Innocoll Holdings plc Appoints Lesley Russell, MBChB, MRCP, as Chief Medical Officer

ATHLONE, Ireland - Innocoll Holdings plc (Nasdaq:INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need, today announced that Lesley Russell, MBChB, MRCP, has been appointed chief medical officer. Dr. Russell will be responsible for managing all clinical development programs as well as medical and regulatory affairs for the company.

“Lesley’s background in drug development and regulatory experience at both emerging and established biopharmaceutical companies is an excellent fit for us as we progress toward commercialization. Her experience to further develop our programs and articulate them to the FDA will be a critical aspect of our success,” said Tony Zook, chief executive officer of Innocoll. “We expect that she will be a significant contributor to our anticipated label expansion and product life cycle plans for XARACOLL and COGENZIA, the COLLAGUARD clinical development plan, and future product candidates that we expect to emerge from our collagen drug formulation platform.”

Dr. Russell has extensive experience managing the development of pharmaceuticals and biologics across a wide range of therapeutic areas, dosage forms and formulations on a global scale. Most recently, she was chief operating officer and chief medical officer at TetraLogic Pharmaceuticals where she advanced the company’s lead candidate into Phase 2 clinical trials in parallel with the company’s initial public offering. Prior to this role, Dr. Russell held senior executive research and development positions at a number of biopharmaceutical companies including Teva Pharmaceuticals, Cephalon, Inc., and US Bioscience/Medimmune Oncology. In these roles, she managed staff responsible for a variety of functions including regulatory strategy development, clinical research, medical affairs and data management. She is a member of the boards of directors for AMAG Pharmaceuticals and Endocyte Pharmaceuticals. Dr. Russell obtained her medical degree from the University of Edinburgh, Scotland.

“Innocoll’s collagen platform has the potential to generate product candidates into the future beyond the two late-stage candidates that will complete Phase 3 studies this year and a third that will soon enter Phase 3 development,” said Dr. Russell. “I am looking forward to working with the team as the company advances through planned commercialization of its lead candidates and generates new candidates to sustain growth for the long-term.”

About Innocoll Holdings PLC

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering 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. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical 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, Biomet 3i 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.

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.

Amarin Reaches Target Enrollment in Cardiovascular Outcomes Study of Vascepa(R) in Patients With Elevated Triglycerides Despite Statin Therapy

BEDMINSTER, NJ and DUBLIN, IRELAND -- Amarin Corporation plc (AMRN) (NASDAQ (NBI): AMRN) today announced that target patient enrollment has been reached in its REDUCE-IT cardiovascular outcomes trial of Vascepa (icosapent ethyl). Amarin also announced that the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted in approximately six months.

Enrollment Target Achieved

The REDUCE-IT study was designed to enroll approximately 8,000 patients. This enrollment target has been reached and Amarin is winding down patient enrollment on a country by country basis. Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT.

"We are pleased to announce that we have reached the target enrollment in REDUCE-IT, the first multinational cardiovascular outcomes study prospectively designed to investigate whether there is a meaningful reduction in the occurrence of major cardiovascular events when EPA is added to statin therapy in high-risk patients with elevated triglycerides," said Steven Ketchum, Ph.D., president of research and development and chief scientific officer at Amarin. "Vascepa demonstrated a broad spectrum of favorable effects on lipid, lipoprotein, and inflammatory biomarkers compared to placebo in Phase 3 studies focused on patients with high triglyceride levels after statin therapy and on patients with very high triglyceride levels. Through long-term study of patients treated with Vascepa in REDUCE-IT, we aim to provide a robust dataset to determine whether the effects of highly-pure EPA omega-3 prescription drug therapy will lower the risk of cardiovascular events in the high-risk patient population studied."

Interim Analysis Expected in Approximately Six Months

The REDUCE-IT study's event rate continues to track to prior estimates. A pre-specified interim efficacy and safety analysis was designed to be conducted upon achieving approximately 60% of the 1,612 aggregate primary cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the next several months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, regardless of the strength of the study results this data preparation and transfer process is expected to take several months. The DMC's analysis is anticipated to occur in approximately six months.

Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until after the study is ready to be stopped either at the interim analysis or at the final analysis. Guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve statistical significance on the primary endpoint and generate robust findings on certain, pre-specified secondary outcome measures. Given the high thresholds of overwhelming efficacy required prior to a DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC's interim analysis will result in a recommendation to continue the REDUCE-IT study as planned. Such a recommendation is most common for cardiovascular outcome studies.

First Multinational Outcomes Study to Evaluate Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to Statin Therapy

Heart disease remains the number one cause of death in the United States. REDUCE-IT is the first multinational outcomes study being conducted to evaluate the cardiovascular benefits of treating patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels.

"In many high-risk patients with cardiovascular disease, substantial residual risk for events remains despite optimal LDL-cholesterol reduction with statin therapy," said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart and Vascular Center, Professor of Medicine, Harvard Medical School, and Principal Investigator for REDUCE-IT. "By design, the REDUCE-IT study has enrolled patients with high cardiovascular risk and elevated triglyceride levels despite statin therapy and will provide important information regarding the potential for high-dose EPA-only omega-3 therapy to confer incremental cardiovascular benefit beyond statin control of LDL-cholesterol."

Amarin believes that the REDUCE-IT study is positioned for success based on extensive review of existing data from clinical, epidemiologic and genetic studies. With the study's event rate tracking on schedule, the onset of the 1,612th primary cardiovascular event is expected to occur in 2017 with the publication of results anticipated in 2018.

About REDUCE-IT

REDUCE-IT is a global Phase 3, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate whether treatment with Vascepa reduces cardiovascular events in patients who have persistently elevated triglyceride levels despite stabilized statin therapy. The primary endpoint of the study is the time to the first occurrence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. Secondary endpoints include time to event analyses of components of the primary endpoint.

Additional information on the REDUCE-IT trial and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.

About VASCEPA ® (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101.

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 United States Food and Drug Administration (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 a 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.

Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2015 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (INNL), a global, specialty pharmaceutical company with late stage development programs targeting areas of significant unmet medical need announced financial and operating results for the three months and full year ended December 31, 2015. We manufacture and supply a range of pharmaceutical products and medical devices using our proprietary collagen-based biodegradable and fully bioresorbable technology platform.

“We have successfully performed against the commitments we made at the beginning of 2015," said Tony Zook, Chief Executive Officer of Innocoll. “Our Phase 3 programs for INL-001, or XaraColl, and INL-002, or Cogenzia, initiated on schedule and all four trials are on track to deliver results on time and on budget. We re-domiciled the company to Ireland, which will enable us to be competitive with other NASDAQ listed companies, while we continue to enjoy our Irish tax residency. We recently had a pre-IDE meeting with the FDA to discuss the INL-003, or CollaGUARD, path toward approval and we are preparing to begin the required non-clinical studies in the second quarter. I expect 2016 to be a transformative year for Innocoll and, together with our experienced leadership team, we are preparing Innocoll to successfully transition to a commercial stage company”.

Fourth Quarter 2015 and Recent Highlights

• Appointed Charles Katzer as Global Supply / Procurement.
• Announced plans in December to move the company’s domicile to Ireland from Germany; completed re-domiciliation on March 16 to become an Irish-incorporated company, Innocoll Holdings plc. Transitioned NASDAQ listing via the exchange of ADSs of our predecessor, Innocoll AG, for ordinary shares of Innocoll Holdings plc, listed directly on NASDAQ under the same “INNL” trading symbol.

Clinical Program Update

INL-001 (XaraColl®)

• Patients continue to be recruited and treated in two identical U.S. Phase 3 trials, MATRIX-1 and MATRIX-2, to evaluate the 300 mg dose versus placebo in patients undergoing abdominal hernia repair. The primary endpoint is 24-hour Summed Pain Intensity. Secondary endpoints include 48 and 72-hour pain relief and opioid use. Topline data from these studies are anticipated to be available in the second quarter and an NDA submission is anticipated by the end of the third quarter of 2016.

INL-002 (Cogenzia®)

• Patients continue to be recruited and dosed in two identical Phase 3 trials, one in the U.S. (COACT-1) and the second in the U.S. and Europe (COACT-2), to evaluate the safety and efficacy of topical gentamicin administered via a collagen matrix in patients with diabetic foot infections. The primary endpoint is “clinical cure” at the test of cure, which will be evaluated by the clinician 10 days post completion of treatment. Topline data from these studies are anticipated to be available in the third quarter of 2016 and we anticipate an NDA submission by the fourth quarter of 2016 under its designation of QIDP, which provides potential access to priority review and eligibility for Fast Track priority review designation by the FDA.

INL-003 (CollaGUARD®)

• A clinical program is under development for CollaGUARD to support approval in the U.S.A. for which a constructive pre-IDE meeting was held with FDA in the first quarter of 2016. We agreed upon a non-clinical program of two small studies, an infectivity study and a burst study. Both studies are anticipated to be completed and reported prior to the filing of a full IDE package in the third quarter of 2016, with the Pilot (Feasibility) Clinical Study to be initiated immediately thereafter, upon availability of resources.

Fourth Quarter 2015 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll AG reported a net loss attributable to its ordinary shares of €6.2 million, or €3.5 per share of Innocoll AG ($0.29 per ADS, converted at an exchange rate as of December 31, 2015), for the fourth quarter of 2015, compared to a loss of €4.2 million, or €2.9 per share of Innocoll AG ($0.24 per ADS) for the fourth quarter of 2014. Each ADS of Innocoll AG represented 1/13.25 of an ordinary share of Innocoll AG, prior to our termination of Innocoll AG's ADS facility.

Non-GAAP diluted net loss excluding nonrecurring items was €15.5 million or €8.7 per share of Innocoll AG ($0.72 per ADS), for the fourth quarter of 2015, compared to a loss of €2.0 million or €1.4 per share of Innocoll AG ($0.11 per ADS), for the fourth quarter of 2014.

The number of Innocoll AG ordinary shares outstanding increased from 1.46 million in the fourth quarter of 2014 to 1.77 million in the fourth quarter of 2015, primarily as a result of Innocoll AG's follow-on public offering in the second quarter of 2015.

Revenues: Revenues were €0.8 million for the fourth quarter of 2015 and fourth quarter of 2015.

Research and Development (R&D) Expenses: R&D expenses were €10.7 million for the fourth quarter of 2015 as compared to €1.3 million for the fourth quarter of 2014. R&D expenses in the fourth quarter of 2015 included €9.7 million in external clinical research expenses, which was primarily driven by the ramp-up of our Phase 3 XaraColl and Cogenzia efficacy trials.

General and Administrative (G&A) Expenses: G&A expenses were €6.5 million for the fourth quarter of 2015 as compared to €4.3 million for the fourth quarter of 2014. Excluding stock-based compensation charges, G&A expenses for the fourth quarter of 2015 were €5.2 million as compared to €2.0 million for the fourth quarter of 2014. The increase in G&A excluding stock-based compensation was primarily due to our continued infrastructure build out to support clinical programs, initiation of our pre-commercialization investment and expenses related to the company's re-domiciliation to Ireland.

Other Operating Income/(Expense): Other operating income was €1.7 million for the fourth quarter of 2015 as compared to €0.0 million for the fourth quarter of 2014. The income in the fourth quarter of 2015 was primarily driven by the reversal of the impairment of certain plant and equipment in earlier years which the company is now utilizing as part of its expansion of manufacturing facilities in Saal, Germany.

Finance Income/(Expense): Finance income was €9.9 million for the fourth quarter of 2015 as compared to €2.1 million for the fourth quarter of 2014. Finance expense in each quarter consisted primarily of non-cash items due to the decrease in the value of liabilities associated with options issued to pre-IPO investors outstanding at the end of each quarter, as well as foreign exchange gains or losses.

Full Year 2015 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll AG reported a net loss attributable to its ordinary shareholders of €43.1 million, or €25.6 per share of Innocoll AG ($2.10 per ADS, converted at an exchange rate as of December 31, 2015), for the year ended December 31, 2015, compared to a loss of €20.7 million, or €28.1 per share of Innocoll AG ($2.31 per ADS) for the year ended December 31, 2014.

Non-GAAP diluted loss excluding nonrecurring items was €38.5 million or €22.9 per share of Innocoll AG ($1.90 per ADS), for the year ended December 31, 2015, compared to a loss of €9.3 million, or €12.6 per share of Innocoll AG ($1.03 per ADS), for the year ended December 31, 2014.

The number of Innocoll AG ordinary shares outstanding increased from 0.74 million during the year ended December 31, 2014, to 1.69 million during the year ended December 31, 2015, primarily as a result of the conversion of preferred shares into Innocoll AG ordinary shares and the follow-on public offering in the second quarter of 2015.

Revenues: Revenues were €2.6 million for the year ended December 31, 2015 as compared to €4.5 million for year ended December 31, 2014. This decrease was primarily due to a decrease in sales to Jazz Pharmaceuticals/EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection

Research and Development (R&D) Expenses: R&D expenses were €26.9 million for the year ended December, 31 2015 as compared to €3.3 million for the year ended December 31, 2014. R&D expenses in the year ended December 31, 2015 included €23.8 million in external clinical research expenses, which was primarily due to the completion of our pivotal pharmacokinetics and safety study of XaraColl and the initiation and running of our Phase 3 Cogenzia and Xaracoll efficacy trials. R&D expenses are expected to continue to increase going forward as the company advances the clinical development of its products.

General and Administrative (G&A) Expenses: G&A expenses were €19.0 million for the year ended December 31, 2015 as compared to €11.7 million for the year ended December 31, 2014. Excluding stock-based compensation charges, G&A expenses for the year ended December 31 2015 were €14.2 million as compared to €6.6 million for the year ended December 31, 2014. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs, initiation of our pre-commercialization investment and expenses related to the company re-domiciliation to Ireland.

Other Operating Income/(Expense): Other operating income was €3.9 million for the year ended December 31, 2015 as compared to €0.0 million for the year ended December 31, 2014. The income in the year ended December 31, 2015 was primarily driven by the reversal of the impairment of certain plant and equipment in earlier years.

Finance Income/(Expense): Finance income was €1.4 million for the year ended December 31, 2015 as compared to finance expense of €4.5 million in the year ended December 31, 2014. Finance income in the year ended December 31, 2015 consisted primarily of €5.1 million in foreign exchange gains, partially offset by €3.7 million fair value expense of investor options outstanding. Finance expense in the year ended December 2014 included €6.3 million fair value expense of investor options outstanding, and €3.1 million interest on convertible preferred shares, partially offset by €4.7 million in foreign exchange gains.

Cash Position

As of December 31, 2015, cash and cash equivalents totaled €38.7 million ($42.2 million, converted at an exchange rate as of December 31, 2015) compared to €34.8 million as of September 30, 2015 ($39.0 million, converted at an exchange rate as of September 30, 2015). In addition, the company has available to it up to €10 million in loan commitments from the European Investment Bank (EIB), which will become available if the company achieves primary end points for either of the XaraColl or Cogenzia studies.

Our rate of expenses will continue to increase as we advance our planned clinical trials of XaraColl, Cogenzia and CollaGUARD and expanding our manufacturing facility in Saal, Germany. As a result, we will be required to seek additional sources of capital during the next 12 months or restrict certain of our expenditures to conserve capital and extend our resources.

For further financial information for the period ending December 31, 2015, please refer to the financial statements appearing at the end of this release. As the financial statements are in euros, all amounts shown in U.S. dollars are for the convenience of the reader only, translated at a rate of $1.0887 per euro, the exchange rate as of December 31, 2015.

Conference Call

Innocoll management will host a conference call today at 8:30 a.m. EDT to discuss Fourth quarter and full-year 2015 financial results and provide a business update.

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

An archived webcast recording and telephone replay will be available on the Innocoll website beginning approximately two hours after the call. To access the telephone replay, please dial 877-870-5176 for domestic callers or 858-384-5517 for international callers and entering the conference code: 13632174. The telephone replay will be available until midnight EDT on March 21, 2016.

About Innocoll

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 treat 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.

Spark Therapeutics Announces Acquisition of Genable Technologies

Spark Adds New Program for One of the Leading Causes of Inherited Retinal Disease, Broadening Its Pipeline of Potential Treatments for Rare Blinding Conditions

PHILADELPHIA -- Spark Therapeutics (NASDAQ:ONCE) today announced that it has acquired Dublin, Ireland-based Genable Technologies, a private gene therapy innovator with which Spark has collaborated since 2014 in the development of Genable's therapeutic program targeting one of the most prevalent forms of inherited retinal disease (IRD).

With the acquisition, Spark acquires RhoNova™, a potential treatment targeting rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO-adRP), an IRD that routinely leads to visual impairment and in the most severe cases to blindness. Using an adeno-associated virus (AAV) vector developed and manufactured at Spark, RhoNova™ is designed to both suppress the expression of a faulty gene and deliver normal copies of the RHO gene to restore normal expression. RhoNova™ has been granted Orphan Drug Designation in both the U.S. and Europe in addition to the Advanced Therapy Medicinal Product designation from the European Medicines Agency. There is currently no approved pharmacologic treatment for RHO-adRP, which affects an estimated 12,000 patients in the United States and the five major European markets (EU5).

