Mainstay Medical Announces Completion of Financing Transactions

  • Funds to be used to support PMA process for ReActiv8® in US and to further European commercial validation efforts

  • Gross proceeds, together with savings from previously-announced debt restructuring, provides approximately $28 million in cash runway extension

Dublin, Ireland: Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and Euronext Growth of Euronext Dublin: 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 completed financing transactions to raise gross proceeds of €16.9 million (US$18.9) million.

Jason Hannon, CEO of Mainstay, commented: “Our objectives for the remainder of 2019 and 2020 are clear: file the pre-market approval (PMA) application for ReActiv8 with the U.S. Food and Drug Administration (FDA) this summer; advance the PMA review process with the FDA, with an approval decision expected in late 2020; and continue the commercial validation effort in Germany and other select European markets by working with key physician partners who identify appropriate ReActiv8 patients in their centres in order to validate commercial adoption, refine patient selection strategies and follow ongoing patient progress. We are pleased with the outcome of this financing, which was oversubscribed. These deals will provide the capital to expeditiously advance each of these goals and, together with our previously-announced debt restructuring, expands our expected cash runway into 2021.”

The total cash runway extension achieved by Mainstay amounts to approximately $28.0 million: approximately $18.9 million in gross proceeds from the financing transactions and approximately $9.1 million in savings that resulted from the Company’s restructuring of its debt completed in April.


Specific information regarding the Financing

The financing transactions consist of the issuance of 4,649,775 new ordinary shares (New Shares) at a purchase price of €3.00 per New Share and the drawdown of €3.0 million in additional debt from the Company’s existing lender. The investors in the equity financing are primarily existing shareholders in the Company (principally Sofinnova Partners, KCK Limited, Fountain Healthcare Partners and several individual investors).

The New Shares, when issued, will represent an increase of approximately 53.0% from the Company's existing issued ordinary share capital. Following issuance of the New Shares, the Company’s issued share capital will consist of 13,421,504 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 13,421,504.

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 Euronext Growth market (Euronext Growth) of Euronext Dublin (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 EU prospectus law. 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 Euronext Growth Markets Rule Book (Euronext Growth Rules)) will subscribe for 533,333, 654,000 and 1,333,333 New Shares, respectively. Their participation in the financing will constitute related party transactions under Rule 5.18 of the Euronext Growth Rules. The Directors, with the exception of Antoine Papiernik (with respect to Sofinnova Partners) and Nael Karim Kassar and Greg Garfield (with respect to KCK Limited), consider, having consulted with J&E Davy, the Company’s Euronext Growth 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.

David Brabazon, who is a Director, will also participate in the financing, subscribing for 155,000 New Shares, so that following completion of the financing, he will hold 212,828 Ordinary Shares, representing 1.6% of the enlarged issued ordinary share capital of the Company.

This announcement contains inside information for the purposes of the Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (the “Market Abuse Regulation” or “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 Matt Onaitis.


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 Euronext Growth market of Euronext Dublin (MSTY.IE).


About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to 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:

LifeSci Advisors, LLC

Brian Ritchie

Tel: + 1 (212) 915-2578

Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)

Jonathan Neilan or Patrick Berkery

Tel. : +353 1 765 0886

Email: mainstay@fticonsulting.com

Euronext Growth Advisers:

Davy

Fergal Meegan or Barry Murphy

Tel: +353 1 679 6363

Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Mainstay Medical Announces Completion of Pre-Submission Meeting with FDA Regarding Pre-Market Approval (PMA) Application for ReActiv8

PMA submission for ReActiv8 expected this summer

Dublin – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today announces that on 25 June 2019 the Company completed a pre-submission meeting with the U.S. Food and Drug Administration regarding a Pre-Market Approval (PMA) application submission for ReActiv8.

Jason Hannon, CEO of Mainstay, said: “We believe in a rigorous, evidence-based approach to the evaluation of ReActiv8, and we appreciate the opportunity to meet with the FDA on the data we have generated to date relating to the efficacy and safety of this novel therapy. We expect to submit the final module of our PMA application to the FDA relating to ReActiv8 this summer, with a decision on approval expected around the end of 2020.”

Separately, Mainstay also announced that it has entered into an amendment to its agreement with IPF Partners relating to its existing debt facility. Under the amendment, the deadline for Mainstay to qualify to draw down a new tranche of €3.0 million (approximately $3.34 million) in debt was extended from June 30, 2019 to July 31, 2019.

About Mainstay

Mainstay is a medical device company focused on commercializing 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 is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (MSTY.IE).

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to 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:

LifeSci Advisors, LLC

Brian Ritchie

Tel: + 1 (212) 915-2578

Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)

Jonathan Neilan or Patrick Berkery Tel. : +353 1 765 0886

Email: mainstay@fticonsulting.com

Euronext Advisers:

Davy

Fergal Meegan or Barry Murphy

Tel: +353 1 679 6363

Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

NeRRe Therapeutics announces positive findings from Phase 2b study with orvepitant in chronic cough

~ Statistically significant and clinically relevant improvements in patient reported outcomes in refractory chronic cough

~ Findings support further development of orvepitant in refractory chronic cough and meetings with the FDA and EMA are planned for Q4 2019 to discuss next steps

~Results provide important insights into the evolving field of chronic cough and methods used to clinically evaluate symptoms

Stevenage, UK – NeRRe Therapeutics today announces important results from the Phase 2b clinical trial (VOLCANO-2) with its neurokinin-1 receptor antagonist, orvepitant, in refractory chronic cough.

VOLCANO-2 was a 12-week, randomised, double-blind, placebo-controlled, Phase 2b dose-ranging clinical study designed to evaluate the efficacy, safety and tolerability of orvepitant in the treatment of refractory chronic cough in 315 patients from sites in the UK and North America. This was only the second Phase 2b dose ranging study in refractory chronic cough and the first with this mechanism.

Orvepitant, 30 mg once daily, resulted in statistically significant and clinically relevant improvements compared to placebo in the three key patient reported outcomes in the full analysis set at Week-12: Leicester Cough Questionnaire (p=0.009), Cough Severity VAS (p=0.034) and Urge-to-Cough VAS (p=0.005). The primary endpoint of awake cough frequency was not significant in this full analysis set, however in a pre-defined sub-group of higher frequency coughers, the reduction in cough frequency was near significant (p=0.066) at 12 weeks despite this sub-group analyses not being powered in the study. The trial confirmed the effectiveness of once daily dosing with orvepitant, and there were no safety concerns in this population; the excellent tolerability shown is seen as a major advantage of this class.


Professor Jaclyn Smith, Professor of Respiratory Medicine and Honorary Consultant, Director NIHR Manchester Clinical Research Facility added:

“Refractory chronic cough is a common and disabling condition and, with no proven therapies to treat the condition, there is a clear unmet medical need. The hypothesis being tested in this trial was that orvepitant could suppress the dysfunctional cough reflex and neuronal hypersensitivity which is thought to cause excessive coughing in patients with refractory chronic cough. The VOLCANO-2 study confirmed that orvepitant significantly improves the cough symptoms reported by patients and in so doing improves the quality of their lives. Orvepitant represents a novel first in class, non-opioid option to treat this common and debilitating condition.”


Commenting on the study outcome, Dr Mike Trower, Chief Scientific Officer and Founder at NeRRe Therapeutics said:

“Our intention was to design and execute a robust refractory chronic cough clinical study and, although there wasn’t a statistically significant reduction in awake cough frequency, the fact that patients are unequivocally reporting benefits cannot be underestimated.

“Awake cough frequency was monitored using an Ambulatory Cough Monitor and, whilst a very valuable tool, our data suggest that cough frequency is a more variable endpoint in patients with lower cough frequencies. In contrast, the cough frequency signal in this study was less variable in those patients with higher cough frequency at baseline, allowing a clear separation from placebo to be seen with the 30 mg once daily dose on all efficacy parameters, including cough frequency. This important observation will be incorporated in the design of the planned Phase 3 studies, thereby maximising their probability of success.”

The study outcomes support further development of orvepitant in refractory chronic cough and we intend to meet with the FDA and the EMA during Q4 this year to discuss next steps. The VOLCANO-2 data will be presented in full at a forthcoming international scientific meeting.

For more information, please contact:

NeRRe Therapeutics

Mary Kerr, CEO of NeRRe Therapeutics

Tel: +44 1438 906960

Email: info@nerretherapeutics.com


Consilium Strategic Communications

Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs

Tel: +44 (0) 20 3709 5700

Email: NeRReTherapeutics@consilium-comms.com


About NeRRe Therapeutics

NeRRe Therapeutics, a private UK based clinical-stage company founded in 2012 as a spin out from GSK, is developing a unique pipeline of three neurokinin (NK)-1 antagonists for the treatment of chronic cough caused by neuronal hypersensitivity associated with neurokinin-1 receptor system dysfunction.

