Mainstay Medical Publishes 2017 Full Year Results

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 disabling Chronic Low Back Pain, announces today the publication of its 2017 Full Year results and Annual Report.


Business Update

  • In December 2017, we announced the positive outcome of the Interim Analysis of the ReActiv8-B Study. The Independent Data Monitoring Committee recommended the continuation of the Study with a definitive size of 168 evaluable patients. The DMC also reported that they had no safety concerns in the Study.
  • The ReActiv8-B Study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. The ultimate number of patients in the Study will be higher than 168 due to the nature of the enrollment process.
  • Mainstay has continued to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites.
  • To date, 5 centers in Germany and Ireland have implanted patients with ReActiv8, and several additional sites have been trained.
  • We were recently issued a new US Patent, U.S. Patent No. 9,861,811 “Electrical Stimulator for Treatment of Back Pain and Methods of Use”, bringing the total current number of US issued patents in the Mainstay portfolio to nine.



Financial Update

  • Revenue during the year ended 31 December 2017 was $0.3 million (2016: nil).
  • Operating expenses related to on-going activities were $27.9 million during the year ended 31 December 2017 (2016: $16.8 million).
  • Cash on hand as at 31 December 2017 was $10 million (2016: $36.7 million) and operating net cash outflows for the year ended 31 December 2017 were $24.9 million (2016: $16.7 million). This operating cash outflow reflects the cost of the research and development of ReActiv8, undertaking our clinical trials, commercialization expenditure, the ongoing costs of being a public company, and running the Group.
  • The Company had $7.8 million cash on hand at 31 January 2018.

– End –

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 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 Announces €30 million Financing

New Capital to Complete US Pivotal ReActiv8-B Clinical Study and Advance European Commercialization
 

Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain, announces today that it has raised gross proceeds of €30.1 million through the issue of 2,151,332 new ordinary shares (New Shares) to new and existing shareholders.

The funds raised in this financing will be used to significantly advance Mainstay’s business. In particular, the net proceeds will be used:

  • to complete the U.S. Pivotal ReActiv8-B Clinical Study in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA)
  • to advance the initial commercialization of ReActiv8 in Germany and additional markets
  • to invest in early commercial activities in preparation for launch in the United States
  • for general corporate purposes.

Jason Hannon, CEO of Mainstay, commented: “Our goals for the next two years are clear: complete the ReActiv8-B clinical study, file the PMA for ReActiv8 with the FDA, and build our commercial presence in 2018 for more meaningful commercial expansion starting in 2019.  A key focus in 2018 will be building market awareness in Germany and developing reference sites who care for chronic back pain patients and believe in ReActiv8. Over the next year we are targeting to have 10 or more physician partners who have performed multiple implants, with whom we will work to expand market awareness and adoption, refine patient selection strategies and follow ongoing patient progress. This financing provides the capital to drive forward on all these goals.”

 

Business Update

  • In December 2017, we announced the positive outcome of the Interim Analysis of the ReActiv8-B Study. The Independent Data Monitoring Committee recommended the continuation of the
  • Study with a definitive size of 168 evaluable patients. The DMC also reported that they had no safety concerns in the Study.
  • The ReActiv8-B Study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. The ultimate number of patients in the Study will be higher than 168 due to the nature of the enrollment process.
  • Mainstay has continued to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites.
  • To date, 5 centers in Germany and Ireland have implanted patients with ReActiv8, and several additional sites have been trained.
  • We were recently issued a new US Patent, U.S. Patent No. 9,861,811 “Electrical Stimulator for Treatment of Back Pain and Methods of Use”, bringing the total current number of US issued patents in the Mainstay portfolio to nine.

 

Investors in the Financing

The investors in this pivotal financing are primarily institutions in Europe and North America, at a price of €14 per New Share. The Ireland Strategic Investment Fund) (ISIF) is participating in the financing, subscribing for 714,285 New Shares, representing approximately 33.2% of the total number of New Shares, for an amount of approximately €10 million. ISIF is an Irish sovereign development fund with a statutory mandate to invest on a commercial basis in a manner designed to support economic activity and employment in Ireland. ISIF played a key role in this transaction.

Mainstay is implementing plans to bring additional elements of its operations to Ireland following the ISIF investment. Mainstay will build on its Irish footprint and benefit from the strong local talent base. These elements of operational infrastructure will take shape as the Company’s business scales commercially. These investments will, the Directors believe, support the Company’s growth over time and allow it to reach more customers, while simultaneously adding investment and job creation to the Irish market.

 

Specific information regarding the Financing

The New Shares will be issued immediately following the publication of this announcement. In addition to ISIF, the Company’s existing long-term investors, Sofinnova Partners, Fountain Healthcare Partners and KCK Limited and several individual investors, are also participating in the financing.

The New Shares, when issued, will represent an increase of approximately 32.5% from the Company's existing issued ordinary share capital. Following issuance of the New Shares, the Company’s issued share capital will consist of 8,770,229 Ordinary Shares of €0.001 each (which carry voting rights) and 40,000 deferred shares with a nominal value of €1.00 each (which do not carry voting rights). Therefore, the figure that should be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their holdings of voting rights, or a change to their holdings of voting rights, over the Ordinary Shares of the Company under the Transparency (Directive 2004/109/EC) Regulations 2007 of Ireland, as amended and the Transparency Rules of the Central Bank of Ireland is 8,770,229.

The New Shares, when issued, will be fully paid and rank pari passu in all respects with the existing issued Ordinary Shares, except that the New Shares will not be admitted to trading on Euronext Paris or the Enterprise Securities Market (ESM) of the Irish Stock Exchange plc (Admission) until the Company has published a prospectus that is required to effect the admission to trading of the New Shares on Euronext Paris in accordance with Directive 2003/71/EC (as amended). The Company expects to publish that prospectus (which requires approval by the Central Bank of Ireland and which will be passported into France), and that Admission will occur, by 15 May 2018. Under the terms of the subscription agreements for the New Shares, the Company has agreed that if Admission does not occur by 120 days after the issuance of the New Shares, then for all or part of one or more of the consecutive 30 day periods following that date (a Relevant Period) during which Admission does not occur the Company shall separately pay to each investor, as liquidated damages, a cash payment of 0.5% of the total subscription price paid by the relevant investor for each Relevant Period (or partial Relevant Period) during which Admission has still not occurred; provided, however that in no event shall the Company be required to pay to any investor an aggregate amount that exceeds 5% of the total subscription price paid by that investor. Any such payment(s) shall be made within five Business Days of the end of each such Relevant Period.

Sofinnova Partners, KCK Limited and Fountain Healthcare Partners (who are considered substantial shareholders under the Enterprise Securities Market Rules for Companies (ESM Rules)) will subscribe for 250,000, 428,572 and 138,280 New Shares respectively. Their participation in the financing will constitute related party transactions under Rule 13 of the ESM Rules. The Directors, with the exception of Antoine Papiernik (with respect to Sofinnova Partners), Nael Karim Kassar and Greg Garfield (with respect to KCK Limited) and Manus Rogan (with respect to Fountain Healthcare Partners), consider, having consulted with J&E Davy, the Company’s ESM Adviser, that the terms of the participation of Sofinnova Partners, KCK Limited and Fountain Healthcare Partners in the financing are fair and reasonable insofar as Mainstay shareholders are concerned.

Jason Hannon, who is a Director, will also participate in the financing, subscribing for 30,000 New Shares, so that following completion of the financing, he will hold 30,000 Ordinary Shares, representing 0.3% of the enlarged issued ordinary share capital of the Company.

David Brabazon, who is also a Director, will also participate in the financing, subscribing for 30,000 New Shares, so that following completion of the financing, he will hold 57,828 Ordinary Shares, representing 0.7% of the enlarged issued ordinary share capital of the Company.

Greg Garfield, who is also a Director, will also participate in the financing, subscribing for 2,912 New Shares, so that following completion of the financing, he will hold 2,912 Ordinary Shares, representing 0.03% of the enlarged issued ordinary share capital of the Company.

Kempen (Amsterdam) acted as financial adviser and coordinating placement agent, J&E Davy (Dublin) acted as financial adviser and ESM Adviser, Merrion Capital (Dublin) acted as financial adviser and placement agent and LifeSci Capital acted as financial adviser and placement agent.

This Announcement contains inside information for the purposes of the Market Abuse Regulation (EU) No 596/2014 (MAR). Market soundings, as defined in MAR, were taken in respect of the Financing, with the result that certain persons became aware of inside information, as permitted by MAR. That inside information is set out in this Announcement. Therefore, those persons that received inside information in a market sounding are no longer in possession of inside information relating to the Company and its securities.

The person responsible for arranging release of this Announcement on behalf of Mainstay is Tom Maher.

 

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, Germany and the Netherlands, and is listed on regulated market of the Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).

 

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

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, Jessica Hodgson, Nicholas Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland):
Jonathan Neilan Tel: +353 1 765 0886
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

 

 

 

 

 

Chrono Therapeutics Announces Appointment of David Happel as Chief Executive Officer

Dr. Alan Levy, Ph.D., to Retire as CEO

Chrono Therapeutics, a pioneer in digital drug therapy, today announced that Alan Levy Ph.D., chief executive officer and chairman of the board of directors is retiring. David A. Happel has been appointed as the new chief executive officer, and current board member James Young, Ph.D., will assume the role of chairman of the board.  Dr. Levy will continue to serve as a member of the board.

