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
AOP Health on Rare Diseases: Information. Collaboration. Innovation.23.2.2026 11:00:00 EET | Press release
Between 27 and 36 million1 people in Europe are living with a rare disease, yet only around six percent currently have access to an approved treatment2. Progress in diagnosis and treatment is often slowed by knowledge gaps, including the lack of clear, reliable, and patient-friendly information needed to support informed decision-making. Drawing on 30 years of experience in researching and developing therapies for rare diseases, AOP Health underscores the importance of collaboration across the healthcare community. On Rare Disease Day 2026, the company joins healthcare professionals, researchers and patient representatives in highlighting the need for closer cooperation to generate, share and better use scarce data to improve care for people living with rare diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223167500/en/ Rare Diseases: Collaboration is key. image: AdobeStock_1308212316 “Working in rare diseases sin
ŌURA Named Official Wearable of Team Finland23.2.2026 10:00:00 EET | Press release
ŌURA, maker of the world’s leading smart ring, Oura Ring, today announced a long-term partnership as the Official Wearable of Team Finland. As the exclusive provider in the category of continuous health and fitness tracking devices, ŌURA will equip Team Finland Olympic athletes with Oura Ring beginning immediately and continuing through the LA28 Olympic Games and the French Alps 2030 Winter Games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223559508/en/ Team Finland delivered a strong showing on the world stage at the Olympic Winter Games Milano Cortina 2026, capturing a total of six Olympic medals across a range of winter sports. During the Games, many Finnish athletes wore Oura Ring to help manage their performance and recovery. The partnership marks the start of a multi-year collaboration focused on supporting athlete preparation, recovery, and overall wellbeing across two Olympic cycles. “At ŌURA, we believe susta
AHS Tower Fully Sold During Development, Generating More Than USD 700 Million23.2.2026 09:55:00 EET | Press release
AHS Properties has confirmed that 100 percent of inventory at AHS Tower has been sold, generating more than USD 700 million in revenue during the development phase, a clear indicator of strong market demand for its flagship commercial project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260222540070/en/ AHS Tower Fully Sold During Development on Sheikh Zayed Road (Photo: AETOSWire) Rising 69 storeys above Sheikh Zayed Road, the tower is positioned within minutes of DIFC and the Museum of the Future. Designed by internationally acclaimed architecture firm Killa Design, with interiors by AHS Atelier, it represents a defining step in AHS Properties’ expansion from ultra-luxury residential developments into Grade A commercial real estate. This demand comes amid a year of exceptional business growth in the UAE, with more than 250,000 new companies established in 2025, bringing the total number of operating companies to 1.4 mil
AGCO Power’s Core80 Engine Named Diesel Engine of the Year 202623.2.2026 09:00:00 EET | Press release
Developed and manufactured in Linnavuori, Finland, the engine represents the most advanced technology in AGCO Power’s new Core engine family. The award is among the most respected in the industry and has been recognizing groundbreaking off‑highway powertrain innovations for 20 years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260222724310/en/ Powertrain International Editor-in-Chief Fabio Butturi (left) presents the Diesel Engine of the Year 2026 award to AGCO Power Vice President Juha Tervala. Next to them, AGCO Power Project Manager for Engineering Juha-Pekka Asikainen applauds. In the background: the CORE80 engine. According to Powertrain International Editor‑in‑Chief Fabio Butturi, the decision was straightforward: “Core80 represents exactly the kind of technical courage and innovation we want to highlight. The award truly belongs to the entire Core engine family, which opens a new era for AGCO Power across tractors
SOLUM Brings Retail in Sync to EuroShop 2026 with Integrated Retail Innovations23.2.2026 09:00:00 EET | Press release
SOLUM (KOSPI: 248070) brings ‘Retail in Sync’ to EuroShop 2026, unveiling new retail display innovations and integrated solutions that connect technology, operations and data to create more agile and scalable retail environments. By connecting pricing, communication and store operations within a unified framework, SOLUM aims to help European retailers improve efficiency, create new value and advance sustainability initiatives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260222220569/en/ At EuroShop, SOLUM will present practical applications that combine connected display technologies with data and analytics in real store environments. (Image: SOLUM) At EuroShop, SOLUM will present practical applications that combine connected display technologies with data and analytics in real store environments. Vision AI will demonstrate personalized product recommendations linked to electronic shelf labels (ESL), while Bluetooth Low E
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