Mainstay Medical Publishes 2016 Full Year Results and Business Update

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 restorative neurostimulation system to treat people with disabling Chronic Low Back Pain (“CLBP”), announces today the publication of its 2016 Annual Report.
 

• ReActiv8-B Clinical Trial - on track to complete enrolment around the end of 2017, with data availability in 2018
• First sale and implant of ReActiv8 in Germany announced in February 2017
• CE Marking based on positive results from ReActiv8-A Clinical Trial, one year data showed performance maintained
• Completion of €30m private placement in June 2016
• Cash at hand on 31 December 2016 - $36.7m

Peter Crosby, CEO of Mainstay, said: “We are pleased to have moved forward to the commercial phase of Mainstay’s development. Our ReActiv8-B Clinical Trial is on track and is a key step towards commercialization in the US, our most significant target market. Early in 2017, we began commercialization in Europe, with the first sale and implantation of ReActiv8 in Germany, and look forward to gaining experience from our focused activities in this first market ahead of potential expansion to other territories.”

Business Update

• Enrollment in the ReActiv8-B Clinical Trial commenced in September 2016 and the first subject was implanted on 6 October 2016. The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham-controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). The purpose of the ReActiv8-B Clinical Trial is to gather data in support of an application for pre-market approval (PMA) to the FDA, a key step towards the commercialization of ReActiv8 in the US. Summary details of the ReActiv8-B Trial, including enrollment criteria and a list of sites, can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
• We are pleased with the progress of the ReActiv8-B Clinical Trial. We have selected 27 Clinical Trial sites of which 18 are enrolling subjects and the remainder are working with us to begin enrolling as soon as possible. 75 subjects have been enrolled of whom 22 have been implanted with ReActiv8 and 9 subjects are either awaiting implant or are still being assessed. Based on our experience to date, we estimate completion of enrollment in the ReActiv8-B Trial around the end of 2017, with data availability in 2018, which is in line with our target.
• The first sale and implant of ReActiv8 in Germany was announced on 1 February 2017. The implant was performed by Dr. med. Francis Kilian, Orthopedic and Neurosurgeon at the Catholic Hospital Koblenz-Montabaur in Koblenz Germany. We are progressing discussions with a number of customers across Germany. Our European commercial activities for ReActiv8 are initially focused on Germany where we aim to drive adoption of ReActiv8 in a select number of high volume multi‑disciplinary spine care centers which will become reference sites.
• During 2016, we received CE Marking approval for ReActiv8 based on positive results from the ReActiv8-A Clinical Trial. This Clinical Trial demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling Chronic Low Back Pain and few other treatment options. One year results announced in 2016 showed sustained performance.
• In January 2017, we applied for regulatory approval to commercialize ReActiv8 in Australia.
• During 2016, two new US Patents were issued, bringing the total current number of issued US Patents in the Mainstay portfolio to eight.

Financial Update

On 17 June 2016, we announced the completion of a private placement of €30 million (approximately $33.7 million) through a placement of 2,307,694 new ordinary shares with new and existing shareholders (the “Placement”). On 11 August 2016, we announced the publication of a prospectus (the “Prospectus”) in connection with the Placement. Cash on hand at 31 December 2016 was $36.7 million.

As at 31 December 2016, the Group had fully drawn down the debt facility of $15 million with IPF Partners. This facility was announced during 2015, and the last tranche of $4.5 million was received in July 2016 following CE Marking approval of ReActiv8.

Operating expenses were $16.8 million for the year and have increased by $3.9 million compared to 2015 primarily due to costs associated with the commencement and ramp up of the ReActiv-8 B Clinical Trial, and with commercialization activities. Operating cash outflows for 2016 were $16.7 million.

Outlook

We are pleased with the progress of the ReActiv8-B Clinical Trial. Enrollment is well under way and we estimate that enrollment will complete around the end of 2017 with data availability in 2018, which is in line with our target. If successful, the ReActiv8-B Clinical Trial will yield level 1 evidence of efficacy, which we will use to support an application for PMA approval to allow for commercialization in the US. We also anticipate the data from this Clinical Trial will help with expansion of commercialization of ReActiv8 outside the US.

The initial focus for our European commercial activities for ReActiv8 is on Germany where we aim to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. We have recruited a direct sales force, which is supported by our team of experienced field clinical specialists, and we are working with customers to integrate ReActiv8 into their routine clinical practice and provide a new treatment option for the many people suffering from Chronic Low Back Pain. As we gain experience and momentum, and as we identify other early opportunities to build our business, we will consider expansion to other sites and countries.

About Mainstay

Mainstay is a medical device company focused on bringing to market an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading 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 low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

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

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

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

Innocoll Holdings plc Announces Fourth Quarter and Full-Year 2016 Financial and Operating Results and Provides Corporate Update

ATHLONE, Ireland -- Innocoll Holdings plc (Nasdaq:INNL), a global, commercial stage, 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, 2016. Innocoll manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based biodegradable and fully bioresorbable technology platform.

“In 2016, Innocoll successfully achieved milestones, but also faced challenges.  On the one hand, XARACOLL achieved positive pivotal results in Phase 3 trials and we were able to substantially finalize the expansion of our manufacturing facility in Saal, Germany. On the other hand, COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI) and XARACOLL received the Refusal-to-File letter from the U.S. Food and Drug Administration (FDA)," said Tony Zook, Chief Executive Officer of Innocoll. “In February 2017, we attended a Type-A meeting with representatives of the FDA to review pathways forward following our receipt of the Refusal-To-File letter.  During the meeting, we proposed a plan to conduct an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which we believe will allow us to submit a revised NDA to the FDA by the end of 2017.  If the formal minutes from the Type-A meeting, which we expect to receive at the end of this month, confirm that the FDA agrees with our plan, we would submit a revised NDA to the FDA soon after the completion of the additional studies, assuming adequate financing to commence the proposed studies, and further assuming positive results."

Innocoll plans to update investors with additional information about the outcome of its Type A meeting shortly after receiving formal written FDA minutes. In the interim, Innocoll intends to continue to explore strategic options to maximize value to its shareholders.

Fourth Quarter 2016 and Recent Updates

• Substantially finalized expansion of its Saal, Germany manufacturing facility.
• Following receipt of the XARACOLL Refusal to File Letter in December, 2016, in January 2017, Innocoll requested a Type A meeting with the FDA, which was held in late February 2017. At the meeting, management presented a plan for a path forward, including an additional short-term Pharmacokinetic study and several short-term non-clinical studies, which assuming FDA concurrence, adequate financing and further positive trial results, could enable Innocoll to submit a revised NDA for XARACOLL in the latter part of 2017.

Fourth Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shares of $3.8 million, or $0.13 per share, for the fourth quarter of 2016, compared to a loss of $7.7 million, or $0.33 per share for the fourth quarter of 2015.

Non-GAAP diluted loss excluding nonrecurring items was $7.6 million or $0.26 per share, for the fourth quarter of 2016, compared to a loss of $16.9 million or $0.72 per share, for the fourth quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.5 million in the fourth quarter of 2015 to 29.7 million in the fourth quarter of 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues: Revenues were $0.6 million for the fourth quarter of 2016 as compared to $0.9 million for the fourth quarter of 2015. This decrease was primarily due to lower sales to EUSA Pharma of CollatampG®.

Research and Development (R&D) Expenses: R&D expenses were $4.7 million for the fourth quarter of 2016 as compared to $11.7 million for the fourth quarter of 2015. R&D expenses in the fourth quarter of 2016 included $3.7 million in external clinical research expenses, which was primarily driven by the finalization of our Phase 3 Cogenzia efficacy trials.

