{"id":51127,"date":"2022-11-22T14:02:23","date_gmt":"2022-11-22T13:02:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/mainstay-medical-announces-publication-of-post-market-clinical-trial-data-from-ongoing-reactiv8-c-study-in-chronic-low-back-pain-patients\/"},"modified":"2022-11-22T14:02:23","modified_gmt":"2022-11-22T13:02:23","slug":"mainstay-medical-announces-publication-of-post-market-clinical-trial-data-from-ongoing-reactiv8-c-study-in-chronic-low-back-pain-patients","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/mainstay-medical-announces-publication-of-post-market-clinical-trial-data-from-ongoing-reactiv8-c-study-in-chronic-low-back-pain-patients\/","title":{"rendered":"Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8\u00ae-C Study in Chronic Low Back Pain Patients"},"content":{"rendered":"
\n

\nNew real-world evidence further supports the efficacy and use of ReActiv8\u00ae Restorative Neurostimulation\u2122 for the treatment of intractable Chronic Low Back Pain<\/i>\n<\/p>\n

DUBLIN–(BUSINESS WIRE)–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\u00ae-C study. Patients implanted with ReActiv8 at Klinikum Itzehoe were consecutively included into this cohort if they presented with back pain \u22656 and no prior lumbar surgery. The one-year results, published in World Neurosurgery<\/i>, 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).\n<\/p>\n

<\/a>
<\/a><\/p>\n

\nThis 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.\n<\/p>\n

\nDr. Med. Ardeshir Ardeshiri, Head physician of the Spine Surgery Section of the Clinic for Trauma Surgery and Orthopedics, Klinikum Itzehoe, said:<\/b> \u201cThese 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.\u201d<\/i>\n<\/p>\n

\nJason Hannon, CEO of Mainstay Medical<\/b>, said<\/b>: “These real-world results further validate ReActiv8\u2019s 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.\u201d<\/i>\n<\/p>\n

\nLink to publication of the study Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain\u2014a Consecutive Cohort Study – ScienceDirect<\/a>\n<\/p>\n

\nAbout ReActiv8\u00ae<\/b>\n<\/p>\n

\nReActiv8 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.\n<\/p>\n

\nAbout Mainstay Medical<\/b>\n<\/p>\n

\nMainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation\u2122 system, ReActiv8\u00ae<\/sup>, 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.\n<\/p>\n

\nFurther information can be found at www.mainstaymedical.com<\/a>.<\/b>\n<\/p>\n

\nForward-Looking Statements<\/b>\n<\/p>\n

\nAll 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\u2019s intentions, beliefs or current expectations concerning, among other things, the company\u2019s commercial efforts and performance, financial position, financing strategies, product design and development, regulatory applications and approvals, and reimbursement arrangements.\n<\/p>\n

\nForward-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\u2019s Annual Report for the year ended 31 December 2021, which should be read in conjunction with the company\u2019s public disclosures (available on the company\u2019s website (www.mainstaymedical.com<\/a><\/span>). The forward-looking statements herein speak only as of the date of this announcement.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nPR and IR Enquiries:
\n
LifeSci Advisors, LLC<\/b>
Brian Ritchie
\n
Tel: + 1 (212) 915-2578
\n
Email: britchie@lifesciadvisors.com<\/a>\n<\/p>\n

\nFTI Consulting (for Ireland)<\/b>
Jonathan Neilan or Patrick Berkery
\n
Tel. : +353 1 765 0886
\n
Email: mainstay@fticonsulting.com<\/a>\n<\/p>\n

\nMainstay Medical<\/b>
Corporate Communications
\n
Email: Media@mainstaymedical.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

New real-world evidence further supports the efficacy and use of ReActiv8\u00ae Restorative Neurostimulation\u2122 for the treatment of intractable Chronic Low Back Pain DUBLIN–(BUSINESS WIRE)–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\u00ae-C study. Patients implanted with ReActiv8 at … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51127","6":"format-standard","7":"category-industry"},"yoast_head":"\nMainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8\u00ae-C Study in Chronic Low Back Pain Patients - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/mainstay-medical-announces-publication-of-post-market-clinical-trial-data-from-ongoing-reactiv8-c-study-in-chronic-low-back-pain-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8\u00ae-C Study in Chronic Low Back Pain Patients - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"New real-world evidence further supports the efficacy and use of ReActiv8\u00ae Restorative Neurostimulation\u2122 for the treatment of intractable Chronic Low Back Pain DUBLIN–(BUSINESS WIRE)–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\u00ae-C study. 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