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
OPEX® Corporation Offers a Simplified, One-Touch Document Scanning Solution with the Introduction of Axis™6.10.2026 11:00:00 EEST | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, has announced the launch of Axis™, a new document scanner that brings the benefits of one-touch scanning to a simplified, single-bin configuration. Designed for document capture workflows where minimal document preparation, mixed media handling or operational simplicity are priorities, Axis bridges the gap between OPEX’s desktop scanner series and its multi-bin production scanner portfolio. “We developed Axis in direct response to market demands,” said Dann Worrell, President, Document and Mail Automation, OPEX. “Our customers want to simplify their scanning processes, reduce operating costs, and improve quality. Axis delivers on these priorities by combining our minimal-prep, One-Touch scanning technology with a single-bin design. With a lower market accessible entry point, Axis helps customers process documents more efficiently while achieving m
Rothera Goes Live on Smartstream’s Air to Automate High-Volume Derivatives Reconciliations6.10.2026 11:00:00 EEST | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announced that Rothera, the U.S.-based CFTC-regulated event contract market, has gone live on Smartstream’s Air. Rothera has deployed Smartstream’s Cash and Data modules to automate high-volume derivatives reconciliations across its CFTC-regulated exchange and clearinghouse business. As transaction volumes on the exchange grew, Rothera sought to scale and automate its existing reconciliation processes to support greater operational efficiency and robust audit controls. To support this growth, Rothera selected Air’s Cash and Data modules as a new implementation. The AI-powered platform ingests, matches, and reconciles high-volume data flows with minimal manual intervention, providing a fully audited environment aligned with regulatory obligations of a CFTC-regulated venue. Following an initial go-live for two data reconciliations: Exchange-to-Clearing Instruments and Exchang
Convatec Survey Challenges Assumptions About Leakage in Ostomy Care6.10.2026 10:00:00 EEST | Press release
Convatec, a leading medical products and technologies company focused on solutions for the management of chronic conditions, today released Rethinking leakage in ostomy care, new international research highlighting a significant gap in how peristomal skin health is understood and managed in ostomy care. The findings indicate that skin health plays a critical role in preventing leakage, and supporting confidence in daily life, yet remains widely under-recognised in routine care. For many people, leakage is not only a clinical or product issue; it can shape whether they feel able to travel, exercise, socialise or take part fully in everyday life. More than half of respondents said they avoid such activities due to worry about their ostomy. The results of the survey, which included more than 1,800 people living with an ostomy and over 400 healthcare professionals, point to a significant opportunity to improve outcomes through greater focus on peristomal skin health, the specific area of s
Oulu2026 Boosts Tourism as Björk, Art and Technology Lead the European Capital of Culture Year’s Finale6.10.2026 10:00:00 EEST | Press release
The Oulu2026 European Capital of Culture programme has attracted visitors to northern Finland and contributed to strong tourism growth. According to Visit Oulu statistics, Oulu recorded nearly 475,000 registered overnight stays between January and August 2026, an increase of 12 per cent year on year. International overnight stays rose by 21 per cent to more than 96,600, while domestic overnight stays increased by 9 per cent. The trend continued in August, when international overnight stays grew by almost 29 per cent year on year. Hundreds of events combining art, technology, science, music, theatre and sport continue throughout the final months of 2026. “The programme’s diversity is clearest in the final months. There is something for culture enthusiasts and families alike, with experiences that cannot be found anywhere else. If ever there was a time to visit Oulu, it is now,” says Samu Forsblom, Programme Director of Oulu2026. A major highlight is the Lumo Art & Tech Festival, taking
Ant International and HSBC Expand Real-Time Treasury Management Services to the Middle East6.10.2026 09:30:00 EEST | Press release
Ant International today announced an expanded collaboration with HSBC to enhance real-time treasury management services in the Middle East. By leveraging HSBC’s global Tokenised Deposit Service (TDS), Ant International aims to improve the efficiency of its treasury operations across the region. As part of the collaboration, Ant International has successfully completed pilot transactions across two payment corridors connecting the United Arab Emirates and Hong Kong: Intra-UAE dirham transfers: Real-time, dirham-denominated tokenised deposit transactions within the UAE. Cross-border US dollar payments initiated from the UAE: US dollar-denominated tokenised deposit transfers between the UAE and international markets, including Hong Kong and Singapore. These transactions were initiated via WhaleRTP – Ant International’s proprietary, blockchain-based real-time treasury management platform – and executed in real-time through HSBC’s TDS. Ant International and HSBC jointly designed the transac
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