"I'm very pleased with the progress we have made over the last four years, including the excellent clinical results in our smoking cessation application as well as the progress we have made on our Parkinson's disease and opioid-tapering programs that target important unmet clinical needs," said Dr. Levy.  "With David's background and experience in both the biotech and pharmaceutical industries, and his focus on commercialization, he is the ideal person to take the company through its next chapter."

"It is an honor to succeed Alan, and I am very excited to build on the foundation that has been created at Chrono Therapeutics as the company continues to advance its proprietary SmartDermal therapeutics and technology platform into the later stages of clinical development and commercialization," said Mr. Happel.

Mr. Happel joins Chrono Therapeutics from Horizon Pharma, PLC where he was executive vice president of commercial development and strategy. During his tenure at Horizon, Mr. Happel was responsible for the commercialization of Horizon's five marketed orphan disease products and the development of Horizon's rare disease pipeline portfolio. Prior to Horizon Pharma, he was the chief commercial officer of Raptor Pharmaceuticals where he had worldwide responsibility for the commercialization of Raptor's two marketed orphan disease products and the development of Raptor's pipeline portfolio. Previously, Mr. Happel held senior management positions at Allergen Research Corporation, Dynavax Technologies, Dr. Reddy's Laboratories, Chiron Corporation and Intermune. Mr. Happel received his B.A. in chemistry from Indiana University and his M.B.A in marketing from Indiana State University.

"On behalf of the entire board, we thank Alan for his endless dedication and commitment to the company over the last four years. Under his leadership Chrono Therapeutics has built a rich pipeline of product candidates to address unmet needs in addictions and central nervous systems disorders with a vision to improve patient outcomes and lives," said James Young, chairman of Chrono's board of directors.

About Chrono Therapeutics

Chrono Therapeutics is dedicated to improving the lives of patients living with addictions and other neurological conditions by combining smart drug delivery, personalized behavioral support, data analytics, and improved compliance into one integrated product. Chrono Therapeutics' transdermal drug delivery platform is smarter: providing just the right amount of medication timed to when patients' symptoms are at their strongest and medication is most needed. With our technology, drug delivery is personalized and has the potential to be significantly more efficacious.

For more information, visit: www.chronothera.com.

UCB and investor syndicate led by Novo Seeds launch Syndesi Therapeutics to develop novel therapeutics for cognitive disorders

  • Syndesi Therapeutics to leverage UCB’s expertise in neurology drug discovery to develop potential therapeutics in cognitive disorders with a first-in-class mechanism 
  • Series A financing of €17 M from a syndicate of Belgian and international investors

The creation of Syndesi Therapeutics (‘Syndesi’) was announced today as the result of a partnership between UCB and a syndicate of Belgian and international investors. The investor syndicate is led by Novo Seeds and Fountain Healthcare together with Johnson & Johnson Innovation – JJDC, Inc. (JJDC), V-BIO Ventures, the Walloon Investment Fund (SRIW) and VIVES Louvain Technology Fund. Syndesi Therapeutics has exclusively licensed a first-in-class small molecule program from UCB and the series A investment totalling €17M will fund the clinical development of the lead compound up to early proof-of-concept in humans. 
 
Syndesi Therapeutics is based in Belgium and will leverage UCB’s neurology expertise in modulating the synaptic vesicle protein SV2A. UCB’s Neuroscience researchers in Belgium have designed a unique class of novel SV2A modulators. Unlike levetiracetam and other types of SV2A modulators   discovered and developed by UCB for epilepsy, the novel compounds are devoid of anti-epileptic properties but have demonstrated robust pro-cognitive properties in preclinical models. Cognitive impairment currently being outside UCB’s strategic scope, the decision was made to have the program further developed externally to leverage its full potential. The discovery of these novel pro-cognitive SV2A modulators at UCB has benefitted from prior support of the Walloon Region, and Syndesi will use the Series A investment to build upon that work and move the lead molecule into clinical development.
 
“UCB is the world leader in SV2A research, having discovered and developed two major anti-epileptic drugs treating patients around the world. We are excited to see Syndesi develop our novel pro-cognitive SV2A modulators to create value for patients with cognitive impairment,” said Dhavalkumar Patel, UCB’s Chief Scientific Officer and Executive Vice President. “The Belgian life science ecosystem is particularly vibrant and we realised that it was the right environment to promote this research as part of our biotech model approach.”
 
Jonathan Savidge, PhD CEO of Syndesi noted “Development of these small molecules that modulate the SV2A target in a distinct manner represents an intriguing new approach for the treatment of cognitive deficits since they specifically target synaptic dysfunction, a hallmark of Alzheimer’s Disease and other indications characterized by cognitive impairment. Syndesi benefits both from UCB’s research expertise and from an impressive syndicate of experienced investors and their respective networks.”
 
“Cognitive impairment remains an area of significant unmet need for patients not only with Alzheimer’s Disease but also more broadly across a range of neurological disorders, and we are excited about the potential promise of this novel therapeutic approach,” says Morten Graugaard Døssing, Principal at Novo Seeds. “I am thrilled to be working with the company which is supported by scientists at UCB and able to leverage Janssen neuroscience expertise via a presence at the JLINX incubator, all in an effort to develop products that could one day make a meaningful difference for patients suffering from cognitive impairment.”
 
About Syndesi Therapeutics
Syndesi Therapeutics (www.syndesitherapeutics.com) has been established at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve and will have a presence at the JLINX incubator facilities to access expertise at the Janssen campus in Beerse, Belgium. Syndesi has an exclusive, worldwide license from UCB to develop and commercialise a series of novel, pro-cognitive SV2A modulators. Syndesi will build on a rich legacy of work by UCB to further develop these novel SV2A modulators to investigate their potential to improve cognition in diseases such as Alzheimer’s Disease, other dementias and cognitive impairment associated with schizophrenia. 
 
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology and neurology. With more than 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
 
About Novo Holdings and Novo Seeds
Novo Seeds is the early-stage investment arm of Novo Holdings (www.novoholdings.dk). Novo Holdings is a private limited liability company wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group, comprising Novo Nordisk A/S, Novozymes A/S and NNIT A/S, and is responsible for managing the Foundation’s assets. In addition to being the major shareholder in the Novo Group companies, Novo Holdings provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within the life sciences and manages a broad portfolio of financial assets. 
 
About Fountain Healthcare Partners
Fountain Healthcare Partners (www.fh-partners.com) 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. 
 
About Johnson & Johnson Innovation – JJDC, Inc. (JJDC)
Johnson & Johnson Innovation – JJDC Inc. (JJDC) is the strategic venture capital arm of Johnson & Johnson and a long-term investment partner to global healthcare entrepreneurs. Founded in 1973, JJDC continues a legacy of customizing deals for data-driven companies across the continuum of healthcare, with the goal of turning great ideas into transformative new pharmaceutical, medical device and consumer healthcare products. www.jjdc.com
 
About V-Bio Ventures
V-Bio Ventures (www.v-bio.ventures) is an independent venture capital firm specialized in building and financing young, innovative life science companies. V-Bio Ventures was established in 2015 and works closely with Belgium-based VIB, one of the world’s premier life science institutes. The fund invests throughout Europe in start-up and early-stage companies with high growth potential focusing on technologies that provide transformational improvements in the biopharmaceutical, pharmaceutical, diagnostics and agricultural sectors. 
 
About SRIW SA
SRIW Société Régionale d'Investissement de Wallonie (www.sriw.be) provides equity and/or debt to companies that generate added value and employment in Wallonia.  SRIW facilitates the region's economic development, contributing effectively to the modernisation, growth and restructuring of the businesses that make up the Walloon industrial network. In the life science sector, SRIW is investor in more than 30 companies such as I.B.A., Celyad, or Ogeda of which it recently exited. Its current portfolio fair value is above 150 million €.
 
About VIVES-Louvain Technology Fund
The VIVES Louvain Technology Fund (www.vivesfund.com) is a multi-sector technology fund which invests in the spin-offs of the Université catholique de Louvain (UCL) and start-ups in Belgium and neighboring countries. VIVES II is funded by a dozen leading Belgian and European investors such as the EUROPEAN INVESTMENT FUND (EIF), SFPI-FPIM, BNP PARIBAS FORTIS PRIVATE EQUITY BELGIUM, BPI FRANCE (France), ING BELGIUM, SOFINA, AXA BELGIUM, BELFIUS, IRD (France), NIVELINVEST, REGION BRUXELLES CAPITAL and by SOPARTEC. The objective of the fund is to invest in the development of start-ups, from validation of the technology to commercial maturity. The funds (VIVES I - €15 million and VIVES II - €43 million) are managed by SOPARTEC, UCL’s technology transfer company, member of the Louvain Technology Transfer Office.
 
For further information, UCB: 
 
Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com
 
Laurent Schots
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com
 
Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com
 
Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 

Neuromod announces the appointment of Dr. Hubert Lim, as Chief Scientific Officer

Dublin, Ireland | Neuromod Devices Limited ("Neuromod"), an Irish medical technology company specialising in non-invasive neuromodulation technologies, announces the appointment of Dr. Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience, neuroplasticity and neuromostimulation, as Chief Scientific Officer.

Dr. Lim is a widely-published leader in the neural engineering field, and has been at the forefront of the development and translation of brain-machine interfaces from scientific concept into clinical application. His work has a strong focus on the improvement of invasive and non-invasive neurostimulation approaches for treating unmet medical needs in hearing and other therapeutic areas. Dr. Lim is Associate Professor and Institute for Translational Neuroscience Scholar at the University of Minnesota, United States and will continue to oversee a number of activities at his SONIC (Sensory Optimization and Neural Implant Coding) Lab from his new base in Ireland.

TENT-A Tinnitus Trial 
Dr. Lim's expertise complements Neuromod's focus on developing and advancing non-invasive bimodal neuromodulation for tinnitus. Initially Dr. Lim will focus on concluding Neuromod's TENT-A tinnitus trial, currently taking place in Ireland and Germany. When complete, the TENT-A trial will have enrolled more than 500 patients. It is one of the largest randomised double-blind clinical trials conducted to date in tinnitus. Dr. Lim will apply his deep insight into the evolving neuroscience of tinnitus to completing the trial and in communicating the results to the global scientific and clinical communities. Over time, Dr. Lim will play a key role as the company advances towards international markets, including regulatory applications to the U.S. Food and Drug Administration. If you are interested in learning more about the trial, please visit www.tinnitustrials.ie

Commenting on the appointment, Dr. Ross O'Neill, CEO of Neuromod said: "Dr. Lim will continue to expand the therapeutic applications of Neuromod's non-invasive neuromodulation platform to additional indications to meet the unmet needs of many patients. In addition, his strong ties to the global neuroscience and neuromodulation communities will be important to ensure that Neuromod's clinical and scientific approach continues to robustly and conclusively build the evidence base to support widespread acceptance. We are excited that someone of Dr. Lim's scientific integrity and global scientific connections has agreed to join Neuromod. We welcome Dr. Lim and his family as he settles in Ireland to take up this role."

Dr. Lim commented: "I am excited to join the Neuromod team in Ireland, where I see a vibrant environment for innovation, medical technology and business. Neuromod's rigorous and transparent approach towards developing and evaluating their non-invasive neuromodulation device in large systematic clinical trials in tinnitus has impressed me. Moreover, the company's inclusive approach listening to experts including their highly respected scientific advisory board of Professors Berthold Langguth, Deborah Hall and Sven Vanneste, to find better treatments for patients with chronic conditions is consistent with the scientific spirit for advancing knowledge and developing evidence-based treatments that I admire."

Dr. Hubert H. Lim Biography
Dr. Lim completed a B.S.E. in Bioengineering at UC-San Diego, followed by a dual Masters in Biomedical Engineering and Electrical Engineering & Computer Science and a Ph.D. in Biomedical Engineering at the University of Michigan. In collaboration with Cochlear Limited, Dr. Lim completed postdoctoral research with Dr. Thomas Lenarz at the Hannover Medical School in Germany, overseeing a clinical trial for a new deep brain stimulation implant to restore hearing.

Dr. Lim is an investigator on a number of ground breaking clinical trials including evaluating a new deep brain stimulation array for hearing restoration and tinnitus treatment (funded by the U.S. National Institutes of Health involving University of Minnesota in the United States, Hannover Medical School in Germany, and Cochlear Limited), an electrical ear and sound stimulation approach for tinnitus treatment (funded by the U.S. National Institutes of Health REACH Program), and non-invasive ultrasound neuromodulation of the spleen and vagus/splenic nerve pathways to elicit anti-inflammatory control in rheumatoid arthritis patients (funded by the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense and based on animal research performed with Medtronic).

Dr. Lim is a recipient of the prestigious Peter and Patricia Gruber International Research Award from the Society for Neuroscience, serves as a grant reviewer for the U.S. National Institutes of Health BRAIN Initiative, is a member of the Program Committee for the Association for Research in Otolaryngology, has been a co-organizer of the annual Minnesota Neuromodulation Symposium since 2013, and is co-organizing the upcoming international meeting, Neural Interfaces Conference 2018.

About Neuromod Devices Limited
Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O'Neill, as a spin-out from Maynooth University. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod is conducting extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the illusory sound that is often described as a ringing or buzzing in the ears.

www.neuromoddevices.com

Contact 

FTI Consulting | Media Relations
Melanie Farrell, FTI Consulting
neuromod@fticonsulting.com

Inflazome Appoints Renowned Harvard Cardiologist to its Scientific Advisory Board

Prof. Paul Ridker joins Inflazome’s Scientific Advisory Board


Dublin (IE), Cambridge (UK) | Inflazome Ltd, a biotech company developing small molecule drugs that stop harmful inflammation, today announces the appointment of Prof. Paul Ridker to Inflazome’s Scientific Advisory Board. Prof. Ridker is a leading scientific expert in cardiovascular disease and is renowned for his work on inflammation and its role in heart disease. Medical researcher and the Eugene Braunwald Professor of Medicine at Harvard University, Prof. Ridker also directs the Center for Cardiovascular Disease Prevention at the Brigham and Women’s Hospital in Boston, Massachusetts.

Dr. Matt Cooper, Co-founder and CEO of Inflazome Ltd, commented: “We’re delighted to welcome Prof. Paul Ridker to Inflazome’s Scientific Advisory Board. Prof. Ridker is a world-renowned cardiologist who has clinically validated the link between inflammation and heart disease. His work has been instrumental in understanding biological mechanisms of heart disease and developing therapeutic approaches to treat the disease. At Inflazome, we are dedicated to improving lives by delivering new medicines that stop inflammation. Prof. Ridker’s scientific and medical expertise will be invaluable to the development and progress of science as we expand our pipeline of novel inflammasome inhibitors into the cardiovascular disease space. Following the recent appointments of Prof. Frances Balkwill and Dr. David Morris, Prof. Ridker’s appointment complements and augments the strength of our Scientific Advisory Board, whose contributions will help us achieve our mission; to improve lives by delivering new medicines that stop harmful inflammation.”

Paul M. Ridker, MD, Brigham and Women’s Hospital, Boston, commented: “I am pleased to be joining Inflazome’s Scientific Advisory Board. I believe the NLRP3 inflammasome plays a critical role in driving inflammation associated with cardiovascular disease and that orally bioavailable inhibitors may have the potential to make a significant impact on heart disease patients.  I look forward to contributing my knowledge and expertise to help achieve this goal.”

 

About Prof. Paul Ridker

Prof. Paul M. Ridker MD, MPH, FACC is a Eugene Braunwald Professor of Medicine at Harvard Medical School and serves as a Director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital. Prof. Ridker specialised in atherosclerosis and cardiovascular disease including the role of inflammation in the disease process and the role of CRP.

Prof. Ridker’s particular areas of interest involve molecular and genetic determinants of hemostasis, thrombosis, and inflammation with a focus on "predictive medicine", early disease diagnosis, and the underlying causes and prevention of acute coronary syndromes. His research efforts are primarily supported by RO1 research grants from the National Heart, Lung, and Blood Institute (NHLBI), a Distinguished Clinical Scientist Award from the Doris Duke Charitable Foundation, and through philanthropic research grants from the Leducq Foundation and the Donald W Reynolds Foundation.

Prof. Ridker has been the recipient of a Clinician Scientist Award (1992-1997), an Established Investigator Award (1997-2002), and a Distinguished Scientist Award (2013) from the American Heart Association. His pioneering work on inflammation, CRP, and atherothrombosis, was also recognized by Time Magazine who named him among America's Ten Best Researchers in Science and Medicine in 2001 and as one of the "Time 100" in 2004.

In addition to his work in cardiovascular epidemiology, Prof. Ridker has been the Principal Investigator or Study Chairman of several multinational clinical trials including PREVENT, PRINCE, Val-MARC, LANCET, JUPITER, SPIRE-1, SPIRE-2, as well as the Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) and the NHLBI-funded Cardiovascular Inflammation Reduction Trial (CIRT), both designed to directly test the inflammatory hypothesis of atherothrombosis. Prof. Ridker is also Trial Chairman of PROMINENT, an ongoing study of triglyceride reduction among patients with diabetes.

Prof. Ridker is the author of over 800 original articles and 5 textbooks related to cardiovascular medicine. A frequent invited lecturer at national and international conferences, he is also a member of multiple editorial boards and co-inventor on patents filed by the Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease.

 

Members of Inflazome’s Board of Directors include:

•                Dr. Manus Rogan, Chair, Managing Partner, Fountain Healthcare Partners

•                Dr. Matt Cooper, Co-founder & Chief Executive Officer

•                Florent Gros, Managing Director, Novartis Venture Fund

•                Prof. Luke O’Neill, Co-founder & Chief Scientific Officer

•                Dr. Dhavalkumar Patel, Independent Director

 

Members of the Inflazome’s Scientific Advisory Board include:

•                Prof. Luke O’Neill, Trinity College Dublin

•                Prof. Frances Balkwill, Queen Mary University of London

•                Dr. Douglas Golenbock, University of Massachusetts Medical School

•                Dr. Veit Hornung, Ludwig Maximilian University of Munich

•                David Morris, MD, Novartis Venture Fund

•                Prof. Mihai G. Netea, Nijmegen University

•                Paul M. Ridker, MD, Brigham and Women’s Hospital

 

About Inflazome

Utilising the scientific expertise of our founders and advisors, Inflazome is leading the way in developing orally available drugs to address clinical unmet needs in inflammatory diseases by targeting the inflammasome, which is now thought to drive many chronic inflammatory conditions.

Headquartered in Dublin, Ireland, Inflazome was founded by leading academics Prof. Matt Cooper, The University of Queensland (Australia) and Prof. Luke O’Neill, Trinity College Dublin (Ireland), following a highly productive joint collaboration. inflazome.com

Founding investors are Fountain Healthcare Partners (Dublin, Ireland) and Novartis Venture Fund (Basel, Switzerland).

 

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. fh-partners.com 

 

About The Novartis Venture Fund

The Novartis Venture Fund (NVF) manages over $700 million in committed capital. NVF invests in companies that have the potential to change a core therapeutic field or explore new business areas that will be critical to patient care. NVF’s primary interest is in the development of novel therapeutics and platforms as well as medical devices, diagnostics, and delivery systems. The Funds invest for financial objectives at all stages, but prefers to invest in the early-stages of company development. With investment professionals located in Basel, Switzerland and Cambridge, MA the team has extensive experience in pharmaceutical R&D and venture capital. nvfund.com

 

Contacts:

Inflazome

Dr. Jeremy Skillington | VP Business Development | j.skillington@inflazome.com | +353 1 679 8591
Ruth Neale | Communications and Outreach |r.neale@inflazome.com  | +44 1223 751549

Mainstay Medical Announces Positive Outcome of Interim Analysis

Jason Hannon, CEO, to host business update call

 

Mainstay Medical International plc (“ Mainstay” or the “ Company” , Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE)(Bourse: MSTY), a medical device company focused on bringing to market ReActiv8 ® , an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces a positive outcome of the Interim Analysis in its U.S. Pivotal ReActiv8-B Study (the “Study”), comprising a definitive size and an estimated completion date.

Key updates relative to the Study (and its design) are as follows:

  • The Study utilizes an adaptive trial design, inclusive of an Interim Analysis, to determine the definitive size of the Study of up to 232 patients in the pivotal cohort. With this adaptive design, Mainstay commenced the Study with a sample size of 128 patients pending the Interim Analysis;
  • The independent Data Monitoring Committee (“ DMC ”) has completed the Interim Analysis, which is based on data from the first 58 patients in the pivotal cohort to complete the primary endpoint. The DMC has recommended continuation of the Study with a definitive size of 168 evaluable patients. The ultimate number of patients in the Study will be slightly higher than 168 due to the nature of the enrollment process;
  • The DMC also reported that they have observed no safety concerns in the Study; and
  • The Study is expected to be fully enrolled by the end of the second quarter of 2018, and the Company expects to announce full data readout towards the end of 2018.
  • 133 patients have been implanted in the pivotal cohort in the Study to date and clinical study sites have continued to implant patients pending the outcome of the Interim Analysis.

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

Richard Rauck MD, President and Founder, Carolinas Pain Institute, Medical Director for The Center for Clinical Research, Pain Fellowship Director at Wake Forest University School of Medicine and Chairman of the DMC said: “The outcome of the Interim Analysis has validated the adaptive Study design agreed with the FDA, which provided for a sample size of up to 232 patients in the pivotal cohort. By following this course, we have been able to determine an appropriate sample size for the Study. We also reviewed the safety data and I am pleased to report there are no safety concerns in the Study thus far.”

Jason Hannon, CEO, said: “We are pleased to now have a definitive enrollment goal for the Study, which compares favorably in total size to other neuromodulation studies. We will now push forward to the data collection point in a highly efficient manner, and I am confident we will complete the Study in the coming months and announce the full data readout towards the end of 2018.”

Chris Gilligan MD, Chief, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical School, and Principal Investigator for the ReActiv8-B Study said: “The treatment of Chronic Low Back Pain is a significant challenge around the world with many patients experiencing disabling effects for large portions of their lives. These patients can be left with few treatment options. I’m proud to be part of a clinical study that is analyzing whether we can use ReActiv8 to help patients truly restore their muscle function and thereby reduce the effects of chronic pain, rather than rely on short term analgesics such as opioids. I look forward to the compilation of the data.”

 

Investor Conference Call and Business Update

Jason Hannon will host an investor conference call to discuss this positive news and will also provide a broader business update at 16:00 GMT (11:00 EST) on 11 December 2017 in English.

Dial-ins for the call are outlined below:

Europe: +44 203 139 4830
Ireland: +353 1 696 8154
USA: +1 718 873 9077

Participant PIN: 65178331#

In addition to the update on the Interim Analysis, the business update will include the following developments:

  • The Company continues to advance the initial commercialization of ReActiv8 in Europe. Our European commercial activities are initially focused on Germany, where we are working to drive adoption in a select number of high volume spine care centers to develop reference sites. Four centers in Germany and Ireland have implanted patients with ReActiv8 to date, and several additional sites have been trained. We have begun recruiting an experienced sales team of direct Mainstay employees. The team currently consists of eight people, located in key regions in Germany and one person in Ireland.
  • Mainstay is planning to add to its investment in commercial infrastructure to expand commercialization in Europe and in preparation for commercialization in other markets including Australia and the U.S. We will be building a market development team of clinical experts to drive market penetration, identify the right physician partners, help educate the market about Reactiv8, and support implants.
  • We will also increase our investment in the training of physicians; the education of referring physicians regarding the potential of ReActiv8; and in the collection and dissemination of clinical data regarding the expanding use of ReActiv8.
  • Cash on hand at 30 November 2017 was $12.7 million. The Company on an ongoing basis explores potential financing opportunities to fund the business.

This announcement contains inside information within the meaning of the EU Market Abuse Regulation 596/2014

 

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, Germany and the Netherlands, 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 Study

The ReActiv8-B Study is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE). In summary, this means that eligible subjects will have baseline data collected and then following verification that the enrollment criteria are met, ReActiv8 will be implanted. At the 14-day post implant follow up visit, half the patients will be randomized to receive appropriately programmed stimulation (the treatment arm), and half will be randomized to receive sham stimulation/minimal stimulation (the control arm) .The ReActiv8-B Study is designed to generate data to form part of the Pre-Market Approval Application (PMAA) of ReActiv8 to the FDA.

 

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

 

 

Inflazome Appoints Renowned Scientific, Industry & Clinical Experts

-   Prof. Frances Balkwill, OBE FMedSci, and Dr. David Morris join Inflazome’s Scientific Advisory Board
 
-  Dr. Dhavalkumar Patel, Executive Vice President and Chief Scientific Officer of UCB, appointed to Inflazome’s Board of Directors


 
Dublin (IE), Cambridge (UK):  Inflazome Ltd, the biotech company developing small molecule drugs that stop harmful inflammation, today announces the appointment of three leading scientific, industry & clinical experts to its Scientific Advisory Board and Board of Directors.
 
Prof. Frances Balkwill, OBE, FMedSci, a scientific expert in cancer biology joins Inflazome’s Scientific Advisory Board from Queen Mary University of London, where she leads the Centre for Cancer and Inflammation. With a clinical, scientific background and extensive operational experience, Dr. David Morris also joins the Scientific Advisory Board from Novartis Venture Fund. Furthermore, Dr. Dhavalkumar Patel, Executive Vice President and Chief Scientific Officer of global biopharma company UCB, based in Brussels, Belgium, has been appointed to Inflazome’s Board of Directors as an Independent Director, following a distinguished career in Novartis.
 
Dr. Matt Cooper, Co-founder and CEO of Inflazome Ltd, commented: “We’re delighted to welcome these renowned and accomplished experts to Inflazome. Prof. Balkwill’s knowledge of translating cancer biology and its links to inflammation will progress the development of anti-inflammatory drugs in the field of oncology. Dr. Morris’s and Dr. Patel’s experience and guidance will be instrumental as we transition Inflazome’s research programmes into clinical development and expand our pipeline of novel inflammasome inhibitors. These appointments significantly augment Inflazome’s senior advisory team and their contributions will help us towards achieving our mission; improving lives by delivering new medicines that stop harmful inflammation.”
 
Prof. Frances Balkwill, OBE FMedSci, commented: “I’m excited to join Inflazome’s Scientific Advisory Board and contribute to their outstanding scientific underpinnings. Understanding the role inflammasomes play in driving tumour progression could deliver innovative cancer therapies from Inflazome’s portfolio of potent and selective NLRP3 inhibitors.”
 
Dr. David Morris, Novartis Venture Fund, commented: “Inflazome is attacking harmful inflammation which causes many of our most challenging medical conditions today. I‘m pleased to join the Scientific Advisory Board to help steer the company forward to develop potential new and necessary treatments for patients.”
 
Dr. Dhavalkumar Patel, Executive Vice President and Chief Scientific Officer, UCB, commented: “I’m excited to join Inflazome’s Board of Directors to help guide Inflazome’s pipeline of drugs that target aberrant, innate immune system activation. The company has an advanced portfolio of potent drug leads and drug candidates, led by an accomplished management team with a wide range of expertise and capabilities.”
 
About Prof. Frances Balkwill
Prof. Frances Balkwill OBE FMedSci is Professor of Cancer Biology at Barts Cancer Institute, Queen Mary University of London where she leads the Centre for Cancer and Inflammation. She studies the links between cancer and inflammation, with a special interest in translating knowledge of cancer biology into new biological treatments for cancer, the role that inflammatory cytokines play in cancer promotion and novel ways of modelling the human tumour microenvironment. Prof. Balkwill runs a research centre of approximately 30 scientists, postgraduate students and clinicians. She is an author on 250+ scientific papers and reviews and has written and edited a number of academic books on her subject. In 2006, she was made a Fellow of the Academy of Medical Sciences and has served on its Council.
 
