Mainstay Medical

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

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

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.

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

Mainstay Medical Announces 2018 Half Year Financial Results and Business Update

  • ReActiv8-B study on track – full data readout expected towards the end of 2018

  • Successfully completed financing of $37.5m (€30m) to fund completion of ReActiv8-B study and advance European commercialization

  • Cash on hand of $29.7m at 30 June 2018

Mainstay Medical International plc, 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 the publication of its results for the Half Year ended 30 June 2018 and provides a company update.

Jason Hannon, CEO of Mainstay, said: “The recent period has seen us make significant progress across the business. We announced completion of all implants in the ReActiv8-B study and remain on track to have full data towards the end of 2018. This is a significant step as we continue to build momentum in our efforts to bring ReActiv8 to patients in the U.S.

“We are dedicated to making rapid progress in Germany, our first commercial market. Starting in March of this year we refined our commercial strategy, repositioned our sales team, focused the training of our new and existing sales team members, and increased our communication to potential implanting physicians. We also appointed a new Managing Director with responsibility for growing the commercial business in Germany, building relationships with key implanting physicians, and growing our team with experienced sales people who are capable of rapidly expanding ReActiv8 in the market.

In recent months we have seen encouraging signs that these initiatives are working. Importantly, we remain on track to meet our target of having 10 or more physician partners performing multiple implants by the end of this year. We believe this momentum will set us up for more meaningful commercial expansion in 2019 as more customers begin to adopt and get comfortable with selecting the appropriate patients for the therapy.”

Business Update

  • During the first half of 2018, significant further progress was made in Mainstay’s pivotal IDE clinical study, ReActiv8-B, which is intended to gather data in support of a pre-market approval (PMA) application to the FDA, a key step towards the commercialization of ReActiv8 in the U.S. Completion of all implants was announced at the start of the third quarter of 2018. A total of 204 patients were implanted in the study, reflecting the strength of interest in study participation. The completion of implants in the clinical study means the Company remains on track to announce full data towards the end of 2018.

  • 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 March 2018, post our financing announced in February 2018, and are gaining traction. The rates of implants and new implanting sites have increased sharply in July and August 2018 as compared to the first six months of the year.

  • Wolfgang Frisch was appointed VP and Managing Director for Germany on 20 June 2018. Mr. Frisch has over 30 years’ experience in the medical technology industry and will be instrumental in continuing to drive the commercial strategy forward, with a focus on adoption in a select number of high volume spine care centers.

  • Matthew Onaitis was appointed Chief Financial Officer, effective 20 August 2018, bringing with him more than 20 years of experience working with dynamic healthcare businesses and deep knowledge of financing innovative growth companies like Mainstay.

Financial Update

  • 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. The funds are being used to complete the ReActiv8-B clinical study, advance the initial commercialization of ReActiv8 in Germany and other markets and invest in early commercial activities in preparation for launch in the U.S.

  • Revenue during the six-month period ending 30 June 2018 was $0.4 million ($0.3 million in 1H17).

  • Operating expenses were $15.8 million ($12.3 million in 1H17). This increase was driven primarily by costs relating to the ReActiv8-B study and associated with commercialization efforts.

  • Cash on hand at 30 June 2018 was $29.7 million (31 December 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 recognized root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine in the low back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.

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

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

Mainstay Medical Announces the Appointment of Matthew Onaitis as Chief Financial Officer

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and 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, announces the appointment of Matthew Onaitis as Chief Financial Officer, effective August 20, 2018.

Mr. Onaitis has worked with dynamic healthcare businesses for 20 years, ranging from global multinationals including Biogen Idec and Elan Pharmaceuticals, to innovative specialty pharmaceutical companies such as Ignyta, Trius Therapeutics, and Somaxon Pharmaceuticals. He most recently served as Chief Financial Officer of Cidara Therapeutics (NASDAQ: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies. During his tenure at Cidara, the company raised over $185 million and successfully progressed its lead program into late-stage clinical trials. Cidara is one of four publicly-traded healthcare companies at which Mr. Onaitis has been a senior executive. His experience includes building finance teams, leading numerous public and private financings, mergers and acquisitions and strategic collaborations, and the management of finance, accounting, business development, manufacturing, legal, and human resource functions.

Jason Hannon, CEO of Mainstay, said: “I am delighted Matt is joining Mainstay as we continue to build the business, expand our geographic reach and move towards the potential launch of ReActiv8 in the US. His breadth of experience, as well as his deep knowledge in financing innovative growth companies like ours, are the very skills Mainstay needs at this stage of its growth. Matt has also demonstrated an excellent cultural fit with Mainstay, which will be key as he builds relationships with our customers, employees and investors, who share a strong belief in our ability to create and rapidly grow the market for ReActiv8.”

Matt Onaitis said: “I am very excited by Mainstay’s ReActiv8 technology and its potential to address an underlying cause of chronic low back pain. I have been impressed by the Company’s progress and look forward to joining the team as we prepare for the completion of the US clinical study, expansion of the commercial business in Germany and additional markets, and the eventual launch in the US.”

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

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

Mainstay Medical announces the completion of all implants in the ReActiv8-B Study

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and 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, announces the completion of all implants in ReActiv8-B, its US IDE clinical study.

A total of 204 patients were implanted in the study, reflecting the strength of interest in study participation. The implants were completed in accordance with the Company’s planned timeline and the Company expects to announce a full data readout towards the end of 2018.

Jason Hannon, CEO of Mainstay, said: “Completing all implants in the ReActiv8-B study is a significant step for Mainstay and represents continued momentum in our efforts to bring ReActiv8 to patients in the US. We remain on track to have full study data towards the end of 2018. I would like to thank the study participants and investigators for their participation -- we look forward to announcing the results of the study later this year.”

ReActiv8-B is an international, multi-centre, prospective, randomized, sham-controlled triple-blinded study with one-way crossover, conducted under an IDE from the US Food & Drug Administration (FDA). The study is intended to gather data in support of a pre-market approval (PMA) application to the FDA, a key step towards the commercialization of ReActiv8 in the US. The study utilizes an adaptive trial design, inclusive of an interim analysis. In December 2017 the Company announced a positive outcome of the interim analysis.

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

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

 

Mainstay Medical Appoints Wolfgang Frisch as VP and Managing Director for Germany

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and 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, announces that it has appointed industry veteran Wolfgang Frisch as Vice President and Managing Director for Germany, effective 2 July.

Mainstay Medical has launched ReActiv8 in Germany, its first commercial market. Commercialization began in earnest over the last few months, following the Company’s fundraising that was completed in February 2018. Mr. Frisch will be instrumental in driving the commercial strategy forward, with a focus on adoption in a select number of high volume spine care centers to develop reference sites.

Mr. Frisch has over 30 years’ experience in the medical technology industry, including 20 years in leadership positions in sales, market access, market development, and general management positions, having spent a combined 15 years with Stryker and Medtronic. He most recently served on the executive board of Medtronic Germany, where he was also managing director for the strategic and tactical deployment of the sales organization in the entirety of Germany.

Jason Hannon, CEO of Mainstay, said: “I am delighted to announce that Wolfgang will be joining us as Managing Director for Germany. It is reflective of the clinical and market opportunity of ReActiv8 that we are able to attract a leader of Wolfgang’s caliber. Wolfgang will be instrumental in growing our commercial business in Germany, building clinical data around the commercial experience, and developing key reference sites throughout Germany who reflect their experience with ReActiv8 to the rest of the world.”

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

Press Release
Further information can be found at www.mainstaymedical.com
 

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

Update on Regulatory Application for ReActiv8 in Australia

Dublin, Ireland: Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today provides an update on its application for the admission of ReActiv8 to the Australian Register of Therapeutic Goods (ARTG), which the Company filed in January 2017.

 

The Therapeutic Goods Administration (TGA) has requested additional clinical data with respect to ReActiv8. To provide the most meaningful clinical data possible, we intend to rely on the clinical data being gathered as part of the ongoing ReActiv8-B clinical study. As stated previously, this clinical study is expected to be fully enrolled by the end of the second quarter of 2018, with a full data readout expected towards the end of 2018. Upon availability of the ReActiv8-B data, we plan to submit a new application to the TGA seeking admission of ReActiv8.

 

The Therapeutic Goods Administration may request additional information during the review process. Review of an application for admission of a product to the ARTG has varied historically. The TGA is required to complete assessment of applications within approximately one year.

 

About Mainstay

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

About Chronic Low Back Pain

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


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

Further information can be found at www.mainstaymedical.com

Mainstay Medical Publishes 2017 Full Year Results

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, announces today the publication of its 2017 Full Year results and Annual Report.


