Mainstay Medical Announces Commercial Launch of ReActiv8® in Australia

March 8, 2021

DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc (“Mainstay” or the “Firm”) right now introduced the industrial launch in Australia of ReActiv8®, its implantable neurostimulation system to deal with persistent low again ache.

“Launching ReActiv8, our Restorative Neurostimulation remedy, commercially in Australia is a big milestone for our international industrial enlargement. A number of prime Australian physicians have been a part of our scientific research since inception and are among the many most skilled globally in deciding on and treating sufferers with ReActiv8. We’re excited to make ReActiv8 commercially obtainable to Australian physicians and their sufferers affected by mechanical persistent low again ache,” mentioned Jason Hannon, CEO of Mainstay.

The primary industrial ReActiv8 implant in Australia was carried out by Affiliate Professor Bruce Mitchell, Sports activities and Interventional Ache Doctor and Director of Metro Ache Group in Melbourne, Australia.

“Having been concerned in each the ReActiv8-A and -B Scientific Trials, I’m excited to have the ability to broaden this restorative remedy to different sufferers in my apply. The launch in Australia is a good milestone for ReActiv8 and, in the end, the sufferers that undergo from persistent mechanical low again ache who now have a brand new remedy possibility,” mentioned Affiliate Professor Bruce Mitchell.

About ReActiv8

ReActiv8 is an energetic implantable medical gadget designed to deal with adults with intractable persistent low again ache related to dysfunction of the lumbar multifidus muscle, a key stabilizing muscle of the low again, as evidenced by imaging or physiological testing in adults who’ve failed remedy, together with ache medicines and bodily remedy, and will not be candidates for backbone surgical procedure. ReActiv8 supplies bilateral electrical stimulation of the L2 medial department of the dorsal ramus nerve because it crosses the transverse course of at L3. Stimulation of this nerve that provides the multifidus muscle elicits contraction of the muscle which might result in restoration of management over time, permitting the again to get well from CLBP.

The ReActiv8 Restorative Neurostimulation remedy has a CE Mark permitting for commercialization within the European Financial Space and has been centered on constructing scientific validation in Germany in choose facilities forward of wider industrial availability. ReActiv8 has additionally been admitted to the Australian Register of Therapeutic Items (ARTG), enabling commercialization all through Australia, and has been accredited for inclusion on the Protheses Listing of reimbursed merchandise in Australia, efficient as of 1 July 2020. The Prostheses Listing identifies implantable units eligible for reimbursement from all non-public medical health insurance funds in Australia. Within the U.S., ReActiv8 is FDA accredited and the Firm plans to commercially launch in early 2021.

About Continual Low Again Ache

One of many root causes of CLBP is impaired management by the nervous system of the muscle tissue that dynamically stabilize the backbone. ReActiv8 is designed to electrically stimulate the nerves answerable for contracting these muscle tissue to enhance dynamic backbone stability, permitting for enchancment in CLBP and its disabling results.

Folks with CLBP normally have a tremendously lowered high quality of life and rating considerably greater on scales for ache, incapacity, despair, anxiousness, and sleep issues. Their ache and incapacity can persist regardless of one of the best obtainable medical remedies, and solely a small share of circumstances consequence from an recognized pathological situation or anatomical defect which may be correctable with backbone surgical procedure. Their skill to work or be productive is significantly affected by the situation and the ensuing days misplaced from work, incapacity advantages and well being useful resource utilization put a big burden on people, households, communities, business, and governments.

About Mainstay

Mainstay is a medical gadget firm centered on commercializing an progressive implantable Restorative Neurostimulation system, ReActiv8^®, for individuals with disabling mechanical persistent low again ache (“CLBP”). The Firm is headquartered in Dublin, Eire and has subsidiaries working in the USA, Australia, Germany, and the Netherlands.

Additional data may be discovered at www.mainstay-medical.com

Ahead trying statements

This announcement consists of statements which might be, or could also be deemed to be, ahead trying statements. These forward-looking statements may be recognized by means of forward-looking terminology, together with the phrases “anticipates”, “believes”, “estimates”, “expects”, “intends”, “could”, “plans”, “initiatives”, “ought to”, “will”, or “discover” or, in every case, their unfavourable or different variations or comparable terminology, or by discussions of technique, plans, goals, objectives, future occasions or intentions. These forward-looking statements embrace all issues that aren’t historic info. They seem all through this announcement and embrace, however will not be restricted to, statements relating to the Firm’s intentions, beliefs or present expectations regarding, amongst different issues, the Firm’s plans to commercialize ReActiv8 in the USA, the U.Okay., Australia and elsewhere; the industrial efficiency of ReActiv8; and the Firm’s outcomes of operations, monetary place, prospects, financing methods, expectations for product design and growth, regulatory functions and approvals, reimbursement preparations, prices of gross sales and market penetration and different industrial efficiency.

By their nature, ahead trying statements contain threat and uncertainty as a result of they relate to future occasions and circumstances. Ahead trying statements will not be ensures of future efficiency, and precise outcomes could differ materially from these described in, or instructed by, the forward-looking statements contained on this announcement. As well as, even when future outcomes and developments are in step with the forward-looking statements contained on this announcement, these outcomes or developments might not be indicative of outcomes or developments in subsequent intervals. Various elements may trigger outcomes and developments of the Firm to vary materially from these expressed or implied by the ahead trying statements, together with, with out limitation, the profitable launch and commercialization of ReActiv8, common financial and enterprise situations, international medical gadget market situations, business tendencies, competitors, the supply and value of capital, modifications in regulation or regulation, modifications in taxation regimes, the time required to begin and full scientific trials, the time and course of required to acquire regulatory approvals, foreign money fluctuations, modifications in its enterprise technique, and political and financial uncertainty. The forward-looking statements herein communicate solely on the date of this announcement.