Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up
Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240319164677/en/
The long-term responses across pain, disability, and health-related quality of life measures are shown in the following graphs. (Graphic: Business Wire)
The publication is available here:
https://www.sciencedirect.com/science/article/pii/S1094715924000552
The ReActiv8-B study saw multiple patients have their implants removed for resolution of back pain. These removals for success suggest a restorative mechanism, and the therapy shows no evidence of the loss of efficacy commonly observed with palliative treatments.
Dr. Chris Gilligan, Chief Medical Officer and Chief Quality Officer at Robert Wood Johnson University Hospital, stated: “The long-term, durable patient outcomes from this study are unprecedented in the field of neuromodulation. This is truly a unique therapy that is restorative in nature and does not show any of the loss of efficacy seen with other treatments in our field. With 5 year published outcomes, we are no longer limited to providing temporary or palliative treatments to our patients. ReActiv8 is changing the way we treat properly selected patients.”
Jason Hannon, CEO of Mainstay Medical, stated: "We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to sharing this data with our physician customers and their patients, as well as using it to further engage managed care organizations in the United States to expand commercial insurance access to this incredible therapy.”
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.
Mainstay 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 clinical outcomes, commercial efforts and performance, research studies and results, financial position, financing strategies, product design and development, intellectual property portfolio and its scope, 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 2022, 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/20240319164677/en/
Contact information
Mainstay PR and IR Enquiries:
L
ifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Email: britchie@lifesciadvisors.com
FTI Consulting (for Ireland)
Jonathan Neilan or Patrick Berkery
Tel. : +353 86 602 5988
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
AmTrust Financial Services and Blackstone Credit & Insurance Close Strategic Transaction and Launch Newly Formed Multinational MGA Company Named ANV Group Holdings Ltd.5.12.2025 14:00:00 EET | Press release
AmTrust Financial Services, Inc. (“AmTrust” or the “Company”), a global specialty property casualty insurer, and Blackstone Credit & Insurance (“BXCI”), today announced the closing of a strategic transaction under which AmTrust and funds managed by BXCI have partnered to spin-off certain of AmTrust’s Managing General Agencies (“MGAs”) and fee-based businesses in the U.S., United Kingdom, and Continental Europe, into ANV Group Holdings Ltd. (“ANV”), a newly formed independent company, following receipt of regulatory approvals. AmTrust and ANV have entered into a ten-year capacity agreement through which AmTrust will remain the underwriter for the existing books of business offered through the MGAs. As previously announced on September 15, 2025, the agreement includes seven AmTrust subsidiaries: ANV Specialty, Risico, Collegiate, ANV Nordic, Arc Legal, Qualis, and Abacus. These businesses provide diverse risk and insurance coverages including cyber excess and surplus (E&S), directors and
Galderma Opens up New Chapter for Sculptra ® with MDR Certification and New Expanded Indication for Body5.12.2025 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU Medical Device Regulation (MDR). This expands Sculptra’s current clinical use on the face, to include four new areas: gluteal area, posterior thighs, décolletage, and upper arms. Sculptra can be used across these areas to address varied treatment goals – from improving skin quality (including the improvement in cellulite appearance), to enhancing firmness, as well as lift, projection, and contouring.1-5 Sculptra’s versatility allows practitioners to meet each patient’s unique needs, delivering natural-looking, long-lasting improvements across face and body. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204988559/en/ Meeting the moment: evolving patient needs As aesthetic expectations shift, patients are seeking more holistic
Northern Escape Heli-Skiing Takes the Title of “World’s Best Heli-Ski-Operator” for the 4th Year Running5.12.2025 03:40:00 EET | Press release
Northern Escape Heli-Skiing (NEH) has been named World’s Best Heli-Ski Operator 2025 by the World Ski Awards, marking its fourth straight victory following years 2022, 2023 and 2024. This recognition places NEH amongst an elite group of ski tourism operators consistently voted best in the world by industry leaders and enthusiasts alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204074550/en/ A four-year run built on reliability NEH operates in British Columbia’s Skeena Mountains, where deep northern snow and vast terrain come together with small-group heli-skiing and heli snowboarding. When helicopters can’t safely fly, NEH has cat skiing readily available as a backup — an exceedingly rare offering in this industry. The operation spans over 833,571 wild acres of alpine bowls, glaciers and old-growth tree skiing. The NEH experience Guests choose from three lodge formats designed for different group styles and expectat
Helical Fusion, Developer of Next-Generation Clean Energy Through Nuclear Fusion, Completes USD 5.5M Series A Extension Round5.12.2025 02:00:00 EET | Press release
Helical Fusion Co., Ltd. (Head Office: Chuo-ku, Tokyo; CEO: Takaya Taguchi; hereafter “Helical Fusion”), which is developing a next-generation energy source using Japan’s original Helical Stellarator technology to realize commercially viable fusion power plant in the 2030s, announced the completion of its Series A Extension round, raising approximately USD 5.5 million (≈ JPY 870 million). The round included investments from “Ecrowd NEXT”, a fund designed for individual investors, as well as multiple corporate investors and individual investors. As a result, Helical Fusion’s total Series A funding, including loans, amounts to approximately USD 21 million (≈ JPY 3.2 billion), bringing the company’s cumulative fundraising—including grants and loans—to approximately USD 38 million (≈ JPY 6.0 billion). With this funding, Helical Fusion will further accelerate development under its flagship program, the Helix Program—a comprehensive roadmap to achieve the world’s first commercially viable fu
IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance5.12.2025 02:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers. IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development. Dr. Yue
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