General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the fourth quarter of 2016 as compared to $6.1 million for the fourth quarter of 2015. Excluding stock-based compensation charges, G&A expenses for the fourth quarter of 2016 were $2.6 million as compared to $5.7 million for the fourth quarter of 2015. The decrease in G&A excluding stock-based compensation was primarily due to reduction in discretionary expenses and prior year expenses relating to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $7.1 million for the fourth quarter of 2016 as compared to $10.9 million for the fourth quarter of 2015. Other income in the fourth quarter of 2016 consisted primarily of fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the European Investment Bank (EIB). Other income in the fourth quarter of 2015 consisted primarily of $9.7 million fair value income of warrants outstanding.

Full Year 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll reported a net loss attributable to ordinary shareholders of $57.0 million, or $2.12 per share, for the year ended December 31, 2016, compared to a loss of $50.9 million, or $2.28 per share for the year ended December 31, 2015. 

Non-GAAP diluted loss excluding nonrecurring items was $59.1 million or $2.20 per share, for the year ended December 31, 2016, compared to a loss of $42.8 million, or $1.92 per share, for the year ended December 31, 2015. 

The weighted average number of ordinary shares outstanding increased from 22.3 million during the year ended December 31, 2015, to 26.9 million during the year ended December 31, 2016, primarily as a result of the follow-on public offering in the second quarter of 2016.

Revenues:  Revenues were $4.4 million for the year ended December 31, 2016 as compared to $2.9 million for year ended December 31, 2015.  This increase was primarily due to an increase in sales to EUSA Pharma of Collatamp G, our gentamicin implant for the treatment and prevention of post-surgical infection.

Research and Development (R&D) Expenses:  R&D expenses were $38.7 million for the year ended December, 31 2016 as compared to $29.8 million for the year ended December 31, 2015. R&D expenses in the year ended December 31, 2016 included $34.8 million in external clinical research expenses, which was primarily due to the completion of our pivotal Phase 3 studies of XARACOLL and Cogenzia. R&D expenses are expected to significantly decrease going forward.

General and Administrative (G&A) Expenses:  G&A expenses were $25.4 million for the year ended December 31, 2016 as compared to $19.7 million for the year ended December 31, 2015.   Excluding stock-based compensation charges, G&A expenses for the year ended December 31 2016 were $16.9 million as compared to $15.7 million for the year ended December 31, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure build out to support clinical programs and expenses related to the company’s re-domiciliation to Ireland.

Other Operating Income: Other operating income was $10.0 million for the year ended December 31, 2016 as compared to $1.6 million for the year ended December 31, 2015. Other income for the year ended December 31, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding and foreign exchange gains, partially offset by accrued interest on the company’s existing loan with the EIB. Other expense for the year ended December 31, 2015 consisted primarily of foreign exchange gains of $5.6 million, partially offset by fair value expense of warrants outstanding of $4.0 million.

Cash Position

As of December 31, 2016, cash and cash equivalents totalled $15.8 million compared to $30.4 million as of September 30, 2016. For further financial information for the period ending December 31, 2016, please refer to the financial statements appearing at the end of this release.

In management's opinion, Innocoll's anticipated expenditures during the next 12 months to advance its current operations, including plans to conduct further studies to enable it to submit a revised NDA for XARACOLL and to develop CollaGUARD will be greater than the amount of its current cash and cash equivalents.  The Company may not be able to generate revenues from the sale of XARACOLL until the end of 2018, if at all.

Innocoll's need for additional capital will vary depending on a variety of circumstances, including, for example, if it is required to conduct additional tests not currently contemplated, the level and timing of regulatory approval, as well as the extent to which it chooses to establish collaboration, co-promotion, distribution or other similar agreements for its products and product candidates. Moreover, changing circumstances may cause it to spend cash significantly faster than it currently anticipates, and it may need to spend more cash than currently expected because of circumstances beyond its control.

To the extent that Innocoll's capital resources are insufficient to meet its future operating and capital requirements, it will need to finance its cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements, or strategic alternatives.

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs that is dedicated to engineering better medicines to help patients get better. Its proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to surgery sites, they are designed to provide a range of benefits. Its late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain and CollaGUARD (INL-003), a barrier for the prevention of post-surgical adhesions.

Innocoll's 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 its native collagen products — from extraction/purification of type-1 collagen through final delivery form — are manufactured at its 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.

Innocoll Holdings Announces Statement re: Possible Offer

ATHLONE, Ireland -- The Board of Innocoll Holdings plc (“Innocoll” or the “Company”) (NASDAQ:INNL) notes anomalous movements in Innocoll’s share price this week and confirms that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

Management has been investigating and continues to investigate strategic options for the Company to maximise shareholder value. There can be no certainty that this will lead to an offer for Innocoll or any of its share capital nor as to the terms on which an offer, if any, might be made. The Company has participated in a Type A meeting with the United States Food and Drug Administration ("FDA") regarding the re-submission to the FDA for approval of XARACOLL. It expects to receive the minutes of the Type A meeting before the end of March and will make a further announcement at that time. 

A further announcement will be made when appropriate.

ENQUIRIES

Innocoll Holdings plc

Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com

Piper Jaffray & Co

Peter Day, Managing Director
Peter.c.day@pjc.com

Peter Lombard, Managing Director
peter.a.lombard@pjc.com

Michael Burton-Williams, Principal
michael.g.burton-williams@pjc.com

Neuravi Announces Completion of Patient Enrollment in Clinical Trial of a Novel Stent Retriever for Acute Ischemic Stroke

ARISE II Data Will Be Submitted to the 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, today announced completion of enrollment in the company’s international clinical trial assessing the safety and effectiveness of the EmboTrap®II Revascularization Device, an advanced stent retriever platform 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 market clearance of the device in the United States.

The ARISE II study enrolled 228 patients in 19 enrolling sites across the United States and Europe.  Sam Zaidat, M.D., Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital in Toledo, Ohio, is the study’s principal investigator.  Professor Tommy Andersson, M.D., Ph.D., of the Karolinska Institute in Stockholm, Sweden, is the European principal investigator of the study.

“The value of stent retrievers has been demonstrated by multiple positive trials. Now our focus has moved on to further refinements of mechanical thrombectomy that will yield better patient outcomes,” said Dr. Zaidat. “International cooperation has been excellent. I’m excited to be a part of the process to provide physicians and patients in the United States with access to the latest technology.” 

The study enrolled ahead of schedule, with enrollment led by Dr. Hormozd Bozorgchami’s team at Oregon Health Sciences University in Portland and Dr. Marc Ribo’s team at Vall d’Hebron in Barcelona. 

 “Evaluating new technology is an important part of advancing stroke treatment and we are enthusiastic about our experience in the ARISE II trial,” said Raul Nogueira, M.D., director of Neuroendovascular Service at Grady Memorial Hospital at Emory University in Atlanta, where the final U.S. patient was enrolled. “As we continue to learn more about the clots that cause stroke, it is important that we have the best tools available to treat those occlusions.”     

The EmboTrap platform is designed to restore blood flow to the brain by retrieving and retaining clot with a proprietary dual-layer stent-like structure. 

“We’d like to thank the stroke center teams in the United States and Europe for their dedication and commitment to the ARISE II trial. In fully enrolling the ARISE II clinical trial, we are building a strong data set in support of our EmboTrap device as well as adding to the broader pool of stent retriever thrombectomy data for stroke treatment,” said Eamon Brady, Neuravi CEO. “Our vision is to be the therapy leader in acute ischemic stroke intervention and we will continue to develop innovative therapy solutions to advance patient care.”

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. Approximately one million Europeans and 700,000 Americans suffer ischemic strokes each year. 

About Neuravi
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s stroke therapy platform, the EmboTrap®II Revascularization Device, is CE marked and commercially available in Europe.   The device has been 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.

 

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

Mainstay Medical Starts Commercialization of ReActiv8® for the Treatment of Chronic Low Back Pain

First sale and implant in Germany following CE Marking
 

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 ("CLBP"), today announces the first sale and implant of ReActiv8 in Germany.

The ReActiv8 implant was performed by Dr. med. Francis Kilian, Orthopedic and Neurosurgeon at the Catholic Hospital Koblenz-Montabaur in Koblenz Germany.

Dr. Kilian commented: "As spine surgeons we are always looking to address the underlying cause of a patient's condition but until now we had no effective option to offer to patients with Chronic Low Back Pain due to impaired control of their back muscles. ReActiv8 represents a significant breakthrough for this large group of patients who are not candidates for spine surgery and fills an important void in our restorative treatment portfolio."

ReActiv8 works by electrically stimulating the nerves responsible for contracting the key stabilizing muscles of the lumbar spine. Activation of these muscles to restore functional spine stability has been shown to facilitate recovery from CLBP.

Peter Crosby, CEO of Mainstay, commented: "The first sale and implant of ReActiv8 in Germany is an important milestone for Mainstay. We are fully committed to working with our customers to integrate ReActiv8 into their routine clinical practice and provide a new option for many people suffering from chronic low back pain."

Mainstay's European commercial activities for ReActiv8 are initially focused on Germany where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. As the Company gains experience and momentum, it will expand to other sites and countries.

Mainstay received CE Marking for ReActiv8 supported by positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading 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 low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

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

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

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

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com

Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Mainstay Medical Applies for Approval to Market ReActiv8® in Australia

Application for inclusion in Australian Register of Therapeutic Goods a key step towards commercialization of innovative treatment of Chronic Low Back Pain in Australian market

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 (“CLBP”), announces that it has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialization in Australia.

Mainstay’s ARTG application 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 options.
 

Peter Crosby, CEO of Mainstay, said: “This application for approval to sell ReActiv8 in Australia is another step on our path to commercializing ReActiv8 in major world markets, adding to our initial commercialization activities in Germany and plans for other European markets. We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval.”
 

The Therapeutic Goods Agency will review the application and may request additional data during the review process. Subject to successful ATRG registration and reimbursement, Mainstay plans to establish its own direct sales force to market ReActiv8 in Australia.
 

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading 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 low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
 

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

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

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

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
 

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com
 

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
 

AndreasBohne.Com/Kötting Consulting (for Germany)
Andreas Bohne
Tel : +49 2102 1485368
Email: abo@andreasbohne.com
 

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
 

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
 

NeRRe Therapeutics raises £23million in oversubscribed Series B financing round

New funds to advance unique neurokinin receptor antagonist pipeline towards late-stage clinical development in common, chronic and debilitating respiratory and women’s health conditions.

New investors Fountain Healthcare Partners, Forbion Capital Partners and Orbimed join existing investors Advent Life Sciences, Novo A/S and GlaxoSmithKline

Stevenage, UK – NeRRe Therapeutics (‘NeRRe’), a clinical-stage company developing a unique portfolio of neurokinin (NK) receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity, announced it has raised £23 million in an oversubscribed Series B financing round.

The funds will be used by NeRRe to generate Phase 2 data on orvepitant, its lead oral NK-1 antagonist candidate as a potential new treatment for a common, chronic respiratory condition; and to advance NT-814, a dual NK-1,3 antagonist, into Phase 2 trials as a potential non-hormonal treatment of distressing post-menopausal vasomotor symptoms. 

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Fountain Healthcare Partners, and co-led by Forbion Capital Partners and OrbiMed. Existing investors, Advent Life Sciences and Novo A/S also participated, and the round was supported by GlaxoSmithKline plc (GSK).

Dr Ena Prosser, Partner at Fountain Healthcare Partners; Geert-Jan Mulder MD, General Partner at Forbion Capital Partners; and Dr Iain Dukes, Venture Partner at OrbiMed will join Dr Kaasim Mahmood, General Partner at Advent Life Sciences (Chairman), Dr Mary Kerr, NeRRe’s CEO and Jo Craig, Vice-President GSK (Board Observer) on the NeRRe Board of Directors.

OrbiMed’s Iain Dukes, formally Senior Vice President, Business Development & Licensing at Merck & Co., said: “We have been impressed by NeRRe's clear strategy, and are pleased to be involved in funding the company to deliver important Phase 2 clinical data on both of these exciting candidates. We look forward to supporting the company in achieving these aims.”

Mary Kerr, NeRRe’s CEO, said: “NeRRe is delighted to have attracted such a substantial investment from these high profile life sciences investors. Now that we are fully funded to execute the next phase of development, everyone at the company is focused on moving orvepitant and NT-814 closer to the market for the alleviation of these common, chronic and debilitating conditions.”

*Biographies of the Board of Directors can be found at www.nerretherapeutics.com

Notes to Editors About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a private, UK-based clinical-stage company focused on the development of its unique portfolio of NK receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity. 

NeRRe Therapeutics was founded in 2012 as a spin out from GSK, which transferred its NK antagonist portfolio, including clinical data, toxicity, safety and formulation packages, and all associated IP to NeRRe. NeRRe is led by an experienced management team including Dr Mary Kerr (CEO), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (Co-founder, CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK.

NeRRe Therapeutics is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, Orbimed, Novo A/S, and by GSK. 

NeRRe is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science focused venture capital fund 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 Forbion Capital Partners

Forbion Capital Partners is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies in the pharmaceutical, as well as the medical device space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in multiple companies. With the new FCFIII fund, Forbion manages well over EUR 700M across six funds, including the new fund FCF III. Its investors include the EIF through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP - Venture Capital Fondsfinanzierung facility. Forbion also operates a joint venture with BioGeneration Ventures, who manages two separate seed and early stage funds focused on Benelux. For further information please visit www.forbion.com.

About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $16 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies utilizing a range of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya.

As the largest investment firm dedicated to the healthcare sector globally, OrbiMed seeks to be a capital provider of choice. OrbiMed has the flexibility to provide equity and debt capital along with the global team resources required to be an exceptional long-term partner for building world-class healthcare companies. www.OrbiMed.com

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com 

For more information, please contact:

Mary Kerr, CEO of NeRRe Therapeutics
Tel:  +44 1438 906960
Email: info@nerretherapeutics.com 

Katja Stout/Mark Swallow, Citigate Dewe Rogerson
Tel: +44 20 7282 1066/2948
Email: NeRRe@citigatedr.co.uk

Innocoll Receives Refusal to File Letter from U.S. FDA for XARACOLL® (bupivacaine HCl collagen-matrix implants) New Drug Application

ATHLONE, Ireland - Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.

Upon preliminary review, the FDA determined that the application, which was submitted in October 2016, was not sufficiently complete to permit a substantive review.  In the Refusal to File letter, the FDA indicated among other things, that XARACOLL should be characterized as a drug/device combination, which would require that the Company submit additional information.  The company will request a Type A meeting with the FDA to respond to several issues believed to be addressable and seek clarification of what additional information, if any, will be required.  Additional details will be disclosed in the future after discussions with the FDA.