The company is led by an experienced management team and is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, and OrbiMed. NeRRe Therapeutics is based at Stevenage Bioscience Catalyst.

You can find more information about NeRRe Therapeutics at www.nerretherapeutics.com

About VOLCANO-2

VOLCANO-2 was a randomised, double-blind, placebo-controlled, parallel group study that recruited subjects with refractory chronic cough of ≥1 year in duration and baseline awake cough frequency >10 coughs/hr. Subjects received placebo or one of three orvepitant doses (10, 20 or 30mg) once daily (OD) for 12-weeks. The primary endpoint was awake cough frequency at Week-12, recorded on a VitaloJAK ambulatory cough monitor. Other efficacy assessments included the Patient Recorded Outcomes (PROs): the Leicester Cough Questionnaire, Cough Severity Visual Analogue Scale (VAS) and Urge-to-Cough VAS. In total 315 subjects were randomised and 275 were evaluable at Week-12.


About Orvepitant

Orvepitant is a neurokinin-1 receptor antagonist that acts to reduce the central neural hypersensitivity that underlies chronic cough.

Fountain Healthcare Partners Raises €118M for Third Fund

Fund Raise Exceeds Target of €100m

Total Capital Under Management Reaches €294 million

DUBLIN & NEW YORK - Fountain Healthcare Partners (“Fountain”) today announces the initial closing of its third fund, Fountain Healthcare Partners Fund III, L.P. (“Fund III”) with €118 million of committed capital, exceeding its initial target raise of €100 million.

Fund III is a dedicated life science venture capital (“VC”) fund and brings Fountain’s total capital under management to €294 million. Within the life science sector, Fund III will primarily focus on specialty pharmaceuticals, biotechnology and medical devices.

Fountain will invest a majority of the capital in Fund III within Europe but expects to also make investments in the US market. Fund III is expected to make 10 to 12 investments in predominantly private life science companies.

The €118 million capital raised was sourced from major domestic and international institutional investors, including fund of funds, sovereign funds, corporate investors and family offices. Investors in Fund III include the European Investment Fund (EIF); Coolidge Limited, an investment vehicle of Mr Dermot Desmond; the Ireland Strategic Investment Fund (ISIF) and Allied Irish Bank (AIB).

Dr Manus Rogan, co-Founder and Managing Partner at Fountain, commented:

“Fountain’s investment strategy focuses on building a balanced portfolio of companies with complementary risk and return profiles within the life science sector. This strategy has resulted in a strong portfolio of investments for both Fund I and Fund II. The performance of our first and second funds is reflected in both the level and quality of new and existing investor participation in Fund III. With €118 million raised we are also pleased to have exceeded our initial close target of €100 million.

With almost €300 million of capital under management, we are Ireland’s largest dedicated life science venture capital fund. We will continue to seek opportunities to identify life science investment opportunities with exciting potential both in Ireland and internationally. Our ability to deploy significant capital together with our proven track record of helping early stage companies commercialise their potential, positions us a partner of choice for ambitious life science growth companies.”

Aidan King, co-Founder and Managing Partner at Fountain, added:

“Life sciences continues to be one of the best performing sectors for investor returns, driven by a consistent stream of IPOs and trade sales. Strong demand for life science investments is a reflection of investor’s belief in the underlying growth dynamics of the sector and the investment return opportunities presented by innovative life science companies.

In addition to financial returns, we are proud of the fact that to date, funding by Fountain has resulted in US FDA approval of three products in the areas of Parkinson’s disease, stroke and cardiovascular disease. These products are transforming the standard of care in these therapeutic areas and will greatly benefit patients worldwide”

Andrew McDowell, European Investment Bank Vice President said:

“The new €45 million European Investment Fund support for Fountain Healthcare represents our largest backing in more than a decade of successful cooperation with venture capital funds. It will further strengthen Ireland’s impressive venture capital ecosystem. Fountain’s third dedicated healthcare venture capital fund will benefit from proven success enabling world-class companies across Europe to develop impressive new treatments and technologies.”

Paul Saunders, Senior Investment Director, ISIF said:

“Fountain is an excellent example of ISIF co-investing with private sector partners to attract significant levels of international capital to Ireland, supporting economic activity and employment here and generating commercial returns.

This investment, our third with Fountain, builds on the success of our earlier investments in the biotech, medtech and life science sectors in which Ireland has emerged as a leading global hub. It will also help drive ISIF's commitment to regional development by supporting these sectors in clusters located throughout Ireland and helping them to thrive.”

Finlay McFadyen, Head of Investment Banking of AIB said:

“We are delighted to continue our support for Fountain Healthcare Partners in this fund which will invest in international and Irish early stage life science companies. These companies will benefit from Fountain’s expertise and experience. Fountain’s previous track record demonstrates their successful investment strategy of identifying companies and entrepreneurs with growth potential and assists to create value as they transition to the next phase of their business lifecycle. This strategy aligns to AIB’s strong focus on this growth sector.”

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin, and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €294 million under management.

Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. The three principals at Fountain Healthcare Partners Fund III, Manus Rogan, Aidan King and Ena Prosser brings to investees over 70 years of collective experience in the pharmaceutical industry, corporate venture capital and VC across multiple investment and market cycles.

For more information please visit: www.fh-partners.com

Contacts

Manus Rogan | Managing Partner

Manus.Rogan@fh-partners.com

T: +353 1 5225111

Jonathan Neilan | FTI Consulting

jonathan.neilan@fticonsulting.com

T: +353 1 7650886

M: +353 86 231 4135

Neuromod Broadens Senior Leadership Team in Preparation for Global Commercialisation of Lenire™ Tinnitus Treatment

DUBLIN - Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today provides an update on organisational and leadership growth in preparation for European commercialisation and US regulatory clearance application.

Following the completion of two of the largest clinical trials ever conducted in tinnitus; including 517 participants, the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany, which will be marketed under the brand name Lenire™. To support commercialisation activities, Neuromod is investing in establishing the appropriate quality, regulatory and supply chain infrastructure to support near term European plans and lay the foundation for the Company’s US strategy.

Senior Leadership Appointments

Neuromod is delighted to announce the appointment of Deborah Arthur as Head of Quality and Regulatory Affairs, Suzanne O’Rourke as Director of Quality and Regulatory Affairs and Cathal Mc Fadden as Director of Operations. Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters. They will be supported by a team of qualified industry experts in navigating the regulatory pathway to market the treatment in the United States and transitioning to the new EU Medical Devices Regulation (MDR (EU) 2017/745). Cathal’s experience in manufacturing scale up and supply chain management will ensure that Neuromod is ready to meet the anticipated demand for Lenire™ in Europe and globally.

Dr. Ross O’Neill, CEO of Neuromod commented: “This is a very exciting time for Neuromod as we move towards commercialisation, supported by encouraging data from our recent clinical trials. I am delighted that industry leaders of the calibre of Deb, Suzanne and Cathal have agreed to join our team. Neuromod is investing in growing our organisation; we have been working tirelessly to ensure that all systems are in place to bring our much-anticipated breakthrough treatment to the large population of people living with tinnitus globally.”

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 tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University. Neuromod has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation treatment for this extremely 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 incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

Contacts

FTI Consulting
Media Relations
Melanie Farrell
neuromod@fticonsulting.com

Syndesi Therapeutics announces initiation of Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment

Belgium – Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that its lead molecule, SDI-118, has entered into Phase I clinical development.

The first-in-human Phase I study is investigating the safety, tolerability and pharmacokinetics of single ascending doses of SDI-118 in healthy subjects. The study also includes PET imaging in a group of subjects to directly measure the binding of SDI- 118 to SV2A in the brain and to assess the relationship between SV2A occupancy and plasma exposure.

Jonathan Savidge, CEO of Syndesi, said “We are delighted to announce the entry of SDI- 118 into clinical development following successful completion of pre-clinical studies during the first year following Syndesi’s incorporation. Conducting PET imaging in parallel with the dose escalation provides us with highly valuable data very early in the development program. This ability to measure the degree of target engagement of our compound in humans greatly facilitates the choice of doses in future trials, de-risking one of the major challenges in CNS drug development.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. In February 2018 the company announced €17M in Series A funding from a syndicate of Belgium and international investors. In March 2019, Syndesi announced the award of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI- 118 through Phase I clinical development. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as cognitive impairment associated with schizophrenia. For more information please visit www.syndesitherapeutics.com

Mainstay Medical Provides Company Update and Publishes 2018 Full Year Results

  • ReActiv8-B study results received; pre-PMA submission meeting with FDA expected during the second quarter

  • European commercialization continues to advance

  • Cash on hand of $15.5m at 31 December 2018

Dublin,Ireland – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today provides a company update and announces the publication of its 2018 Full Year results and Annual Report.

