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
Murata Develops World’s Smallest 008004-inch Size (0.25mm × 0.125mm) NTC Thermistor for Space-Constrained Temperature Sensing20.10.2026 05:00:00 EEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the development of the world’s smallest* 008004-inch size (0.25mm × 0.125mm) NTC thermistor, the NCU01 series. Compared with Murata’s previous smallest 01005-inch size (0.4mm × 0.2mm) product, the new series reduces mounting area by approximately 60% while achieving equivalent temperature-sensing performance, with resistance tolerance of ±1% and B-constant tolerance of ±1%. Its ultra-compact size enables temperature sensing to be positioned in increasingly restricted spaces and closer to heat-generating components, supporting more accurate and responsive thermal monitoring in smartphones, wearable devices, and other densely integrated electronic devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019189089/en/ [Murata Manufacturing Co., Ltd.] World’s smallest 008004-inch size (0.25mm × 0.125mm) NTC thermistor Murata plans to begin sample shipm
Hologic Signs Definitive Agreement to Acquire Reveal Genomics19.10.2026 22:30:00 EEST | Press release
Hologic, a global leader in women’s health, today announced that it has signed a definitive agreement to acquire Reveal Genomics, a precision oncology company based in Barcelona, Spain, that develops advanced genomic diagnostic tests to help personalized cancer treatment, including its HER2DX test to help optimize therapy for patients with HER2-positive breast cancer. Breast cancer remains one of the most significant health challenges women face today. Reveal Genomics’ tests are highly complementary to Hologic’s existing oncology diagnostics, including the Breast Cancer Index® (BCI) test, the guideline-recognized genomic assay to help inform decisions regarding extended endocrine therapy in women with HR+ early-stage breast cancer. The combination of Hologic’s existing testing with Reveal Genomics’ portfolio represents a significant expansion of Hologic’s diagnostic oncology solutions, with the combined offering of new and existing testing expected to help inform treatment decisions fo
An Active Role in Freshness: ProAmpac Introduces ProActive Intelligence Shelf Protect19.10.2026 22:27:00 EEST | Press release
ProAmpac, a global leader in flexible packaging and material science, introduces ProActive Intelligence™ Shelf Protect (SP) Series, giving food producers a new way to help preserve product quality and reduce costly spoilage. Designed for select meat, seafood, and dairy applications, the technology is FDA- and USDA-compliant for intended uses in fresh beef, fresh pork, cooked sausage, deli meat, fresh salmon, and fresh cheese. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019305953/en/ Clearshield®-SP Shrink Bag This direct food-contact biotechnology packaging helps reduce microbial growth associated with food spoilage in intended applications, supporting longer shelf life throughout storage and distribution. Shelf Protect’s patented biotechnology is built directly into food-contact packaging film. “For meat processors, every product lost represents an investment in production, packaging, and distribution that goes unreal
Vedanta Ltd Doubles Zinc Capacity in South Africa with US$ 600 Mn investment19.10.2026 20:19:00 EEST | Press release
Vedanta Limited doubled its annual zinc production capacity to 500,000 tonnes1in South Africa through an investment of nearly US$ 600 Mn at Gamsberg (Phase II) at Vedanta Zinc International (VZI). Gamsberg has one of the world’s most significant zinc deposits and is VZI’s flagship zinc mine. Inaugurated by South African President Cyril Ramaphosa and Vedanta Limited Director Priya Agarwal-Hebbar, this expansion marks one of the decade’s largest mining investments in South Africa. It advances Vedanta Limited’s position as the world’s largest2 zinc producer, with a vision of achieving 3 million tonnes of annual production across India and South Africa. Of this, 2 million tonnes are targeted from its subsidiary, Hindustan Zinc Limited the world’s largest integrated zinc producer, while Vedanta Zinc International business aims to contribute 1 million tonnes annually. This expansion strengthens the ZAR 21 Bn (nearly US$ 1.5 Bn) investment commitment Vedanta made at the 2018 South Africa Inve
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 19:00:00 EEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
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