Additional real-world proof supporting the efficacy and use of ReActiv8® Restorative NeurostimulationTM for the therapy of intractable Power Low Again Ache
DUBLIN–July 20, 2023 (BUSINESS WIRE)–Mainstay Medical Holdings plc right now introduced the publication of three-year scientific knowledge from the Publish-Market Medical Comply with-up (PMCF) research of 33 ReActiv8 sufferers from 5 medical centres throughout the UK. The three-year outcomes, printed in British Journal of Ache, demonstrated {that a} substantial portion of sufferers skilled statistically important enhancements in measures of ache (NRS), incapacity (ODI) and high quality of life (EQ-5D-5L). The publication could be discovered right here: https://journals.sagepub.com/doi/10.1177/20494637231181498.
These outcomes point out that the response to ReActiv8 for these sufferers is sturdy and improves over time, validating ReActiv8’s restorative mechanism of motion. As well as, these real-world outcomes are in keeping with the three-year knowledge from the pivotal ReActiv8-B scientific trial, introduced in September 2022, as proven within the following desk:
| % of Sufferers Exhibiting Medical Enhancements at 3 Years | ||||||||
| End result Measures | ReActiv8-B (N=133) |
PMCF (N=33) |
||||||
| CLBP Remitter (VAS ≤ 2.5/NRS ≤3) | 64% | 70% | ||||||
| ≥ 50% discount in low again ache | 77% | 67% | ||||||
| ≥ 15-point discount in ODI | 71% | 55% | ||||||
| ≥50% in VAS/NRS and/or ≥20 factors in ODI | 79% | 75% | ||||||
| Completion Fee | 76% | 79% |
Dr. Simon Thomson MBBS FFPMRCA, Guide Lead on the Ache and Neuromodulation Centre, Mid and South Essex College Hospitals NHS, Essex, UK, acknowledged: “These outcomes show sturdiness and security of this remedy in continual again ache victims who would have continued to be crippled and dominated by their signs however for ReActiv8. These sufferers, drawn from normal UK Ache clinics, are actually pretty much as good as these seen within the continuation cohort from the extra extremely chosen randomised ReActiv8-B trial.”
Jason Hannon, CEO of Mainstay Medical, acknowledged: “We’re happy so as to add these compelling outcomes to the rising world physique of optimistic peer-reviewed proof supporting the flexibility of ReActiv8 to supply optimistic long-term outcomes to this severely affected affected person inhabitants. Most significantly, the continued enchancment in affected person outcomes noticed within the real-world setting is in keeping with the outcomes from our managed scientific trials.”
About ReActiv8®
ReActiv8 is an implantable medical machine designed to deal with adults with intractable continual low again ache (CLBP) related to multifidus muscle dysfunction, which can be evidenced by imaging or physiological testing. Candidates for ReActiv8 are sufferers with multifidus muscle dysfunction who’ve failed different types of remedy (together with ache treatment and bodily remedy) and aren’t candidates for spine surgical procedure. ReActiv8 has acquired regulatory approval in a number of geographic areas, and is commercially obtainable within the European Financial Space, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical machine firm targeted on commercializing its revolutionary implantable Restorative Neurostimulation system, ReActiv8®, for folks with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Eire and has subsidiaries working in Eire, the USA, Australia, Germany, and the Netherlands.
Additional info could be discovered at www.mainstaymedical.com.
Ahead-Wanting Statements
All statements on this announcement aside from statements of historic reality are, or could also be deemed to be, forward-looking statements. These forward-looking statements might embrace, with out limitation, statements concerning the corporate’s intentions, beliefs or present expectations regarding, amongst different issues, the corporate’s analysis research and outcomes, industrial efforts and efficiency, monetary place, financing methods, product design and growth, regulatory functions and approvals, and reimbursement preparations.
Ahead-looking statements contain danger and uncertainty and aren’t ensures of future efficiency. Precise outcomes might differ materially from these described in, or urged by, the forward-looking statements. A lot of elements may trigger outcomes and developments to vary materially from these expressed or implied by the forward-looking statements herein, together with, with out limitation, the dangers and uncertainties included within the firm’s Annual Report for the 12 months ended 31 December 2022, which needs to be learn together with the corporate’s public disclosures (obtainable on the corporate’s web site (www.mainstaymedical.com)). The forward-looking statements herein converse solely as of the date of this announcement.
Contacts
PR and IR Enquiries:
LifeSci Advisors, LLC
Brian Ritchie
Tel: + 1 (212) 915-2578
Electronic mail: britchie@lifesciadvisors.com
FTI Consulting (for Eire)
Jonathan Neilan or Patrick Berkery
Tel. : +353 1 765 0886
Electronic mail: mainstay@fticonsulting.com
Mainstay Medical
Company Communications
Electronic mail: Media@mainstaymedical.com
Discussion about this post