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
FERM FOOD Acquires Orkla’s Former Site and Scales Up: Up to 20,000 Tonnes of Fermented Ingredients Per Year11.3.2026 08:00:00 EET | Press release
Danish ingredient producer FERM FOOD is acquiring Orkla’s former manufacturing site in Skovlund, Denmark, effective 1 April 2026. The acquisition provides new production facilities to expand the output of fermented plant-based ingredients for the food industry — driven by export demand that has emerged faster than expected. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310904877/en/ Jens Legarth (CEO), Rikke Matthiesen (CSO), and Torbjørn Tyndkjær-Thomsen (Food & Process Developer) at FERM FOOD’s new production facilities. “We have outgrown our current facilities. With the Skovlund site, we can supply many more food manufacturers in Denmark and abroad. Global interest has developed faster than we expected — and that is why we are scaling up now,” says Jens Legarth, CEO of FERM FOOD. Once fully ramped up, the new fermentation facility is expected to reach an annual capacity of up to 20,000 tonnes, depending on product mix
Galderma Buys Back Shares Worth CHF 232 Million in the Context of Accelerated Bookbuild Offering11.3.2026 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that it has agreed to repurchase 1.6 million shares at a price of CHF 143.75 per share for a total consideration of CHF 232 million in the context of the accelerated bookbuild offering (“ABO”) of Galderma shares by Sunshine SwissCo GmbH (“EQT”), Abu Dhabi Investment Authority (Private Equities Department) and Auba Investment Pte. Ltd. (all together the “Selling Shareholders”) launched yesterday evening. The repurchase was made at the same price per share determined by the bookbuilding offering. As a result of yesterday evening’s ABO, the Selling Shareholders have fully divested their remaining stake in Galderma. The repurchase, which is expected to settle on March 13 is being financed by Galderma’s existing liquidity on hand and will not affect the company’s ability to deliver on its strategic and financing priorities. The shares will be held in treasury for future use in connection with Galderma's employe
Thales Launches SkyDefender: The Integral Air and Missile Defence Dome With Artificial Intelligence11.3.2026 08:00:00 EET | Press release
As air and missile threats are evolving faster than ever, from slow-moving drones to hypersonic missiles, attacks are becoming increasingly complex, saturating and unpredictable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310398606/en/ SkyDefender © Thales Thales SkyDefender provides full protection against all types of air threats, from a few kilometres to several thousands of kilometres: Short-range: for protection of forces, vital assets and sensitive sites: ForceShield creates a real protection bubble against lower layer and surface threats at very short- and short-range, such as drones. Medium-range: for protection at theatre-level defence: SAMP-T NG by eurosam1 with up to 150 km engagement range, including Thales’ powerful Ground Fire radar with 350 km range and 360°/90° coverage against medium-range defence. Long-range: for protection against long-range threats with early-warning capabilities: a unique capacity
Curatis and Neupharma Announce Exclusive Licensing Agreement to Develop and Market Corticorelin (C-PTBE-01) for the Treatment of Peritumoral Brain Edema in Japan11.3.2026 08:00:00 EET | Press release
Curatis Holding AG (SIX: CURN) and Neupharma Co., Ltd. (“Neupharma”), a Japanese pharmaceutical company specializing in oncology, immunology, pulmonology and cardiology disorders, today announce an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan. Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialize corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumor-associated condition for which no approved targeted therapies currently exist. Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%. The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with
Galderma Completes Successful Placement of EUR 500 Million Eurobond11.3.2026 07:55:00 EET | Press release
Galderma Group AG (SWX:GALD): NOT FOR DISTRIBUTION IN THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE RESTRICTED BY APPLICABLE LAW OR REGULATION. Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced the successful placement of a single-tranche EUR 500 million Eurobond. The bond has a 5-year maturity and carries a fixed-rate annual coupon of 3.375%. The Eurobond was placed on March 10, 2026, with settlement expected on March 17, 2026, and will be listed on the SIX Swiss Exchange. Citigroup, ING, J.P. Morgan and RBC Capital Markets jointly led the transaction. Net proceeds from the transaction will be used to fully repay Galderma’s existing bank term loan issued in connection with the company’s initial public offering in March 2024. The transaction represents the final step in Galderma’s refinancing process, having obtained two investment grade credit ratings. Galderma is currently rated ‘BBB’ (stable outlook) by Fitc
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