“This transaction advances our strategy of leveraging Spark’s best-in-class gene therapy platform through a combination of internal innovation, acquisition and collaboration,” said Jeffrey D. Marrazzo, Spark co-founder and chief executive officer. “Genable’s technology and promising RhoNova™ development program further strengthens our portfolio of treatments for IRDs, which is led by our Phase 3 program for RPE65-mediated blindness which recently reported overwhelmingly positive pivotal stage data.”

“Genable has provided convincing data in animals to support their innovative scientific approach for the treatment of autosomal dominant diseases, where it is critical to both suppress faulty genes and replace them with a functional copy in order to have a meaningful therapeutic effect,” said Katherine A. High, MD, co-founder, president and chief scientific officer of Spark. “We look forward to using our validated gene therapy development platform and expertise to accelerate the clinical development of RHoNova, while examining other potential applications for the Genable suppression/augmentation approach outside of this initial indication.”

The consideration paid to Genable shareholders consisted of $6 million in cash and 265,000 shares of Spark common stock. Additional financial terms were not disclosed.

About Spark Therapeutics

Spark is a gene therapy leader seeking to transform the lives of patients with debilitating genetic diseases by developing one-time, life-altering treatments. Spark’s initial focus is on treating rare diseases where no, or only palliative, therapies exist. Spark’s most advanced product candidate, SPK-RPE65 (voretigene neparvovec), which has received both breakthrough therapy and orphan product designation, recently reported positive top-line results from a pivotal Phase 3 clinical trial for the treatment of rare blinding conditions. Spark’s validated gene therapy platform is being applied to a range of clinical and preclinical programs addressing serious genetic diseases, including inherited retinal dystrophies, hematologic disorders and neurodegenerative diseases. Spark builds on two decades of research, development and manufacturing at The Children’s Hospital of Philadelphia, including human trials conducted across diverse therapeutic areas and routes of administration. To learn more, please visit www.sparktx.com.

About Genable Technologies

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

Chrono Therapeutics' Smoking Cessation Technology Demonstrates Significant Reduction in Nicotine Cravings

Personal smoking cessation therapy combines optimized nicotine delivery, personalized behavioral support and monitoring and compliance

CHICAGO - Chrono Therapeutics, a pioneer in digital drug therapy, today announced that clinical data for the company's smoking cessation technology showed a statistically significant reduction in nicotine cravings in a trial of adult male smokers. The data were presented today at the Society for Research on Nicotine & Tobacco's 22nd Annual Meeting.

Chrono's wearable transdermal drug delivery device times nicotine delivery to when smokers have their strongest cravings. For example, 75% of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono Solution is designed to deliver the first dose of nicotine replacement therapy (NRT) shortly before a smoker wakes up and then creates a pattern of "peaks and troughs" of nicotine delivery throughout the rest of the day to assure the smoker has more nicotine support when cravings are predicted to be strongest.

"In the United States, 70 percent of smokers want to quit, but quitting is extremely difficult. In fact, most people try 8 to 10 times and this includes quit attempts with standard cessation medications like nicotine patch and gum and prescription drugs like varenicline," said Alan Levy, Ph.D., chairman and CEO of Chrono Therapeutics. "Gums and patches are designed to help manage cravings, but they are only 5 to 9 percent effective. Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path."

The clinical trial was a randomized, double blinded study of 24 adult males who smoked 11 or more cigarettes per day, indicating a high level of nicotine dependence. The subjects were divided into two groups. Test group subjects had nicotine administered over a 30-hour time period via Chrono's prototype device that delivered nicotine according to Chrono's "peaks and troughs" profile. Control subjects had a placebo solution, with no nicotine, administered at the same intervals via the same prototype device. Across both groups, subjects showed no serious adverse events or study withdrawals due to an adverse event. Skin irritation assessment showed no signs of irritation or erythema.

Cravings were assessed via three different methods: the Questionnaire for Smoking Urges (QSU), the Mood and Physical Symptoms Scale (MPSS) and a single craving question, each of which is a validated tool to assess cravings. When compared to subjects treated with placebo, test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p=0.035; p=0.034 and p=0.016, respectively).

"Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging," noted Wende Hutton, general partner at Canaan Partners and a member of Chrono's board of directors. "Quitting smoking is one of the simplest ways to improve global public health, but as the dismal efficacy of current therapies demonstrates, it is also one of the hardest. I'm very excited to be working with a company that has the potential to solve such a serious problem."

About Chrono Therapeutics

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 achieve 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.

Media Contact
Margaux Stack-Babich
619-849-5385
margaux@canalecomm.com

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.