Jason Hannon, CEO of Mainstay, said: “I believe fully in ReActiv8 as a therapeutic option for patients suffering from disabling Chronic Low Back Pain, and I believe that the value we can deliver to both our physician customers and their patients, as well as the investing market, will be demonstrated in the months and years to come. The primary endpoint of our ReActiv8-B clinical trial was not achieved due to a higher response (at 120 days) in the control (active sham) patient group than was expected. However, we believe the overall results from the trial represent solid evidence of the efficacy and safety of ReActiv8. This belief is based on, among other things:

  • A pre-specified analysis of the primary endpoint where we adjusted for patients who increased their pain medications for reasons unrelated to their back pain. As a reminder, to be considered a “Responder” in the clinical trial, a patient must have reported 30% or greater pain relief on the VAS scale and not increased their pain medications leading up to the 120 day measurement point;

  • Statistically significant differences between the treatment and control groups on key secondary efficacy endpoints at 120 days;

  • A responder rate of 72% in the patients in the treatment and control groups combined that have reached one year since implantation; and

  • A significant reduction in the use of pain medications (including opioids) by patients at one year.

We believe these results will support sales growth in Germany and other markets under our existing CE Mark, as well as our plan to file a Pre-Market Approval Application with the U.S. Food and Drug Administration. We plan to submit a PMA to the FDA in mid-2019, with a decision on approval expected in late 2020.”

Business Update

  • In November 2018, Mainstay announced top line results from the ReActiv8-B clinical study, its international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the U.S. Food & Drug Administration (FDA). A total of 204 patients with chronic low back pain refractory to physical therapy were implanted with ReActiv8 at leading clinical sites in the U.S., Europe and Australia and randomized 1:1 to therapy or control. The average duration of symptoms was 14 years. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed-over to receive levels of electrical stimulation similar to those in the treatment group. A summary of the clinical trial results is as follows:

    • The primary efficacy endpoint of the study was a comparison of responder rates between the treatment and control groups as measured on the visual analog scale (VAS) of pain, with responders defined as having a 30% or greater improvement on this measure between baseline and 120 days after randomization, without any increase in pain medication and/or muscle relaxants taken in the two weeks prior to the primary endpoint assessment visit. In the treatment group the responder rate at 120 days was 57%, compared to 47% in the control group, resulting in a difference that is not statistically significant.

    • Statistically significant differences on a number of key secondary endpoints were observed in the treatment group as compared to the control group at 120 days, including change from baseline in disability measured by the Oswestry Disability Index (ODI), change from baseline in quality of life measured by the European Quality of Life Score on Five Dimensions (EQ-5D), percent pain relief (PPR) compared to baseline and subject global impression of global change (SGIC).

    • Improvements in the percentage of patients reporting pain reduction continued beyond the 120-day assessment through one year for both groups. The percentage of the 116 patients in the treatment group and control groups that had completed the one-year assessment having a 30% or greater reduction in low back pain VAS at that assessment without a significant increase in pain medication was 72%. These data are subject to change as the remaining patients reach the one-year assessment.

    • The protocol permitted patients to adjust their back pain medication usage after the 120-day assessment point. At one year, 44% of the 50 patients in both groups combined who were on opioids at baseline had voluntarily eliminated (28%) or significantly reduced (16%) their use of opioids. These results are subject to change as the remaining patients reach the one-year assessment.

    • The incidence and type of adverse events (AEs), including serious AEs, were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs related to the device, procedure or stimulation.

  • Mainstay is preparing to submit a PMA application to the FDA based upon the totality of its clinical data for ReActiv8. The Company expects to have a pre-PMA submission meeting with the FDA during the second quarter to obtain feedback on its filing content and strategy. A PMA application filing is expected in mid-2019 after that meeting, with a decision on approval expected in late 2020. The FDA’s review of the PMA may result in the FDA not agreeing with Mainstay’s interpretation of its clinical data, including whether statistical significance was achieved for one or more endpoints.

  • In Germany, Mainstay’s initial European market, the commercial team was repositioned in order to better focus efforts on key physician targets. Commercialization efforts in line with this strategy began in earnest in late-2018. We are beginning to see the early fruits of these efforts as we regularly onboard new implanting physicians. We expect this early momentum to continue, leading to meaningful sales and revenue by the end of this year and the beginning of 2020.

Financial Update

  • Since the beginning of 2018, Mainstay has conducted significant financing activities:

    • On 18 April 2019, Mainstay and its subsidiary, Mainstay Medical Limited, entered into an amendment to its agreement with IPF Partners relating to their existing debt facility. Pursuant to the amendment:

      • The repayment schedule for the three existing tranches drawn under the debt facility was amended such that no principal or interest will be repaid until 2021, with the principal and accrued interest to be amortized over the period from January 1, 2021 through September 30, 2023.

      • A new tranche of €3.0 million (approximately $3.34 million) was made available to Mainstay, conditioned upon Mainstay raising at least $10 million in gross proceeds from one or more offerings of equity prior to June 30, 2019. The repayment schedule for the new tranche will be the same as the amended repayment schedule for the three existing tranches.

      • The interest rate for all tranches will be 8% per annum, with interest accruing but capitalized prior to January 1, 2021.

      • The 5% repayment fee applicable to each existing tranche was eliminated.

      • All principal and accrued interest from all tranches will automatically convert into ordinary shares of the Company at a price per share of €8 upon the earlier of (a) FDA approval of Mainstay’s PMA application for ReActiv8, (b) the date by which at least 900,000 ordinary shares of the Company are publicly sold on-market by non-affiliates of Mainstay since 18 April 2019 at a price per share of at least €8, or (c) IPF Partners’ election to undertake such conversion, in each case unless the Company elects to satisfy such obligation in whole or in part in cash.

      • The minimum cash covenant was amended so that Mainstay is required to hold cash at least equal to its projected cash expenditures for operations and debt repayment for the next three months, and the covenant relating to the achievement of commercial milestones was eliminated.

      • Mainstay issued to IPF Partners warrants to purchase 1.5 million of its ordinary shares at a price per share of €6 at any time prior to the 6th anniversary of the amendment date. Mainstay has issued further conditional warrants to IPF Partners that will become exercisable only to the extent Mainstay elects to repay the debt in cash rather than issue ordinary shares when a conversion of the debt is triggered. As such, the conditional warrants are intended to ensure that, notwithstanding any such election to repay in cash, IPF Partners retains the right to subscribe for ordinary shares of the Company on the terms and conditions that would otherwise have applied.

    • On 15 February 2018, the Company announced the completion of a €30.1 million financing (approximately $37.5 million) through a placement of 2,151,332 new ordinary shares to new and existing shareholders.

  • Revenue during the year ended 31 December 2018 was $0.7 million (2017: $0.3 million).

  • Operating expenses related to on-going activities were $29.6 million during the year ended 31 December 2018 (2017: $27.9 million).

  • Cash on hand as at 31 December 2018 was $15.5 million (2017: $10 million).

About Mainstay

Mainstay is a medical device company focused on commercializing 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 is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (MSTY.IE).

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to 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:

Investor Relations:

LifeSci Advisors, LLC

Brian Ritchie

Tel: + 1 (212) 915-2578

Email: britchie@lifesciadvisors.com

Euronext Advisers:

Davy

Fergal Meegan or Barry Murphy

Tel: +353 1 679 6363

Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie

Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)

  • Study VEL-2002 further validates solabegron’s potential for best-in-class efficacy across multiple primary and secondary endpoints

Wayne, PA - Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, as measured by the mean change in number of micturitions per day, the study’s primary endpoint. Solabegron also demonstrated statistical significance across multiple secondary endpoints including percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes.


The 12-week placebo-controlled VEL-2002 study enrolled 435 women ages 18 to 80 suffering from OAB. Solabegron was generally well-tolerated. Treatment emergent adverse events and serious adverse events were infrequent and comparable between the solabegron and placebo-treated groups. Velicept plans to submit the data from the VEL-2002 study for presentation at upcoming scientific meetings.


“We are encouraged by these positive top-line results for VEL-2002 as they are consistent with what we’ve seen in a prior study with solabegron undertaken by GSK and further validate the potential for best-in-class efficacy and improved safety for patients with OAB,” said James Walker, President and Chief Executive Officer, Velicept Therapeutics. “We look forward to the results of our second study, which will help us finalize our plans for moving forward with a pivotal Phase 3 program early next year.”


