Mainstay Medical Full Year 2015 Preliminary Results and Business Update

Dublin, Ireland – Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announced the publication of preliminary results for the year ended 31 December 2015.

Business Highlights

We continue to make progress towards commercialization of ReActiv8. On 2 November 2015 we announced that we had submitted an application for CE Marking to our Notified Body. We have since had several interactions with the Notified Body to progress the application.

Following CE Marking, we plan to commence commercialization in Germany, our first target market. Preparations for commercialization are ongoing, including interaction with initial physician customers, and recruiting direct sales and support staff. In Germany we plan to use a small direct sales force to focus on a select group of multi-disciplinary centers who see a large number of people with CLBP. As we gain experience with this commercialization strategy, we will consider expanding to additional customers and additional countries.

Positive results of the ReActiv8-A Clinical Trial were announced on 31 August 2015, and on 4 December 2015 we announced additional data confirming the positive results from this clinical trial. These results were presented at the scientific meeting of the North American Neuromodulation Society in December by Professor Sam Eldabe (Middlesbrough, UK), an investigator in the ReActiv8- A Clinical Trial. ReActiv8 also featured in a number of other presentations on back pain presented by leading neuromodulation physicians at this meeting.

On 29 May 2015, we announced FDA approval to begin the ReActiv8-B Clinical Trial under an Investigational Device Exemption (IDE). We have since worked with the FDA to refine the protocol, and we are progressing clinical trial site selection and initiation, physician training, and submissions to Ethics Committees (Institutional Review Boards (IRBs) in the US). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Following Pre-Market Approval (if obtained), we plan to commercialize ReActiv8 in the US.

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover. In summary, eligible subjects will have baseline data collected and then following verification that the enrolment criteria are met, ReActiv8 will be implanted. At the 14-day post implant follow up visit, half the subjects will be randomized to receive appropriately programmed stimulation (the treatment arm), and half will be randomized to receive minimal stimulation (the control arm). Subjects will not be informed about their allocation to the treatment or control arm, and all subjects will be told that they may or may not feel something with stimulation, and all will be encouraged to continue using ReActiv8 at least until the 120-day primary outcome assessment visit. Subjects will be instructed to not use any other therapies for CLBP from the time of enrolment until after data collection at the primary outcome assessment visit. Subjects will also be instructed to keep constant the use of medications prescribed and used for low back pain until the primary outcome assessment visit. The primary efficacy endpoint of the Trial is a comparison of responder rates between the treatment and control arms. The Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. A responder is defined as having at least a 30% improvement in low back pain reported on a 100mm Visual Analog Scale (VAS) between baseline and the 120-day primary outcome assessment visit, with no increase in medications prescribed and taken for pain in the 14 days prior to the visit. Data for multiple secondary outcome measures will also be gathered. After the primary outcome assessment visit, subjects in the control arm will be crossed over to receive appropriately programmed full strength stimulation, and all subjects will continue to be followed.

The statistical design of the Trial requires data from 128 subjects at the 120-day primary outcome assessment visit. Additional subjects will likely be enrolled and implanted as part of the surgical roll-in phase and to achieve data from 128 subjects in the pivotal cohort. The Trial is designed with an “interim look” when primary outcome data are available from half the subjects, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. Up to 40 clinical trial sites may be involved in the Trial, some of which may be referring sites and some may be implanting sites.

A summary of the protocol can be found at https://clinicaltrials.gov/show/NCT02577354.

Based on our experience with enrolment in the ReActiv8-A Trial, we estimate that full enrolment of the pivotal cohort in the ReActiv8-B Trial will take 12-18 months from ramp up of enrolment, with results anticipated to be available approximately six months following full enrolment. The work required to complete a PMAA submission to the FDA is estimated to take approximately six months from data availability.

The ReActiv8-B Trial, if successful, will provide what is referred to as Level 1 Evidence of safety and efficacy of ReActiv8, and Level 1 evidence may be used to support applications for favourable reimbursement in the US.

We plan to ramp up enrolment in the ReActiv8-B Trial once we determine that we have sufficient financial resources to complete the Trial through data availability. A small number of subjects may be enrolled in the ReActiv8-B Trial prior to securing such financial resources.

We are also pleased to announce the issuance of two new U.S. Patents, bringing the total current number of issued U.S. issued Patents in the Mainstay portfolio to seven:

• U.S. Patent No. 9,186,501 entitled “Systems and Methods for Implanting Electrode Leads for Use with Implantable Neuromuscular Electrical Stimulator”; and
• U.S. Patent No. 9,248,278 entitled “Modular Stimulator for Treatment of Back Pain, Implantable RF Ablation System and Methods of Use”.

Corresponding applications have been filed for other countries. Mainstay continues to add to its portfolio of issued patents and pending patent applications.

Financial Update

On 24 August 2015, we announced the closing of debt financing for up to $15 million. The secured debt facility is non-dilutive to existing shareholders, and is being provided by IPF Partners, a leading financing provider focused on the European healthcare sector. As at 31 December 2015, the Group had drawn down $10.5 million. The last tranche of $4.5 million can be drawn down at the Company’s discretion up to 31 July 2016 following CE Marking approval of ReActiv8.

Operating expenses were $12.9 million for the year and have decreased by $2.3 million compared to 2014 due to costs associated with the European IPO included in 2014 not arising in 2015, offset by costs related to the expansion of the Mainstay team.

Cash on hand at 31 December 2015 was $16.6 million and operating cash outflows for 2015 were $11.6 million.

Outlook and future developments

While we await CE Marking approval for ReActiv8, we are preparing for commercialization in Europe. We are also preparing for the ReActiv8-B Clinical Trial and, subject to the availability of sufficient financial resources, we look forward to ramping up enrolment in the Trial.

The principal risks and uncertainties faced by the Group remain substantially unchanged from the disclosures included in the 2014 Annual Report. Those risks and uncertainties should be read in conjunction with this announcement and the Company’s press releases and other public disclosures (copies of which can be found on the Company’s website) and could cause actual events to differ materially from those described in this announcement and our disclosures.

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

About the ReActiv8-A Trial

The ReActiv8-A Clinical Trial is a prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Data from the first 47 subjects in ReActiv8-A Trial have been submitted as part of an application for CE Marking. Further details can be obtained at https://clinicaltrials.gov/show/NCT01985230.

About the ReActiv8-B Trial

The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). The ReActiv8-B Clinical Trial is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA. Further details can be found at https://clinicaltrials.gov/show/NCT02577354.

About Chronic Low Back Pain (CLBP)

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

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

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

ReActiv8 is an investigational device and is not approved for commercialization anywhere in the world. CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only

Vivasure Medical receives CE Mark for First and Only Fully Bioabsorbable Percutaneous Closure Device for Large-Bore Transcatheter Procedures

Sutureless Technology Designed to Facilitate Less-Invasive, Shorter Procedures

GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical today announced Conformité Européenne (CE) Mark approval of the world’s first fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The Vivasure closure device is the first product from the company’s patented PerQseal™ technology platform, and is the only approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.

An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. Large-bore arteriotomies, such as those made to facilitate transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR), have traditionally required a surgical cut-down and sutured repair via a 3- to 5- centimeter incision. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to sutured repair.

“Percutaneous transfemoral access is a key enabler for TAVR procedures, which are rapidly becoming standard of care for patients with aortic valve disease,” said Michael Laule, M.D., cardiologist at Charité University Hospital, Berlin. “The Vivasure closure device is an easy-to-use option that promises to significantly improve the patient experience and shorten overall procedure times by allowing physicians to utilize a fully percutaneous procedure to repair the access site.”

“The bioabsorbable nature of the Vivasure closure device allows the surgeon to provide a complete repair at the surgery site, which helps avoid stenosis and maintains the integrity of the vessel,” said Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic, director of the Scripps Prebys Cardiovascular Institute for Scripps Health, and chief medical officer of Vivasure Medical. “The demand for bioabsorbable solutions is growing as the transient nature of these products continues to demonstrate as good or better therapeutic results for patients.”

“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive procedures that offer improved clinical outcomes and faster recovery times over the open surgery alternative. The Vivasure closure device is intended to further facilitate the less invasive nature of these treatments,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “CE Mark is an important milestone for Vivasure as we continue development of our technology, which we plan to launch in Europe in the coming months.”

The Vivasure closure device includes a delivery system and single-use patch-like device. The system has been evaluated in clinical studies, with patients treated in four EU countries, achieving 97 percent device technical success with no major device related complications. Long-term follow-up data has been collected to 12 months post-procedure.

To view an animation of the Vivasure closure device, please visit www.vivasuremedical.com.

The Vivasure closure device is not currently approved in the U.S.

About Vivasure Medical
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal™ platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com.

Contacts
for Vivasure Medical
Jessica Volchok
424-271-6471 (O)
310-849-7985 (C)
jessica@nicoleosmer.com

Innocoll AG Appoints Charles Katzer as Head of Manufacturing and Technical Operations

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that Charles Katzer has been appointed head of Manufacturing and Technical Operations effective immediately. The addition of this role to the senior management team is part of its strategic plan to transition Innocoll into a commercial-stage, fully-integrated specialty pharmaceutical company.

“2016 is anticipated to be an important transitional year for Innocoll,” said Tony Zook, chief executive officer of Innocoll. “We expect to announce results of our two Phase 3 trials of XaraColl for the treatment of post-operative pain in the second quarter of 2016. Results of our two Phase 3 trials of Cogenzia for treatment of diabetic foot infections are expected to be announced in the third quarter of 2016. Both products are anticipated to receive marketing approval in 2017 and, thus, will require a manufacturing ramp-up that is already in progress. We have already initiated pre-commercial activities for both candidates. The addition of Chuck adds his skills and experience in manufacturing, QA/QC, supply chain management and related activities to our team and will help us make both XaraColl and Cogenzia commercial successes.”

Throughout Mr. Katzer’s over 40-year career, he has been responsible for the leadership and direction of manufacturing, quality operations, product & process development, supply chain operations, and engineering functional disciplines in the biopharmaceutical industry. Most recently, he was the senior vice president of technical operations of Auxilium Pharmaceuticals, where he was responsible for the overall leadership and direction of manufacturing, supply chain, process development, among other activities, for Auxilium’s products. Prior to his tenure at Auxilium, Mr. Katzer was responsible for a variety of operational activities including manufacturing, QA/QC and process development at a number of biopharmaceutical companies including Discovery Laboratories, Medimmune Vaccines, US Bioscience, Immunomedics and Rhone-Poulenc Rorer. Mr. Katzer received his B.S. in Zoology from the University of Wisconsin.

“Innocoll’s collagen matrix technologies, as evidenced by its advanced product pipeline, are platforms that provide significant potential to make medicines work better, and, therefore, offer ideal opportunities for long-term successful pharmaceutical product development and commercial success,” said Mr. Katzer. “I’m am looking forward to contributing to this success and to participate in the growth of the company in 2016 and beyond.”

About Innocoll AG

Innocoll is dedicated to making better happen—better ways for patients to recover from surgeries and better ways to treat limb-threatening infections. We strive to engineer better medicines to help patients get better.

Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits.

Our robust, late-stage product pipeline is focused on addressing a number of significant unmet medical needs: INL-001, a bupivacaine-collagen bioresorbable implant (Phase III), is being studied to provide better postoperative analgesia; INL-002, a gentamicin-collagen topical matrix (Phase III), is being investigated as a topical treatment to better cure diabetic foot infections; and INL-003, a bioresorbable collagen film surgical adhesion barrier (approved ex-US), is scheduled to enter clinical trials in the US for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

Innocoll is a global company operating in Europe and the US, with plans to further partner in other high- potential areas around the world.

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

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

Corporate:

Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com

Investor Contact:

Russo Partners, LLC
Robert E. Flamm, Ph.D.
(212) 845-4226
robert.flamm@russopartnersllc.com

Neuravi Announces Meeting of World Stroke Leaders at Inaugural Clot Summit 2015

Galway, Ireland - The world’s first Clot Summit was held in Heidelberg, Germany, last week, chaired by Werner Hacke, MD, PhD, senior professor of Neurology at the University of Heidelberg Medical School, an eminent leader in the field of stroke.

The meeting was attended by internationally renowned clinicians from 12 countries, including many who played leadership roles in the recent positive clinical trials for endovascular stroke therapy, together with engineers and scientists focused on various areas of research in clot and acute stroke. The purpose of the multidisciplinary gathering was to identify ways to further advance the field of stroke therapy and improve patient care, with a focus on the main culprit in ischemic stroke – the clot that causes the occlusion. The summit’s design emphasized collaboration and cross-fertilization of ideas from clinicians, academics and engineers.

“This gathering of experts provided a valuable exchange of ideas and knowledge, and I am grateful for the opportunity to learn from respected colleagues in the field,” Prof. Hacke said. “The summit was well received, with attendees expressing interest in further interdisciplinary research on clot to improve stroke intervention and patient outcomes.”

During the summit, Neuravi presented insights gained from five years of the company’s pioneering research on the mechanical characteristics of clot and acute stroke occlusion dynamics.

“Understanding the science of occlusions is fundamental to Neuravi’s interest in advancing stroke therapy, and having the opportunity to collaborate with a diverse group of experts greatly enriches the process of discovery and learning. We are delighted with the success of the inaugural Clot Summit,” said Eamon Brady, CEO of Neuravi. “Through the Neuravi Thromboembolic Initiative (NTI), we will continue to pursue research, facilitate discussions, and build collaborations to deepen the understanding of the role of clot in acute stroke.”

“Thrombectomy has been proven as the best treatment for large vessel occlusive stroke, and now it is time to better understand clot in order to further advance care. This summit has contributed greatly to that discussion,” said Diederik Dippel, MD, PhD, senior consultant in the Department of Neurology at the Erasmus Medical Center in Rotterdam, the Netherlands and lead investigator of the MR CLEAN trial.

Raul Nogueira, MD, director of Neuroendovascular Service and Neurocritical Care at Grady Memorial Hospital in Atlanta, Georgia, also recognized the need for better clot science. “It is up to us to continue to push the envelope to further improve stroke care so that even more patients will benefit. I strongly believe that one of the best ways to do this is to build a better understanding of clot and occlusions.”

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Innocoll AG Announces Plan to Move Corporate Domicile to Ireland

ATHLONE, Ireland - Innocoll AG (NASDAQ:INNL) today announced that its supervisory board has unanimously approved a plan to move the company's legal domicile from Germany to Ireland.

We expect Innocoll to have a transformative year in 2016. Our two lead product candidates are well advanced in their Phase 3 efficacy trials. We expect the Phase 3 data from XaraColl and Cogenzia to be available in the first half and in the third quarter of 2016, respectively. We expect to commence a clinical program in the US for CollaGUARD, our third product in the pipeline, which helps fight post-surgical adhesions, after a pre-submission meeting planned for the first quarter of 2016 with the FDA. We intend to build commercial capabilities in the U.S. to effectively support our brands, and we will evaluate the benefits of select partnerships or co-promotions outside the U.S. Finally, we have started to expand our manufacturing capabilities in our facility in Saal, Germany, in order to supply our late-stage products.

The re-domicile to Ireland is a critical strategic step that will help us capitalize on our strategic initiatives and enhance our corporate profile as there are significant potential benefits of having our publicly-traded parent incorporated in Ireland. It will provide us with greater flexibility in structuring our equity issuances and other financing transactions. Also, the re-domicile will help eliminate certain burdensome formalities and costs to the company and our shareholders. Finally, it positions the company to have better access to the global financial market, and enable us to continue to further attract and retain talent.

The proposed move to a jurisdiction like Ireland will put Innocoll in line with the majority of the NASDAQ listed peers in our sector while preserving Innocoll AG's current Irish tax residency without impacting Innocoll's operations.

"We believe that our proposed corporate re-domicile is in the best interest of Innocoll and our shareholders," said Tony Zook, chief executive officer of Innocoll. "We believe this move will enable Innocoll to benefit from advantages offered by Irish corporate law and provide important economic and operational benefits for our company."

Innocoll's proposed re-domicile will be achieved through a cross border merger under European Union law pursuant to which Innocoll AG will merge into Innocoll Holdings plc, an Irish shell company, the ordinary shares of which will be exchanged for those of Innocoll AG (including those shares underlying existing ADSs on a 1:1 basis). Upon completion of the transaction, Innocoll Holdings plc intends to list its shares directly on NASDAQ under the same "INNL" trading symbol currently used by Innocoll. Innocoll Holdings plc will be the sole surviving entity after the merger and will assume all of the assets and liabilities of Innocoll AG.

The proposed change in domicile is subject to approval from Innocoll's shareholders at an extraordinary general meeting anticipated to occur in January 2016, the final approval of Innocoll's management board, and the satisfaction of other customary closing conditions. If approved, the re-domicile merger and share exchange are expected to close in March 2016.

Innocoll Holdings plc will file a Registration Statement on Form F-4 with the Securities and Exchange Commission which will contain a prospectus relating to the re-domicile merger, including the share exchange. Upon completion of the transaction, Innocoll Holdings plc will remain subject to the reporting, disclosure and governance requirements of the NASDAQ and the SEC.

About Innocoll AG

Innocoll is dedicated to making better happen—better ways for patients to recover from surgeries and better ways to treat limb-threatening infections. We strive to engineer better medicines to help patients get better.

Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits.

Our late-stage product pipeline is focused on addressing a number of significant unmet medical needs: INL-001, a bupivacaine-collagen bioresorbable implant (Phase III), is being studied to provide better postoperative analgesia; INL-002, a gentamicin-collagen topical matrix (Phase III), is being investigated as a topical treatment to better cure diabetic foot infections; and INL-003, a bioresorbable collagen film surgical adhesion barrier (approved ex-US), is scheduled to enter clinical trials in the US for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

Innocoll is a global company operating in Europe and the US, with plans to further partner in other high- potential areas around the world.

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

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

Additional Data Confirm Positive Results for Clinical Trial of ReActiv8®

Additional data confirm clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options

Dublin, Ireland – Mainstay Medical International plc (Mainstay or the Company, listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (CLBP), today announced additional results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial to gather data for a submission for CE Marking for ReActiv8. The additional results are consistent with those released on 31 August, 2015 and continue to show clinically important, statistically significant and lasting improvement in pain, disability and quality of life in this clinically challenging population.

NOTE: Results in this release have been updated including data from 13 subjects who had not yet reached the 180 day follow-up at the time of the August press release. A full description of the ReActiv8-A Trial and updated results are provided in an addendum to this release.

ReActiv8 is for treatment of people who suffer from CLBP, have attempted most or all available treatment options, and are not candidates for back surgery or spinal cord stimulation. The ReActiv8-A Trial population was relatively young (mean age 43.9 years) and had a long history of low back pain (mean 13.8 years). All of the subjects had attempted physical therapy, and 70% were taking opioids for back pain. The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have reached the 90 day follow up and 45 have reached the 180 day follow up.

Results highlights:

Clinical performance of ReActiv8 at 90 days compared to baseline for all subjects is:

o 63% with clinically important improvement in back pain defined as ≥2 point reduction on the 0-10 Numerical Rating Scale (NRS) for low back pain1 measured on the day.

o 57% responder rate for pain: A responder is defined as a subject with a clinically important improvement in mean of prior 7 days NRS with no clinically significant increase in medications taken for low back pain.

o 57% with a clinically important improvement2 in disability on the Oswestry Disability Index (ODI).

o 67% with a clinically important improvement3 in quality of life on the EQ-5D scale.

Clinical performance at 90 days is even better for the group of subjects who do not receive financial compensation for being out of work due to their back pain. For those 32 subjects the results are:

o 72% with clinically important improvement in low back pain NRS on the day.

o 69% responder rate for pain.

o 63% with clinically important improvement in ODI.

o 69% with a clinically important improvement in EQ-5D.

 Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days (n=45). Paired data for all subjects at 90 and 180 days respectively are:

o 63% and 58% with clinically important improvement in low back pain NRS on the day.

o 57% and 60% with clinically important improvement in ODI.

o 67% and 73% with clinically important improvement in EQ-5D.

o 61% and 67% reported >50% Percent Pain Relief.

Adverse Events (AEs) incidence and type were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs and no serious AEs related to the device, therapy or procedure.

The observed lead migration incidence (<1%) demonstrates that the ReActiv8 lead mitigates the risk of lead migration identified with commercially available neurostimulation leads in the earlier Feasibility Trial.

In the August press release, the Company announced a modification of the implant technique with different lead routing developed to mitigate the risk of breaks of the wires inside the lead, which had been observed in the ReActiv8-A Trial. Experience to date with the first 14 subjects implanted with the modified approach (new implants and revisions) are encouraging.

The Company announced on 2 November, 2015 that a submission for CE Marking was made.

Subjects continue to be enrolled in the ReActiv8-A Trial to gather additional data on performance and safety which the Company plans to incorporate into the Post Market Clinical Follow Up. To date there have been 6 additional subjects implanted in the ReActiv8-A Trial.

About Mainstay

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

About the ReActiv8-A Trial

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

About Chronic Low Back Pain

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

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

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

Neuravi Announces First Patient Treated in International Pivotal Clinical Trial of Novel Stent Retriever for Acute Ischemic Stroke

Data from ARISE II Will Be Submitted to FDA in support of Market Clearance for EmboTrap in the U.S.

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, announced today that the Tennessee Interventional and Imaging Associates at Erlanger Medical Center in Chattanooga, Tenn., have treated the first patient in an international clinical trial assessing safety and effectiveness of the EmboTrap® Revascularization Device, a novel stent retriever for the treatment of acute ischemic stroke. Data from the pivotal study, called ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap), will be submitted as part of an application to U.S. Food and Drug Administration (FDA) for approval for the device.

The ARISE II study will enroll 210 patients in up to 25 sites across Europe and the United States. Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, Toledo, Ohio and Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden are the U.S. and European principal investigators of the study. Neurologists Jeff Saver, M.D., of UCLA Medical Center in Los Angeles, Calif. and Heinrich Mattle, M.D., of Inselspital in Bern, Switzerland, serve on the study’s initiating Executive Steering Committee.

“Stroke care has entered a new age. Now that multiple trials have demonstrated the value of endovascular therapy for treating acute ischemic stroke, we are looking for ways to further improve patient care through new technology, better techniques, and streamlined systems,” stated Dr. Zaidat. “The ARISE II trial is the first IDE clinical trial to evaluate innovative stent retriever technology in this new era for stroke.”

The Southeast Regional Stroke Center at Erlanger Medical Center was the first of the ARISE II sites to treat a patient as part of the trial. The center is a Joint Commission-certified Comprehensive Stroke Center that has played a leadership role in international clinical trials for stroke treatment.

“We are pleased to treat the first patient in this international trial of a cutting edge technology that may offer advantages over currently available devices,” said Blaise Baxter, M.D., chief of radiology at Erlanger. “Evaluating new technology with the goal of improving patient outcomes is all part of our effort to deliver the best patient care possible. ”

Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent retrievers’, to perform these life-saving procedures.1 The Cleveland Clinic recently recognized stent retrievers as one of the top 10 medical innovations for 2016.

The design of the EmboTrap thrombectomy device is informed by extensive research on a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot escaping during retrieval, which could cause additional harm to the patient.

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4

“Working to improve clinical outcomes in stroke is central to Neuravi’s mission, and we are committed to investing in clinical research in order to deliver advanced technologies and new clinical tools to physicians,” said Mairsil Claffey, vice president of Clinical, Regulatory & Quality for Neuravi. “We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the ARISE II trial.”

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Mainstay Medical Applies for CE Mark for ReActiv8®

A key step towards European commercialisation of innovative treatment of chronic low back pain

Dublin, Ireland – Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain, announces it has submitted an application for CE Mark for ReActiv8. The submission represents a further key step towards commercialisation of ReActiv8 in Europe.

Mainstay’s application for CE Mark includes the results of the ReActiv8-A Clinical Trial which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options1.

Peter Crosby, CEO of Mainstay, said: “The application for CE Mark approval is a significant milestone for Mainstay and follows the successful results of our ReActiv8-A trial. With FDA approval to start the ReActiv8-B Clinical Trial to gather data for an application for US approval, we are moving towards our goal of commercialisation of ReActiv8 in major world markets. We believe ReActiv8 has the potential to change the lives of millions of people who have no effective treatment for their chronic low back pain and we are now a step closer to selling ReActiv8 in Europe.”

ReActiv8-A (http://clinicaltrials.gov/show/NCT01985230) is an international, multi-centre, prospective single arm clinical trial that recruited subjects who were not candidates indicated for surgery or spinal cord stimulation, and who had attempted other therapies, including at least physical therapy.

Data have been reported for the first 46 subjects in the ReActiv8-A trial. After 90 days of treatment with ReActiv8, 63% of people showed a clinically important improvement in their low back pain, 57% showed a clinically important improvement in their disability and 67% showed a clinically important improvement in their quality of life. Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days.

In addition to the clinical results, the application for CE Mark includes extensive information about the design, testing, manufacturing, and quality system for ReActiv8, and is the culmination of several years’ work.

Mainstay’s notified body will review the application for CE Mark, and Mainstay will respond to questions and/or requests for additional data during the review process.

Mainstay Medical plans to establish its own direct sales force for commercialisation of ReActiv8 in key European markets starting in 2016, subject to CE Mark approval.

- End -

CE Marking

CE Marking is a mandatory conformity marking for certain products sold within the European Economic Area since 1985, and is a declaration that the product meets the essential requirements of the applicable EC directives. For Active Implantable Medical Devices (AIMDs) like ReActiv8, CE Marking is granted by a Notified Body after review of the design dossier and other information for conformity to the AIMD Directive. Following CE Marking, a product can be sold in the EEA, and certain other countries.

About Mainstay

Mainstay is a medical device company which is developing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States 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 dynamically stabilise the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

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

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

ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

Neuravi Announces European Launch of Innovative Minimally Invasive Stroke Therapy

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced commercial availability of the company’s EmboTrap® Revascularization Device for the treatment of acute ischemic stroke in Europe. The device will be marketed through the sales and distribution network the company has established in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland.

Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent-retrievers’, to perform these life-saving procedures.1

The design of the EmboTrap thrombectomy device is informed by extensive research on the wide range of different clot types that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4

The EmboTrap has been used extensively to treat patients with large vessel ischemic stroke during clinical evaluation and in an initial phased launch in Europe. Professor Michael Söderman, Chief of Neuroangiography at Karolinska University Hospital in Sweden, shared his experience with the device during the European Society of Minimally Invasive Neurological Therapy (ESMINT) congress in Nice, France, last month.

“At Karolinska, we are using the EmboTrap to treat the majority of our stroke patients. It is our first choice for middle cerebral artery occlusions because it is highly deliverable, and we have found the device to be very effective in removing clots in just one to two passes. It is also quite flexible, which is important both for getting to the clot quickly and helps in being gentle on the cerebrovasculature during removal,” stated Prof. Söderman.

At the congress, Prof. Söderman presented data from a case series evaluating use of the EmboTrap device in 42 stroke patients at two European centers. In the series, treatment with the device restored significant blood flow in 86 percent of patients, with the majority of patients recovering to be able to function independently.5

“The EmboTrap device represents a new wave in innovation for stent retrievers based on clot research and a fuller understanding of the underlying challenge,” said Eamon Brady, Neuravi’s CEO. “We are excited to announce our launch and pleased that, following the compelling clinical data published earlier this year, use of thrombectomy devices for endovascular stroke therapy is on the rise, which should save and improve the lives of many patients.”

The company’s ARISE II clinical trial will begin enrolling patients this year at select centers in the United States and Europe. The trial will gather data to support the use of the EmboTrap and to seek FDA approval.

The EmboTrap Revascularization Device is not currently approved in the U.S., where it is available for investigational use only.

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

# # #

[1] Furlan AJ. Endovascular therapy for stroke—it’s about time [editorial]. N Engl J Med. 2015.

[2] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015 ;e29-322.

[3] Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598.

[4] CDC, NCHS. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015.

[5] Söderman et al, ‘Initial Experience in 42 patients from 2 European Centers’, presented at ESOC 2015 and ESMINT 2015.

Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com

Neuromod Announces €5.5 million in financing to Advance Neuromodulation based Medical Device to Treat Chronic Tinnitus

Leading Venture Capital Fund, Fountain Healthcare invests in Neuromod Devices

DUBLIN, Ireland – Neuromod Devices Limited (Neuromod), an Irish medical device company specialising in the treatment of chronic tinnitus, announces that it has raised €5.5 million ($6.2million) in Series A Funding from international life sciences venture capital fund Fountain Healthcare Partners. The investment will be used to further enhance scientific and clinical understanding of its bi-modal neuromodulation device, mutebutton®, and commence US clinical trials of the device. The international launch of mutebutton® is targeted for 2018.

This investment by Fountain Healthcare marks a significant milestone for Neuromod and brings the total raised by the company to-date to over €8 million ($9 million). As part of the Series A financing, Dr Manus Rogan of Fountain Healthcare Partners will join the Board of Directors of Neuromod.

mutebutton®

Neuromod’s non-invasive mutebutton® device uses bi-modal neuromodulation via simultaneous auditory stimulation in the ear and sensory stimulation on the tongue to promote positive changes in neuroplasticity in parts of the brain implicated in tinnitus. Recent developments in international tinnitus research have uncovered many forms of tinnitus and bi-modal neuromodulation is emerging as one of the most promising therapies for certain forms of the condition. Neuromod has already generated promising clinical data with the mutebutton® in over 50 people suffering from chronic tinnitus thereby validating its approach. Results from this study are soon to be published in a peer reviewed journal.

Neuromod will use the proceeds from the investment to advance dose optimisation and patient sub-typing research, commence US clinical trials and promote its international adoption as the next generation treatment for chronic tinnitus. Neuromod received a medical device CE mark in Europe in October 2014 for the mutebutton® device and was granted a US Patent for its technology in September 2015.

Earlier this year Neuromod was recognised as the ‘Emerging Company of the Year’ at the Irish Medical Device Association (IMDA) Awards, by its medical device industry peers.

Tinnitus

About 250 million people worldwide experience chronic tinnitus on a daily basis. The condition manifests itself as an illusory sound with no external source or origin. Despite being commonly described as ‘ringing in the ears’, international research has shown that chronic tinnitus actually originates in the brain. In the US alone, there are an estimated 15 million people with clinically significant tinnitus, with 2 to 3 million people experiencing debilitating symptoms. Chronic tinnitus can have a severe impact on a patient’s quality of life, with documented secondary symptoms including anxiety, insomnia, headaches and depression, resulting in repeat visits to GP’s, ENT surgeons and Clinical Audiologists.

There are currently limited clinically validated treatments available in the market place for treating chronic tinnitus. Neuromod’s objective is to address this significant unmet medical need with its mutebutton® device.

Dr Ross O’Neill, Founding CEO of Neuromod commented, “Neuromod is delighted to announce this investment, which will help us to advance our unique chronic tinnitus treatment technology. As an emerging company we welcome the support and knowledge offered to us from partnering with an experienced international life sciences venture capital fund such as Fountain Healthcare Partners. We are also particularly grateful for the ongoing support we have received from our manufactuing partners, M&M Qualtech and Molex, and from Enterprise Ireland, which enable innovative Irish companies, like Neuromod, to grow and succeed on the international stage.”

