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
CORRECTING and REPLACING Yamaha to Acquire Disguise, Expanding Its Capabilities in Integrated Audio, Video, Lighting and Media13.11.2026 19:10:00 EET | Press release
Please replace the release issued Nov. 12, 2026, at 11:00 p.m. PT/Nov. 13, 2026, at 2:00 a.m. ET with the following corrected version due to multiple revisions in the third paragraph. This release has been updated to ensure the accuracy of certain references in the original version. The updated release reads: YAMAHA TO ACQUIRE DISGUISE, EXPANDING ITS CAPABILITIES IN INTEGRATED AUDIO, VIDEO, LIGHTING AND MEDIA Acquisition combines Yamaha’s audio expertise with Disguise’s software and media server technologies Yamaha Corporation today announced an agreement to acquire Disguise Technologies Limited (“Disguise”), a London-based provider of software and media server technologies for live and immersive experiences. Yamaha will acquire the company by purchasing all shares in its parent, Butterfly Topco Limited. The acquisition will expand Yamaha’s capabilities beyond audio into integrated audio, video, lighting and media solutions, in line with its strategy to expand beyond hardware into soft
VELOCIFERO Takes Action Against Counterfeiting in China13.11.2026 18:32:00 EET | Press release
VELOCIFERO is taking action against counterfeiting in China. White s.r.o., the exclusive owner of the VELOCIFERO brand and its related intellectual property rights, has launched decisive measures to protect its creative and industrial assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261113797570/en/ Photo courtesy of White s.r.o. “Vehicle sealed in Chongqing as part of actions undertaken to protect VELOCIFERO’s intellectual property rights.” The matter originated in June 2026 when, according to the company’s complaint, computers were removed from the technical office of Taizhou Siweiluo, the company appointed to manufacture VELOCIFERO products. White s.r.o. subsequently became aware of the promotion and sale of vehicles that it believes were produced in violation of its intellectual property rights. White s.r.o. therefore decided to take direct action in China, entrusting the protection of its rights to Shanghai-based
LangChain Raises $300M to Enable Every Company to Own Their Intelligence13.11.2026 17:53:00 EET | Press release
LangChain today announced it has raised $300 million in new funding at a $3 billion valuation, bringing total funding to date to $460 million. The round was led by existing investor CapitalG, with significant participation from new investors GIC and DFJ Growth and existing investors IVP and Sapphire Ventures. LangChain is advancing its mission to help every company own its intelligence. As agents transform the economy, companies are building domain-specific agents differentiated by their knowledge, data, and user experience. These agents will power new products and transform internal company operations, creating lasting competitive advantages for the companies that control them. "Agents are going to transform how companies operate and the products they deliver. The companies that control these systems will build lasting competitive advantages," said Harrison Chase, Co-Founder and CEO of LangChain. "Every company should be free to choose the best models for its needs, control its data a
Kinaxis Named a Leader in Five 2026 IDC MarketScapes for Worldwide Supply Chain Planning13.11.2026 14:00:00 EET | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced it has been named a Leader in five 2026 IDC MarketScape vendor assessments for worldwide supply chain planning. The recognition spans the overall market and four industries - discrete industries, process industries, consumer packaged goods and life sciences industries - all served by a single platform, Kinaxis Maestro®, the company's AI-powered supply chain orchestration platform. "Supply chain leaders don't need a better forecast once a month. They need to know what changed this morning, what it means across the business, and what to do about it," said Andrew Bell, Chief Product Officer of Kinaxis. "I believe being named a Leader across five IDC MarketScape vendor assessments, in industries that plan in very different ways, shows that a single concurrent platform is the right foundation for that. Operational orchestration builds on it by connecting planning, decisions and ex
SBC Medical Announces Capital and Business Alliance with NeuroBrain Dynamics to Advance Clinic Profitability Through Medical AI13.11.2026 13:30:00 EET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced a strategic capital and business alliance agreement with NeuroBrain Dynamics Inc. (“NBD”), a Taipei-based company dedicated to enterprise generative AI solutions. As part of the agreement executed on November 13, 2026, SBC Medical has made a minority equity investment in NBD. Through this alliance, SBC Medical plans to introduce two complementary suites of generative AI solutions across its network of 287 clinics in Japan and overseas*: “revenue-growth AI,” to elevate average revenue per visit and customer retention through personalized customer guidance, and “cost-reduction AI,” to streamline medical documentation, staff scheduling, and promotional workflows. These initiatives are designed to improve per-clinic profitability. Furthermore, SBC Medical has secured priority sale
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