“We expect to work with the FDA over the coming weeks in an effort to address the open issues and to define a path forward for a successful re-filing of our application at the earliest point in time,” said Tony Zook, CEO of Innocoll.

About XARACOLL® 
XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postsurgical pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

About Innocoll Holdings plc
Innocoll is a global, specialty pharmaceutical company with late stage development programs 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 surgery sites, they are designed to provide a range of benefits. The company's late stage product pipeline is focused on addressing large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain and COLLAGUARD (INL-003), a barrier for the prevention of postsurgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®.

Opsona Therapeutics Ltd. announces preliminary results from ongoing study in second line lower risk MDS recently presented at the 58th Annual ASH Meeting

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces the preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS) which created interest when presented recently at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego by Prof Garcia-Manero from the MD Anderson Cancer Center.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system. Opsona has recently received orphan drug designation from the United States Food and Drug Administration for MDS.
The study in patients with lower risk, red cell transfusion dependent, MDS who have failed hypomethylating agents (HMA) ± an erythropoiesis stimulating agent is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA.

As of December 2016, 24 eligible patients have been enrolled, 11 at 5 mg dose and 13 at 10 mg/kg. A total of 15 (75%) patients are evaluable for response. Hematological improvement has been seen in 53% (8/15) with 3 (20%) patients achieving transfusion independence and of these 2/5 (40%) were receiving 10 mg/kg while on OPN-305 monotherapy. 12 patients remain on study.
Median age was 72 years (range 42-87). Nine (43 %) patients were classified as Low risk and 15 (63%) as Intermediate-1 risk by IPSS. Thirteen patients (61%) had diploid cytogenetics, 8 (38%) RAEB,5 (23%) RCMD, 3 (14%) RA, 2 (10%) RARS, and 1 (4%) 5q-, RCMD-RS, CMML.

The median number of prior HMA therapies was 2 (range 1-4) with a median duration of prior therapies from time of diagnosis to enrollment of 22.7 months (range 6.3-56.1). The median number of OPN-305 cycles administered is 5 (2-22) with 5 of 9 (55.5%) patients having received azacitidine add-back after 16 weeks of OPN-305 monotherapy. A total of 5 (29%) patients developed AEs related to OPN-305 all grade 1 with gastrointestinal disorders being the most
frequent (23.5%). At this point, no significant drug related toxicity or unexpected infectious complications have been seen and combination with azacitidine has been well tolerated.

To date three (20%) patients were taken off study due to progression to AML and 4 (27%) due to no response all at the 5 mg/kg dose. There is no evidence of treatment related anti-drug antibodies or statistically significant dynamic changes in cytokines in any of the patients.

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of well tolerated, novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life and reduce the social and economic burden of transfusion dependence.

Commenting on today’s announcement Mary Reilly VP Pharmaceutical Development & Operations said “OPN-305 data emerging in this heavily pre-treated group of patients is very encouraging, the unmet need for a safe and tolerable product for this patient population is significant and we are happy to be in collaboration with the MD Anderson Cancer Center one of the leading clinical center’s in this hematological area”

For further information, please contact:
Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics
Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Innocoll Holdings plc Announces Third Quarter 2016 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 needs, today announced financial and operating results for the three months ended September 30, 2016. Using our proprietary collagen-based technology platform, we manufacture and supply a range of biodegradable and fully bioresorbable pharmaceutical products and medical devices that are precision-engineered for targeted use.

“As we recently announced, Innocoll achieved an exciting, new milestone with the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for XARACOLL for the treatment of post-surgical pain,” said Tony Zook, Chief Executive Officer of Innocoll. “We anticipate an FDA acceptance of the NDA, for review, by the end of this year, and with a target Prescription Drug User Fee Act (PDUFA) action date in late August 2017, this achievement will take us another step closer to the approval and launch of XARACOLL in potentially less than one year. In preparation, our Saal Germany based manufacturing facility has completed its construction phase, and we are on schedule to undergo pre-approval inspections soon. In addition to progressing XARACOLL, we were also pleased to announce the advancement of COLLAGUARD upon successful demonstration of medical safety in its pre-clinical studies, which cleared the way for our submission of an Investigational Device Exemption (IDE) this month for the prevention of post-surgical adhesions. The COLLAGUARD program is an ideal complement to XARACOLL, which we believe will position Innocoll competitively in the hospital segment. We reported earlier this month that while COGENZIA showed trends of clinical improvement as adjunct treatment of Diabetic Foot Infections (DFIs), the top-line results did not reach statistical significance for the primary endpoint. We will continue to assess all strategic options to bring these much needed new products to the market and the medical community. We plan to manage our cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017, and we feel confident about our ability to finance the commercialization of XARACOLL as well as our pipeline”.

Third Quarter 2016 and Recent Highlights

• Submitted an NDA for XARACOLL to the FDA for the treatment of postsurgical pain
• FDA acceptance anticipated by the end of 2016, with a target PDUFA action date in late August 2017.
• Presented supportive pharmacokinetic data at American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, in October.
• Medical publication and presentation of full Phase 3 data are targeted for 2Q 2017. Also under preparation to be published next year are the results of our Health Economics (HECON) study, demonstrating the health economic benefits of using XARACOLL.
• Assessment of strategic options around product development continues, as well the planning and preparation for commercialization has ramped up.
• Advanced COLLAGUARD (INL-003), a collagen film being developed as a medical device implanted at the time of surgery for the prevention of postsurgical adhesions
• Completed pre-clinical studies that demonstrated safety as a surgical adhesion barrier in preclinical studies.
• The positive data support filing of an IDE this quarter, 4Q 2016. Thereafter, a Pilot (Feasibility) Study, for the prevention of post-surgical adhesions in patients undergoing open myomectomy, could be initiated next year, assuming the availability of resources to fund the study.
• Announced that Phase 3 clinical trials for COGENZIA showed trends toward clinical response, but top-line data did not achieve statistical significance in improving clinical cure in DFIs.
• The two COACT Phase 3 clinical trials in patients with moderate to severe DFIs studied COGENZIA administered in conjunction with the standard of care (SOC): systemic antibiotics and wound therapy. Based on top-line data, the COGENZIA plus SOC arm did not meet its primary endpoint of clinical cure of infection after 28 days versus placebo plus SOC or versus SOC alone.
• While Innocoll continues to analyze the results, and there were trends toward clinical response in the COGENZIA and placebo collagen-matrix arms, the top-line data suggests that neither COACT-1 nor COACT-2 achieved statistical significance.
• COGENZIA and the placebo collagen-matrix were well tolerated, and the incidence of overall adverse events was similar across all three treatment arms.
• Continued expansion of Saal manufacturing facilities on schedule with successful completion of key stages
• New Quality Control Laboratories approved and operational.
• On-time completion of the CMC Sections and submission of the XARACOLL NDA to the FDA.
• Construction phase of the commercial manufacturing area completed.  Site qualification/validation activities on target for completion prior to year-end.
• Successful completion of a EU “Notified Body” medical device inspection.
• Continuing efforts in preparation for Pre-approval Inspection by FDA.  Initial 3rd Party, ex-FDA compliance audit completed.

Third Quarter 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shares of $17.2 million, or $0.58 per share, for the third quarter of 2016, compared to a loss of $9.1 million, or $0.39 per share, for the third quarter of 2015.

Non-GAAP basic and diluted net loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $15.2 million or $0.51 per share, for the third quarter of 2016, compared to a loss of $12.5 million or $0.53 per share, for the third quarter of 2015.