About Dr. David Morris
Dr. Morris joined Novartis in Basel in 2009 and has held multiple positions within the organization including the Development Franchise head for Respiratory and Primary Care. His team were responsible for the clinical development, regulatory approvals and lifecycle management of multiple Novartis medications including new treatments for serious respiratory diseases (Chronic obstructive pulmonary disease (COPD), asthma, pulmonary hypertension) and diabetes. He also held overall responsibility for global clinical operations, quantitative sciences, digital innovation, development informatics, and global clinical research capabilities development for Novartis Global Drug Development. In September 2016, he transitioned to the Novartis Venture Fund to leverage his basic and clinical scientific background and operational experience to better speed the discovery and development of new medicines by working closely with external entrepreneurs and venture backed start-ups.
 
About Dr. Dhavalkumar Patel
Dr. Dhavalkumar Patel joins Inflazome as an Independent Director on the Board of Directors. Dr Patel brings extensive experience in drug discovery in industry. During a 10 year career in Novartis, he led Research in Europe and the Autoimmunity, Transplantation and Inflammation Disease Area which contributed to the registration of several leading drugs in multiple indications. Dr Patel has most recently been appointed Executive Vice President and Chief Scientific Officer, UCB, the global biopharmaceutical company.
 
Members of Inflazome’s Board of Directors include:
•             Dr. Manus Rogan, Chair, Managing Partner, Fountain Healthcare Partners
•             Dr. Matt Cooper, Co-founder & Chief Executive Officer
•             Florent Gros,  Managing Director, Novartis Venture Fund
•             Prof. Luke O’Neill, Co-founder & Chief Scientific Officer
•             Dr. Dhavalkumar Patel, Independent Director
 
Members of Inflazome’s Scientific Advisory Board include:
•             Prof. Luke O’Neill, Trinity College Dublin
•             Dr. Douglas Golenbock, University of Massachusetts Medical School
•             Prof. Veit Hornung, Ludwig Maximilian University of Munich
•             Prof. Mihai G. Netea, Nijmegen University
•             Prof. Frances Balkwill, Queen Mary University of London
•             Dr. David Morris, Novartis Venture Fund
 
About Inflazome
Utilising the scientific expertise of our founders and advisors, Inflazome is leading the way in developing orally available drugs to address clinical unmet needs in inflammatory diseases by targeting the inflammasome, which is now thought to drive many chronic inflammatory conditions.
 
Headquartered in Dublin, Ireland, Inflazome was founded by leading academics Prof. Matt Cooper, The University of Queensland (Australia) and Prof. Luke O’Neill Trinity College Dublin (Ireland), following a highly productive joint collaboration. inflazome.com
 
Founding investors are Fountain Healthcare Partners (Dublin, Ireland) and Novartis Venture Fund (Basel, Switzerland).
 
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. fh-partners.com
 
About The Novartis Venture Fund
The Novartis Venture Fund (NVF) manages over $700 million in committed capital. NVF invests in companies that have the potential to change a core therapeutic field or explore new business areas that will be critical to patient care. NVF’s primary interest is in the development of novel therapeutics and platforms as well as medical devices, diagnostics, and delivery systems. The Funds invest for financial objectives at all stages, but prefers to invest in the early-stages of company development. With investment professionals located in Basel, Switzerland and Cambridge, MA the team has extensive experience in pharmaceutical R&D and venture capital. nvfund.com
 

Contacts:

Inflazome
Dr. Jeremy Skillington | VP Business Development | j.skillington@inflazome.com | +353 1 679 8591

Media
Jonathan Neilan | FTI Consulting | jonathan.neilan@fticonsulting.com | +353 1 765 0886
Patrick Berkery | FTI Consulting | patrick.berkery@fticonsulting.com | +353 1 765 0884

Vivasure Enrolls First Patient in Frontier IV Clinical Trial

International Trial Designed to Expand Indications for PerQseal Closure Technology
 

GALWAY, Ireland -Vivasure Medical® (“Vivasure”) is pleased to announce the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of its proprietary PerQseal® large arteriotomy closure technology. The patient was enrolled by Dr. Peter Crean at the Blackrock Clinic, Dublin, Ireland.

Large arteriotomies (12F+) are vessel punctures created to facilitate endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), balloon valvuloplasty (BAV) and ventricular assist devices (VAD). PerQseal is the world’s first fully absorbable, patch-based large-bore percutaneous closure technology.

“Driven by clinical and economic outcomes data, percutaneous access-site management has become an increasingly important aspect of TAVR procedures,” said Dr. Christoph Naber of the department of cardiology and angiology, Contilia Heart and Vascular Centre, Essen, Germany, and TAVR principal investigator of Frontier IV. “I strongly believe PerQseal, which is designed specifically to address large arteriotomies, will help improve outcomes for these patients.”

“We are very excited to begin the Frontier IV trial as the next phase in our commitment to build the clinical experience with PerQseal,” said Gerard Brett, co-founder and CEO of Vivasure. “A percutaneous approach has now become the gold standard for procedures such as TAVR and EVAR, driven by clinical outcomes data. As patient volumes increase, access site management and closure has become an increasingly important aspect of complication and cost reduction. The data from this trial will be used to support our goal of expanding the indication range of the PerQseal technology.”

 

About PerQseal®

PerQseal® utilises a fully absorbable, intravascular patch, which seals large arteriotomies from the inside. It is comprised of a synthetic polymer implant, and an easy-to-use, ergonomically designed delivery system. The implant has a flexible, low-profile intravascular patch and a supporting scaffold. A portion of the scaffold extends through the arteriotomy, and includes a locator which helps maintain the implant in position. After deployment, the implant is rapidly endothelialised and fully absorbed.

 

About Vivasure

Based in Galway, Ireland, one of Europe’s largest medtech hubs, Vivasure is focused on the development of bioabsorbable implant technologies with vascular applications. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors.

 

Contacts
for Vivasure Medical
United States:
Jessica Volchok, +1 310-849-7985
jessica@healthandcommerce.com
or
Europe:
Jonathan Neilan, +353 (0)86 231 4135
jonathan.neilan@fticonsulting.com

 

 

 

 

Mainstay Medical Announces Jason Hannon Joins Board of Directors

Mr. Hannon appointed as a Director and begins his role as CEO
 

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 disabling Chronic Low Back Pain (“CLBP”), announces that following the announcement of his appointment on 5 September, 2017, Mr. Jason Hannon has today taken up his role as CEO and been appointed as a Director of Mainstay.

Mr. Hannon joins Mainstay at a critical time in the Company’s development with the dual focus of commercializing the market-changing ReActiv8 technology in Europe and beyond, while simultaneously completing the global clinical trial in support of submission for FDA approval. 

Mr. Hannon said: “Mainstay has pioneered a new approach to treating chronic low back pain which seeks to help the body repair itself rather than merely masking pain. ReActiv8 is aimed at providing a new therapy for the large number of patients for whom other treatments have failed. I look forward to working with the team to maximize the potential of ReActiv8 globally and build on Mainstay’s technology platform.”

Mr.  Hannon joins Mainstay having most recently served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions.  During his 12-year tenure at NuVasive, the company’s commercial presence was expanded globally to more than 40 countries and revenue grew from $61M to $962M.

NeRRe Therapeutics Appoints Andrew Kay as Chairman of the Board

Extensive development & commercial expertise to guide company growth 
 

NeRRe Therapeutics, which is developing a unique portfolio of neurokinin (NK)-1 receptor antagonists for the treatment of common debilitating conditions caused by neuronal hypersensitivity, has appointed Andrew Kay as Chairman of the Board. Mr. Kay, who has extensive product development and commercial experience across the pharma and biotechnology sectors, takes over from Dr Kaasim Mahmood of Advent, who remains on the Board. Following the demerger of KaNDy Therapeutics, announced today, NeRRe Therapeutics is primarily focused on its lead product orvepitant, which is in a multinational Phase IIb trial for chronic refractory cough.

Mr Kay has worked in the biotechnology sector as CEO of Algeta ASA, which was sold to Bayer for $2.9bn in 2014, and as Chief Commercial Officer and a Board Director of Renovo. He started his industry career in the pharmaceutical sector, working in international roles at Novartis, AstraZeneca and Eli Lilly, following a BPharm Hons degree from Nottingham University School of Pharmacy. Other current roles include Chairman of Blueberry Therapeutics, Chairman of Wilson Therapeutics and Senior Advisor to HealthCap VC. Mr Kay has also been appointed an adviser to KaNDy Therapeutics.

Dr Mary Kerr, CEO of NeRRe Therapeutics, said, "With his broad experience, Andrew's appointment as Chairman will bring tremendous value to the company as we advance orvepitant towards late-stage clinical development and commercialisation. NeRRe Therapeutics would also like to thank Kaasim for his guidance and we are pleased that he remains on the Board as Advent's representative."

Andrew Kay, Chairman of NeRRe Therapeutics, said, "With its focus on conditions caused by neuronal hypersensitivity related to neurokinin-1 receptor system dysfunction, the company has the opportunity to make a real difference in areas of unmet medical need such as chronic refractory cough. These are debilitating conditions for thousands of patients worldwide, and I am looking forward to helping NeRRe Therapeutics develop further."


About NeRRe Therapeutics (http://www.nerretherapeutics.com)

NeRRe Therapeutics is a private UK based clinical-stage company developing a unique pipeline of three neurokinin (NK)-1 antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity associated with neurokinin-1 receptor system dysfunction. Its portfolio is tackling a range of disorders with high unmet need including chronic refractory cough and chronic pruritus. The company 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 was founded in 2012 as a spin out from GSK.  Since it was founded, it has raised £31.5 million and is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, Novo A/S, and by GSK. KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017. NeRRe Therapeutics is based at Stevenage Bioscience Catalyst.  You can find more information about NeRRe Therapeutics at http://www.nerretherapeutics.com.