Velicept has also developed a novel, once-daily formulation of solabegron which is being evaluated in an ongoing Phase 2b study (VEL-2001). VEL-2001 has completed enrollment and the company expects to announce top-line results in the second quarter of this year.


About Solabegron

Solabegron is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). A Phase 2 study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day. Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase 2 study also indicated a safety and tolerability profile for solabegron that was similar to placebo.


About Velicept

Velicept Therapeutics, Inc. is a privately-held, clinical development company focused on advancing best-in-class compounds for the treatment of urological and gastrointestinal disorders. Its lead product, solabegron, is a highly potent and selective beta-3 adrenoceptor agonist being investigated for overactive bladder (OAB) and irritable bowel syndrome (IBS). For more information, visit www.velicept.com.


Contacts

Media:

W2Otwist

Sheryl Seapy, (213) 262-9390

sseapy@twistmktg.com

Inflazome receives funding from The Michael J. Fox Foundation for Parkinson’s Research

  • Funding in excess of US$1 million to support the development of a brain imaging probe for patient diagnosis and the clinical development of drugs to treat neurodegenerative diseases

  • Inflazome is developing orally available drugs to address clinical unmet needs in inflammatory diseases by targeting the NLRP3 inflammasome

  • NLRP3 activation is now associated with the progression of Parkinson’s Disease

Dublin (IE), Cambridge (UK): Inflazome (inflazome.com), the pioneering biotech company developing several small molecule drugs that inhibit harmful inflammation, today announces it has been awarded funding in excess of US$1 million by The Michael J. Fox Foundation for Parkinson’s Research (MJFF). The grant will fund the development of a NLRP3-specific Positron Emission Tomography (PET) tracer to allow non-invasive imaging of inflammasome-driven inflammation in the brain.

To enhance the accuracy and probability of success of a clinical trial in neurodegenerative disease, it is important to select suitable patients at the appropriate staging of the disease. It is also essential to determine whether the biological target of interest is being engaged by the drug in the brain. One approach to achieve this in the central nervous system (CNS) is by using an NLRP3-specific tracer during a PET scan. The tracer could quickly, accurately and non-invasively produce images showing the drug binding to target inflammasomes in the brain.

The NLRP3 inflammasome is believed to drive chronic inflammation associated with the progression of many neurodegenerative diseases, including Parkinson’s Disease. The PET tracer will also help Inflazome to determine what doses are needed for patients in larger clinical trials in the future. The Principal Investigator on this project is Prof. Matthew Cooper, CEO and co-founder of Inflazome, who is assisted by Co-Investigator Dr David Miller, Head of Medicinal Chemistry.

Inflazome is developing orally available drugs to address clinical unmet needs in inflammatory diseases by targeting the NLRP3 inflammasome, which is now understood to drive many chronic and acute inflammatory conditions. The NLRP3 inflammasome was recently shown to be associated with the progression of Parkinson’s Disease in humans and in non-clinical models, in research published on 31 October 2018 in Science Translational Medicine (Link).

This innovative research was co-authored by Prof. Cooper with research teams at The University of Queensland, Australia, led by A/Prof. Trent Woodruff and funded by The Michael J. Fox Foundation for Parkinson’s Research and the Shake It Up Australia Foundation.

Prof Matt Cooper, Co-Founder and CEO of Inflazome, commented: “The Michael J. Fox Foundation is a fantastic organisation with a passionate commitment to new science, science translation and candidate therapies for Parkinson’s. We are fully aligned in our shared goal to help patients with Parkinson’s and other debilitating neurodegenerative diseases, for which there are inadequate therapies and no cures. Their support will help us advance and hopefully validate our disruptive approach to diagnose and then treat patients by focusing on neuroinflammation.”

Dr Jamie Eberling, Director of Research Programs at MJFF, said, “An imaging tool to visualize neuroinflammation may help investigate Parkinson’s onset and progression as well as evaluate new treatments that could alter the course of the disease. Our Foundation is investing in this research due to the significant potential impact on drug development and patient lives.”


About Parkinson’s Disease

Parkinson’s disease is the second most common neurodegenerative disorder worldwide, affecting more than 10 million people. It is characterised by the loss of dopamine-producing neurons, accompanied by chronic inflammation in the brain. Inflazome has identified drugs to stop the chronic cycle of inflammation in the brain. Research published in Science Translational Medicine on 31 October 2018 found that the tool compound MCC950, a potent inhibitor of the NLRP3 inflammasome, given orally once a day could stop neuroinflammation. MCC950 arrested the effects of Parkinson’s in several animal models of the disease, leading to reduced brain neuron loss and higher levels of dopamine.

A link to a Parkinson’s Disease explainer video can be found here


About Inflazome

Utilizing the scientific expertise of our founders and advisors, Inflazome is leading the way in developing rally available drugs to address clinical unmet needs in inflammatory diseases by targeting the NLRP3 inflammasome, which is now understood to drive many chronic inflammatory conditions. Headquartered in Dublin, Ireland, Inflazome was founded in 2016 by leading academics Professor Matt Cooper, The University of Queensland (Australia) and Professor Luke O’Neill, Trinity College Dublin (Ireland), following a highly productive joint collaboration.

To learn more visit: inflazome.com


About The Michael J. Fox Foundation for Parkinson's Research

As the world's largest nonprofit funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $800 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges ground-breaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

Syndesi Therapeutics awarded non-dilutive funding of up to €3.2M for development of its lead program, SDI-118, aimed at treating cognitive impairment

Syndesi Therapeutics SA, a biotechnology company developing novel SV2A modulators for cognitive impairment, today announced it has been granted up to EUR 3.2 M in non-dilutive funding from the Walloon Region. The funding is provided in the form of an ‘avance récupérable’ (recoverable loan), repayable under certain conditions with the majority of the repayment linked to the success of the programme.

Jonathan Savidge, CEO of Syndesi, said “We very much appreciate the Walloon Region’s ongoing support for the continued development of this program. This is an area of high unmet need where it has proven challenging to develop new therapeutics. This additional support will enable us to leverage our investor financing to expand the clinical development program for SDI-118 and maximize the chance of bringing this promising molecule to patients.”

The funding will support the development of SDI-118 through Phase I clinical studies, which will include PET imaging to directly measure the binding of SDI-118 to its target in the brain, providing key information for subsequent dose selection.

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB, and in February 2018 announced €17M in Series A funding from a syndicate of Belgium and international investors. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as cognitive impairment associated with schizophrenia and other conditions. The discovery of the lead molecule, SDI-118, at UCB benefitted from prior support of the Walloon Region. For more information please visit www.syndesitherapeutics.com

Prof. Marco Colonna M.D. Join's Inflazome's Scientific Advisory Board

Distinguished scientist with deep expertise in innate immunity and its role in neurodegenerative diseases

Dublin (IE), Cambridge (UK): Inflazome (inflazome.com), the pioneering inflammasome company, announces the appointment of distinguished scientist, Prof. Marco Colonna M.D. to its Scientific Advisory Board. Prof. Colonna has deep expertise and extensive experience in innate immunity. His team is responsible for the innovative discovery of Triggering Receptors Expressed on Myeloid cells (TREM), important regulators of the innate immune response. Prof. Colonna is currently investigating TREM’s link to Alzheimer’s Disease at the Washington University School of Medicine in St. Louis, MO, where he has been a Professor of Pathology and Immunology since 2001.

With the appointment of Prof. Colonna, Inflazome continues to strengthen its Scientific Advisory Board, a collaboration of eminent, world renowned scientists who will work closely with the management team as Inflazome prepares to advance its lead product candidates into clinical studies later this year.

On his appointment Prof. Colonna commented: “Neurodegenerative diseases are growing at an alarming rate. A small molecule that crosses the blood brain barrier and inhibits NLRP3 in the brain has the potential to open a new exciting avenue for therapeutic intervention. I am delighted to join the Inflazome Scientific Advisory Board to help advance this potential”.

Prof Luke O’Neill, Co-Founder and CSO of Inflazome, commented: “I am delighted to welcome Marco to Inflazome’s SAB. He brings a wealth of experience in the molecular and cellular basis of innate immunity, especially in the Central Nervous System. He will bring tremendous new insights into our research and clinical programs”.

About Prof. Marco Colonna

Prof. Marco Colonna, born in Parma, Italy, received his medical degree at Parma University and completed his postdoctoral training at Harvard Medical School (Cambridge, MA, USA). He became a scientific member of the Basel Institute for Immunology in Basel, Switzerland. Since 2001 he has been a Professor of Pathology & Immunology at Washington University School of Medicine in St. Louis, MO. Prof. Colonna’s research focuses on immunoreceptors. In this field, his accomplishments include identification and characterization of the Killer cell Ig-like receptors and HLA-C polymorphisms as their inhibitory ligands, as well as the discovery of the LILR and TREM inhibitory and activating receptor families.

Through analysis of the cellular distribution of these receptors, Prof. Colonna identified plasmacytoid dendritic cells as source of IFNa/b in anti-viral responses and innate lymphoid cells that produce IL-22 in mucosae. His current areas of research include:

1) TREM2 and innate immunoreceptors in Alzheimer's disease.

2) Innate lymphoid cells in mucosal immunity.

3) Plasmacytoid dendritic cells in host defense and autoimmunity.


Prof. Colonna has published over 80 primary last-author studies in peer-reviewed journals, and holds editorial appointments for many publications, including European Journal of Immunology, Immunity, Journal of Experimental Medicine, Blood, Journal of Clinical Investigation, and Human Immunology.

Members of the Inflazome’s Scientific Advisory Board include:

- Prof. Luke O’Neill, Trinity College Dublin

- Prof. Marco Colonna, MD, Washington University School of Medicine

- Prof. Veit Hornung, Ludwig Maximilian University of Munich

- Dr. David Morris, MD, Novartis Venture Fund

- Prof. Mihai G. Netea, Nijmegen University

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

About Inflazome

Utilizing 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 NLRP3 inflammasome, which is now understood to drive many chronic and acute inflammatory conditions from Alzheimer’s and Parkinson’s to cardiovascular, liver, kidney and inflammatory bowel diseases.

Headquartered in Dublin, Ireland, Inflazome was founded in 2016 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.

To advance its programs to clinical development, Inflazome recently closed a successful Series B financing of €40M / US$46M led by Forbion Capital Partners with Longitude Capital, with Series A investors, Fountain Healthcare Partners and Novartis Venture Fund, also participating.

To learn more visit: inflazome.com

KaNDy Therapeutics announces initiation of Phase 2b trial of NT-814 for the treatment of troublesome post-menopausal symptoms

Stevenage, UK - KaNDy Therapeutics, a clinical-stage company developing a potential breakthrough non-hormonal treatment for multiple debilitating symptoms of the menopause, today announces initiation of the Phase 2b clinical trial evaluating NT-814 in women with troublesome symptoms of the menopause. The study (called SWITCH-1) will evaluate the effect of treatment with NT-814 on hot flashes and other symptoms of the menopause.

Dr. Steve Pawsey, Chief Medical Officer of KaNDy Therapeutics, said: “We are very pleased to have initiated the Phase 2b, SWITCH-1 study, on schedule with our previous guidance. We anticipate that results from this trial will validate the Phase 2a results and position NT-814 as a novel, non-hormonal treatment for women suffering from troublesome symptoms of the menopause. We will continue to enrol patients over the coming months and look forward to reporting results in late 2019. We expect NT-814 to be fully Phase 3 ready in H2 2020”

Prof. James A. Simon, Coordinating Principal Investigator on the SWITCH-1 Study and Scientific and Clinical Advisor to KaNDy Therapeutics said: “There are millions of women worldwide suffering from debilitating symptoms of the menopause and a non-hormonal treatment that could offer relief would be extremely valuable to this population. NT-814 has delivered very encouraging results to date and I am hopeful that findings from this trial will be equally promising.”

SWITCH-1 is a Phase 2b, double-blind, randomised, placebo-controlled, adaptive study designed to determine the effectiveness and safety of NT-814, taken once daily, for the treatment of troublesome post-menopausal symptoms. Four doses of NT-814 (40 mg once a day, 80 mg once a day, 120 mg once a day and 160 mg once a day) will be investigated and compared to placebo, in five parallel groups. The study is anticipated to enrol approximately 165 postmenopausal women aged 40 to 65 years although the exact number will be determined during the adaptive design reviews. Subjects will participate in the study for a total of approximately 19 weeks, comprising a screening period of three weeks, a 12-week treatment period and then a final follow up visit four weeks after the end of the treatment period. The co-primary efficacy endpoints will be the change from baseline in frequency and severity of moderate and severe hot flashes at Weeks 4 and 12 of treatment.

More information can be found at www.clinicaltrials.gov, identifier: NCT03596762

For more information, please contact:

KaNDy Therapeutics

Mary Kerr, Chief Executive Officer

Tel: +44 1438 906960

Email: info@kandytherapeutics.com

Consilium Strategic Communications

Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs

Tel: +44 (0) 20 3709 5700

KaNDyTherapeutics@consilium-comms.com

KaNDy Therapeutics is a clinical-stage company developing a potential breakthrough non-hormonal treatment for multiple debilitating symptoms of the menopause including hot flashes and sleep disturbance due to night sweats. KaNDy’s drug in development, NT-814 is a unique dual mechanism NK(neurokinin)-1,3 receptor antagonist with the potential to ‘switch off’ multiple debilitating symptoms of the menopause without the need for oestrogen exposure.

Data from a Phase 1b/2a study in post-menopausal women with troublesome hot flashes showed NT-814 was able to rapidly and profoundly reduce both the frequency and severity of hot flashes as well as sleep disturbances due to night sweats. NT-814, is now being evaluated in a Phase 2b clinical trial in postmenopausal women with moderate to severe vasomotor symptoms. Headline results are expected at the end of 2019 and NT-814 will be fully Phase 3 ready by H2 2020.

For more information please visit https://www.kandytherapeutics.com/

Mainstay Medical to Showcase ReActiv8 and Key Clinical Data at the 13th German Spine Congress of the DWG

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical device company focused on commercializing ReActiv8®, an implantable restorative neurostimulation system designed to treat an underlying cause of disabling Chronic Low Back Pain, today announces that it will participate in the 13th German Spine Congress of the Deutsche Wirbelsäulengesellschaft (DWG), taking place in Wiesbaden from December 6-8. DWG will be the first medical meeting at which pivotal clinical data from the Company’s ReActiv8-B clinical study will be discussed.

A distinguished faculty of physicians, each of whom has deep experience with Reactiv8, will present the clinical data and the scientific background of the therapy, and describe commercial treatment of patients in Germany:

  • Dr. Jörg Franke, Chief, Department of Orthopedics, Klinikum Magdeburg, will chair the symposium where the results from the ReActiv8-B study will be presented, and also provide his experience with ReActiv8 in Germany;

  • Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of Anaesthesiology, Perioperative and Pain Medicine Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical and Principal investigator of the study, will present the pivotal clinical data from the ReActiv8-B study;

  • Dr. Jan Schilling, Chief of Spine and Neurosurgery, Tabea Hospital in Hamburg, will introduce the scientific background and the underlying physiological mechanisms of this new restorative treatment for chronic low back pain; and

  • Dr. Ardeshir Ardeshiri, Chief of Spine Surgery at Klinikum Itzehoe, will present his “real world” experience with ReActiv8 in Germany via his initial series of patient outcomes.

“As Germany is our first commercial market for ReActiv8, I am excited to be unveiling the data from our ReActiv8-B clinical study to the scientific community at the German Spine Congress,” said Jason Hannon, Chief Executive Officer of Mainstay. “We believe the long-term clinical results demonstrated in the study are compelling, particularly that we are seeing more than 60% of the study patients reporting greater than 50% pain relief at one year. We look forward to discussing the results with the attending physicians, and we plan to leverage the study results in continuing to drive our commercial business in Germany and more broadly in Europe.”

“The data from the ReActiv8-B clinical study through one year, and the favourable safety profile demonstrate that ReActiv8 is a viable restorative treatment option for patients with chronic low back pain,” said Dr. Franke. “ReActiv8 has the potential to provide long-term pain relief to this patient population, which suffers from a lack of available treatment alternatives.”

The ReActiv8 B clinical study is an international, multi-center, prospective, randomized, active-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the U.S. Food & Drug Administration (FDA). A total of 204 patients were implanted with ReActiv8 at leading study centers in the U.S., Europe and Australia and randomized 1:1 to therapy or control 14 days after implant. The initial results from this clinical study were announced by Mainstay on November 19, 2018.

“The results from this study confirm the results we have seen in our own experience with chronic mechanical low back pain patients with ReActiv8,” said Dr. Schilling. “There is an urgent need for new, effective therapies to treat long-term, mechanical low back pain, and the data from the studies demonstrate that ReActiv8 can provide sustained pain reduction over time.”

Mainstay will hold a ReActiv8-B symposium at which the physician faculty will make their presentations. The symposium will take place on Friday, December 7 from 13:00 - 14:30 in Studio 1.2 A & B at the Rhein Main Congress Center. Seating is limited. Pre-registration is available through www.reactiv8-B.de.

