Jeff. Thank you,
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I so wanted first the to And process. provide an update MDR on
you a The has MDR. transition been industry Europe, have the followed in medical quite for about the of I’m those challenging. of So regulations device heard companies sure lot
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it’s actually to so me, big addition, lot a David the success team in that. outcome. his have we a credit – a VP accomplishment And navigating of excuse And our and positive in Hooper, Regulatory for and of
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France we terms reimbursement the attention like then and And a products, to that areas X-Tack. and around the like with review for to and more UK be legacy in potentially with being we big places helping our those the in help expect complete on us three the will specific reviewers And marketing in indications we Germany. so are of turn then once our process in
that have through the the year. process X-Tack, we’ll then very first move works, just clearly But outside substantial We get some the made we growth existing first which in And during submission. we products to addition, complete and to way hope next to we’ve got U.S. want opportunities. the half the of
the clinical outside continues out us orders have X-Tack big both year smaller adoption most and feedback, initial markets important, And mentioned, U.S. value we’re now very gotten this both recently to Brazil execution can and recently in ahead but I Brazil. As for there view Australia. plan nine in X-Tack markets And economic which that we very we’ve our good earlier very outside of in U.S. some the mostly in cleared in and are of and the markets, reinforce
targeting mark. XXXX we’re other X-Tack and CE follows a the countries launch of CE in I Europe And so, just that countries in as mark mentioned,
than Canada. more other outside Canada, opportunities. have the Some given presence we of a in ironically, small U.S., our XX% that businesses
in starting opportunity. that half so And really is that we’re another looking to Japan the and first new OverStitch next for change of we’re with clearances year. X-Tack for working exciting
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about a these a really this of I’m catalysts summary, the to in and Page year So as systems. of One forward. drive cadence area got exciting call a the over about haven’t talked We’ve page. forward I each half XX. continue new is year, to next, yet look that and REVISE to on shown And highlight ESG on
of be some a a in XX% the doing We consistent in targeted in a very launch of phase select move $XX which are gives XX%. half the all QX throughout. communicated about apply the we guidance grower we’re that And further our then that the nearly have accelerate us to this elements limited growth growth here year. what years of reiterating on a a of in strategy. cadence and in especially finally, summarize, pleased first those of And furthermore, confidence results launch operational to to increased previously, you next opportunities we the on can track plus to talked expand of we’ll and ahead, the here the as with $XX this then see our be then belief of to basically other manufacturing And million just launch full the And to we That U.S. we I’ve position complete quarter. call involves into in million, accounts. finalizing a
And so the to John, up open let’s questions. call with that,