KaNDy Therapeutics launched to advance a breakthrough treatment in Women's Health

First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company

Stevenage, UK - KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. 

NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity. 

KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women's Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK. 

NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication. 

Iain Dukes, Chairman of KaNDy Therapeutics, said, “The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women's Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we're looking forward to advancing this exciting new product into a Phase 2b programme.”
 
Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented, “For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.” 

For further information, please contact:
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel:  +44 1438 906960
Email: info@kandytherapeutics.com


About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)). 

PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.

The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis. 

KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com. 

 

 

 

Mainstay Medical Announces Half Year Financial Results

  • ReActiv8-B Clinical Trial advancing well – enrollment on track to complete around end 2017
  • Initial commercialization of ReActiv8 in Europe is underway
  • Cash on hand at 30 June 2017 – $24.5 million

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 disabling Chronic Low Back Pain (CLBP), today announces the publication of its report for the Half Year ended 30 June 2017.

Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is a key step towards commercialization in the US, our most significant target market. The Trial is advancing well, and the enrollment rate has been accelerating as the number of active sites increased during 2017, and based on our experience to date, we anticipate enrollment will complete around the end of 2017, with results available in 2018.

“Meanwhile, we have begun commercialization of ReActiv8 in Europe. Following the first sale and implant in early 2017, our initial customers are gaining experience with ReActiv8 and we are working with them to help integrate it into their clinical routine. We continue to advance our strategy of targeting key reference centers in Germany, and then building on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”


Business Update:

  • 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). It is intended to gather data in support of an application for pre-market approval (PMA) from the FDA, a key step towards the commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

During 2017, we have continued to advance the ReActiv8-B Clinical Trial and over half the required number of implants have now been performed.

  • In February 2017, we announced the first sale and implant had been performed at the Catholic Hospital Koblenz-Montabaur in Koblenz, Germany. We are focusing commercialization of ReActiv8 initially on Germany, where we aim to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. As our pioneering customers are gaining more experience with the ReActiv8 therapy we are working with them towards the goal of making ReActiv8 part of their routine clinical practice. We are progressing discussions with other key centers in Germany, and implanter training for these centers is underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.

More recently, in May 2017, we announced that commercialization has begun in Ireland, Mainstay’s home market.
 

Financial Update:

  • Revenue during the six-month period ending 30 June 2017 was $0.25 million.
  • Operating expenses were $12.3 million ($8.0 million in 1H16) and the increase is driven by the ramp up of enrollments and implants in the ReActiv8-B Trial, and expenditure arising on sales activities (which commenced in 2017).
  • Cash on hand at 30 June was $24.5 million, and operating cash outflows for the period were $11.4 million.


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 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 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 Announces CEO Leadership Transition

Jason Hannon Joins Mainstay as CEO from Recent Post as NuVasive President and COO

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 disabling Chronic Low Back Pain (“CLBP”), announces that Mr. Jason Hannon will succeed Mr. Peter Crosby as Chief Executive Officer with effect from October 9, 2017. Mr. Hannon’s appointment results from the Company’s succession planning associated with the retirement of Mr. Crosby at the end of October, 2017. Mr. Hannon will also be appointed as a Director with effect from October 9, 2017.

Mr. Hannon most recently served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions. His prior roles at NuVasive, Inc. include Executive Vice President of International, Executive Vice President of Business Development and Strategy, and General Counsel. During his 12 year tenure at NuVasive, the company’s commercial presence was expanded globally to more than 40 countries and revenue grew from $61M to $962M.

Dr. Oern Stuge, Chairman of Mainstay commented: “Mainstay has made tremendous progress since the founding of the Company in 2008 under Mr. Crosby’s leadership, and as we move forward to the next phase we are delighted that Jason is joining as our new CEO. Jason’s broad medical device experience has spanned areas critical to the future success of Mainstay: commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management and the building of a high-performance culture that will attract the most talented people to our company.”

Mr. Hannon said: “Mainstay has developed a strong foundation in its scientific, clinical and regulatory accomplishments to date. The dedicated team has done the pioneering work to establish a new market - ReActiv8 seeks to help the body repair itself rather than merely masking pain. This has created the potential of bringing an entirely new option to people suffering from chronic back pain. I am impressed by the work done to get to this point, and I look forward to working with the entire team to advance the mission.”

In the period up to his retirement date, Mr. Crosby will act as Special Adviser to the new CEO, and will continue to work with the Company as a consultant up to the end of 2020. He will also continue to act as a Director until the conclusion of the Company’s Annual General Meeting to be held on Friday, 22 September 2017, when he will retire as a Director.

Mr. Crosby led Mainstay in its development of ReActiv8 from concept to commercialization. He was recruited as the Company’s first CEO in 2009 to build the Company and its team and to develop ReActiv8. Mr. Crosby led Mainstay through its Series A and Series B fundraisings to its IPO on Euronext Paris and the ESM of the Irish Stock Exchange in 2014, and its subsequent debt and equity fundraisings. In addition to fundraising, Mr. Crosby was a driving force in the development of ReActiv8 from concept stage through multiple clinical trials to CE Mark approval in 2016, start of the ReActiv8-B clinical trial to gather data for US approval, and first commercialization in Germany and Ireland in 2017. Mr. Crosby said: “I am proud of what we have achieved as a team, and I am confident that the Company will be in good hands under Jason’s leadership. I look forward to remaining involved with the Company into the future, to ensure continuity with our employees, consultants and investigators.”

Dr. Stuge concluded: “On behalf of Mainstay’s Board, management team and staff, I would like to thank Peter for his substantial contribution to the Company’s growth over the last eight years. Peter’s tireless efforts in building the Company from start-up stage through multiple fundraisings, product development and clinical trials to initial commercialization has positioned the Company well for the future. We look forward to continuing to work with Peter into the future.”


ADDITIONAL INFORMATION:

Mr Hannon holds no interest in ordinary shares of Mainstay, and, other than as set out below, there is no further information to be disclosed under schedule 2(g) and Rule 17 of the ESM Rules in respect of Mr Hannon's appointment to the board of Mainstay.

Mr Jason Marshall Hannon (aged 45) is, or has been, a director of the following companies during the previous five years:

Previous Directorships:

Nemaris, Inc.

- End –

This announcement contains inside information within the meaning of the EU Market Abuse Regulation 596/2014


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 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 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’s ReActiv8-B Clinical Trial Passes Mid-point

Trial on target to complete enrolment around end 2017

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 disabling Chronic Low Back Pain (“CLBP”), announces that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.

The 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. Information about the trial can be found at https://clinicaltrials.gov/show/NCT02577354.
 
69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re‑estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.
 
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 CLBP and few other treatment options. Mainstay has begun commercialization in Europe, focusing initially on Germany, where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. More recently, commercialization has begun in Ireland, Mainstay’s home market.

Peter Crosby, CEO of Mainstay, commented: “The ReActiv8-B Clinical Trial is advancing well, and, based on our experience to date, we anticipate completing enrolment around the end of this year, with results available in 2018. The ReActiv8-B trial is a key step towards commercialization in the US, our most significant target market, and we are pleased with the progress.

“Our initial commercialization of ReActiv8 in Europe is well underway. Our strategy is to work with key reference centers in Germany, and then build on that experience and data from the ReActiv8-B Trial to expand commercialization to additional centers and other countries.”

ReActiv8-B Clinical Trial
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). 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. Total number of subjects implanted will also include some enrolled and implanted as part of the surgical roll-in phase, in addition to subjects in the pivotal cohort. The Trial is designed with an “interim look” for sample size re-estimation when primary outcome data are available from half the subjects in the pivotal cohort, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. The interim analysis will be performed by a third-party independent statistician under the direction of the Data Monitoring Committee (DMC), and the interim results, other than a DMC recommendation regarding the findings, will remain blinded to the Company, study subjects, investigators and Clinical Trial sites.
 
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 1A Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

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 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 recognized 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 utilization put a significant burden on individuals, families, communities, industry and governments.

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

 

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

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 restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces the first sale and implant of ReActiv8 in Ireland.

The ReActiv8 implant was performed at St. Joseph’s Hospital, part of the Beaumont Hospital Group, in Dublin, by Dr. Josh Keaveny and Dr. Alexander Moudrakovski, Consultants in Anaesthesia and Pain Medicine.

Dr. Keaveny commented: “ReActiv8 represents a novel approach to Chronic Low Back Pain which addresses the underlying cause of the condition. We now have a new option for treating patients who have suffered from debilitating back pain for years who are not candidates for spine surgery and have attempted many other conventional therapies without adequate relief.”

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 Chronic Low Back Pain.

Peter Crosby, CEO of Mainstay, commented: “As part of our early commercialization strategy, we are building a network of reference sites in Europe, who can champion ReActiv8 and help expand the market. As an Irish company, Ireland is our home market, and we are pleased to partner with Dr. Keaveny and Dr. Moudrakovski to establish a foothold in our second European market following the start of commercialization in Germany.”

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 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.

Codman Neuro Announces Acquisition Of Neuravi Limited To Accelerate Innovation In Acute Ischemic Stroke Therapy

Second Acquisition in Months Demonstrates Commitment to Addressing Unmet Needs in Stroke

 

IRVINE, Calif. -- Codman Neuro today announced the acquisition of Neuravi Limited, a privately held Irish company dedicated to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients. This acquisition, and the recent acquisition of Pulsar Vascular Inc., demonstrates the company's strong commitment to delivering innovative products for stroke therapy and complements its comprehensive portfolio of products for hemorrhagic and ischemic stroke. DePuy Ireland Unlimited Company, an affiliate of Codman Neuro, is the acquiring entity. Financial terms of the transaction were not disclosed.

Founded in 2009, Neuravi has invested extensively in scientific research on the varieties of clots that cause acute ischemic stroke, and has translated learnings into its EmboTrap® Revascularization Platform. The EmboTrap® device is engineered to restore blood flow to the brain by retrieving a clot with its proprietary dual-layer stent-like structure, and it has already been used to treat over 3,000 patients in Europe.

Globally, stroke is the second leading cause of death after the age of 601, and ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes.2 According to the European Journal of Neurology, the number of stroke events in Europe is projected to rise from 1.1 million in 2000 to 1.5 million per year by 20253, while the American Heart Foundation estimates someone dies of a stroke every 4 minutes.4 In the U.S. alone, the economic burden of stroke is estimated at $33 billion annually, including the cost of health care services, medications, and lost productivity.5

"Rapid restoration of flow is of utmost importance when treating stroke patients," said Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. "The EmboTrap® platform was designed to address this critical need and we are excited to combine Neuravi's expertise in clot research with Codman Neuro's global resources to accelerate innovation in acute ischemic stroke treatment."

The EmboTrap and EmboTrap II Revascularization Devices are commercially available in Europe and has been available in the U.S. for investigational use only under the ARISE II clinical trial, which will support a U.S. Food and Drug Administration (FDA) submission planned for later this year.

 

About Codman Neuro
 

Codman Neuro is a global neurosurgery and neurovascular business that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery, as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Visit www.codman.com for more information.

 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the acquisition of Neuravi Limited and anticipated market expansion of Neuravi Limited's technology and products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Ireland Unlimited Company and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges related to integrating the products and employees of Neuravi Limited, as well as the ability to ensure continued performance or market growth of its products; the potential that the expected benefits and opportunities related to the transaction may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of obtaining regulatory approvals; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Ireland Unlimited Company nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1 World Heart Federation http://www.world-heart-federation.org/cardiovascular-health/stroke/
2 Stroke Facts, Centers For Disease Control and Infection https://www.cdc.gov/stroke/facts.htm
3 Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598
4 Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association http://circ.ahajournals.org/content/135/10/e146#sec-2
5 Centers for Disease Control https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_stroke.pdf

Gurnet Point L.P. enters into agreement to acquire Innocoll Holdings plc

Transaction Unanimously Supported by Innocoll Board and Key Shareholders

 

CAMBRIDGE, Mass. & ATHLONE, Ireland--(BUSINESS WIRE)--Gurnet Point L.P., a healthcare investment fund, and Innocoll Holdings plc (NASDAQ:INNL), a global pharmaceutical and medical device company, today announced that they have reached an agreement on the terms of a recommended offer. Under the recommended offer, Gurnet Point will acquire Innocoll for $1.75 per share in cash, and up to $4.90 in cash from a contingent value right (CVR), for a total potential per share value of up to $6.65 or up to approximately $209 million in aggregate. The initial cash consideration of $1.75 represents a premium of approximately 120 percent to the closing price per Innocoll Share on March 10, 2017, the last dealing day prior to the date on which the anomalous movement in Innocoll’s shares commenced (and a premium of approximately 28 percent to the closing price per Innocoll Share on March 15, 2017, the day prior to Innocoll initiating the commencement of the offer period).

During the offer period, Gurnet Point plans to provide a term loan of $10 million to give Innocoll additional resources needed for the continued development of XARACOLL within the post-operative pain market. Innocoll believes that the loan will provide it with the additional capital needed to prepare for the re-submission of the XARACOLL new drug application (“NDA”) to the U.S. Federal Drug Administration (“FDA”) in order to achieve the milestones related to the CVR.

This transaction builds on Gurnet Point’s strategy of investing in life science, medical technology and healthcare service companies. Since its initial NASDAQ public offering in 2014, Innocoll has leveraged its proprietary collagen-based technology to successfully complete two Phase 3 studies for XARACOLL, Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix. XARACOLL was developed to provide sustained post-operative pain relief through controlled delivery of bupivacaine at the surgical site.

Innocoll noted that its Board had explored a sale of the company, to achieve its goal of bringing XARACOLL to market, as well as keeping the company independent and funding the over $100 million required to fund operations through 2019 from raising equity or debt. The “go-it-alone” option was dismissed due to the potential for significant shareholder dilution and execution risk. A potential license for XARACOLL in the United States was also investigated, but no suitable partner has been found.

“Having studied a number of strategic options over the past several months, our Board and management team believe this strategic transaction will give Innocoll access to the financial resources it needs to pursue its goals of bringing XARACOLL through its development to commercialization, and address important unmet medical needs in the post-operative pain market. We believe that the combined leadership of the two companies, supported by Gurnet Point’s financial strength, will better position Innocoll to pursue a successful filing and subsequent commercialization of XARACOLL,” said Jonathan Symonds, Chairperson of Innocoll. “The Innocoll directors unanimously support the offer, which represents a significant premium to the recent share price. In addition, the CVR allows shareholders to participate in the continued development of XARACOLL without further investment."

The directors of Innocoll and major shareholders, including holdings managed by Fortress, Morgan Stanley, Sofinnova and Unique Technologies, have provided irrevocable undertakings to vote in favor of the scheme. In total, management, directors and shareholders have provided irrevocable undertakings representing 46% of the issued ordinary share capital of Innocoll. Details of these irrevocable undertakings, including the circumstances in which they cease to be binding, are set out in the announcement pursuant to Rule 2.5 of the Irish Takeover Rules made by Gurnet Point, Gurnet Bidco and Innocoll today.

“Gurnet Point intends to work with Innocoll’s team to help bring XARACOLL to market by infusing substantial additional capital for its continued development and regulatory approval. We have great respect for Tony Zook and his team at Innocoll and look forward to investing in the business and assisting with the approval of XARACOLL and its commercialization,” said Christopher Viehbacher, Managing Partner at Gurnet Point Capital.

Innocoll had expected to receive FDA approval of XARACOLL this year. On December 29, 2016, Innocoll announced that it had received a Refusal to File Letter from the FDA for XARACOLL. Among other points, the FDA indicated that XARACOLL should be characterized as a drug-device combination product and that additional clinical and nonclinical information on XARACOLL may be required. To provide this information, Innocoll proposes to conduct an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies.

The Innocoll directors believe that, if adequately financed and successful, such studies may be completed in time for an end of year re-submission of the XARACOLL NDA. Data from these studies, along with additional manufacturing information required to address the new combination product designation by the FDA and other chemistry, manufacturing and control activities, are also expected to be included in the re-submission.

If the re-submitted NDA is accepted by the FDA, thereby allowing XARACOLL to ultimately be approved, the Innocoll directors believe that Innocoll could be in a position to commercialize XARACOLL by the end of 2018.

 

Terms of the Transaction

The transaction, which is valued at up to approximately $209 million (including the maximum amount payable upon achievement of the CVR milestones listed below), is expected to be implemented by means of a court-sanctioned scheme of arrangement under Irish law or, with the consent of the Irish Takeover Panel, a takeover offer if Gurnet Bidco so chooses. Innocoll's Board of Directors intends to recommend unanimously that Innocoll shareholders vote or procure votes in favor of the Transaction.

Under the terms of the acquisition, each CVR represents the right to receive a specified amount of cash payments, with each payment conditioned upon the achievement of certain events, called CVR Payment Events.

These CVR Payment Events are:

  • First CVR Payment Event: Gurnet Bidco will pay $0.70 in cash per CVR if on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following open abdominal Hernia repair.
  • Second CVR Payment Event: Gurnet Bidco will pay an additional $1.33 in cash per CVR if, on or before December 31, 2018, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Soft Tissue repair (and not limited to hernia repair).
  • Third CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.00 in cash per CVR if, on or before December 31, 2019, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair; or, if not $0.60 in cash per CVR if, after December 31, 2019 but on or before June 30, 2020, XARACOLL is approved by the FDA with a label covering indications for the treatment of postsurgical pain immediately following Hard Tissue repair.
  • Fourth CVR Payment Event: If the milestone is met, Gurnet Bidco will either pay: $1.87 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to December 31, 2019; or, if not, $1.00 in cash per CVR if global net sales of XARACOLL exceed $60 million in any four consecutive Calendar Quarters ending on or prior to March 31, 2020.
  • In the event that none of the CVR Payment Events occur by the relevant dates, then the CVR will have no value. The minimum payment of the CVR is zero and the maximum payment is $4.90 in cash per Innocoll Share.


About Gurnet

Gurnet Point is a healthcare investment fund led by Christopher Viehbacher, managing partner, Gurnet Point Capital. Gurnet Point is based in Cambridge, Massachusetts, USA, and invests in life sciences and medical technologies as well as healthcare services across all stages of development through to commercialization.


About Innocoll

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll’s shares are listed for trading on the NASDAQ under the symbol “INNL.” Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application. Using its proprietary processes at its manufacturing facility, Innocoll derives and purifies bovine and equine collagen and then utilizes its technology platform to incorporate the purified collagen into its topical and implantable products. Innocoll’s proprietary processes and technologies also enable it to control the texture, consistency, drug elution dynamics, resorption time and other physical characteristics of the finished product. All of Innocoll’s native collagen products – from extraction/purification of type-1 collagen through final delivery form – are manufactured at its certified, integrated plant in Saal, Germany.