Dr Manus Rogan, Co-Founder and Managing Partner at Fountain Healthcare Partners added. "Neuromod is an exciting company, with the potential to offer a superior treatment to and improve the quality of life of the millions of patients suffering with chronic tinnitus. The company has a proprietary neuromodulation technology, promising clinical results and a highly committed team. Neuromodulation is a key area of interest for Fountain Healthcare and chronic tinnitus is a poorly served global market opportunity with relatively little competition. We are investing in Neuromod to help build a credible and sustainable business in tinnitus with prospects for strong future growth.” - ENDS –

About Neuromod

Neuromod, headquartered in NexusUCD Dublin, is an emerging medical device company, specialising in the design and development of neuromodulation technologies, to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions such as tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University.

www.NeuromodDevices.com

About Fountain Healthcare Partners

Fountain Healthcare Partners is the largest dedicated life science venture capital fund in Ireland, with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York.

www.fh-partners.com

About mutebutton®

mutebutton® is a non-invasive, bi-modal neuromodulation based medical device that combines auditory and sensory stimulation to promote positive therapeutic changes in the parts of the brain implicated in tinnitus. The device simultaneously delivers sensory stimulation to the tongue via the tonguetip™ and auditory stimulation through headphones. The mutebutton® device was awarded European regulatory approval with a medical device CE mark in 2014, by the British Standards Institute (BSI), certifying the product's safety and clinical efficacy.

FTI Consulting | Media Relations
Jonathan Neilan
Melanie Farrell
Aoife Kelly
T: +353 1 6633686
neuromod@fticonsulting.com

Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-2 Phase 3 Study for the Treatment of Postoperative Pain

ATHLONE, Ireland - Innocoll AG (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the first patient was dosed in the MATRIX-2 (Multisite Assessment of PosToperative PainReduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain following open hernioplasty with mesh using XaraColl, Innocoll's surgically implantable and bioresorbable bupivacaine-collagen matrix.

The MATRIX-2 Phase 3 study is the second of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix. The MATRIX-1 study had its first patient enrolled last month. Each study is expected to enroll approximately 300 patients aged 18 and older in the United States. Patients with a unilateral inguinal hernia undergoing open hernioplasty with mesh placement will be treated in one of two arms per study: three 100 mg XaraColl matrices for a total dose of 300 mg of bupivacaine hydrochloride or three placebo matrices. The matrices are placed at the site of the hernia repair in order to provide local levels of bupivacaine directly at the location of surgical trauma.

The primary efficacy endpoint is the sum of pain intensity difference (SPID) over 24 hours comparing the XaraColl matrix to placebo. Additional endpoints include the SPID at 48 and 72 hours as well as total opioid use at 24, 48 and 72 hours. Safety will be evaluated through the collection of adverse events through 30 days postoperatively.

Enrollment for both studies is expected to complete in the first quarter of 2016 and topline results from the studies are expected in the second quarter of 2016.

Postoperative pain management is a serious concern for surgeons and patients. In the U.S., approximately 750,000 hernia operations are performed annually. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.

XaraColl acts locally following implantation at the surgical site to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.

"We remain committed to delivering our late-stage portfolio and realizing the potential of these exciting therapeutics for the physicians and patients they serve," said Tony Zook, Chief Executive Officer. "With the dosing of the first patient in our MATRIX-2 study, we continue to execute on the deliverables we set for ourselves. Both the Cogenzia and XaraColl Phase 3 programs are fully underway and before the close of the year, we also hope to have discussions with the FDA to advance CollaGuard."

More information on the study will be posted at www.clinicaltrials.gov.

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 EUSA Pharma. All of the company's products and product candidates 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.

Innocoll AG Announces Departure of Chief Medical Officer

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that James P. Tursi, M.D., will depart Innocoll to pursue another opportunity. Dr. Tursi will remain with Innocoll until September 21, 2015.

"James has done a great job advancing our lead assets into advanced clinical development during his tenure at Innocoll," said Tony Zook chief executive officer of Innocoll. "Phase 3 clinical trials for both Cogenzia and XaraColl are actively recruiting patients. The U.S clinical program plans for CollaGUARD are in place and we anticipate initiating interactions with the FDA to discuss them in the fourth quarter. Although we are disappointed by his leaving, we credit James with completing the key groundwork that is enabling us to focus on clinical trial execution for Cogenzia and XaraColl and moving toward discussions of our CollaGUARD clinical plan with regulators. We are in good position while we search for his successor. We wish James well in his next career role."

Dr. Tursi joined Innocoll in March 2015. His initial priorities upon assuming the position were to initiate the Phase 3 programs for Cogenzia and XaraColl and to finalize the U.S. clinical program plans for CollaGUARD. Both the Cogenzia and XaraColl Phase 3 programs began recruiting patients in 2015 as planned. Interactions with regulators on the CollaGUARD pivotal trial proposed program are on track to begin in the fourth quarter of 2015.

"I appreciate the challenge and opportunity to work with the team on advancing Innocoll's late stage clinical pipeline," said Dr. Tursi. "I leave Innocoll with the conviction that the company's key clinical programs will continue to progress as anticipated and that the team is fully prepared to execute on its objectives. I wish the Innocoll team the best as they bring needed medicines to patients."

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 EUSA Pharma. All of the company's products and product candidates 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.

Innocoll AG Announces First Patient Dosed in the XaraColl MATRIX-1 Phase 3 Study for the Treatment of Postoperative Pain

ATHLONE, Ireland, -- Innocoll AG (INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the first patient was dosed in the MATRIX-1 (Multisite Assessment of PosToperative Pain Reduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain following open hernioplasty with mesh using XaraColl, Innocoll's surgically implantable and bioresorbable bupivacaine-collagen matrix.

Postoperative pain management is a serious concern for surgeons and patients. According to Life Science Database, there are over 76 million surgeries performed annually in the US with approximately 1.4 million being hernia operations. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.

XaraColl acts locally following implantation at the surgical site and is intended to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.

"Postoperative pain management is critical for a successful result of nearly any surgical procedure. When pain is adequately controlled, patients have a better experience." said Dr. James Tursi, Chief Medical Officer at Innocoll. "A better experience for the patient means a better experience for the surgeon. Importantly, the ability to limit or reduce exposure to opioids may enable patients to avoid opioid related side effects and potentially opioid related complications."

The MATRIX-1 Phase 3 study is one of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix. The second Phase 3 study, MATRIX-2 is expected to start later this quarter. Each study is expected to enroll approximately 300 patients age 18 and older in the United States. Patients with a unilateral inguinal hernia undergoing open hernioplasty with mesh placement will be treated in one of two arms per study: three 100 mg XaraColl matrices for a total dose of 300 mg of bupivacaine hydrochloride or three placebo matrices. The matrices are placed at the site of the hernia repair in order to provide local levels of bupivacaine directly at the location of surgical trauma.

The primary efficacy endpoint is the sum of pain intensity difference (SPID) over 24 hours comparing the XaraColl matrix to placebo. Additional endpoints include the SPID at 48 and 72 hours as well as total opioid use at 24, 48 and 72 hours. Safety will be evaluated through the collection of adverse events through 30 days postoperatively.

To qualify for the study, patients must have a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Following screening and determination of eligibility, study participants will be assigned to one of two groups. Patients will be treated with implantation of three 100 mg XaraColl matrices (total dose 300 mg) or three placebo matrices. Pain measurements will be recorded at predetermined intervals over the first 72 hours following implantation of the matrices. Enrollment is expected to complete in the first quarter of 2016 and topline results from the study are expected in the second quarter of 2016.

More information on the study will be posted at www.clinicaltrials.gov.

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(R) for the treatment of post-operative pain; Cogenzia(R) for the adjuvant treatment of diabetic foot infections; and CollaGUARD(R), a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp(R) G, Septocoll(R), RegenePro(R), Collieva(R), CollaCare(R), Collexa(R), and Zorpreva(TM), which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx(R), Collatamp(R), CollaGUARD(R), Collieva(R), CollaCare(R), Collexa(R), Cogenzia(R) LidoColl(R), LiquiColl(R), Septocoll(R), and XaraColl(R) are registered trademarks, and CollaPress(TM), DermaSil(TM), Durieva(TM), and Zorpreva(TM) are trademarks of the company.

Neuravi Ltd. Appoints Experienced Neurovascular Executive Robert Stern to Board of Directors

25-Year Health Care and Startup Veteran Brings Wealth of Experience to Board

Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced that Robert A. Stern has joined the company’s board of directors.

