic Low Back Pain (“CLBP”), today announces its intention to raise funds through an initial public offering of new ordinary shares (the “Offer”) and to seek admission of its shares to trading on Euronext Paris and the Enterprise Securities Market of the Irish Stock Exchange.

Mainstay is an Irish medical device company with operations in Ireland, Australia and the United States. Mainstay is focused on the development of ReActiv8®, an innovative implantable medical device designed to treat people with Chronic Low Back Pain.

Mainstay is led by an experienced Board and management team with a strong track record in the medical device industry. Mainstay has a committed shareholder base, including experienced venture capital investors in France, Ireland, Belgium and the United States.

Highlights

• ReActiv8 is targeted at people with debilitating Chronic Low Back Pain. Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.
• Mainstay estimates that the initial target market for ReActiv8 is approximately two million people in the US and Europe.
• ReActiv8 is an innovative implantable neurostimulation medical device. The design of ReActiv8 is based on experience gained in a European Feasibility Study conducted in 2011 and 2012, which showed the therapy provided by ReActiv8 yielded improvements in pain and disability of people with Chronic Low Back Pain.
• Product development of ReActiv8 is complete, and enrolment in clinical trials in Australia commenced in March 2014.
• Mainstay intends to progress clinical trials in Australia; obtain CE Mark in Europe; obtain initial approvals for US clinical trials; and subject to regulatory approval, advance the commercialisation of ReActiv8.
• Strong and experienced Board, management team and existing investor base to continue the commercialisation of ReActiv8.
• Existing shareholders have committed to make a substantial investment in the Offer.

Dr Oern Stuge, Chairman, commented:

“We believe that ReActiv8 offers an innovative therapy for the millions of people who suffer from Chronic Low Back Pain. We further believe there is a significant market opportunity for ReActiv8 and the results of the recent Feasibility Study demonstrate the premise of our unique therapeutic approach. The Board is confident that we have the right management team, led by Peter Crosby, to commercialise ReActiv8 and is excited about the prospects for Mainstay.”

Peter Crosby, Mainstay CEO, added:

“Back pain specialists from all over the world have indicated the need for a new approach to help people with Chronic Low Back Pain. We believe our approach of using electrical stimulation to help restore control to the key stabilizing muscles in the lower back can play an important role in helping these people.”

“The therapy was investigated in a recently completed European Feasibility Study. The results presented in mid-2013 showed improvement in back pain and the disabling effects of back pain.”

“The energy and experience of the Mainstay team has enabled us to complete the development of ReActiv8 and obtain approval to start the clinical trials within a year of the publication of Feasibility Study results, and we have now commenced clinical trials and have a clear plan to obtain regulatory approval and the commercialisation of ReActiv8.”

About Mainstay Medical

Mainstay is an Irish medical device company that is developing an innovative implantable neurostimulation medical device, ReActiv8™, for people with debilitating Chronic Low Back Pain.

Mainstay is headquartered in Dublin, Ireland and has subsidiaries in Australia and the United States. Mainstay is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).

Chronic Low Back Pain

Chronic Low Back Pain is generally defined as Low Back Pain where the pain persists for more than three months.

Low Back Pain is a leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments. The Company estimates that in approximately 7% of all cases of Low Back Pain, the pain persists for more than three months.

ReActiv8

ReActiv8 represents a new approach to the treatment of Chronic Low Back Pain. ReActiv8 is an implantable device which applies electrical stimulation to nerves that supply one of the key stabilising muscles in the back, the lumbar multifidus muscle. The hypothesis on which ReActiv8 is based is that electrical stimulation of the nerve that innervates the lumbar multifidus muscle to cause contraction of the muscle can help reactivate the muscle control system, thereby leading to improved spine stability and a reduction in the effects of Chronic Low Back Pain.

Kempen & Co and Société Générale are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Initial Public Offering. Davy has been appointed as Co-Lead Manager and ESM advisor.

FOR FURTHER DETAILS, CONTACT:

Joint Global Coordinators and Joint Bookrunners

Kempen & Co N.V.
Beethovenstraat 300
1077 WZ Amsterdam
Postbus 75666
1070 AR Amsterdam
The Netherlands

Société Générale
Tour Société Générale
17, Cours Valmy,
92972 Paris La Défense Cedex
France

ESM Adviser and Co-Lead Manager

Davy
Davy House
49 Dawson Street
Dublin 2, Ireland

Media & Investor Relations Adviser

FTI Consulting (Dublin)
10 Merrion Square
Dublin 2, Ireland
+353 1 663 3600 or mainstay@fticonsulting.com
Eilish Joyce/Jonathan Neilan

FTI Consulting (Paris)
5, Rue Scribe
Paris, 75009, France
+33 1 47 03 68 10 or mainstay@fticonsulting.com
Arnaud de Cheffontaines/ Stephan Dubosq

