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
AGC Pharma Chemicals Validates Facilities for CDMO Services via Scientist.com’s VERIF.i ® Program1.7.2026 14:55:00 EEST | Press release
Scientist.com, the life sciences industry’s leading AI-enabled R&D orchestration platform and digital marketplace, and AGC Pharma Chemicals, a leading global Contract Development and Manufacturing Organization (CDMO) for small molecule API and HPAPI, announced today that AGC has successfully completed an onsite assessment of its new Barcelona facility using the VERIF.i® supplier pre-assessment program. The newly expanded Barcelona site strengthens AGC’s position as a global leader in the development and commercialization of complex small molecule Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs). Designed for maximum flexibility, safety, and energy efficiency, the facility expands AGC’s end-to-end capabilities from gram-scale to ton-scale production under the highest quality and sustainability standards. “At AGC Pharma Chemicals, we place the highest priority on the integrity of our operational processes and the expertise of our frontline teams,” said Jun Kurihar
Introducing Arbex: a New Global Leader in Tissue and Hygiene1.7.2026 14:37:00 EEST | Press release
Arbex, a new global leader in tissue and hygiene, today commences operations as an independent business and unveils details of its brand, leadership team, and company structure. Announced in June 2025 as a $3.4 billion joint venture between Suzano (NYSE: SUZ), the world’s largest pulp supplier, and Kimberly-Clark Corporation (NASDAQ: KMB), a global leader in consumer goods and personal care, the new business will manufacture, market and distribute consumer and professional products across more than 70 markets on five continents. Arbex has assumed ownership of assets previously run by Kimberly-Clark’s International Family Care & Professional (IFP) business unit, which includes 22 manufacturing sites in 14 countries, and a portfolio of more than 40 regional brands including Andrex®, Hakle®, and Scottex®. The company also holds a long-term license for the use of Kimberly-Clark’s global brands, including Kleenex®, Cottonelle®, Scott®, WypAll®, Viva®, and Kimberly-Clark Professional. Ehab A
Klarna has received a favorable ruling in PriceRunner litigation, awarding damages of $1.97 billion1.7.2026 14:19:00 EEST | Press release
Klarna Group plc (NYSE: KLAR) today announces that the court has ruled in PriceRunner’s favor, awarding $1.97 billion in damages in an antitrust case brought by PriceRunner against Google. The award compensates for lost revenue caused by Google's preferential treatment of its own comparison-shopping service over independent price-comparison services, conduct that also drives up costs for consumers. "When markets work well, everyone benefits. Consumers get higher quality at lower cost, companies stay focused on serving customers rather than defending position, and society is better off for it. This ruling supports a healthier, more competitive market for the way people compare products and services — and that is good for everyone who shops," said Dan Greaves, Head of Communications and Policy, Klarna. Klarna acquired PriceRunner in 2022 to add rich product discovery, price comparisons, and product reviews to the Klarna app, and drive high-intent traffic to retail partners. Klarna has si
Objectway Acquires Swiss Private Banking Technology Business From FNZ to Strengthen Its Pan-European Positioning1.7.2026 14:10:00 EEST | Press release
Objectway, a global wealthtech partner for banking, wealth and asset management firms, today announced the acquisition from FNZ of their Swiss private banking technology business FNZ Switzerland SA (formerly operating as New Access). The business will now be operated under the Objectway Switzerland brand. Objectway welcomes a team of over 160 professionals, bringing their expertise and professionalism honed in developing innovative, award-winning solutions for over 40 private banks. The acquisition is a significant step in Objectway’s growth strategy, reinforcing its commitment to expanding its presence in key international wealth hubs such as Switzerland, Liechtenstein, Luxembourg, Monaco and the Bahamas, where the newly joined business already serves both domestic and international cross-border clients. The agreement further expands Objectway’s scalable core-to-digital capabilities supporting end-to-end private banking operations, while leveraging an international team and operationa
NIQ Completes Acquisition of Flywheel’s China and Southeast Asia eCommerce Data & Insights Business, Expanding Digital Commerce Intelligence Capabilities1.7.2026 14:00:00 EEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced that it has completed the acquisition of Flywheel’s China and Southeast Asia eCommerce Data & Insights business. The acquired business operates in China under the YiMian (“一面”) brand and is a leading provider of eCommerce, social commerce, and digital shelf solutions. The acquisition expands NIQ’s capabilities across China and Southeast Asia and strengthens its ability to measure and understand consumer behavior across retail, eCommerce, social commerce, and digital environments — advancing NIQ’s mission to deliver The Full View™, the most complete understanding of consumer behavior across online and offline channels. It also enhances NIQ’s data and analytics foundation by expanding access to rich digital commerce signals that support the development of more advanced analytics and AI-powered solutions. By bringing together NIQ’s global intelligence, analytics, and retail measurement capabilities with the ac
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