Mr. Stern has more than 25 years of experience as a senior executive for medtech and biotech health care companies, including deep neurovascular experience. He is currently chief executive officer and president of Vascular Dynamics, Inc., a venture-backed company developing a novel implantable technology designed to manage resistant hypertension. Prior to Vascular Dynamics he held several senior executive roles in publicly traded companies, including president and chief operating officer at Micrus Endovascular Inc., a manufacturer of medical devices to treat cerebrovascular disease, which was acquired by Johnson & Johnson in 2010. He has also served as a director on the boards of Reverse Medical and Flexible Stenting Solutions.

“We’re thrilled that Bob has joined the Neuravi board at this important time in the company’s growth. His track record of value creation and direct neurovascular experience are key as we embark upon European commercialization of the EmboTrap® Revascularization Device and the initiation of ARISE II, our international clinical trial,” said Eamon Brady, CEO.

Mr. Stern’s organizational experience includes spearheading global licensing and distribution agreements, forging corporate alliances, improving profitability, and developing corporate infrastructure for companies in a variety of industries. In addition, he has played an instrumental role in initial public offerings and acquisitions.

“I’m very pleased to be working with a company that will truly make a difference in improving the lives of patients suffering from acute ischemic stroke,” said Mr. Stern. “With recent clinical data reinforcing the value of device intervention for stroke patients, this is an exciting time for companies developing thrombectomy solutions, and Neuravi’s talented team has made significant progress with its innovative stent-retriever. I look forward to helping navigate this rapidly growing field.”

Mr. Stern received a B.S. degree from the University of New Hampshire, Whittemore School of Business, and an MBA from the University of New Mexico, Anderson School of Management.

About the EmboTrap Revascularization Device

The design of the EmboTrap Revascularization Device is informed by extensive research into a full range of clots that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

About Neuravi

Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked, and commercially available in Europe, while it is for investigational use only in the United States. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.

Positive Results for Mainstay Medical’s Clinical Trial of ReActiv8

Clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options

63% of people with clinically important improvement in back pain; and 72% with clinically important improvement in back pain in the cohort with no financial compensation related to back pain

Dublin, Ireland – Mainstay Medical International plc (Mainstay or the Company, listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (CLBP), today announced results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial to gather data for a submission for CE Marking for ReActiv8. The ReActiv8-A Trial shows clinically important, statistically significant and lasting improvement in pain, disability and quality of life in this clinically challenging population.

ReActiv8 is for treatment of people who suffer from CLBP, have attempted most or all available treatment options, and are not candidates for back surgery or spinal cord stimulation. The ReActiv8-A Trial population was relatively young (mean age 43.9 years) and had a long history of low back pain (mean 13.8 years). All of the subjects had attempted physical therapy, and 70% were taking opioids for back pain. The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have reached the 90 day follow up and to date 33 have reached the 180 day follow up.

Results highlights:

• Clinical performance of ReActiv8 at 90 days compared to baseline for all subjects is:
  • 63% with clinically important improvement in back pain defined as ≥2 point reduction on the 0-10 Numerical Rating Scale (NRS) for low back pain1 measured on the day.
  • 54% responder rate for pain: A responder is defined as a subject with a clinically important improvement in mean of prior 7 days NRS with no clinically significant increase in medications taken for low back pain.
  • 57% with a clinically important improvement1 in disability on the Oswestry Disability Index (ODI).
  • 67% with a clinically important improvement2 in quality of life on the EQ-5D scale.
• Clinical performance at 90 days is even better for the group of subjects who do not receive financial compensation for being out of work due to their back pain. For those 32 subjects the results are:
  • 72% with clinically important improvement in low back pain NRS on the day.
  • 66% responder rate for pain.
  • 63% with clinically important improvement in ODI.
  • 69% with a clinically important improvement in EQ-5D (90% at 180 days).
• Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days (n=33). Paired data for all subjects at 90 and 180 days respectively are:
  • 63% and 58% with clinically important improvement in low back pain NRS on the day.
  • 57% and 58% with clinically important improvement in ODI.
  • 67% and 79% with clinically important improvement in EQ-5D
  • 61% and 64% reported >50% Percent Pain Relief.

Adverse Events (AEs) incidence and type were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs and no serious AEs related to the device, therapy or procedure.

• The observed lead migration incidence (<1%) demonstrates that the ReActiv8 lead mitigates the risk of lead migration identified with commercially available neurostimulation leads in the earlier Feasibility Trial.
• The incidence of surgical revision (19%) to date is within the range published for other neurostimulation systems. Mainstay has identified a modification to the implant technique which it believes has the potential to reduce revision rates.

A full description of the ReActiv8-A Trial and results is provided below.

The Chairman of the ReActiv8-A Data Monitoring Committee is Professor Chris Gilligan, Chief of the Division of Pain Medicine and Co-Director of the Spine Center at the Beth Israel Deaconess Medical Center of the Harvard Medical School. Commenting on the positive results he said: “As physicians we struggle to provide solutions for people with chronic low back pain. The results from this clinical trial open the prospect of a new treatment option for clinicians and significant benefit for people suffering from chronic low back pain.”

Mainstay estimates that there are over two million people in the US and EU who could be candidates for treatment with ReActiv8. They are people with CLBP, in whom the root cause of the persistence of pain is disruption in control of the key muscles that stabilize the lumbar spine, particularly the lumbar multifidus. ReActiv8 is designed to deliver episodic electrical stimulation to nerves that cause these muscles to contract, helping to restore stability, and thus allowing recovery from CLBP.

ReActiv8 is not spinal cord stimulation. SCS targets different clinical conditions and delivers electrical stimulation to interfere with the perception of pain, without addressing the root cause. The market for SCS is estimated to be approximately $1.4Bn in 2015 or approximately 100,000 patients.

Dr. Marc Russo, Director of the Hunter Pain Clinic in Newcastle, Australia and investigator in the Trial said: “It was pleasing to see ReActiv8 have such an impact on people’s quality of life after so many other conventional treatments have been unsuccessful for such a long time.”

Peter Crosby, CEO of Mainstay, added: “The results from the ReActiv8-A Trial show improvements which are better than any other therapy for this group of people as reported in the literature. We are excited that our unique approach to treating this type of chronic low back pain offers the potential to change the lives of millions of people worldwide who have no effective treatment alternative.”

The Company believes that data from the subjects reported may be sufficient to apply for a CE Mark for ReActiv8, and is engaging with its notified body about the Company’s submission for CE Marking.

Subjects continue to be enrolled in the ReActiv8-A Trial to gather additional data on performance and safety which the Company plans to incorporate into the Post Market Clinical Follow Up.

Mainstay Medical Announces Half Year Financial Results

Dublin, Ireland: Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, a new implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), today announced the publication of its report for the half year ended 30 June 2015.

Highlights

• On 31 August 2015, the Company announced positive clinical results of the ReActiv8-A Clinical Trial, which the Company plans to use to support its submission for CE Mark approval, after which commercialization in Europe can commence. The detailed Clinical Results announcement is available on the Company’s website at http://www.mainstay-medical.com/news/press_releases.
• On 24 August 2015, Mainstay announced the closing of debt financing for up to $15 million. The secured debt facility is non-dilutive to existing shareholders, and is being provided by IPF Partners, a leading financing provider focused on the European healthcare sector.  The facility can be drawn in three tranches, and an initial tranche of $4.5 million has been called. The second and third tranches can be drawn upon achievement of milestones related to progress through the CE Mark process for ReActiv8.
• In July and August 2015, Mainstay announced the issuance of three new U.S. Patents:
  • U.S. Patent No. 9,072,897 entitled “Systems and Methods for Restoring Muscle Function to the Lumbar Spine”
  • U.S. Patent No. 9,079,019 entitled “Apparatus and Methods for Anchoring Electrode Leads for Use with Implantable Neuromuscular Electrical Stimulator”.
  • U.S. Patent No. 9,108,053 entitled “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation”
• In May 2015, Mainstay announced it had received approval from the United States Food and Drug Administration (“FDA”) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption (“IDE”). The FDA approval is for the planned ReActiv8-B Clinical Trial, an international, multi-centre, prospective randomized sham-controlled trial designed to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with CLBP and no prior back surgery.  The approval is to conduct the ReActiv8-B Clinical Trial at up to 40 clinical trial sites and for 128 randomized subjects to be implanted with ReActiv8 in the pivotal cohort. The IDE approval allows the Company to engage with investigators, clinical trial sites, and Institutional Review Boards (“IRBs” or “Ethics Committees”) leading towards the first subject recruitment and implant. Upon successful completion of the ReActiv8-B Clinical Trial and if the results support it, the Company plans to submit an application for a Pre-Market Approval (“PMA”) which is required to allow the start of commercialization in the United States.
• Operating expenses were $6.3 million during the period and have increased by $1.5 million compared to 1H14 due to costs associated with increased activity in the ReActiv8-A Clinical Trial, and the expansion of our team.
• Cash on hand at 30 June 2015 was $12.5 million and operating cash out flows for the period were $5.7 million.

About Mainstay

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

About the ReActiv8-A Trial

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

About Chronic Low Back Pain

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

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

Chrono Therapeutics Receives Second Fast Track SBIR Grant from National Cancer Institute for Patient-individualized Smoking Cessation Therapy

HAYWARD, Calif., Chrono Therapeutics, a pioneer in digital drug therapy, today announced it has received a second Phase 1 and Phase 2 Fast Track Small Business Innovation Research (SBIR) grant award from the National Cancer Institute (NCI). This award of up to $2.3 million will support final product development of the digital portion of Chrono's patient-individualized smoking cessation therapy as well as pilot efficacy trials of the system. This is the second Fast Track SBIR grant award Chrono has received from the NCI. Chrono successfully executed on a 2012 $2.23M grant that funded early product engineering and a second in human pharmacokinetic study.

Chrono's smoking cessation solution is the first nicotine delivery system to time medication delivery to when smokers' cravings are predictably strongest. The wearable component automatically begins delivering nicotine before smokers wake up, helping to curb the strong morning craving most smokers experience – something other nicotine replacement products cannot do. Embedded with sensors and Bluetooth, the wearable monitors compliance and securely connects with a companion mobile application that provides real-time behavioral coaching in response to cravings and the nicotine-dosing regimen.

"Receiving our second grant award from the NCI is an endorsement of Chrono's cessation platform, which takes a fresh approach to a serious addiction that kills 5 million people worldwide each year," commented Alan Levy, the CEO and Chairman of Chrono Therapeutics

Dr. Michael Burke and Dr. Taylor Hays of the Mayo Clinic are among several of the world's leaders in nicotine dependence treatment working with Chrono to integrate tailored nicotine delivery with evidence-based, proactive and personalized behavioral strategies to help smokers quit.

"Integrating a smart digital coach that leverages the best in behavioral science with a new and adjustable method to deliver nicotine replacement has the potential to save many thousands of lives by providing new hope and support to people struggling to become tobacco free. We are very excited to collaborate with Chrono on this innovation," stated Dr. Burke, Assistant Professor of Medicine at the Mayo Clinic School of Medicine and Program Coordinator at the Mayo Clinic Nicotine Dependence Center.

The smoking cessation solution is the first product targeted to be commercialized from Chrono's platform, which represents the convergence of optimized drug delivery, embedded sensor technology to monitor compliance, and connected and personalized behavioral support to transform how medicine is delivered and how people achieve their health goals.

Guy DiPierro, the Founder of Chrono and VP of Intellectual Property and Governmental Affairs commented, "We appreciate NCI's ongoing support and leadership in helping Chrono combat one of the world's leading pandemics."

About CHRONO

Effective care of the most hard-to-treat conditions requires approaches beyond simply taking medicine. Chrono's team is developing the first wearable transdermal drug delivery device that optimizes drug dosing, is embedded with sensor technology to track usage and is connected via Bluetooth to an evidence-based smartphone application that delivers real-time personalized behavioral support to keep users on track to achieving their goals. Chrono's first application is in smoking cessation, enabling smokers to overcome the world's deadliest addiction. For more information, visit www.chronothera.com

Mainstay Medical Secures $15M Debt Financing

Mainstay Medical International plc (“Mainstay” or the “Company” listed on Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an innovative implantable medical device for people suffering from disabling Chronic Low Back Pain (“CLBP”), today announced a debt facility for up to $15 million.

The secured debt facility is non-dilutive to existing shareholders, and is being provided by IPF Partners, a leading financing provider focused on the European healthcare sector.

“We are pleased to have secured this $15 million debt facility. These funds strengthen our financial position, and allow us to continue building momentum towards commercialisation of ReActiv8,” said Peter Crosby, CEO of Mainstay.

The facility can be drawn in three tranches, with an initial tranche of $4.5 million available immediately. The second and third tranches can be drawn following the achievement of milestones related to progress through the CE Mark process for ReActiv8.

Each tranche has a repayment term of 60 months from drawdown, with interest only payments for the first 12 months. The interest rate is 3-month Euribor plus a margin ranging from 10.5% to 12.5%.

The terms of the agreement include a requirement that the Company hold a minimum cash balance of $2 million until it achieves revenue targets, initially $1 million. The facility is subject to customary terms and conditions and includes an exit fee (in lieu of warrants) of 5% of each tranche payable upon repayment, and voluntary prepayment provisions. The facility does not include any preferential right to participate in a future financing of Mainstay.

- End -

About Mainstay

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

About IPF Partners

IPF Partners is an investment platform founded by a team of 4 fund managers and health sector leaders. The IPF I fund, which was launched in October 2011 with 80 million euros of funding and which is aiming to obtain institutional investor commitments of 150 million euros, provides bespoke debt and other financing solutions to health sector companies that have reached the marketing stage in order to help them handle their ongoing and acquisition financing requirements. IPF I has already committed over 50 million euros to various European health product companies.

About the ReActiv8-A Trial

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

About Chronic Low Back Pain

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

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

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

ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world.

CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

Innocoll AG Appoints Rich Fante as Chief Commercial Officer and Head of Business Development

ATHLONE, Ireland -- Innocoll AG (NASDAQ:INNL) announced that Rich Fante has been appointed Chief Commercial Officer and Head of Business Development effectiveAugust 20, 2015. The addition of this role to the senior management team is an additional step in the transition of the company to a commercial-stage, fully-integrated specialty pharmaceutical company.

"Our two lead product candidates, Cogenzia and XaraColl, are rapidly progressing in advanced clinical development so we need the additional skills and experience to finalize and execute on our commercial strategies for both products in the near-term," said Tony Zook, Chief Executive Officer of Innocoll. "The addition of Rich Fante to our executive team adds the critical skills and commercial experience we need to ensure commercial success. Cogenzia, currently in Phase 3 trials, recently received Qualified Infectious Disease Product (QIDP) designation from the FDA, which may lead to a priority review and accelerated time to market. We also anticipate initiating Phase 3 trials for XaraColl this quarter. Both sets of pivotal trials are expected to read out data in 2016. Rich's joining the team is timely."

Mr. Fante has deep experience in the management and execution of commercial product strategies in the pharmaceutical industry. Most recently, he was founder and president of RF Consulting, a firm that assists emerging biopharmaceutical companies in their commercialization efforts. Prior to founding RF Consulting, Mr. Fante spent over nineteen years at AstraZeneca pharmaceuticals in the United States, where he served a number of rolls, most recently as President of its U.S. business, CEO North America and Regional Vice President of the Americas. During his tenure at AstraZeneca, the company became the second largest pharmaceutical company in the U.S. He helped to build some of the most successful brands in pharmaceutical industry history including Nexium®, Crestor®, Symbicort®, Arimidex®, Seroquel® and Prilosec®. Before joining AstraZeneca in January 1995, Mr. Fante began his career in pharmaceutical sales and marketing as a sales representative followed by brand management at Lederle Laboratories. Mr. Fante has served as Board Chairman of the National Pharmaceutical Council and was a member of the Institute of Medicine of the National Academies of Science Roundtable on Value and Science. Mr. Fante is currently a non-executive director of the privately held biotech company Inhibikase Therapeutics, Inc. Mr. Fante received his B.A. in Biology from Princeton University and his M.B.A. from University of North Carolina at Chapel Hill.

