Mainstay Medical Announces Completion of Enrollment of RESTORE Clinical Trial of ReActiv8® in the United States
Mainstay Medical Holdings plc today announced the completion of enrollment in its RESTORE randomized clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimized medical management for the purpose of testing the hypothesis that the addition of ReActiv8 Restorative Neurostimulation therapy to current care paradigms results in significant improvements in back pain-related disability.
The RESTORE (ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation) clinical study is a prospective, randomized controlled trial conducted at 25 leading centers in the U.S. Eligible patients were randomized to either continue with their optimal medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. The Co-Principal Investigators of the RESTORE study are Dr. Frank Schwab, Chair of Orthopedic Spine Surgery at Lenox Hill Hospital and Chief of Orthopedic Spine Surgery for Northwell Health System; Dr. Chris Gilligan, Director of the Spine Center at Brigham and Women’s Hospital and assistant professor of Anesthesia at Harvard Medical School; and Dr. Kiran Patel, Director of Pain Medicine, Lenox Hill Hospital and Founder & CEO, NYC Neuromodulation Center of Excellence.
Jason Hannon, CEO of Mainstay Medical, stated: “We are proud to have reached this important milestone in the RESTORE clinical trial as we continue to demonstrate the clinical efficacy and positive economic impact of ReActiv8. We expect the initial data readout from the study in the second half of 2024, and we look forward to sharing the data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy. I would like to thank Dr. Frank Schwab, Dr. Chris Gilligan, and Dr. Kiran Patel for acting as Co-Principal Investigators of this important study, as well as each of the enrolling sites and all of the participating patients.”
“This type of randomized, controlled clinical trial in this difficult-to-treat and underserved patient population will produce high-quality data comparing ReActiv8 to the current standard of care,” said Drs. Frank Schwab, Chris Gilligan, and Kiran Patel, Co-Principal Investigators of the RESTORE study . “Once the data is published, it will meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establish the role of this therapy in treating mechanical low back pain patients .”
Drs. Schwab, Gilligan, and Patel continued: ”The RESTORE trial represents a substantial addition to the clinical evidence behind treatment options for this patient population who have extremely limited options beyond temporary palliative treatments and drugs. Directly addressing the underlying issue of muscular dysfunction can represent a substantial advancement in treatment options. We would like to express sincere thanks to the patients who agreed to be screened for this study, the trial investigators and their hard-working staff, and the Mainstay team for their passion and commitment to the program. We look forward to the results of this trial to prove the degree to which ReActiv8 can improve the lives of these patients above and beyond what is currently used to treat them.”
About the RESTORE Clinical Study
The RESTORE clinical study is a multi-center, prospective, randomized trial with one-way cross-over. A total of 226 patients were randomized in the study at 25 leading centers in the U.S. Eligible patients were randomized to either continue with their optimal medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. Assessment of the patients will continue for an additional year.
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.
Further information can be found at www.mainstaymedical.com.
All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s research studies and results, commercial efforts and performance, financial position, financing strategies, product design and development, regulatory applications and approvals, and reimbursement arrangements.
Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
PR and IR Enquiries:
LifeSci Advisors, LLC
Tel: + 1 (212) 915-2578
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SLB Announces Third-Quarter 2023 Results Conference Call22.9.2023 20:00:00 EEST | Press release
SLB (NYSE:SLB) will hold a conference call on October 20, 2023 to discuss the results for the third quarter ending September 30, 2023. The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 8858313. A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until November 20, 2023, and can be accessed by dialing +1 (866) 207-1041 within North America or +1 (402) 970-0847 outsid
Energy Dome's CO2 Battery™ to Revolutionize U.S. Energy Landscape With First Installation Slated for 202622.9.2023 18:45:00 EEST | Press release
A groundbreaking development in sustainable energy storage is on the horizon for Columbia County, Wisconsin, U.S., spearheaded by Alliant Energy in collaboration with Energy Dome and other key stakeholders. Alliant Energy has just announced its selection to receive a federal grant of up to approximately $30 million from the U.S. Department of Energy's Office of Clean Energy Demonstrations (OCED) for the pioneering Columbia Energy Storage Project, a proposed 200-megawatt hour energy storage system, based on Energy Dome’s signature technology: the CO2 Battery™. This visionary battery system, aptly named the “Columbia Energy Storage Project”, is poised to be a trailblazer in the United States, marking a pivotal stride towards a more sustainable, reliable, and cost-effective energy future. Claudio Spadacini, CEO of Energy Dome, declared: “I’m honored to be part of this remarkable journey alongside Alliant Energy. The Columbia Energy Storage Project marks the genesis of a new era, where the
Settlement Administrator Angeion Group Announces Proposed Settlement In U.S. Dollar LIBOR-Based Instrument Class Action22.9.2023 16:00:00 EEST | Press release
There are lawsuits impacting individuals and institutions that entered into over-the-counter financial derivative and non-derivative instruments directly with 17 banks and that received payments tied to U.S. Dollar LIBOR. A Settlement totaling $101 million has been reached with Coöperatieve Rabobank U.A. (“Rabobank”), Lloyds Banking Group plc, Lloyds Bank plc, HBOS plc, and Bank of Scotland plc (together, “Lloyds”), Royal Bank of Canada (“RBC”), and Portigon AG and Westdeutsche Immobilien Servicing AG (together “Portigon”). Earlier settlements totaling $680 million were reached with Barclays, Citibank, Deutsche Bank, HSBC, MUFG, Norinchukin, and SocGen bringing the total settlement amount to $781 million. The remaining Non-Settling Defendants include Bank of America, Credit Suisse, JPMorgan Chase, Royal Bank of Scotland, and UBS. What does the Settlement provide? The Settlement will create a Settlement Fund totaling $101 million that will be used to pay eligible Class Members who submi
Kenvue to Announce Third Quarter 2023 Results on October 26, 202322.9.2023 13:30:00 EEST | Press release
Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, will announce its financial results for the third quarter ending October 1, 2023, before market open on October 26, 2023. The company will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its third quarter results. The conference call can be accessed by dialing 877-407-8835 from the U.S. or 201-689-8779 from international locations. A live webcast of the conference call will be available at https://investors.kenvue.com. A replay will be available approximately two hours after the live event. About Kenvue Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage, our iconic brands, including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena® and Tylenol®, are science-backed and recommended by healthcare professionals around the world. At Kenvue, we believe in the extraordinary
OS Achieves 800-Puff Milestone with FEELM Max Technology22.9.2023 12:34:00 EEST | Press release
A significant mark in the vaping industry was set when OS Vape, a pioneering disposable product series from OS, showcased its dynamic range at the InterTabac from September 14th to 16th in Germany. Recognized as a leading brand in Germany's shisha product market, OS boasts an extensive local network of channels. Drawing upon this rich resource base, OS's foray into the disposable e-cigarette domain promises consumers enhanced puff counts, cost-efficiency, and unparalleled vapor consistency. As revealed by Future Marketing Insights, Europe's disposable market witnessed a substantial surge, accounting for a 32.3% revenue share in 2022. This robust growth underscores the escalating consumer preference for hassle-free, smokeless alternatives that eliminate the need for recharges or refills. The evolution of the disposable sector brings heightened convenience and a broader array of choices for consumers. Capitalizing on this trend, OS, through its innovative product series and leveraging it
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom