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
RS2 Financial Services GmbH Selected to Participate in ECB Digital Euro Pilot14.7.2026 15:22:00 EEST | Press release
RS2 Financial Services GmbH, an electronic money institution supervised by BaFin and part of the RS2 Group, operating under its innovation brand Beyond by RS2, has been selected to participate as an acquiring payment service provider in the Eurosystem’s digital euro pilot. The pilot marks the transition from technical preparation to practical validation, testing how a potential digital euro could function in everyday consumer and merchant payment scenarios. According to the official announcement of the European Central Bank, RS2 Financial Services GmbH is one of 36 payment service providers selected to participate in the programme. The participating organisations reflect a range of institution sizes, business models and markets across the euro area. RS2 Financial Services GmbH will contribute its expertise in acquiring and merchant payments to the pilot, leveraging the RS2 Group’s cloud-native payment technology and technical capabilities to support pilot execution. The Eurosystem plan
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 15:00:00 EEST | Press release
Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 2026,” said Marcello Allegretti, Chief Scientific Officer at Dompé. “Dosing the first patient in our NAION trial marks a critical step in our mission to unlock the full potential of NGF. By advancing our proprietary intranasal NGF in clinical investigation, we are taking a bold, non-invasive approach that bypasses the blood-brain barrier and has the potential to redefine the standard of care.” NAION refers to a loss of blood flow to the optic nerve which causes rapid vision loss that u
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world applications that demonstrate the growing impact of geographic information system (GIS) technology. The first two other books starting the collection are Geowater: A Geographic Approach to Water Data and Forecasting and Parcels: How Property Shapes Geography. Together, these titles illustrate how spatial thinking and GIS are transforming how organizations understand systems, manage resources, and plan for the future. The Power of Where Collection reflects Esri’s ongoing commitment to helping organizations make smarter, more informed decisions across industries—on topics ranging from water sustainabi
Esri Helps Bring Up-to-Date Road Closure Information to Google Maps and Waze14.7.2026 15:00:00 EEST | Press release
Esri has expanded its Community Maps Program, enabling road closure data to be shared with Google Maps and Waze. The Road Closures solution, in Esri's ArcGIS platform, was introduced last year as a way for users to easily share road closure updates directly with popular consumer mapping providers so they can update their maps with this important information. The solution aimed to bridge the gap between government agencies managing timely road updates and the public, who rely on mapping apps for real-time navigation. Over 100 communities around the United States and other countries are actively sharing their road closure information. ArcGIS users can now easily share that same authoritative data with Google Maps and Waze via the Waze for Cities program. "For over a year, we've been working with dozens of our local government users to share their road closure information with our initial consumer mapping partners, Apple Maps and TomTom," said Deane Kensok, chief technology officer for Ar
CE-IVDR Mark for Hologic’s Aptima ® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 15:00:00 EEST | Press release
Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25% to 80%, with some showing stagnation or decline in recent years.3 “Despite the benefits of cervical cancer screening, there are still barriers
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