Business Wire

Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up

Share

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/

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

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.

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

J-HOTATE Association Exhibits at Seafood Expo Global in Spain to appeal premium and fresh Japanese scallops15.4.2024 14:00:00 EEST | Press release

Japan Scallop Export Promotion Association (“J-HOTATE Association”), which aims to expand the export of Japanese scallops, will be presenting the Japanese scallops to European markets at the Seafood Expo Global, which will be held in Barcelona, Spain, from April 23rd to April 25th, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240415920416/en/ Japanese Scallop - A Sustainable Gastronomic Delight (Photo: Business Wire) Japanese scallops (we say HOTATE [Hoh-Tah-Teh]) are highly accredited for their flavor, size, and quality. Fresh scallops can be enjoyed year-round under environmentally friendly farming/harvesting methods and the advanced technology to maintain freshness—both of which are unique to Japan. Especially in Hokkaido, Aomori, Iwate, and Miyagi where scallops are produced, local ocean currents provide highly rich nutrients, boasting one of the world’s largest landings of scallops. Scallops are also known as a

AngloGold Ashanti: Notice of 2024 Annual General Meeting15.4.2024 13:43:00 EEST | Press release

Today, AngloGold Ashanti plc (“the Company”, “AGA” or “AngloGold Ashanti”) posted its Notice of 2024 Annual General Meeting (the “Notice”), which can be viewed and downloaded from www.reports.anglogoldashanti.com. The Company’s 2024 Annual General Meeting (the “AGM”) is scheduled to be held on Tuesday 28 May 2024 at 9:00 a.m. Mountain Standard Time (which is 4:00 p.m. British Summer Time and 5:00 p.m. South African Standard Time) at 6363 S Fiddlers Green, Greenwood Village, CO 80111, USA. Shareholders are invited to join the AGM virtually by following the instructions set out in the Notice. By joining the AGM virtually, shareholders will be able to view a live video feed of the AGM, submit voting instructions and submit questions either in writing or via an audio line. The Notice sets out the business proposed to be conducted at the AGM, with the record date set as 2 April 2024 for the purposes of determining eligibility to receive the Notice and to vote at the AGM. The Notice will sho

FPT Unveils Strategic Directions, “All In” on AI, Automotive and Semiconductor15.4.2024 12:38:00 EEST | Press release

FPT Corporation (FPT) announced its strategic directions for the 2024-2026 period at the 2024 Annual General Meeting, with five focused areas defined as Artificial Intelligence (AI), Automotive, Semiconductor, Digital Transformation, and Green Transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240415401317/en/ FPT’s 2024 Annual General Meeting was held in Hanoi, Vietnam (Photo: Business Wire) According to FPT Chairman Dr. Truong Gia Binh, these five areas have shaped the course of modern history and will continue to be of critical importance in decades to come. In Vietnam’s case, they have been instrumental in solidifying the country's position as a global hub for business and innovation. In this direction, AI remains at the heart of FPT's development strategy, aiming to serve at least 50% of Vietnamese citizens and 300 million global citizens. The Corporation is committed to expanding its AI ecosystem, continuin

Europe’s IT, Business Services Sector on the Rebound in Q1: ISG Index™15.4.2024 11:00:00 EEST | Press release

Europe’s demand for IT and business services in the first quarter rose for the first time in a year, powered by growth from the banking, financial services and insurance (BFSI) sector, according to the latest state-of-the-industry report from Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The EMEA ISG Index™, which measures commercial outsourcing contracts with annual contract value (ACV) of US $5 million or more, shows ACV for the combined market (both managed services and cloud-based as-a-service) rose 2.5 percent, to US $7.5 billion, in the first quarter. The market’s year-on-year growth in Q1 broke a string of four consecutive quarters the region was down versus the prior year. “The European market is on the rebound,” said Steve Hall, president, ISG EMEA. “Both managed services and cloud services were higher in Q1, and managed services was up nearly 5 percent year on year for BFSI, the region’s largest business sector. Busine

Counter UAS Technology Europe 2024: Echodyne to Address Key C-UAS Conference Amidst Rapid Expansion into European Market15.4.2024 10:00:00 EEST | Press release

Echodyne, the radar platform company, is excited to announce it will be addressing the second annual Counter UAS Technology Europe 2024 conference, taking place at the Marriott Hotel Grosvenor Square in London over April 16-17, 2024. Echodyne VP of Marketing, Leo McCloskey, will discuss important counter-UAS developments in accuracy and mobility. Echodyne’s participation in this year’s event comes on the heels of significantly expanding its footprint in the region with new, European-based team members. The conference is hosted by SAE Media Group and focuses on gathering European C-UAS stakeholders to address the growing proliferation of small drones and unmanned aircraft system (UAS) technology and the need for European armed forces and security agencies to protect critical national infrastructure and personnel at home and abroad by way of cutting-edge, C-UAS operations. Drones are an increasing threat beyond the battlefield with payload and operational capabilities that challenge exis

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
HiddenA line styled icon from Orion Icon Library.Eye