"Innocoll's late stage product pipeline represents an ideal opportunity to begin to engage with the market," said Mr. Fante. "The promise of the company's products and the experience of the leadership team are a clear combination of factors for commercial success, and I'm pleased to be in the position to make a contribution to the company's transition."

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 EUSA Pharma. All of the company's products and product candidates 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.

First Amendment Decision a Win for Amarin and Physician Plaintiffs

Federal Court Rules Promotion of ANCHOR Clinical Data of Vascepa(R) and Research on the Potential Connection Between Vascepa and Cardiovascular Risk Reduction Is Constitutionally Protected Speech

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 08/07/15 -- Amarin Corporation plc (NASDAQ: AMRN) today announced a United States District Court has ruled that Amarin may promote to healthcare professionals certain uses of Amarin's lead product, Vascepa®(icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is truthful and non-misleading. The Court declaration covers promotion of the FDA-reviewed and agreed effects of Vascepa demonstrated in the ANCHOR clinical trial of patients with persistently high triglycerides after statin therapy and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. Based on today's ruling Amarin plans to begin promotional activities consistent with the opinion as soon as possible.

Decision is a victory aimed at improved patient care

The decision opens more direct and effective paths to communicate truthful and non-misleading information about Vascepa clinical trial results and the state of science relevant to the potential of Vascepa to reduce the risk of cardiovascular disease. With accurate information readily available, healthcare professionals will be better able to assess for themselves how best to choose among available treatment options for their patients. With healthcare professionals better informed, this decision is a victory that Amarin believes will lead to improved patient care.

Cardiovascular disease is the leading cause of death for men and women in the United States. Significant risk from cardiovascular disease remains for tens of millions of Americans after statin therapy and recommended changes in diet and exercise. Given the significant need to reduce the risk of cardiovascular disease, numerous independent national and international treatment guidelines and position statements recommend drug therapy as an adjunct to healthy diet, lifestyle change and statin therapy for at-risk patients with persistently high triglyceride levels in their blood to lower those patients' triglycerides and/or non-high-density lipoprotein cholesterol. The use of Vascepa in this patient population, as studied in the ANCHOR trial, is contemplated by guidelines, is medically accepted and commonly prescribed by physicians. This is the practical reality despite the fact that FDA did not approve Vascepa for this use and even though a link between such treatment and reduced cardiovascular risk has not been determined. Use of Vascepa within these guidelines is also listed on independent drug compendia on which reimbursement from Medicare, Medicaid and private payor plans is based. Amarin's REDUCE-IT cardiovascular outcomes study of Vascepa, which is designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy, is over 95% enrolled.

"This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients," said John F. Thero, President and Chief Executive Officer. "Many physicians are aware of the efficacy data included in FDA-approved labeling for Vascepa but are not aware of efficacy data from the ANCHOR study of Vascepa. FDA has already included the safety data from both the MARINE and ANCHOR studies in approved Vascepa labeling. Amarin will now be able to communicate efficacy data from ANCHOR and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers."

The truthful and non-misleading information about Vascepa protected by the Court order

The Court determined that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and specifically make to healthcare professionals the following truthful and non-misleading statements:

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy.

Vascepa is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered low-density lipoprotein cholesterol on cardiovascular risk among statin-treated patients with residually high triglycerides. No prospective study has been conducted to test and support what, if any, benefit exists.

Recent cardiovascular outcomes trials (ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering triglyceride levels in patients with high triglyceride levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising high-density lipoprotein cholesterol and reducing triglyceride levels, among statin-treated patients with well-controlled low-density lipoprotein cholesterol.

The ANCHOR trial demonstrates that Vascepa lowers triglyceride levels in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy.

In the ANCHOR trial, Vascepa 4g/day significantly reduced TG [triglycerides], non- HDL-C [non-high-density lipoprotein cholesterol or non-"good cholesterol,"] Apo B [Apolipoprotein B], VLDL-C [very-low-density lipoprotein cholesterol], TC [total cholesterol] and HDL-C [high-density lipoprotein cholesterol or "good cholesterol"] levels from baseline relative to placebo in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy. The reduction in TG [triglycerides] observed with Vascepa was not associated with elevations in LDL-C [low-density lipoprotein cholesterol or "bad cholesterol] relative to placebo.

The Court's ruling also permits communication to healthcare professionals of the following information:

• peer-reviewed scientific publications relevant to the potential effect of EPA on the reduction of the risk of coronary heart disease, such as the JELIS cardiovascular outcomes trial of a pure-EPA product in Japanese patients and other publications on omega-3 acid studies; and
• more complete efficacy data from the ANCHOR trial.

To ensure that this speech is non-misleading, Amarin would also disclose the following:

• FDA has not approved to Vascepa reduce the risk of coronary heart disease;
• The effect of Vascepa on the risk of cardiovascular mortality and morbidity has not been determined;
• A cardiovascular outcomes study of Vascepa designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway;
• Vascepa may not be eligible for reimbursement under government healthcare programs, such as Medicare or Medicaid, for treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels or to reduce the risk of coronary heart disease. We encourage you to check that for yourself; and
• Any potential financial or affiliation biases between the firm and those who conducted the ANCHOR study.

About prohibitions on communication of off-label drug information

Once a drug is approved by FDA for a specific use in a specific patient population, physicians may exercise their medical judgment to prescribe the drug for any use in any patient population. It is estimated that approximately 20% of all prescriptions in the United States are used by physicians for such "off-label" indications. FDA has taken the position, however, that federal law prohibits pharmaceutical companies from proactively promoting data to the medical community regarding off-label uses -- even when such information is accurate, not misleading and reflective of accepted medical treatment

FDA has acknowledged the importance of the off-label use of many pharmaceutical products. Federal, state and private health plans routinely pay for many off-label drug uses, including certain off-label uses of Vascepa. FDA permits limited communications on off-label uses, such as in response to unsolicited requests for information, under FDA's publication reprint guidance and in connection with scientific exchanges. Prior to this judgment, these restrictions significantly limited the flow of information about the specified off-label uses of Vascepa.

About the ruling and potential future proceedings

The ruling today by the Honorable Judge Paul Engelmayer of the United States District Court for the Southern District of New York granted Amarin and the physician plaintiffs relief in the form of a declaratory judgment. The ruling declared as unconstitutional, in this case with the specified disclosures, FDA off-label promotion restrictions.

An appeal of the Court's ruling can be filed within 60 days. The ruling will remain in effect until the Court makes a final decision in the case unless the ruling is appealed and overturned. The underlying litigation may proceed until the Court enters a final order in the case. The lawsuit did not seek and the ruling did not grant approval of the indication contemplated by the ANCHOR study.

About the REDUCE-IT cardiovascular outcomes study

The REDUCE-IT cardiovascular outcomes study is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. The REDUCE-IT study is also the first cardiovascular outcomes study to test a high, 4-gram dose of a pure-EPA only omega-3 prescription product. In the REDUCE-IT study, pure-EPA Vascepa is being studied as an adjunct to, and not as a replacement for, statin therapy. If successful, Amarin plans to seek additional indicated uses for Vascepa that extend beyond the populations studied in the successful MARINE and ANCHOR trials of Vascepa. These additional indications would potentially address tens of millions of patients in the United States and worldwide with elevated triglyceride levels despite stable statin therapy.

Amarin is blinded to the results of the REDUCE-IT study. The pooled, blinded event rate in the REDUCE-IT study is tracking to expectations for the study to continue until 2017 with results anticipated to be published in 2018. An interim review by the independent data monitoring committee of the efficacy and safety results of the trial is expected to occur during 2016 upon reaching 60% of the target aggregate number of cardiovascular events.

About VASCEPA ® (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.

FDA-approved Indications and Usage

• VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
• The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for VASCEPA

• VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
• Use with caution in patients with known hypersensitivity to fish and/or shellfish.
• The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
• Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
• Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
• Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Vascepa has been approved for use by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.