The weighted average number of ordinary shares outstanding increased from 23.4 million in the third quarter of 2015 to 29.7 million in the third quarter of 2016, primarily as a result of Innocoll's follow-on public offering in the second quarter of 2016. The total number of shares outstanding as at September 30, 2016 was 29.7 million.

Revenues: Revenues were $0.9 million for the third quarter of 2016 compared to $0.7 million in the third quarter of 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses: R&D expenses were $8.4 million for the third quarter of 2016 compared to $7.7 million for the third quarter of 2015. R&D expenses in the third quarter of 2016 included $7.5 million in external clinical research expenses, which was primarily driven by our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.         

General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the third quarter of 2016 compared to $6.0 million for the third quarter of 2015. Excluding share-based compensation charges, G&A expenses for the third quarter of 2016 were $4.9 million, as compared to $4.2 million for the third quarter of 2015. The increase in G&A, excluding stock-based compensation, was primarily due to our continued infrastructure to support clinical programs and some pre-commercialization investment.

Other Operating (Expense)/Income: Other expense was $0.6 million for the third quarter of 2016 compared to other income of $5.2 million for the third quarter of 2015. Other expense in the third quarter of 2016 consisted primarily of accrued interest on the company’s existing loan with the European Investment Bank (EIB) and foreign exchange losses, partially offset by the fair value income of warrants outstanding. Other income in the third quarter of 2015 consisted primarily of $5.2 million fair value income of investor options outstanding.

Nine Month 2016 Financial Results

Net Loss Attributable to Ordinary Shareholders: Innocoll Holdings plc reported a net loss attributable to its ordinary shareholders of $53.1 million, or $2.05 per share, for the nine months ended September 30, 2016, compared to a loss of $43.1 million, or $1.96 per share, for the nine months ended September 30, 2015. 

Non-GAAP basic and diluted loss excluding non-cash expense with respect to share-based compensation and fair value gains and losses on warrants was $51.5 million or $1.99 per share, for the nine months ended September 30, 2016, compared to a loss of $25.6 million, or $1.17 per share, for the nine months September 30, 2015. 

The weighted average number of Innocoll ordinary shares outstanding increased from 21.9 million during the nine months ended September 30, 2015, to 25.9 million during the nine months ended September 30, 2016, primarily as a result of Innocoll’s follow-on public offering in the second quarter of 2016. The total number of shares outstanding at September 30, 2016 was 29.7 million.

Revenues: Revenues were $3.8 million for the nine months ended September 30, 2016 compared to $2.0 million for nine months ended September 30, 2015. This increase was primarily due to an increase in sales to EUSA Pharma of CollatampG, our gentamicin implant for the treatment and prevention of post-surgical infection, following the stabilization of the EUSA Pharma business following the transfer from Jazz Pharmaceuticals.

Research and Development (R&D) Expenses:  R&D expenses were $34.0 million for the nine months ended September 30, 2016 compared to $18.0 million for the nine months ended September 30, 2015. R&D expenses in the nine months ended September 30, 2016 included $31.1 million in external clinical research expenses, which was primarily due to ramp-up and completion of our Phase 3 XARACOLL efficacy trials and the ramp-up of our Phase 3 COGENZIA efficacy trials. R&D expenses are expected to decrease significantly in the future as the company concludes the COGENZIA clinical studies and files its NDA for XARACOLL.

General and Administrative (G&A) Expenses:  G&A expenses were $20.6 million for the nine months ended September 30, 2016 compared to $13.6 million for the nine months ended September 30, 2015.  Excluding share-based compensation charges, G&A expenses for the nine months ended September 30 2016 were $14.3 million compared to $10.0 million for the nine months ended September 30, 2015. The increase in G&A, excluding stock-based compensation, was primarily due to $2.2 million of one-off expenses related to the re-domiciliation of the company to Ireland, our continued infrastructure to support clinical programs, and some pre-commercialization investment.

Other Operating Income/(Expense): Other income was $2.9 million for the nine months ended September 30, 2016 compared to an expense of $9.3 million for the nine months ended September 30, 2015. Other income in the nine months ended September 30, 2016 consisted primarily of non-cash items due to the fair value income of warrants outstanding, partially offset by accrued interest on the company’s existing loan with the EIB and foreign exchange losses. Other expense in the nine months ended September 30, 2015 consisted primarily of $13.9 million fair value expense of warrants outstanding, partially offset by foreign exchange gains of $4.6 million.

Cash Position

As of September 30, 2016, cash and cash equivalents totaled $30.4 million compared to $53.8 million as of June 30, 2016. 

We expect that our rate of expenses will decrease significantly as our clinical study for COGENZIA concluded and as we finalise completion of the expansion of our Saal, Germany manufacturing facility. We plan to manage our resources to extend the cash runway until after the anticipated XARACOLL NDA approval, expected in the third quarter of 2017.

For further financial information for the quarter ended September 30, 2016, please refer to the financial statements appearing at the end of this release.

About Innocoll Holdings plc

Innocoll is a global, specialty pharmaceutical company with late stage development programs 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 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 and COLLAGUARD (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.

Contact:

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

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com

Opsona Therapeutics Ltd. to present preliminary results from ongoing study in second line lower risk myelodysplastic syndrome at the 58th Annual Meeting of the American Society of Hematology (ASH)

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announces that it will present preliminary results from its ongoing prospective, open label Phase I/II study being conducted with OPN-305 in second-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The presentation will take place on Saturday, 3 December at the 58th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects. Opsona has recently received orphan drug designation (ODD) from the United States Food and Drug

Administration for MDS.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

The study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA with additional sites now being added in the USA. The lead principal investigator Professor Guillermo Garcia-Manero will present the preliminary data at ASH and commenting on today’s announcement said “Inhibition of TLR2 with OPN-305 is safe and is currently demonstrating strong clinical activity in patients with lower risk MDS after hypomethylating agent therapy”

Details of the presentation are as follows:

A Clinical Study of OPN-305, a Toll-like receptor 2 (TLR-2) antibody, in patients with Lower Risk Myelodysplastic Syndromes (MDS) that have received prior Hypomethylating Agent (HMA) Therapy

Abstract # 227
Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Lower Risk MDS Clinical Studies
Session Date: Saturday, December 3, 2016
Session Time: 4:00 PM - 5:30 PM
Presentation Time: 5:00 PM Room: Manchester Grand Hyatt San Diego, Grand Hall C

The ASH abstract is now online can be accessed here:
https://ash.confex.com/ash/2016/webprogram/Paper97931.html


For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: mreilly@opsona.com, mwelschof@opsona.com

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

Innocoll Announces Top-Line Data From Phase 3 Trials With COGENZIA and NDA Submission for XARACOLL

• COACT-1 and COACT-2 Phase 3 clinical trials for COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI)
• New Drug Application (NDA) for XARACOLL submitted to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain
• COLLAGUARD pre-clinical safety studies completed; IDE submission on track for later this month
• Conference call on top-line results scheduled for Friday, November 4, 2016 at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) a global, commercial-stage, specialty pharmaceutical company, today announced that  based on top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of COGENZIA (gentamicin collagen topical matrix) in patients  with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone. 

While there were trends toward clinical response (clinical cure plus improvement) in the COGENZIA arm and the placebo collagen-matrix arm, neither COACT-1 nor COACT-2 achieved statistical significance on their shared primary endpoint of clinical cure after 28 days.  While Innocoll continues to analyze the clinical results, the top-line data suggests that the addition of gentamicin delivered topically through COGENZIA, in conjunction with SOC, does not confer sufficient additional clinical benefit over the placebo, administered with SOC, or SOC alone.  