Spark Therapeutics and Genable Technologies Announce Collaboration to Advance a Gene Therapy Treatment for a Rare Form of Retinitis Pigmentosa

PHILADELPHIA -  Spark Therapeutics and Genable Technologies announced today that they have entered into a collaboration agreement for Genable's lead therapeutic to treat rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO adRP), GT038. Under the terms of the collaboration, Genable will license certain adeno-associated virus (AAV) vector manufacturing patents from Spark. The parties have entered into a broad agreement in which Spark will be the exclusive manufacturer of the product and provide development advice and expertise to Genable to help in the ongoing development of GT038. Spark will receive milestone payments and royalties on future sales of GT038, as well as near-term revenue from the manufacture and supply of product.

"We are excited to apply our deep expertise in AAV clinical development and manufacturing to augment Genable's great work, and expand the number of debilitating diseases of the eye that can be addressed through gene therapy," said Jeffrey D. Marrazzo, Spark Therapeutics co-founder, president and CEO.

Dr. Jason Loveridge, CEO of Genable Technologies commented, "We have chosen Spark as our partner to advise, lend their experience and manufacture GT038 based on their broad expertise in gene therapy. We see them as a world-class organization, and we are excited to be advancing our novel therapy GT038 into the clinic."

"The collaboration with Spark provides an exciting opportunity to greatly expedite development of Genable's novel therapy targeted towards RHO-adRP," said Professor Jane Farrar, founder and director, Genable Technologies; professor, Trinity College (Dublin).

GT038 is a potential treatment for rhodopsin (RHO)-linked autosomal dominant retinitis pigmentosa (adRP), an inherited retinal dystrophy that leads to blindness in most cases. There is currently no approved pharmacologic treatment for adRP, which affects an estimated 30,000 patients worldwide. GT038 utilizes AAV vectors with an established safety and efficacy profile to deliver RNA interference (RNAi) molecules to suppress the expression of faulty and normal copies of RHO and restore normal gene expression. GT038 has been granted Orphan Drug Designation in both the U.S. and Europe.

About Genable Technologies

Genable Technologies Ltd. is a privately held, venture-capital-backed, Dublin (Ireland)- based bio-pharmaceutical company. The company is developing new gene therapies to treat "dominant" genetic diseases. The company has received significant support and investment form Fountain Healthcare Partners, Delta Partners, Fighting Blindness Ireland, Foundation Fighting Blindness Clinical Research Institute (U.S.) and Enterprise Ireland. To learn more please visit www.genable.net

About Spark Therapeutics

Spark Therapeutics is developing potentially curative, one-time gene therapy products to transform the lives of patients and re-imagine the treatment of debilitating diseases. Spark's lead gene therapy candidate, for RPE65-related blindness, is currently in Phase 3 clinical trials with the potential to be the first approved gene therapy in the U.S., and the first treatment to address the significant unmet needs of patients living with blindness due to inherited retinal dystrophies.

Spark's founding team includes scientists who led the movement to develop gene therapy as a new treatment paradigm, establishing clinical proof of concept in the eye and liver and contributing key insights to the field that have resulted in a resurgence of industry interest in gene-based medicines. In addition to the Phase 3 program in RPE65-related blindness, the company has a Phase 1/2 program in hemophilia B, and preclinical programs to address neurodegenerative diseases and other inherited retinal dystrophies and hematologic disorders. Spark has rights to a proprietary manufacturing platform that has an unparalleled track record of success in supporting clinical studies across diverse therapeutic areas and routes of administration. The company's expertise across research, clinical, regulatory and manufacturing builds on a legacy of innovation and excellence in gene therapy established by Spark's team while at The Children's Hospital of Philadelphia Center for Cellular and Molecular Therapeutics. To learn more visit www.sparktx.com.

Media Inquiries:

Jessica Rowlands, 202-729-4089, jessica.rowlands@fkhealth.com

Dr. Jason Loveridge + 33 674177812, jloveridge@genable.net

Mainstay Medical Begins Clinical Trial of ReActiv8® for People with Chronic Low Back Pain

Dublin based medical device company hits key milestone.

Dublin, Ireland – Mainstay Medical today announced that it has secured approval from Ethics Committees in Australia to start a clinical trial of ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain (CLBP). Recruitment of subjects for the trial has commenced at three clinical sites in Australia.

The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with debilitating Chronic Low Back Pain for whom surgery is not indicated.

One of the root causes of CLBP is impaired control by the nervous system of the muscles that stabilize the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from chronic low back pain.

“Our novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of the therapy was demonstrated in the recently completed European Feasibility Study.” said Peter Crosby, the CEO of Mainstay Medical. “The energy and experience of the Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results.”