 

General

This summary should be read in conjunction with the full text of the Rule 2.5 announcement, being the formal transaction announcement made by Gurnet Point, Gurnet Bidco and Innocoll earlier today. The Rule 2.5 announcement and this announcement will be made available on a Gurnet Point website for the purposes of the Acquisition (www.GurnetPointLPOffer.com) and on Innocoll’s website (www.Innocoll.com). Certain capitalized words used in this announcement and not defined have the meaning given to such words in the Rule 2.5 announcement. The bases and sources set out in the Rule 2.5 announcement have been used in this announcement, unless otherwise stated or the context otherwise requires. Certain figures included in this announcement have been subjected to rounding adjustments.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION.

Important Additional Information for U.S. Investors and Where to Find It

Innocoll intends to file the Scheme Document, which will also constitute the proxy statement of Innocoll (the “Proxy Statement”), with the SEC and mail a copy to Innocoll Shareholders in advance of the Scheme Meeting and the EGM and in connection with the Acquisition and the Scheme. INNOCOLL SHAREHOLDERS ARE URGED TO READ THE SCHEME DOCUMENT/PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT INNOCOLL, THE ACQUISITION, THE SCHEME AND RELATED MATTERS. Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement and other documents filed with or furnished to the SEC by Innocoll through the website maintained by the SEC at www.sec.gov. In addition, Innocoll Shareholders will be able to obtain free copies of the Scheme Document/Proxy Statement on www.Innocoll/com/investors.

 

Participants in the Solicitation

Innocoll, Gurnet Point and Gurnet Bidco and certain of its respective directors and executive officers and employees may be considered participants in the solicitation of proxies from the shareholders of Innocoll in respect of the transactions contemplated by the Scheme Document/Proxy Statement. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the shareholders of Innocoll in connection with the proposed transactions, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the Proxy Statement when it is filed with the SEC. Information regarding Innocoll’s directors and executive officers is contained in Innocoll’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 which is filed with the SEC. Information concerning the interests of Innocoll’s participants in the solicitation, which may, in some cases, be different than those of Innocoll’s shareholders generally will be set forth in the Proxy Statement relating to the transaction when it becomes available.

 

No Offer or Solicitation

This announcement is for information purposes only and is not intended to and does not constitute an offer to purchase, sell, subscribe for or exchange, or the solicitation of an offer to purchase, sell, subscribe for or exchange or an invitation to purchase, sell, subscribe for or exchange any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the Acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. The Acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer Document), which will contain the full terms and conditions of the Acquisition, including details of how to vote in respect of the Acquisition. Any decision in respect of, or other response to, the Acquisition, should be made only on the basis of the information contained in the Scheme Document (of, if applicable, the Takeover Offer Document). No offer of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act.

 

Cautionary Statement Regarding Forward-Looking Statements

Certain statements included in this announcement are forward-looking and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements can typically be identified by the use of forward-looking terminology, such as “expects”, “believes”, “may”, “will”, “could”, “should”, “intends”, “plans”, “predicts”, “envisages”, “estimates”, “forecast”, “outlook”, “guidance”, “possible”, “projects”, “potential” or “anticipates” or other similar words and expressions and include, without limitation, any projections relating to results of operations and financial conditions of either Gurnet Point, Gurnet Bidco or Innocoll and their respective subsidiary undertakings from time to time, as well as plans and objectives for future operations, expected future revenues, financing plans, expected expenditures, expected synergies and divestments relating to Gurnet Point, Gurnet Bidco or Innocoll and discussions of Gurnet Point’s, Gurnet Bidco’s or Innocoll’s business plan. All forward-looking statements in this announcement made by Gurnet Point and / or Gurnet Bidco are based upon information known to Gurnet Point and / or Gurnet Bidco on the date of this announcement and all forward-looking statements in this announcement made by Innocoll are based upon information known to Innocoll on the date of this announcement. Except as expressly required by law, Gurnet Point, Gurnet Bidco and Innocoll disclaim any intent or obligation to update or revise these forward-looking statements. None of Gurnet Point, Gurnet Bidco or Innocoll undertake any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, save as may be required by law.

 

Statements under the Irish Takeover Rules

The directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) accept responsibility for the information contained in this announcement, other than the information relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, for which the Innocoll directors accept responsibility. To the best of the knowledge and belief of the directors of Gurnet Bidco and the managers of Waypoint International GP LLC (in its capacity as general partner of Gurnet Point) (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

The Innocoll directors accept responsibility for the information contained in this announcement relating to Innocoll, the Innocoll Group and the Innocoll directors and members of their immediate families, related trusts and persons connected with them, except for statements made by Gurnet Point and Gurnet Bidco in respect of Innocoll. To the best of the knowledge and belief of the Innocoll directors (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Evercore Partners International LLP (“Evercore”), which is authorized and regulated in the United Kingdom by the Financial Conduct Authority, is acting as Financial Adviser exclusively for Gurnet Point and Gurnet Bidco and no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not regard any other person as its client in relation to the Acquisition and the other matters referred to in this announcement and will not be responsible to anyone other than Gurnet Point and / or Gurnet Bidco for providing the protections afforded to clients of Evercore, nor for providing advice in relation to the Acquisition or the other matters referred to in this announcement. Neither Evercore nor any of its subsidiaries, branches or affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Evercore in connection with this announcement, any statement contained herein or otherwise.

Piper Jaffray & Co. (“Piper Jaffray”), which is a securities broker-dealer registered with the U.S. Securities and Exchange Commission (“SEC”) and subject to regulation by the SEC and the Financial Industry Regulatory Authority (“FINRA”), is acting as financial adviser exclusively for Innocoll and for no one else in connection with the Acquisition and the other matters referred to in this announcement, and will not be responsible to anyone other than Innocoll for providing the protections afforded to clients of Piper Jaffray or for providing advice in relation to the Acquisition or any other matters referred to in this announcement.

 

Disclosure Requirements under the Irish Takeover Rules

Persons interested in 1% or more of any relevant securities in Innocoll may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013. See the Rule 2.5 announcement of earlier today for further details.

 

No Profit Forecast / Asset Valuation

No statement in this announcement is intended to constitute a profit forecast for any period, nor should any statements be interpreted to mean that earnings, earnings per share, losses or losses per share will necessarily be greater or lesser than those for the relevant preceding financial periods for any of Innocoll, Gurnet Point or Gurnet Bidco as appropriate. No statement in this announcement constitutes an asset valuation.

 

Contacts
 

Enquiries:
Gurnet Point and Gurnet Bidco
Evercore (Financial Adviser to Gurnet Point and Gurnet Bidco)
Francois Maisonrouge
John Honts Tel: +1 212 857 3100
Edward Banks Tel: +44 (0) 20 7653 6000
or
Abernathy MacGregor (Press Inquiries)
Tom Johnson Tel: +1 212 371 5999
tbj@abmac.com
or
Innocoll
Tel: Jose (Pepe) Carmona, Chief Financial Officer
pcarmona@innocoll.com
Piper Jaffray (Financial Adviser to Innocoll)
Peter Day Tel: + 1 617 654 0772
Peter Lombard Tel: + 1 617 654 0751
Michael Burton-Williams Tel: + 1 212 284 6126

Innocoll announces regulatory path forward after receiving formal FDA Type A meeting minutes regarding its XARACOLL® (bupivacaine HCl collagen-matrix implant) New Drug Application

ATHLONE, Ireland -- Innocoll Holdings plc (NASDAQ:INNL) ("Innocoll" or the "Company"), a global, commercial-stage, specialty pharmaceutical and medical device company, today announced receipt of formal Type A Meeting minutes from the United States Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implant).  XARACOLL is the company’s product in development for the treatment of postsurgical pain.

Innocoll received a Refusal to File (RTF) Letter from the FDA in December 2016 pertaining to the XARACOLL NDA initially submitted on October 31, 2016.  In the RTF 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.  During the Type A meeting, representatives of the FDA, after reviewing information provided by Innocoll to address matters raised in the RTF letter, provided guidance which was confirmed in the formal FDA meeting minutes.  The minutes serve as the official record of the FDA response to our proposal to address certain issues raised in the RTF by conducting an additional short-term pharmacokinetic study and several short-term non-clinical toxicology and biocompatibility studies. Innocoll believes, if adequately financed and successful, such studies may be completed in time for a resubmission of the NDA at the end of 2017.  Data from these studies, along with additional manufacturing information required to address the new combination product designation and other chemistry, manufacturing and control (CMC) issues, are expected to be included in the resubmission.  The acceptability of this data and other data that we reviewed with FDA during the meeting will be evaluated by the FDA during its review of the resubmission.

“I am pleased that we have clarified the data needed to address the questions raised in the RTF letter. With the official minutes from the FDA now in hand, we believe that we have a path forward for a possible resubmission of the XARACOLL NDA by the end of 2017, assuming adequate financing to commence the proposed studies, and further assuming positive results,” said Tony Zook, CEO of Innocoll.


About XARACOLL®

XARACOLL is Innocoll’s late-stage surgically implantable and bioresorbable collagen matrix developed to provide sustained postsurgical pain relief through controlled delivery of bupivacaine at the surgical site.


About Innocoll Holdings plc

Innocoll is a global, commercial stage specialty pharmaceutical and medical device company with late stage development programs targeting areas of significant unmet medical need. Innocoll utilizes its proprietary collagen-based technology platform to develop biodegradable and fully bioresorbable products and product candidates which can be broken down by the body without the need for surgical removal or topical application.

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.