COGENZIA and the placebo collagen-matrix were well-tolerated in both studies.  Incidence of overall adverse events was similar across all three treatment arms in the COACT-1 and COACT-2 studies, respectively.

Innocoll also announced the submission of a New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implants) to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain.  The submission was based upon the successful results of the MATRIX trials which showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.

Finally, Innocoll announced the pre-clinical safety studies for COLLAGUARD (INL-003) have been completed.  COLLAGUARD is a collagen film being developed as a medical device for the prevention of postsurgical adhesions implanted at the time of surgery.  Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this month.

“Having multiple late-stage product opportunities has always underpinned the value of Innocoll,” said Innocoll CEO Tony Zook.  “The submission of the XARACOLL NDA with potential commercialization in 2017 and the progress of the registration program for COLLAGUARD positions Innocoll competitively in the hospital segment.  We will also continue to assess all strategic options to bring these needed therapies to the market.”  

About COGENZIA

COGENZIA is a topical gentamicin collagen-matrix patch that utilizes our COLLARX® proprietary collagen-based delivery technology and was under development to provide topical anti-infective efficacy in combination with systemic antibiotic therapy and standard ulcer care in patients with diabetic foot infections (DFI). 

About COACT-1 and COACT-2

COACT-1 and COACT-2 Phase 3 studies are two identical, randomized, placebo-controlled, blinded studies that enrolled 1,136 patients at 160 separate centers in the United States, Europe and Australia.  The primary objective was to determine the effect of COGENZIA in combination with systemic antibiotic therapy compared to placebo matrix and no matrix, both in combination with systemic antibiotic therapy on diabetic patients’ clinical outcome in the treatment of infected foot ulcers.  Patients were randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (1) daily application of a topical gentamicin collagen-matrix patch, (2) daily application of a topical placebo-matrix patch or (3) no-matrix, in the ratio 2:1:1.  Patients were treated up to 28 days and returned to the clinic weekly for safety and efficacy assessments. Final efficacy assessments used in the primary efficacy analyses were obtained at the first follow-up visit approximately 10 days after treatment was stopped. The remaining follow-up visits occurred at approximately 30, 60 and 90 days after treatment stopped.   The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection at the first follow-up visit per the judgment of each treating clinician using the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.

The study design was in agreement with the FDA under a special protocol assessment (SPA) and COGENZIA was granted a Qualified Infectious Disease Product (QIDP) designation for a potential priority review of 6 months for approval in addition to expanding the marketing exclusivity to 8 years.

About Innocoll

Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen-based products are engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of treatment 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 postsurgical pain; COGENZIA, a topical gentamicin collagen-matrix patch for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier 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. All of our 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.

Ongoing Pipeline Studies

On May 25, 2016 Innocoll announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine HCl collagen-matrix implants) each achieved the primary endpoint as a postsurgical pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction. Based on these results, Innocoll has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).

Additionally, a clinical program is under development for COLLAGUARD (INL-003), a collagen barrier for the prevention of postsurgical adhesions, to support approval in the U.S. The nonclinical program has been completed and Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this year.

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

Neuravi Secures €15 Million to Fund Expansion

Financing Will Support U.S. Commercialization and Broaden the Company’s Product Offering for Stroke Treatment

 

Galway, Ireland – Neuravi, a company dedicated to better clinical outcomes for stroke patients, today announced €15 million in venture debt financing from IPF Partners, a leading alternative financing provider focused on the healthcare sector.
 
This financing allows Neuravi to invest in U.S. commercialization and stroke treatment portfolio expansion, building upon successful commercialization of the company’s EmboTrap® Revascularization Device in Europe and rapid progress enrolling the ARISE II U.S. pivotal study.
 
Landmark acute stroke clinical trials published in 2014 and 2015 demonstrating the superiority of stent retriever technology in treating large vessel strokes have driven a surge in the number of stent retriever procedures. Based on extensive physician engagement and Neuravi’s groundbreaking work on the science of clot, Neuravi has built a strong pipeline of products focused exclusively on acute ischemic stroke and intends to commercialize this pipeline globally in the years ahead.
 
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering next-generation technology for stroke treatment to physicians. This financing allows us to build our commercial presence in the U.S. and further invest in R&D for our exciting product pipeline,” said Eamon Brady, Neuravi CEO. “We see significant innovation opportunity due to the under-developed stroke treatment ‘toolbox’ available to stroke clinicians today. Our vision is to design and build devices that truly address the needs of acute stroke patients and put them in the hands of stroke physicians all over the world. This funding is an important step on our roadmap.”
 

About EmboTrap
The EmboTrap Revascularization Device is engineered to restore blood flow to the brain by retrieving clot with a proprietary dual-layer stent-like structure. The device’s integrated distal protection zone is designed to reduce the risk of clot fragmentation during retrieval, which could cause additional harm to the patient.  The EmboTrap II Revascularization Device is available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the U.S. under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States. 
 

About Neuravi
Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute ischemic stroke. Through the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to improve patient outcomes in stroke by deepening the understanding of the science of clot and occlusions.  Neuravi is exclusively focused on acute ischemic stroke.  More information can be found at www.neuravi.com.
 

IPF Partners
IPF Partners, based in Luxembourg, is a leading alternative financing provider focused on the healthcare sector. IPF invests directly in emerging pharma/biotech, medtech and diagnostics companies. Founded in 2011 by a seasoned multi-disciplinary team combining over fifty years of finance and investment and over thirty years of healthcare experience, IPF has developed a unique business model using the team’s specialist sector knowledge to provide bespoke, long-term financing. For more information visit www.ipfpartners.com.
 

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

Vivasure Medical Appoints Robert (Chip) Hance to Company’s Board of Directors

25-Year Medical Device Veteran Brings Deep Industry, Commercialization Experience

Galway, Ireland — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced the appointment of Robert (Chip) Hance to the company’s board of directors. 

Hance is a 25-year veteran of the medical device industry. He is the former CEO of Creganna Medical, a private equity-backed Ireland-based supplier to the minimally invasive medical device industry, which was recently acquired by TE Connectivity. Previously, he served as an Entrepreneur in Residence at the U.S. Food and Drug Administration (FDA) and in multiple executive roles at Abbott including president of Abbott Vascular, president of Abbott Diabetes Care, president of Vascular Devices and divisional vice president of Abbott Diagnostics in Europe.

“I can think of no one better suited than Chip to help lead Vivasure to the next stage in its evolution,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “Chip is a highly respected leader who has done much to advance innovation in our industry and to improve healthcare outcomes for patients around the world. We look forward to working closely with him as we further our mission of developing novel bioabsorbable technologies for percutaneous vessel closure.”

Hance’s appointment follows the recent completion of Vivasure’s Series C financing of €16.2M ($18.3M) to support European commercialization of the company’s PerQseal™ technology and to advance execution of a FDA regulatory study.

“I look forward to joining the Board as Vivasure advances its progress toward European market expansion and securing U.S. approval and commercialization of the company’s first product,” said Hance. “Vivasure’s closure device meets an important and growing clinical need and I am excited about the potential of this innovative technology to improve arteriotomy closure outcomes for patients.”

“On behalf of the entire Board and Vivasure’s investors, we are pleased to welcome Chip to the company’s Board of Directors,” said Bernard Collins, chairman of Vivasure’s Board of Directors. “His guidance will be invaluable as Vivasure moves toward this next stage of accelerated growth and opportunity.”