People with debilitating CLBP usually have a greatly reduced quality of life and score significantly higher on scales for disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and most of these people have no indications for 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 economies.

“Back pain specialists from all over the world have told us that they need a new approach to help the large group of people with CLBP who are stranded without a viable alternative. We believe, based on published research, that there are millions of such people in Europe and the USA today. The results of the European Feasibility Study encouraged us to believe that ReActiv8 can play an important role in helping these people,” Crosby mentioned.

Results from Mainstay Medical’s European Feasibility Study were presented at the meeting of the International Neuromodulation Society in Berlin in June 2013. Results showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from CLBP and an improved quality of life.

About Mainstay Medical Ltd

Mainstay Medical Limited is a medical device company which is developing an innovative implantable neurostimulation medical device, ReActiv8, for people with debilitating Chronic Low Back Pain (CLBP). Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States and Australia. Mainstay Medical is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA).

Further information can be found at www.mainstay-medical.com

Media queries to:

Eilish Joyce, FTI Consulting
Tel: +353 1 663 3609 / +353 87 7914641
Email: eilish.joyce@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller, FTI Consulting
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com

Mainstay Medical Strengthens Board

Dublin, Ireland – Mainstay Medical Ltd, a medical device company headquartered in Dublin, today announced the appointment of Mr David Brabazon to the Board of Directors of the company. Mr Brabazon brings a wealth of international industry knowledge and commercial expertise garnered from a twenty year career in life sciences.

Mr Brabazon’s appointment to the Board comes as Mainstay Medical continues to advance towards regulatory approval and commercialisation of its innovative medical device for the treatment of chronic low back pain. Mainstay’s ReActiv8 is a small, implantable neurostimulation device that is designed to restore spine stability to ease chronic low back pain.1

The clinical results from a European Feasibility Study were presented at the meeting of the International Neuromodulation Society in Berlin in June 2013, and showed that the therapy delivered by ReActiv8 improves symptoms of back pain, reduces disability from back pain and improves quality of life.2

Commenting on his appointment Mr Brabazon said, “I look forward to working with Mainstay Medical’s board and management team to continue the fast and efficient progress the company has made to date. More than half of us will experience back pain at some point in our lives and for many people, the disabling pain will continue for long periods. We are optimistic that ReActiv8 will make a real difference to people with chronic low back pain, and also ease the economic and social impacts that can stem from this debilitating condition”.

Welcoming Mr Brabazon’s appointment, Mainstay Medical CEO Peter Crosby said, “We are delighted to have David join our Board. He brings a wealth of commercialisation and business development experience as well as knowledge of relevant therapeutic areas. We are at a very exciting stage in our development, we continue to add to our intellectual property portfolio and we are making progress towards regulatory approval for the ReActiv8”.

About David Brabazon

A co-founder of Adapt Pharma Limited in November 2013, a US focused specialty pharmaceuticals company, Mr Brabazon currently serves as the company’s Chief Financial Officer. He previously co-founded Azur Pharma plc in 2005, where he also held the role of Chief Financial Officer. Azur Pharma was a specialty pharmaceuticals business focused on diseases of the central nervous system, pain and women’s health that was acquired by Jazz Pharmaceuticals in January 2012. After the business merged with Jazz Pharmaceuticals, Mr Brabazon served with the new entity as Senior Vice President of Finance and Group Company Secretary. Prior to Azur Pharma, he served as Vice President and Group Financial Controller at Elan Corporation plc.

About Mainstay Medical Ltd

Mainstay Medical Ltd. is a medical device company which is developing innovative neurostimulation therapies for the population of people with debilitating Chronic Low Back Pain. The Company is focused on the development of ReActiv8, an active implantable medical device designed to treat people with Chronic Low Back Pain. Low Back Pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

The Company is headquartered in Dublin, Ireland and has subsidiaries operating in the United States and Australia. Mainstay Medical Inc. was founded in 2008 in Minnesota, United States, and the headquarters of the business moved to Dublin in 2012. Mainstay Medical is backed by investors including Sofinnova Partners (France), Fountain Healthcare Partners (Ireland), Medtronic (US), Capricorn Venture Partners (Belgium), Seventure Partners (France) and Twin Cities Angels (Minneapolis, USA). Further information can be found at www.mainstay-medical.com

Media queries to:

Eilish Joyce, FTI Consulting
Tel: +353 1 663 3609 / +353 87 7914641
Email: eilish.joyce@fticonsulting.com

Paul McSharry, FTI Consulting
Tel: +353 1 663 3609 / +353 87 240 6642
Email: paul.mcsharry@fticonsutling.com

Jeanne Bariller
Tel: +33 1 47 03 6863 / +33 67 412 4452
Email: jeanne.bariller@fticonsulting.com