Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study in Chronic Low Back Pain Patients
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
Philip Morris International Urges FDA Advisory Committee to Recommend Authorizing ZYN as a Modified Risk Tobacco Product23.1.2026 16:15:00 EET | Press release
Experts from Philip Morris International (PMI) (NYSE: PM) yesterday presented scientific evidence to the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for their ZYN nicotine pouch products. This designation would allow PMI’s U.S. family of businesses to communicate to U.S. legal-aged, 21+ adult cigarette smokers that switching completely to ZYN reduces their risk of many smoking-related diseases and we look forward to a decision by FDA. "The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like ZYN, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change. The full-day meeting on January
Business4Land Champions’ Council Launched at Davos to Spur Private Sector Action on Land and Drought23.1.2026 15:58:00 EET | Press release
TheUnited Nations Convention to Combat Desertification(UNCCD) Secretariat and the UNCCD COP16 Presidency, led by the Kingdom of Saudi Arabia, today announced the official launch of the Business4Land (B4L) Champions’ Council at a high-level event hosted at InTent during the World Economic Forum (WEF) Annual Meeting in Davos. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123993933/en/ The United Nations Convention to Combat Desertification (UNCCD) Secretariat and the UNCCD COP16 Presidency launched the Business4Land (B4L) Champions’ Council at the World Economic Forum in Davos (Photo: AETOSWire) The B4L Champions’ Council brings together global CEOs and senior executives from across the agriculture, consulting, environmental services, fashion, food, pulp/paper. renewable energy, and technology sectors. It aims to drive private sector leadership in restoring 1.5 billion hectares of degraded land by 2030—aligning business am
WEF26: Saudi Arabia Becoming ‘A Connector Economy’ as World Trade Evolves23.1.2026 15:47:00 EET | Press release
His Excellency Majid A. Alkassabi, Saudi Arabia’s Minister of Commerce, today at the World Economic Forum Annual Meeting in Davos said the Kingdom stands to benefit from ongoing shifts in global supply chains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123425621/en/ Amid shifting global trade dynamics, Saudi Arabia underscores its role as a stable connector economy linking markets across regions (Photo: AETOSWire) Speaking in a session titled ‘Many Shapes of Trade’, HE commented: “Trade today is definitely shifting from fair trade to a managed and rule-driven trade model. For us in Saudi Arabia, we have a strategic location, we have a lot of resources, we could become a bridge economy. We could become a connector economy where we can connect with Africa, with Europe, with Asia, becoming a logistic hub.” His Excellency Ahmed A. Alkhateeb, Minister of Tourism, in a session called ‘The New Geography of Travel: Elevating
DCX Liquid Cooling Systems Announces New 8MW Coolant Distribution Unit, Optimized for 45°C Warm-Water Cooling in Next-Gen NVIDIA Vera Rubin AI Deployments23.1.2026 15:18:00 EET | Press release
DCX Liquid Cooling Systems is proud to announce the second generation Facility Distribution Unit (FDU V2AT2). Designed to support the infrastructure shift driven by AI deployments at scale, new CDU supports 45°C warm-water cooling for NVIDIA’s NVL72 GB200 / GB300 Blackwell and Vera Rubin architectures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123068139/en/ The Facility Coolant Distribution Unit—the new generation of liquid cooling for hyperscale data centers. FDU V2AT2 delivers up to 8.15MW of heat transfer capacity while providing record breaking flowrate, enabling 45°C warm-water operation—temperature level that can eliminate the need for chillers on the heat-rejection side in many deployments. This new cooling system has also built in most capable heat exchanger in the industry, which further enables heat reuse and chillerless heat transfer. “As the datacenter industry transitions to AI factories, operators need
HUMAIN and Infra Announce AI and Digital Financing Framework Agreement23.1.2026 15:01:00 EET | Press release
HUMAIN and the National Infrastructure Fund (“Infra”) announced on the sidelines of the World Economic Forum (WEF) Annual Meeting 2026 in Davos, Switzerland, a Strategic Financing Framework Agreement of up to $1.2 billion to support the expansion of AI and digital infrastructure projects in the Kingdom of Saudi Arabia. The Framework Agreement outlines non-binding financing terms for HUMAIN’s development of up to 250 MW of hyperscale AI data center capacity. These data centers will deploy leading edge GPUs for AI training and inference and support HUMAIN’s local, regional and global customers. In addition, Infra and HUMAIN have agreed to explore the establishment of an AI data center investment platform. This would be anchored by the two organizations and structured to facilitate participation by global and local institutional investors to support further scaling of HUMAIN’s AI strategy. Today’s Framework Agreement underscores Infra’s key role in partnering with its counterparts to acce
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