Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study in Chronic Low Back Pain Patients
22.11.2022 16:00:00 EET | Business Wire | Press release
Mainstay Medical Holdings plc today announced the publication of data from a single center, real-world study with one-year clinical follow-up of patients selected from the ReActiv8®-C study. Patients implanted with ReActiv8 at Klinikum Itzehoe were consecutively included into this cohort if they presented with back pain ≥6 and no prior lumbar surgery. The one-year results, published in World Neurosurgery, showed that a majority of the 44 patients followed up with demonstrated statistically significant improvements in pain (NRS), disability (ODI) and quality of life (EQ-5D-5L).
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221122005230/en/
(Graphic: Business Wire)
This interim analysis indicates that the response to ReActiv8 for these patients is durable and the benefits improve over time, consistent with both a restorative mechanism of action and the ReActiv8-B randomized clinical trial results.
Dr. Med. Ardeshir Ardeshiri, Head physician of the Spine Surgery Section of the Clinic for Trauma Surgery and Orthopedics, Klinikum Itzehoe, said: “These favorable real-world data are consistent with the ReActiv8-B study, which is extremely important for me in adopting new technologies. I am excited to continue offering restorative neurostimulation with ReActiv8 for my patients with multifidus dysfunction resulting in chronic axial low back pain.”
Jason Hannon, CEO of Mainstay Medical, said: "These real-world results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. German physicians have been some of our foremost implanters of ReActiv8, and we look forward to continuing to make the therapy more broadly available to patients in this region.”
Link to publication of the study Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain—a Consecutive Cohort Study - ScienceDirect
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who 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 .
Forward-Looking Statements
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 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 2021, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221122005230/en/
Contact information
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
Mainstay Medical
Corporate Communications
Email: Media@mainstaymedical.com
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
Murata’s Releases Technology Guide to Enhance Power Stability in AI-driven Data Centers4.2.2026 04:00:00 EET | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has launched a new technology guide entitled: ‘Optimizing Power Delivery Networks for AI Servers in Next-Generation Data Centers.’ Available on the company’s website, the guide introduces specific power delivery network optimization solutions for AI servers that enhance power stability and reduce power losses across the data center infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203101664/en/ [Murata Manufacturing Co., Ltd.] Technology guide to enhance power stability in AI-driven data centers The guide addresses the rapid advancement and adoption of AI, a trend driving the continuous rollout of new data centers worldwide. As the industry moves toward higher voltage operations and increased equipment density, the resulting increase in overall power consumption has made stable power delivery a critical business issue for data center operators.
The Global Photonics Community Converges in San Francisco as More Than 23,000 Register for Photonics West 20263.2.2026 23:14:00 EET | Press release
SPIE, the international society for optics and photonics, brought the global optics and photonics community to San Francisco, California, for another successful and enlivening Photonics West. With more than 23,000 registrants, the annual conference and exhibition connected attendees from 40 countries, showcasing the transnational and collaborative spirit of the interdisciplinary industry. The dynamic event ran from 17 to 22 January, with 4,200 technical presentations across 100 conferences, 4 stages of industry-focused panels and presentations, 49 courses, and approximately 1,600 exhibitors in the five expos: Photonics West, BiOS, Quantum West, AR | VR | MR, plus, in its inaugural year, Vision Tech. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203925940/en/ Attendees of the 2026 SPIE Photonics West fill the Moscone Center, where nearly 1,600 exhibitors showcased their products. With an emphasis on the application of adv
Vena To Acquire Acterys, Creating a New Category of Enterprise Performance Management: Orchestrated Planning3.2.2026 18:00:00 EET | Press release
Vena, the only complete FP&A platform powered by agentic AI and purpose-built to amplify the Microsoft technology ecosystem, today announced it has entered into a definitive agreement to acquire Managility Pty Ltd, operating as Acterys (“Acterys”), the industry’s leading Power BI–based operational planning and app development platform, subject to customary closing conditions and regulatory approval. This acquisition unlocks a category-defining way for enterprises to combine planning, analytics, and application development within the Microsoft tools they already trust to run their business. By combining Vena’s Excel-native financial planning and analysis (FP&A) capabilities with Acterys’ proprietary Power BI write-back engine and unified analytics within Microsoft Fabric, Vena is creating the first Microsoft-native environment for Orchestrated Planning, an operating model that moves organizations beyond integrated planning into fully orchestrated and agentic AI-powered execution. Orches
Volante Technologies named a Leader in Gartner® Magic Quadrant™ for Banking Payment Hub Platforms3.2.2026 17:15:00 EET | Press release
Volante Technologies, the global leader in Payments as a Service (PaaS), today announced its recognition as a Leader in the 2026 Gartner® Magic Quadrant™ for Banking Payment Hub Platforms, which evaluates vendors based on Ability to Execute and Completeness of Vision. In Volante’s view, Gartner positioned them as a Leader based on their capacity to support enterprise-scale payment processing in banks and financial institutions across multiple regions, deployment models, and operational environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203149834/en/ This graphic was published by Gartner, Inc. as part of a larger research document and should be evaluated in the context of the entire document. As the highest positioned provider in Ability to Execute, Volante believes its AI-poweredPayments Platform is ISO 20022 native and provides complete, always-on, and composable payment processing support and can be deployed p
Toptal Ranked #1 Most Reliable Professional Services Company in America by Newsweek3.2.2026 17:00:00 EET | Press release
Toptal, the world’s largest fully remote workforce, has been ranked the #1 most reliable professional services company in America on the America’s Most Reliable Companies 2026 list by Newsweek and Statista. The list ranks top US companies based on trust, dependability, and consistent performance in their industry. In Newsweek’s ranking of 300 companies across all industries, Toptal took 10th place, right behind Bank of America and Oracle, which tied for 9th. As the most reliable professional services organization in America, Toptal, which ranked 11th in absolute rankings across all companies, placed well ahead of companies like Accenture (33), Deloitte (39), and Cognizant (66). The America’s Most Reliable Companies 2026 ranking is based on an independent survey of more than 80,000 evaluations submitted by 2,400 business decision-makers at America’s largest companies, including Apple, Dropbox, Johnson & Johnson, and UPS, making this recognition an especially meaningful indicator of prod
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