Business Wire

Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study in Chronic Low Back Pain Patients

Share

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.

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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Access Advance Announces Initial VVC Advance Patent List29.11.2022 19:31:00 CET | Press release

Access Advance today posted the initial patent list for its VVC Advance Patent Pool (https://accessadvance.com/vvc-advance-patent-list/). The initial patent list includes over 700 VVC standard essential patents (SEPs) issued in sixty-one countries that were independently determined to be essential to the VVC/H.266 Standard. With thirty-three VVC Advance Licensors currently, the size of the VVC Advance patent list is expected to grow substantially as additional VVC SEPs issue and are evaluated, and as additional Licensors join the VVC Advance Patent Pool. As with the HEVC Advance Patent Pool, the VVC Advance Patent Portfolio License (“PPL”) includes all VVC SEPs, current and future, that the program’s Licensors have the right to license, regardless of whether the patents are specifically included in the patent list. This assures that compliant Licensees are licensed to all VVC Advance Licensors’ VVC SEP claims under the terms of the PPL when a patent with VVC essential claims issues, ev

Media Alert: Prosimo to Demonstrate Full Stack Transit for Simplifying Multicloud Networking During AWS re: Invent 202229.11.2022 18:49:00 CET | Press release

Prosimo, the Application Experience Infrastructure company, announced today it is a showcase sponsor at Amazon Web Services (AWS) re: Invent 2022, taking place this week through December 2 in Las Vegas, NV. During the conference, Prosimo will be exhibiting in Booth #842 where it will demonstrate its Full Stack Transit to build a consistent architecture for connecting networks, services and applications in multicloud environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221129005898/en/ Prosimo, a showcase sponsor, will be exhibiting its Full Stack solution for simplifying multicloud networking during AWS re: Invent in booth #842 (Graphic: Business Wire) Prosimo's platform simplifies the orchestration of cloud-native services and gives enterprises a single, integrated architecture to interconnect, replicate and scale applications across multicloud environments, including AWS. With Prosimo, customers can use Cloud Nativ

Cleverbase Selects Verimatrix Code Shield for Strong Cybersecurity29.11.2022 18:30:00 CET | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX) (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced that Netherlands-based Cleverbase turned to Verimatrix Code Shield to protect its Vidua mobile app for Android and iOS. Aiming to make all paper communication, pen signatures and physical identification no longer needed, Cleverbase’s Vidua app is designed to store information easily and securely for Netherlands-based businesses. Organizations throughout the country choose to partner with Vidua to enable their customers to interact fully digitally, saving time and effort while doing so with peace of mind that the app they’re using consistently protects their sensitive data. “The very nature of our business at Cleverbase demands the foremost security technologies that protect against threats such as reverse engineering and tampering,” said Sander Dijkhuis, Chief Technology Officer at Cleverbase. “Verimatrix’s Code Shield, followi

Mary Kay Sustainability Project Featured in Economist Impact’s World Ocean Summit in Singapore29.11.2022 18:03:00 CET | Press release

Mary Kay Inc., a global advocate for corporate sustainability and stewardship and signatory to the UN Global Compact Sustainable Ocean Principles, continues to support global efforts to increase ocean awareness and highlight the important role the ocean plays in efforts to combat climate change. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221129005781/en/ (Credit: Mary Kay Inc.) This week at the Economist Impact’s World Ocean Summit Asia Pacific in Singapore, a Mary Kay-supported project focused on women and conservation was featured in the panel “Innovation and adaptation—coastal solutions to climate change.” The panel covered the effect climate change is having on Asia-Pacific’s coastal ecosystems as well as on the global ocean and featured case studies on how the region is preparing for and adapting to climate change. Mangroves are vital to coastal ecosystems yet are one of the most threatened ecosystems on the planet.

New International Tax and Investment Center Research Reveals Link between Tax and Illicit Alcohol Market Size29.11.2022 16:30:00 CET | Press release

The International Tax and Investment Center (ITIC) released new research on illicit alcohol revealing that high tax rates on alcoholic beverages can divert consumers to the illicit alcohol market, which poses a major threat to public health and finances. Experts examined illicit alcohol in Colombia, the Dominican Republic, Malaysia, South Africa, and the United Kingdom to uncover the largest drivers of these illicit markets, which are bad for consumers, communities, and businesses due to their negative social and economic impacts. In alignment with the OECD’s Illicit Trade in High-Risk Sectors report, the research showed that a significant price difference between the licit and illicit alcoholic beverages is one of the biggest drivers; if consumers struggle to afford legal alcoholic beverages, they will turn to cheaper, illicit ones that can be very dangerous and potentially lethal. Some of the severe consequences of the illicit alcohol market can be observed as recently as in the last