The Company will also have a booth at the DWG Congress, location number 26, and Mainstay leadership and the symposium faculty will be available for further discussions throughout the conference.

About Mainstay

Mainstay is a medical device company focused on commercializing 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 is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (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 patients had baseline data collected and then following verification that the enrollment criteria were met, ReActiv8 was implanted. At the 14-day post implant follow up visit, half the patients were randomized to receive appropriately programmed stimulation (the treatment arm), and half were randomized to receive sham stimulation/low stimulation (the control arm). Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/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

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

Appointment of Dr Thomas Jung as Chief Medical Officer of Inflazome

  • Industry veteran clinician to lead the clinical development of Inflazome’s pioneering NLRP3 inflammasome inhibitors to treat inflammatory diseases

  • Appointment follows Inflazome’s recent successful €40m Series B financing

  • The NLRP3 inflammasome is now associated with a broad range of serious medical conditions driven by harmful inflammation; from neurological disorders such as Alzheimer’s and Parkinson’s, to cardiovascular, liver, kidney and inflammatory bowel diseases.

Dublin, Ireland and Cambridge, UK : Inflazome (inflazome.com), the pioneering inflammasome company, announces the appointment of Dr Thomas Jung M.D., Ph.D., as its Chief Medical Officer.

Dr Jung joins Inflazome’s senior management team to lead the clinical development of its potent and selective small-molecule inhibitors of the NLRP3 inflammasome. Dr Jung will oversee the company's global operations related to the development of Inflazome’s lead and next-generation compounds across a range of therapeutic indications; and will work collaboratively with Dr Jeff Thompson, Inflazome’s Head of Clinical Operations and Joanna Tufnell, Head of Regulatory Affairs.

Dr Matt Cooper, Co-Founder and CEO of Inflazome, commented: “Dr Jung has a long and successful track record in guiding pioneering medicines to the market. He brings significant breadth and depth in clinical immunology to the team. We look forward to working together to drive our novel immunotherapies through clinical trials to benefit patients affected by harmful inflammation.”

On his appointment Dr Jung commented: “I am delighted to join the Inflazome team. I see huge potential in Inflazome’s novel small molecules and their ability to transform patients’ lives in a variety of clinical indications. I am looking forward to working with physicians, scientists and patients to develop these new drugs and to deliver on the promise to modify inflammation for patients’ benefit”.

Dr Thomas Jung

Dr Jung is a M.D., Ph.D. physician-scientist with extensive experience in Translational Sciences, Preclinical and Clinical Development of small molecules and biologics.

During a distinguished career at Novartis, Dr Jung was a member of the Novartis Institute of Biomedical Research and Novartis Pharma for 13 years. His primary focus of immunological research was the study of innovative anti-inflammatory principles. He led the Canakinumab (Illaris®) Team in the US and EU, from bench to first approval for CAPS (Cryopyrin-Associated Periodic Syndromes, a rare monogenetic disease). Dr Jung was also central to its expansion strategy into indications such as systemic juvenile idiopathic arthritis, gout and other rare fever syndromes. He made a significant contribution to the exploration of Canakinumab in cardiovascular diseases and served as the Development Head for Immunology products and, subsequently, as Head of the Translational Medicine Group for Novartis Europe. Thereafter, Dr Jung served as Chief Development Officer and Chief Medical Officer for two biotechnology companies in Switzerland: Auris Medical and Delenex. Dr Jung is a board-certified Dermatologist and holds an Associate Professor position for Dermatology at the University of Göttingen, Germany.

About Inflazome

Utilizing 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 NLRP3 inflammasome, which is now understood to drive many chronic and acute inflammatory conditions from Alzheimer’s and Parkinson’s to cardiovascular, liver, kidney and inflammatory bowel diseases.

Headquartered in Dublin, Ireland, Inflazome was founded in 2016 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.

To advance its programs to clinical development, Inflazome recently closed a Series B financing of €40M / US$46M led by Forbion Capital Partners with Longitude Capital and Series A investors, Fountain Healthcare Partners and Novartis Venture Fund, also participating.

To learn more visit: inflazome.com

Neuromod Appoints Leading Tinnitus Expert Professor Richard S. Tyler, PhD to its Clinical Advisory Board

Dublin, Ireland | Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, is delighted to announce that Professor Richard S. Tyler has agreed to join Neuromod’s Clinical Advisory Board. A clinical expert in tinnitus and audiology, Professor Tyler is a renowned pioneer in the advancement of tinnitus research and treatment, founding the annual International Conference on Management of Tinnitus and Hyperacusis more than 26 years ago. In addition to his roles as Professor in the Department of Otolaryngology, Head & Neck Surgery and in the Department of Speech Pathology and Audiology at the University of Iowa, Professor Tyler continues to see and treat a large number of US tinnitus patients.

Professor Tyler’s appointment to the Clinical Advisory Board follows a number of other exciting appointments by the Company this year. In June, Mr. Christopher M. Smith, a global leader in the hearing and medical device industries agreed to join the Board of Directors and in January, Professor Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience was appointed as Chief Scientific Officer.

Commenting on the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “We’re delighted to welcome Prof. Rich Tyler to Neuromod’s Clinical Advisory Board. Prof. Tyler is a world-renowned audiologist who has advanced our understanding of tinnitus and pioneered research into the development of treatments for tinnitus throughout his illustrious career. As a practising audiologist who continues to see and help a large number of tinnitus patients, Prof. Tyler’s insight and guidance will be invaluable as we prepare for the commercial roll out of our ground-breaking, home-use tinnitus treatment device.”

Prof. Tyler commented: “There are estimates of up to 30% of the population suffering from tinnitus and no one seems to want to help them. Many of these patients cannot sleep at night and take medications for anxiety and depression. I am excited to join Neuromod’s Clinical Advisory Board. Neuromod are working with leading tinnitus scientists and are taking an evidence-based approach to develop treatments for this large unmet clinical need. They have conducted some of the largest and most rigorous clinical trials to date in tinnitus. I am glad to play a part in helping them develop viable treatment options for the millions of patients living with this debilitating condition.”

About Professor Richard S. Tyler

Richard S. Tyler, Ph.D., M.Sc., was trained in Audiology and Psychoacoustics at the University of Western Ontario and the University of Iowa. He worked initially at the Institute of Hearing Research in the United Kingdom and is currently a Professor in both the Department of Otolaryngology – Head & Neck Surgery and in the Department of Speech Pathology and Audiology at the University of Iowa. Prof. Tyler has been a visiting scholar in China, South Africa, Australia, Sweden, Poland, Germany and France. He became interested in tinnitus early in his career while working with Professor Ross Coles. His scientific work includes the quantification of tinnitus, necessary for its investigation, as well as the investigation of different treatments. Prof Tyler has published over 270 articles and edited five books, including three books on tinnitus; the first textbook on tinnitus, a treatment protocol book for clinicians and a self-help book for patients.

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 home-use, non-invasive 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 National University of Ireland, Maynooth. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has conducted 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

Inflazome Completes €40m ($46m) Series B Financing to Develop NLRP3 Inflammasome Inhibitors to Clinical Proof-of-Concept

  • Financing led by Forbion, with Longitude Capital and founding investors, Novartis Venture Fund and Fountain Healthcare Partners, also participating

  • Funding to advance clinical trials of Inflazome’s pioneering orally-available NLRP3 inflammasome inhibitor compounds in several inflammatory diseases

  • NLRP3 is associated with harmful inflammation in a broad range of serious medical conditions including Alzheimer’s, Parkinson’s, inflammatory bowel disease, gout, osteoarthritis, liver, kidney and cardiovascular diseases

Dublin, Ireland and Cambridge, U.K. : Inflazome, a pioneering inflammasome company developing small molecule drugs that block harmful inflammation, today announces the successful completion of a Series B financing round of €40 million ($46 million). The financing round was led by Forbion, with Longitude Capital and founding investors, Novartis Venture Fund and Fountain Healthcare Partners, also participating.

Clinical and scientific data indicates that the NLRP3 inflammasome, a compelling biological target that regulates our innate immune response, is overactive in a broad range of serious medical conditions driven by harmful inflammation. These include neurological disorders such as Alzheimer’s and Parkinson’s as well as inflammatory bowel disease, gout, osteoarthritis, liver, kidney and cardiovascular diseases; conditions often inadequately treated by current therapies.

Inflazome is developing potent and selective small-molecule inhibitors of the NLRP3 inflammasome, to stop the cycle of chronic inflammation that drives such diseases. The Series B proceeds will be used to advance the Company’s first-in-class NLRP3 inflammasome inhibitors into multiple clinical trials in 2019, with next-generation compounds following thereafter.