The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European 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, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021.

Hance holds a bachelor’s degree in chemical engineering from Massachusetts Institute of Technology and an MBA from Harvard Business School.

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

Mainstay Medical Announces Additional U.S. Patent Issued

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 ("CLBP"), today announced the issuance of a new U.S. Patent, which strengthens its intellectual property portfolio.

• U.S. Patent No. 9,474,906 "Systems and Methods for Restoring Muscle Function to the Lumbar Spine"

Corresponding applications have been made in other countries. Mainstay continues to add to its portfolio of issued patents and pending applications.
 
Peter Crosby, CEO of Mainstay, commented: "This new U.S. patent bolsters our growing intellectual property portfolio, which now includes eight issued U.S. patents. We are proud of the continued development of the intellectual property underpinning ReActiv8, a medical device which offers a new approach to the treatment of CLBP, addressing cause and not simply symptoms."

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options.

The ReActiv8-B Clinical Trial is intended to gather data in support of an application for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA), and the first subject in the Clinical Trial was implanted with ReActiv8 in October 2016.

About Mainstay
Mainstay is a medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany, and its ordinary shares are admitted to trading 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 low 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

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Opsona Therapeutics Ltd. receives orphan designation for myelodysplastic syndrome (MDS) with OPN-305, a first-in-class monoclonal antibody that blocks Toll-Like Receptor 2

Dublin, Ireland – Opsona Therapeutics Ltd (‘Opsona’), the innate immune drug and development company focused on novel therapeutic approaches to treat oncology, autoimmune and other inflammatory diseases, today announced that it has received orphan drug designation (ODD) from United States Food and Drug Administration for myelodysplastic syndromes (MDS).

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis, and poor prognosis. There is an urgent need for the development of novel therapies in the treatment of MDS which can delay progression, improve patient survival and quality of life, and which have fewer adverse effects.

OPN-305 is a novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a key target within the innate immune system.

Evaluation of OPN-305 in MDS is the first of a range of oncology indications that the company is exploring with its leading drug in development, OPN-305. A study in patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with MD Anderson Cancer Center in Houston USA. Opsona believes that OPN-305 has the potential to be first and best-in-class while also providing a novel treatment option for a wide variety of oncology, autoimmune and other inflammatory diseases.

Commenting on today’s announcement, Mary Reilly, VP Pharmaceutical Development and Operations at Opsona Therapeutics, said: “We are pleased to receive FDA Orphan Drug Designation for OPN-305 in MDS. This is an important regulatory milestone for the company and a significant step forward in our clinical development of OPN-305 targeting this rare disease associated with an unmet medical need for safe and effective therapeutics."

 

For further information, please contact:

Mary Reilly (VP Pharmaceutical Development and Operations) or Martin Welschof (CEO), telephone: + 353 16770223, e-mail: MReilly@opsona.com, mwelschof@opsona.com
Or
Jim Devlin, FTI Consulting, e. jim.devlin@fticonsulting.com ; d. +353 (0)1 6633600; m. +353 (0)87 2631057
 

About Opsona Therapeutics

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including cancer, autoimmune and other inflammatory diseases. The company was founded in 2004 by three world-renowned immunologists at Trinity College, Dublin. Opsona has a strong international investor consortium including: Amgen Ventures, BB Biotech Ventures, EMBL Ventures, Enterprise Ireland, Fountain Healthcare Partners, Inventages Venture Capital, Novartis Venture Fund, Omnes Capital, Roche Venture Fund, Seroba Life Sciences, Shire and Sunstone Capital

First Subject Implanted in Mainstay Medical's ReActiv8-B Clinical Trial for Treatment of Chronic Low Back Pain

Trial to gather data in support of an application for US pre-market approval (PMA)

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 ("CLBP"), announces that the first subject in the ReActiv8-B Clinical Trial (the "Clinical Trial") has been implanted with ReActiv8.

The first subject was implanted at the Monash House Private Hospital in Melbourne, Australia by Dr. Bruce Mitchell, a sports and interventional pain physician.

Dr. Mitchell commented: "Following our positive experience in the ReActiv8-A trial, we are very excited to be part of this pivotal trial to support a PMA in the US. Many of our patients have been suffering from chronic low back pain for years and have exhausted all available treatment options. ReActiv8 allows us to offer them a new, unique approach which addresses the cause of pain rather than just the symptoms."

The ReActiv8-B Clinical Trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US.

As the Clinical Trial progresses, the information at https://clinicaltrials.gov/show/NCT02577354 will be updated.

ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A Clinical Trial that demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other options.[1]

Peter Crosby, CEO of Mainstay, commented: "The implant of the first subject in the ReActiv8-B Clinical Trial represents further significant progress for Mainstay. During a year in which we have obtained CE Mark for ReActiv8, triggering the start of European commercialization activities, and raised €30m of new capital in June, the ReActiv8-B Clinical Trial provides further traction for our route to market in the US."

ReActiv8-B Clinical 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 statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit.

The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide Level 1 Evidence of efficacy of ReActiv8, which may be used to support applications for favourable reimbursement in the US. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

Based on experience with enrolment in the ReActiv8-A Clinical Trial, it is estimated that full enrolment in the ReActiv8-B Clinical Trial will take 12 to 18 months from first enrolment, with results anticipated to be available approximately six months following full enrolment.

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

________________________________

[1]    Please refer to the Company's web site for the Press Release of 20 September 2016 with details of results of the ReActiv8-A Clinical Trial and follow-up data after a one-year period.

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

 

About the ReActiv8-B Clinical 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
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 low 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

PR and IR Enquiries:
 

Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Jessica Hodgson, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com

NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr

Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com

ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Mainstay Medical Announces Half Year Financial Results

Mainstay Medical International plc (“Mainstay”, “We” 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 (“CLBP”), today announces the publication of its report for the Half Year ended 30 June 2016.

Highlights

• On 14 September 2016, Mainstay announced the enrollment of the first subject in the ReActiv8-B Clinical Trial. The purpose of the ReActiv8-B Clinical Trial is to gather data in support of an application for pre-market approval (“PMA”) from the US Food and Drug Administration (“FDA”), a key step towards commercialization of ReActiv8 in the US. The Clinical Trial, if successful, will provide Level 1 Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. In addition, evidence from the ReActiv8-B Clinical Trial will be used to support market development activities worldwide.
• On 25 May 2016, Mainstay announced the receipt of CE Marking approval for ReActiv8. The CE Marking approval is based on positive results from the ReActiv8-A Clinical Trial which demonstrated clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options. On 20 September 2016 we announced the one-year results from the ReActiv8-A Clinical Trial, which showed long term sustained performance.
• Our commercial launch of ReActiv8 is focused on Germany. We aim to drive adoption of ReActiv8 in a select number of hospitals with a large population of patients with chronic low back pain and with a multi-disciplinary approach to treatment. Our initial customers in Germany (neurosurgeons and orthopedic spine surgeons) have been trained, contract negotiations are well under way, and ethics committee submissions have been made for the ReActiv8-C Registry. We have recruited a direct sales force, which is supported by our team of experienced field clinical specialists. As we gain experience and momentum, we will expand our commercialization efforts to other countries and centers.
• On 17 June 2016, Mainstay announced the completion of a private placement of €30 million (approximately $33.7 million) through a placement of 2,307,694 new ordinary shares with new and existing shareholders.
• In February 2016, a new US Patent was issued bringing the total number of issued US Patents in the Mainstay portfolio to seven.
• Operating expenses were $8.0 million ($6.3 million in 1H15) and the increase was primarily driven by expansion of our team, preparation for the ReActiv8-B Clinical Trial and preparation for our commercial launch.
• Cash on hand at 30 June was $42.8 million and operating cash out flows for the period were $7.5 million.

