Main­stay granted CE mark for back pain sys­tem

Irish Independent - Business Week - - NEWS - Michael Cog­ley

IR­ISH medical firm Main­stay Medical has re­ceived the CE ap­proval mark for its im­plantable sys­tem to treat dis­abling chronic back pain.

Af­ter ac­quir­ing the mark for its ReAc­tiv8 sys­tem, Main­stay can now be­gin the com­mer­cial­i­sa­tion of the prod­uct in Europe.

Main­stay chief ex­ec­u­tive Peter Crosby said the mark­ing is a “piv­otal” mo­ment for the firm.

“We be­lieve ReAc­tiv8 has the po­ten­tial to change the lives of mil­lions of peo­ple who cur­rently have limited treat­ment op­tions for their chronic low back pain.”

Dur­ing pa­tient-controlled ses­sions, ReAc­tiv8 stim­u­la­tion causes repet­i­tive con­trac­tions of the key sta­bil­is­ing mus­cles in the back to sup­port re­cov­ery from chronic low back pain and re­lated symp­toms.

An or­tho­pe­dic sur­geon at the Univer­sity Hospi­tal in Bonn, Dr Robert Pflug­macher, out­lined the po­ten­tial pa­tients for the new de­vice.

“We see sev­eral new chronic low back pain pa­tients ev­ery week who are not in­di­cated for surgery and who meet the in­di­ca­tions for ReAc­tiv8.

“Rather than send­ing them home un­treated, we now have an ex­cit­ing new op­tion we can of­fer them,” he said.

In Septem­ber Main­stay posted in­creased ex­penses, which it said was largely at­trib­ut­able to costs as­so­ci­ated with hir­ing and in­creased ac­tiv­ity in the ReAc­tiv8-A clin­i­cal trial.

Main­stay was es­tab­lished in 2008 in the US be­fore be­ing moved to Ire­land.

Davy an­a­lyst Jack Gor­man de­scribed the newly ac­quired CE mark as a “cat­a­lyst” for the com­mer­cial­i­sa­tion of the prod­uct in the Euro­pean mar­ket.

“Ini­tial mar­ket­ing ef­forts will fo­cus on Ger­many, in par­tic­u­lar the hos­pi­tals seg­ment. A di­rect sales force will be utilised to achieve this, sup­ple­mented by field clin­i­cal spe­cial­ists.

“This is a very pos­i­tive de­vel­op­ment for the busi­ness as it moves towards rev­enue gen­er­a­tion,” Mr Gor­man said.

Main­stay said it will look to de­velop fur­ther data af­ter the sale of the prod­uct and has sig­nalled plans to launch the ReAc­tiv8-B clin­i­cal trial in sup­port of an ap­pli­ca­tion for Pre­mar­ket Ap­proval (PMA) in the US.

Sana Hospi­tal neu­ro­sur­geon Dr Ste­fan Schu ex­pects strong adop­tion of ReAc­tiv8 in the Ger­man mar­ket, where the firm will ini­tially fo­cus sales.

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