Following the completion of the financing round, Dr Marco Boorsma, a General Partner at Forbion, and Dr David Hirsch, a Managing Director and Founder of Longitude Capital, have joined Inflazome’s Board of Directors.

Dr Matt Cooper, Co-Founder and CEO of Inflazome, commented: “We are very pleased to have secured a partnership with leading EU and US investors Forbion and Longitude and additional support from our founding investors, Novartis Venture Fund and Fountain Healthcare Partners. Forbion and Longitude have excellent track records of working closely with biotechs to drive R&D programs to successful clinical outcomes.”

Dr Marco Boorsma, General Partner at Forbion Capital Partners, commented: “Recognizing the important role of the inflammasome in many major diseases, we intensively screened the universe of companies active in this space. We decided to back Inflazome because of their leading position, deep understanding of inflammasome biology, foundational IP position and advanced and diversified pipeline of NLRP3 modulators. We were also highly impressed with the experience and knowledge of the Company’s Management Team and Board.”

Dr David Hirsch, Managing Director and Founder of Longitude Capital, added: “We’re excited by the potential of NLRP3 inhibitors and look forward to generating robust human proof of concept data with this financing.”

Inflazome Chairman, Dr Manus Rogan and Co-Founder and Managing Partner of Fountain Healthcare Partners, commented: “Due to the breadth of therapeutic applications, the market potential for a successful small molecule inhibitor of NLRP3 is clearly very significant. It has been exciting to have been involved in the Inflazome story since its inception and to follow our investment in one of the largest European venture capital backed financing rounds in the biotech sector this year.”

About Inflazome

Utilizing the scientific expertise of our founders and advisors, Inflazome is leading the way in developing rally available drugs to address clinical unmet needs in inflammatory diseases by targeting the NLRP3 inflammasome, which is now understood to drive many chronic inflammatory conditions. Headquartered in Dublin, Ireland, Inflazome was founded in 2016 by leading academics Prof. Matt Cooper, The University of Queensland (Australia) and Professor Luke O’Neill, Trinity College Dublin (Ireland), following a highly productive joint collaboration. For more information, please visit: inflazome.com

Mainstay Medical Announces Headline Results from ReActiv8-B Clinical Study

  • Responder rates at 120 days for treatment and active control groups were 56% vs. 47%; statistically significant difference on primary endpoint not achieved

  • Responder rates in both groups rose steadily from 120 days to one year; preliminary data for the 116 patients that have completed the one-year assessment, including those from the cross-over group, show:

  • 72% of patients achieved a 30% or greater reduction from baseline in low back pain VAS without increase in pain medications

  • 60% of patients achieved a 50% or greater reduction from baseline in low back pain VAS without increase in pain medications

  • 44% of the 50 patients that have completed the one-year assessment and were on opioids at baseline had voluntarily eliminated (28%) or significantly reduced (16%) their use of opioids

  • Incidence and type of adverse events (AEs) similar to AEs in clinical trials reported for other neurostimulation devices

Dublin, Ireland– Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical device company focused on commercializing ReActiv8®, an implantable restorative neurostimulation system designed to treat an underlying cause of disabling Chronic Low Back Pain, today announces headline results from its ReActiv8-B study.

The ReActiv8 B clinical study is an international, multi-center, prospective, randomized, active-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the U.S. Food & Drug Administration (FDA). A total of 204 patients were implanted with ReActiv8 at leading study centers in the U.S., Europe and Australia and randomized 1:1 to therapy or control 14 days after implant. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed-over to receive levels of electrical stimulation as in the treatment group.

The patients in the study had an average age of 46, and an average duration of chronic low back pain of 14 years. This patient population has tried many other treatment alternatives with limited success, and 80% of the patients were on pain medication at baseline.

Efficacy Outcomes

The primary efficacy endpoint of the study was a comparison of responder rates between the treatment and control groups as measured on the visual analog scale (VAS) of pain, with responders defined as having a 30% or greater improvement on this measure between baseline and 120 days after randomization, without any increase in pain medication taken in the two weeks prior to the primary endpoint assessment visit. In the treatment group the responder rate at 120 days was 56%, compared to 47% in the control group, resulting in a difference that is not statistically significant.

ReActiv8-B is the first ever active sham-controlled clinical trial of an implantable neurostimulator for chronic low back pain. The literature from other sham or placebo-controlled studies, involving drugs, device implants or other interventions, suggested that a responder rate of 20% or more could have been expected in the control group. The study design assumed a 25% responder rate in the control group.

“Our study involved surgically implanting a device into patients who had not previously received surgical implants, and further required the patient to activate the device twice daily to administer the therapy,” said Jason Hannon, Chief Executive Officer of Mainstay. “The study design underestimated the amount and duration of the sham effect under these conditions.”

“The overall results of this study, however, are a solid endorsement of the efficacy and safety of ReActiv8,” continued Mr. Hannon. “We saw very high responder rates in the patients in the treatment group that have reached one year of therapy, and substantial improvement in the patients that were crossed-over to treatment from the control group after 120 days. We believe these long-term results represent the most important clinical factors to physicians, and we plan to leverage these results in continuing to drive our commercial business under our existing CE Mark in Europe.”

Responder Rates Grow to 1 Year

Improvements in the percentage of patients reporting pain reduction continued beyond the 120-day assessment through one year for both groups. The percentage of the 56 patients in the treatment group that have completed the one-year assessment having a 30% or greater reduction in low back pain VAS at that assessment without an increase in pain medication was 75%. The percentage of the 60 patients in the cross-over group that have completed the one-year assessment having a 30% or greater reduction in low back pain VAS at that assessment without an increase in pain medication was 68%. The percentage of the 116 patients in the both groups that have completed the one-year assessment having a 50% or greater reduction in low back pain VAS at one year without an increase in pain medication was 60%. Substantial improvements in disability as measured by the Oswestry Disability Index (ODI) were also observed at one year. These data are subject to change as the remaining patients reach the one-year assessment.

“The totality of this data is encouraging for this large group of patients with limited treatment alternatives,” said Dr. Chris Gilligan, 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 study. “The data on the patients that have completed one year of therapy are important, particularly because these patients have not experienced meaningful pain relief from existing treatment options. The data showing 60% of patients experiencing a 50% or greater pain reduction at one year surpasses what many implanting physicians expect from implantable neurostimulation devices.”

Results Demonstrate Voluntary Decrease in Back Pain Medication Use

The protocol permitted patients to adjust their back pain medication usage after the 120-day assessment point. At one year, 44% of the 50 patients who were on opioids at baseline had voluntarily eliminated (28%) or significantly reduced (16%) their use of opioids. These results are subject to change as the remaining patients reach the one-year assessment.

Secondary Endpoints

For secondary endpoints, such as disability measured by the ODI and quality of life measured by the EQ-5D quality of life instrument, numerical improvements in the treatment group as compared to the control group were observed at 120 days. The Company is evaluating the clinical significance of those findings. The Company continues to analyze the efficacy data for the purpose of better understanding the performance of the device.

Device-Related Adverse Events in Line With Other Studies

ReActiv8 is implanted in a minimally invasive procedure utilizing techniques commonly used by our physician customer base in other procedures. The incidence and type of adverse events (AEs), including serious AEs, were comparable to AEs in clinical trials reported for other neurostimulation devices, with no unanticipated AEs related to the device, procedure or stimulation.

“The study showed a comparable safety profile to other implantable neurostimulation devices, including no migration of leads,” said Dr. Richard Rauck, 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. “This safety profile, combined with the efficacy data from this study and the lack of available alternatives for this patient population, suggest that ReActiv8 can be a promising therapy for patients with chronic low back pain.”

PMA Plan

“In summary, we believe the evidence of effectiveness and the favorable safety profile of ReActiv8 show considerable promise, particularly when compared to the response rates and safety profiles of alternative treatments,” continued Mr. Hannon. “We believe that the totality of the data will support the submission of a PMA application for ReActiv8 to the FDA. We plan to seek a pre-PMA meeting with the FDA in the coming months to obtain guidance on our filing content and strategy.”

Investor Conference Call & Webcast

Jason Hannon, Chief Executive Officer, will host a conference call and webcast with Q&A for analysts and investors to discuss the results from the study at 8:00am GMT (9:00am CET) on 19 November 2018. The call will be conducted in English. The webcast will be made available on Mainstay’s website at www.mainstay-medical.com on the News & Events tab. The presentation and webcast will be available on the Mainstay Medical website one hour before the call, and a replay will be available for 30 days.

About Mainstay

Mainstay is a medical device company focused on commercializing 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 is listed on the regulated market of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin (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 patients had baseline data collected and then following verification that the enrollment criteria were met, ReActiv8 was implanted. At the 14-day post implant follow up visit, half the patients were randomized to receive appropriately programmed stimulation (the treatment arm), and half were randomized to receive sham stimulation/low stimulation (the control arm). Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/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

Vivasure Medical Announces Launch of the PerQseal® Large-Bore Closure Device

The world’s first fully absorbable, patch-based large-bore percutaneous closure device is now available to European physicians and patients

GALWAY, Ireland - Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the European launch of the PerQseal® closure device for large-bore transcatheter procedures.

Novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), require large-bore femoral artery access. Closure of these large-bore access sites is challenging and has been associated with significant vascular and bleeding complications.

PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore arterial punctures. The PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state.

“Closing the artery has been a concern since we started using transcatheter techniques for valve implantation,” says Prof. Horst Sievert, of the CardioVascular Center in Frankfurt, Germany. “The PerQseal device is a very innovative solution for closing large holes, and we are enthusiastic to make it part of our armamentarium.”

“We’re excited that the PerQseal device is now widely available to European physicians, providing a safe and simple option for the closure of large puncture holes that leaves behind no sutures, metal implants, or collagen,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “This commercial launch is a key milestone for Vivasure as we journey to enable better patient outcomes in fully percutaneous large-bore endovascular procedures.”

“In my first clinical experience with PerQseal, I found the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully,” said Dr. Saib Khogali, Heart & Lung Centre, New Cross Hospital Wolverhampton, United Kingdom. “I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal® is not available for sale in the United States.

Contacts

Vivasure Medical

Sierra Smith, 408-540-4296

sierra@healthandcommerce.com

Inflazome: Validation of a new target in Parkinson’s Disease

Innovative research was funded by The Michael J. Fox Foundation for Parkinson’s Research and the Shake It Up Australia Foundation 

Dublin (IE), Cambridge (UK): Inflazome Ltd, (“Inflazome”) is a pioneering biotech company developing small molecule drugs that stop harmful inflammation by targeting inflammasomes. Research leading towards a potential approach to treat Parkinson’s patients was published today in Science Translational Medicine. The study was co-authored by Inflazome Co-founder and Chief Executive Officer, Prof. Matt Cooper with research teams at The University of Queensland, Australia, led by A/Prof. Trent Woodruff. Funding for these studies was provided by The Michael J. Fox Foundation for Parkinson’s Research and the Shake It Up Australia Foundation.

Parkinson’s disease is the second most common neurodegenerative disorder worldwide, affecting more than 10 million people. It is characterised by the loss of dopamine-producing neurons, accompanied by chronic inflammation in the brain. Inflazome has identified drugs to stop the chronic cycle of inflammation in the brain. The researchers found that the tool compound MCC950, a potent inhibitor of the NLRP3 inflammasome, given orally once a day could stop neuroinflammation. MCC950 arrested the effects of Parkinson’s in several animal models of the disease, leading to reduced brain neuron loss and higher levels of dopamine.

NLRP3 inflammasome activation drives chronic inflammation and is implicated in many diseases - from Parkinson’s and Alzheimer’s to Asthma, Inflammatory Bowel Disease, Chronic Kidney Disease, Cardiovascular Disease, Arthritis and the liver disease, NASH. Inflazome is developing orally available drugs to address clinical unmet needs in these inflammatory diseases by blocking the activation of inflammasomes in our immune system.

Prof. Matt Cooper, Co-founder and CEO of Inflazome, commented: “We are indebted to The Michael J. Fox and Shake It Up Australia Foundations for supporting this work. We also thank those generous individuals affected by Parkinson’s who donated samples to aid medical research. Drug companies have tried for decades to develop medicines to combat neurodegenerative diseases by blocking the many different neurotoxins and amyloids that build up in the brain as we age.”

“The problem is that if one toxin is blocked by a drug, another may still build up and cause disease. In contrast, our line of research focuses not on individual toxins, but instead on the immune cells in our brains that clear amyloid and other neurotoxins. These cells, called microglia, normally protect us from infections that can lead to encephalitis and meningitis. However, as we age our immune system can become over-activated, which leads to neuroinflammation. Over-active microglia can no longer function as efficient ‘cleaners’ of neurotoxins, but instead contribute to long-term damage in the brain.”

The progression of Parkinson’s disease was studied using brain and blood samples donated by patients for medical research. The study demonstrated a key target in microglia, called the NLRP3 inflammasome, is highly activated in Parkinson’s. The same signals produced by inflammasome activation in human brains were seen in different pre-clinical models of Parkinson’s disease. A small molecule, MCC950, prevented the progression of Parkinson’s in these animal models, leading to reduced brain cell loss, and higher levels of dopamine and motor function to effectively ‘cool the brain on fire’.

Prof. Cooper added “We look forward to progressing this research through to clinical trials using our proprietary, improved drug candidates”.

Kuldip Dave, PhD, Director of Research Programs at The Michael J. Fox Foundation said, “Inflazome has validated a promising new target for Parkinson’s therapeutics and translated that finding into a potential drug to treat Parkinson’s disease. This is a key aspect of The Michael J. Fox Foundation’s research strategy, and we look forward to their candidate drug’s continued development.”

“Shake It Up is proud and excited to be a part of the collaboration’s funding team, allowing highly-talented researchers an opportunity to create world leading breakthroughs that have the opportunity to be a game changer for people with Parkinson’s,” said Clyde Campbell, Founder and CEO of the Shake It Up Foundation.

The Science Translational Medicine paper can be found here

A link to an explainer video can be found here

About Inflazome

Utilizing 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 NLRP3 inflammasome, which is now understood to drive many chronic and acute inflammatory conditions from Parkinson’s and Alzheimer’s to Cardiovascular Diseases.

Headquartered in Dublin, Ireland, Inflazome was founded in 2016 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.

To learn more visit: inflazome.com

Contacts

Inflazome:

Dr Jeremy Skillington | VP Business Development

E: j.skillington@inflazome.com

Media:

Jonathan Neilan | FTI Consulting

E: jonathan.neilan@fticonsulting.com

Paddy Berkery | FTI Consulting

E: patrick.berkery@fticonsulting.com


Opsona Therapeutics Ltd. to present results on Tomaralimab study at the 60th Annual Meeting of the American Society of Hematology (ASH)

Opsona Therapeutics Ltd (‘Opsona’), today announces that it will give an oral presentation on results from its ongoing prospective, open label Phase I/II study being conducted with Tomaralimab (OPN-305), its novel proprietary humanized IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), in second and third-line lower (Low and intermediate-1) risk myelodysplastic syndrome (MDS). The presentation will take place on Dec 03rd 2018 at the 60th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

The study in transfusion-dependent patients with lower risk MDS who have failed hypomethylating agents is ongoing in collaboration with the MD Anderson Cancer Center in Houston, Moffitt Cancer Center in Florida, Weill Cornell in New York and Montefiore in the Bronx USA.

The lead principal investigator Professor Guillermo Garcia-Manero will present the data at ASH and commenting on today’s announcement said “Tomaralimab therapy presents a potential safe and efficacious therapeutic option for heavily pre-treated low risk patients that have failed HMA therapy.”

Myelodysplastic syndromes are a complex and heterogeneous group of bone marrow failure disorders characterized by ineffective hematopoiesis and poor prognosis. Transfusion dependent patients who have failed on HMA have a worse prognosis in terms of survival. The best standard of care for patients in the USA who have failed on HMA is repeated red blood cell transfusions which are associated with reduced Quality of Life outcomes.

There is an urgent need for the development of novel therapies in the treatment of MDS in patients who have exhausted other therapies and which can eliminate the need for red blood cell transfusions, delay progression, improve patient survival and overall quality of life.

Details of the presentation are as follows:

TITLE: A Clinical Study of Tomaralimab (OPN-305), a Toll-like Receptor 2 (TLR-2) Antibody, in Heavily Pre-Treated Transfusion Dependent Patients with Lower Risk Myelodysplastic Syndromes (MDS) That Have Received and Failed on Prior Hypomethylating Agent (HMA) Therapy

Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Prognosis and Prediction

Session Date: Monday, December 3, 2018

Session Time: 2:45 PM - 4:15 PM

Presentation Time: 4:00 PM

Room: Manchester Grand Hyatt San Diego, Grand Hall A

First publication of the abstract will be in the ASH online meeting program on November 1, 2018, at 9 a.m. EDT.

About Opsona Therapeutics

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

Contacts

Opsona Therapeutics

Mary Reilly (COO)

+ 353 16770223

mreilly@opsona.com