Business Update

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



Financial Update

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

– End –

About Mainstay

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

About Chronic Low Back Pain

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

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

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

Mainstay Medical Announces €30 million Financing

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

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

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

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

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

 

Business Update

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

 

Investors in the Financing

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

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

 

Specific information regarding the Financing

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

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

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

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

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

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

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

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

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

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

 

About Mainstay

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

 

About Chronic Low Back Pain

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

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

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

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

PR and IR Enquiries:

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

FTI Consulting (for Ireland):
Jonathan Neilan Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
 

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

Investor Relations:
LifeSci Advisors, LLC

Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com

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

 

 

 

 

 

Mainstay Medical Announces Positive Outcome of Interim Analysis

Jason Hannon, CEO, to host business update call

 

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

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

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

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

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

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

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

 

Investor Conference Call and Business Update

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

Dial-ins for the call are outlined below:

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

Participant PIN: 65178331#

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

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

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

 

About Mainstay

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

 

About the ReActiv8-B Study

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

 

About Chronic Low Back Pain

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

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

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

 

 

Mainstay Medical Announces Jason Hannon Joins Board of Directors

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

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that following the announcement of his appointment on 5 September, 2017, Mr. Jason Hannon has today taken up his role as CEO and been appointed as a Director of Mainstay.

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

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

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

Mainstay Medical Announces Half Year Financial Results

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

Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (CLBP), today announces the publication of its report for the Half Year ended 30 June 2017.

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

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


Business Update:

  • The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham-controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). It is intended to gather data in support of an application for pre-market approval (PMA) from the FDA, a key step towards the commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

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

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

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

Financial Update:

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


About Mainstay

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


About the ReActiv8-B Clinical Trial

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


About Chronic Low Back Pain

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

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

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

Mainstay Medical Announces CEO Leadership Transition

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

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that Mr. Jason Hannon will succeed Mr. Peter Crosby as Chief Executive Officer with effect from October 9, 2017. Mr. Hannon’s appointment results from the Company’s succession planning associated with the retirement of Mr. Crosby at the end of October, 2017. Mr. Hannon will also be appointed as a Director with effect from October 9, 2017.

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

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

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

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

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

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


ADDITIONAL INFORMATION:

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

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

Previous Directorships:

Nemaris, Inc.

- End –

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


About Mainstay

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


About the ReActiv8-B Clinical Trial

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

 

About Chronic Low Back Pain

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

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

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

Mainstay Medical’s ReActiv8-B Clinical Trial Passes Mid-point

Trial on target to complete enrolment around end 2017

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.

The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the US. Information about the trial can be found at https://clinicaltrials.gov/show/NCT02577354.
 
69 subjects have been implanted with ReActiv8 in the trial. The trial design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re‑estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.
 
ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from CLBP. Mainstay received CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling CLBP and few other treatment options. Mainstay has begun commercialization in Europe, focusing initially on Germany, where the Company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centers. More recently, commercialization has begun in Ireland, Mainstay’s home market.

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

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

ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled triple blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit. Total number of subjects implanted will also include some enrolled and implanted as part of the surgical roll-in phase, in addition to subjects in the pivotal cohort. The Trial is designed with an “interim look” for sample size re-estimation when primary outcome data are available from half the subjects in the pivotal cohort, and if necessary the number of subjects in the pivotal cohort may be increased to achieve the targeted statistical significance. The interim analysis will be performed by a third-party independent statistician under the direction of the Data Monitoring Committee (DMC), and the interim results, other than a DMC recommendation regarding the findings, will remain blinded to the Company, study subjects, investigators and Clinical Trial sites.
 
The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1A Evidence of efficacy of ReActiv8, which may be used to support applications for favorable reimbursement in the USA. Evidence from the ReActiv8-B Trial will also be used to support market development activities worldwide.

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

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

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

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

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

 

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

Dublin, Ireland – Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces the first sale and implant of ReActiv8 in Ireland.

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

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

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

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

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

 

About Mainstay
 

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

 

About Chronic Low Back Pain

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

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

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

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

Mainstay Medical Publishes 2016 Full Year Results and Business Update

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable restorative neurostimulation system to treat people with disabling Chronic Low Back Pain (“CLBP”), announces today the publication of its 2016 Annual Report.
 

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


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


Business Update

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


Financial Update

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

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

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

Outlook

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

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


About Mainstay

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

About Chronic Low Back Pain

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

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

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

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

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

First sale and implant in Germany following CE Marking
 

Mainstay Medical International plc ("Mainstay" or the "Company", Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain ("CLBP"), today announces the first sale and implant of ReActiv8 in Germany.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mainstay Medical Applies for Approval to Market ReActiv8® in Australia

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

 

Dublin, Ireland -  Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable neurostimulation system to treat disabling Chronic Low Back Pain (“CLBP”), announces that it has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialization in Australia.


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

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

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

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

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

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

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

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

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

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

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

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

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

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