About Mainstay

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

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

About the ReActiv8-C Registry

The ReActiv8-C Registry is an international, multi-center, data collection registry. All patients who will be implanted with ReActiv8 during commercialization will be invited to enroll in the ReActiv8-C Registry until the target enrollment numbers have been reached. The purpose is to gather additional summary data on the long term performance of ReActiv8 in at least 50 patients.

About Chronic Low Back Pain

One of the recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low 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 utilization put a significant burden on individuals, families, communities, industry and governments.

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

Mainstay Medical International plc: ReActiv8-A Clinical Trial – Sustained Performance at One Year

One-year 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

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 (“CLBP”), today announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling CLBP and few other treatment options.1

The one-year results show sustained performance in the ReActiv8-A Clinical Trial at the one-year follow-up with a clinically important, statistically significant and lasting improvement in the study’s key endpoints for pain2 (NRS), disability3 (ODI) and quality of life4 (EQ-5D).

Peter Crosby, CEO of Mainstay, said: “We are very encouraged to see such strong and lasting benefits in this difficult to treat population. After one year of ReActiv8 treatment, 88% of subjects reported a clinically important improvement in one or more of the study endpoints, 81% were satisfied or very satisfied with the treatment and the majority continued to use the ReActiv8 treatment.”

The results presented are based on data from the first 47 subjects implanted in the ReActiv8-A Trial of whom 46 have completed the 90-day follow-up, 45 the 180-day follow-up and 41 the one-year follow-up.

To facilitate future comparison of results in the ReActiv8-A and the ReActiv8-B trial, all outcomes are presented relative to the data collected at the enrolment visit.

Results for all subjects at 90 days, 180 days and 1 year respectively are:

• 93%, 87% and 88% with clinically important improvement in one or more of the study’s key endpoints.
• 63%, 58% and 56% with clinically important improvement in low back pain NRS on the day.
• 50%, 53% and 59% with clinically important improvement in ODI.
• 89%, 82% and 80% with clinically important improvement in EQ-5D.
• 61%, 67% and 62% reported>50% pain relief.
• 89%, 84% and 81% were satisfied with ReActiv8 treatment.

The results for EQ-5D and ODI previously announced were relative to data collected at the pre-implant visit to 90 days and 180 days and were:

• 57% and 60% with clinically important improvement in ODI.
• 67% and 73% with clinically important improvement in EQ-5D.

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 Company previously announced a modification of the implant surgical approach to mitigate the risk of conductor fractures inside the lead, which had been observed in the ReActiv8-A Trial at that time. To date, no subject implanted with the currently used midline approach has required lead revision surgery.

Subjects continue to be enrolled in the ReActiv8-A Trial as part of a Post Market Clinical Follow Up to gather additional data on performance and safety.

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. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial.

Further details can be found at https://clinicaltrials.gov/ct2/show/NCT01985230.

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

About Mainstay

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

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

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 low 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

Forward looking statements

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

By their nature, forward looking statements involve risk and uncertainty because they relate to future events and circumstances. Forward looking statements are not guarantees of future performance and the actual results of the Company’s operations, and the development of its main product, the markets and the industry in which the Company operates, may differ materially from those described in, or suggested by, the forward looking statements contained in this announcement. In addition, even if the Company’s results of operations, financial position and growth, and the development of its main product and the markets and the industry in which the Company operates, are consistent with the forward looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. A number of factors could cause results and developments of the Company to differ materially from those expressed or implied by the forward looking statements including, without limitation, the successful launch and commercialisation of ReActiv8, the progress and success of the ReActiv8-B Clinical Trial, general economic and business conditions, the global medical device market conditions, industry trends, competition, changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and complete clinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in its business strategy, political and economic uncertainty. The forward-looking statements herein speak only at the date of this announcement.

1 Please refer to the Company’s web site for the Press Release of 4 December 2015 with details of results of the ReActiv8-A Trial

2 Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., Zavisic, S. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical Trials: IMMPACT recommendations. The Journal of Pain: Official Journal of the American Pain Society, 9(2), 105–21.

3 Ostelo, R. W. J. G., Deyo, R. A., Stratford, P., Waddell, G., Croft, P., Von Korff, M., … de Vet, H. C. W. (2008). Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine, 33(1), 90–4.

4 Soer, R., Reneman, M. F., Speijer, B. L. G. N., Coppes, M. H., & Vroomen, P. C. A. J. (2012). Clinimetric properties of the EuroQol-5D in patients with Chronic Low Back Pain. Spine Journal, 12(11), 1035–1039.

Mainstay Medical International plc
PR and IR Enquiries:
 

Consilium Strategic Communications (international strategic communications – business and trade media)
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Email: mainstaymedical@consilium-comms.com
or
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Jonathan Neilan
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Email: jonathan.neilan@fticonsulting.com
or
NewCap (for France)
Julie Coulot
Tel: +33 1 44 71 20 40
Email: jcoulot@newcap.fr
or
Investor Relations:
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Email: britchie@lifesciadvisors.com
or
ESM Advisers:
Davy
Fergal Meegan or Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Mainstay Medical's ReActiv8-B Clinical Trial for Treatment of Chronic Low Back Pain Enrolls First Subject

Trial to gather data in support of an application for US pre-market approval (PMA)

 Dublin - Ireland, 14 September 2016 - 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 ("CLBP"), announces the enrolment of the first subject in the ReActiv8-B Clinical Trial ("the Clinical Trial"), which is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US.
 
The first subject was enrolled at the Genesis Research Services center in Newcastle, NSW, Australia by Dr. Marc Russo, and if all eligibility criteria are met, will be implanted with ReActiv8 within a few weeks. As more investigational sites are activated, the information at https://clinicaltrials.gov/show/NCT02577354 will be updated.
 
ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling Chronic Low Back Pain and few other options.
 
Dr Chris Gilligan, Chief of the Division of Pain Medicine and Co-Director of the Spine Center at Beth Israel Deaconess Medical Center in Boston, MA, and Principal Investigator for the ReActiv8-B Clinical Trial said: "Chronic Low Back Pain is a major global challenge and many patients have been suffering from the condition for many years and are left with few treatment options. ReActiv8 offers a unique new approach which addresses cause and not simply symptoms. We look forward to gathering the clinical evidence required for Mainstay to make an application for PMA approval which would make ReActiv8 also commercially available to patients in the US."
 
Peter Crosby, CEO of Mainstay, commented: "The enrolment of the first subject in the ReActiv8-B Clinical Trial is yet another significant step for Mainstay this year following the CE Marking for ReActiv8 in May, triggering the start of commercialization activities in our first European market, Germany, and the raising of €30m new capital in June."
 
 

ReActiv8-B Clinical 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 statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit.
 
The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1 Evidence of safety and efficacy of ReActiv8, which may be used to support applications for favourable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.
 
Based on experience with enrolment in the ReActiv8-A Clinical Trial, it is estimated that full enrolment of the pivotal cohort in the ReActiv8-B Clinical Trial will take 12 to 18 months, with results anticipated to be available approximately six months following full enrolment.
 
Further details can be found at https://clinicaltrials.gov/show/NCT02577354.
 
CAUTION - in the United States, ReActiv8 is limited by federal law to investigational use only.
 
 

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

About the ReActiv8-B Clinical 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
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 low 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