Business Wire

MAINSTAY-MEDICAL

Share
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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

(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/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

LTIMindtree Launches GCC-as-a-Service1.7.2025 11:30:00 CEST | Press release

An integrated, AI-powered offering with deep industry expertise to drive growth and transformation LTIMindtree [NSE: LTIM, BSE: 540005], a global technology consulting and digital solutions company today introduced its GCC-as-a-Service. The services cater to organizations that may want to set up GCCs, scale their existing ones to optimize costs and create added value. The catalogue covers a spectrum of Build, Operate, Transform and Transfer services, offering clients the option to pick and choose what they require. GCC-as-a-Service commercials are designed on a per-seat or per service basis to ensure cost optimization and value realization. LTIMindtree’s Talent Solutions, part of our Build Services enables clients efficiently onboard business-ready talent from day one through its in-house AI-powered talent acquisition ecosystem. As a part of Transform Services, the Company provides industry specific offerings; technological solutions and frameworks that lead to acceleration of value re

Network Failures Cost $5M A Year for More Than a Quarter of Global Businesses, According to Expereo1.7.2025 10:00:00 CEST | Press release

Half of global businesses have been forced to urgently re-evaluate their tech infrastructure following a wave of high-profile IT outages Network instability is taking a serious toll on global businesses, with over a quarter (28%) reporting revenue losses of up to $5 million due to network outages or poor performance. Alarmingly, an additional 23% have experienced losses exceeding $5 million. These findings come from an IDC InfoBrief commissioned by Expereo, titled “Enterprise Horizons 2025: Technology Leaders Priorities: Achieving Digital Agility.” Following a series of high-profile IT disruptions over the past year, ranging from cybersecurity breaches to connectivity failures, nearly half (49%) of global businesses have been compelled to re-evaluate their technology infrastructure, and 40% of global tech leaders say it’s caused networking and connectivity to rise higher up the C-suite agenda. Perhaps as a result, networking/connectivity now comes out on top in terms of the technologie

Record Financing for NeXtWind: €1.4 Billion for the Expansion of Wind Energy in Germany1.7.2025 09:52:00 CEST | Press release

Innovative platform financing enables debt investments in renewable energy on an unprecedented scale NeXtWind plans to quadruple the capacity of more than half of its 37 wind farms by 2028 as part of an increase of its total generation capacity to 3 GW Lars B. Meyer, Co-CEO of NeXtWind, said: “Thanks to this novel platform approach, we can optimize our wind farms more quickly and accelerate our growth. In the long term, we aim to transform them into state-of-the-art, integrated clean energy hubs.” NeXtWind, a leading renewable energy company, has secured €1.4 billion in debt financing. The agreement also includes an additional €1.3 billion in so-called accordion facilities, which can be activated in tranches over the coming years. This syndicated loan is the largest of its kind for an independent wind energy provider in Germany, and it opens the onshore wind market to debt investments from major financial institutions both domestically and internationally. NeXtWind will use the new fin

Celero Ventures Opens $25 Million Early-Stage Fund to Investors Backing the Next Generation of European Software Companies1.7.2025 09:30:00 CEST | Press release

Celero Ventures, a new venture capital firm founded by experienced software operators Dave Wyatt and Nick Cochran, is now raising its debut $25 million fund to invest in early-stage startups across the UK and Europe. The fund, which is already 25% subscribed, targets pre-seed and seed-stage companies building next-generation AI and data infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701820933/en/ Nick Cochran and David Wyatt (right) Founders of Celero Ventures Based in London, Celero Ventures is inviting limited partners (LPs) to join its mission of backing exceptional technical founders and accelerating their path to product-market fit and scalable growth. Wyatt and Cochran bring a rare combination of deep go-to-market (GTM) experience and startup leadership. Together, they helped scale both MuleSoft and Databricks—two of the most successful enterprise software companies of the past decade. Their experien

3GPP MCX Standards-Based Hytera HyTalk MC 6.0 Released Globally1.7.2025 09:00:00 CEST | Press release

Hytera, a leading global provider of professional communications technologies and solutions, announced the worldwide release of Hytera HyTalk MC 6.0, its new-generation broadband mission-critical communication platform fully compliant with the 3GPP MCX standard Release 18. As a key part of Hytera’s convergence-native communications strategy, it delivers inclusive, efficient and secure communication over LTE cellular network. Hytera HyTalk MC 6.0 leverages 3GPP standard interfaces and Hytera’s proprietary protocols to enable deep interworking across different technologies and vendors. It enables real-time mapping between the signaling of 3GPP MCX and Hytera DMR, and interconnects with HyteraTETRA systems, allowing a smooth migration path to data-rich communications for mission- and business-critical institutions and users. Hytera DMR or TETRA two-way radios can communicate with LTE/5G terminals through the Hytera HyTalk MC platform in a hybrid network. The Ad-Hoc Temporary Group Call fe

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye