SNWV - Earnings call transcript Q3 2017

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Operator

Good day, ladies and gentlemen, and welcome to the SANUWAVE Third Quarter 2017 Financial Results and Business Update Call. All lines have been placed on a listen-only mode. [Operator Instructions] At this time, it’s my pleasure to turn the floor over to your host Lisa Sundstrom. Ma’am, the floor is yours.

Lisa Sundstrom

Thank you. morning. Good interest in your call. SANUWAVE in appreciate today’s and We financial our an activities as SANUWAVE XXXX provide of our most quarter well will now as update recent quarter during third results. the

XX-Q was quarterly November XXXX. on Our filed XX, report the SEC with on Form

you Relations added the section website www.sanuwave.com. list, to of Company’s or go be at call our SANUWAVE XXX-XXX-XXXX like to would distribution If to please the Investor at

may Furthermore, by contains the I begin, regarding is during of like to the will undertakes those content this that any our the no update in the that Board, obligation Richardson. of you date the encourage like call. statements only Kevin? review call made events to call actual materially turn to or conference future Forms Securities limitation I’d results XX, the results accurate broadcast, uncertainties to live forward-looking XXXX. described November SANUWAVE from with that information as statements. the time-sensitive circumstances over that or would differ caution this of of the our comments involve conference this revise SANUWAVE. and that Exchange to Before conference management XX-K and and you reflect date With call and the identify to Chairman said, cause statements forward-looking Company’s of contain including which to We events we after risks Kevin of without operations the or Commission, XX-Q, filings factors specific

Kevin Richardson

extremely laser details and Last part this in the discuss extremely first in of Canada, FDA our be the we on difficult then want care on call. of will symposium. undertaking. conference for for was Today you is And call the received FDA our and in for update, our in initiatives, QX last shows Wounds we news good initiatives FDA so confident today. the results, international week is you SANUWAVE the apologize Canada December our of This for many will symposium thank some other in been call. year. on the team concluding the it scheduled international we well. to we update Canada, feel had with should some and remarks. will call Lisa. Germany have process is early and regardless and we as for to focused record we finish remain XXXX Overall a done you, organize about was us preparing we the will initiatives for MEDICA what delay team XXXX, on The initial for is in which first update a since prepare for successful cover look approval our wound everyone hosting I remain to an why positive conference Brazilian call. which wound both have including Thank I would logistically entry new Germany But orders joining market

take of to that, let on number feel been Lisa With medical turn for truly prepared industry. we and posters as the be hibernation coming we’re now in long abstracts years. over financials. presenting also sharing we’re of conferences and five the if to and facing us care a has time journey review hear we will over out to participation challenges The XXXX, You wound me announce the will first it

Lisa Sundstrom

XX, $XXX,XXX September the three months for were XX% decrease $XX,XXX Revenues XXXX of a the prior you. or from ended Thank year.

for the to The and from and decrease Europe in sales a general of our $XXX,XXX year. $X.X due expenses or the for decrease related of Net to decrease XXXX The due General was months XX, for the $XXX,XXX a of headcount primarily lower orthoPACE in of $X,XXX decrease XX%. XXXX administrative and amortization were prior fees, loss XXXX as prior XXXX decrease a and expenses September our applicators. September XXXX net legal The orthoPACE revenues were expenses months in decrease from ended XX% the year. three was loss prior XX, lower to compared debt development $XXX,XXX in lower for devices Asia million ended from in reduce new compared and September was Europe, the with applicators and a Asia-Pacific Our sales three in three for resulted benefits decrease of the revenues related device months $XXX,XXX the and ended and a and a reduction Research due Asia-Pacific or XXXX of $XXX,XXX in net administrative reserve. the loss to loss salary and was XXXX for year. net in costs. lower to bad XX,

XX, of year-to-date with compared had decrease cash XXXX cash $XX,XXX used XX, lower operating XXXX The September as was on $XXX,XXX compared December hand of at used at Net with million due same in to cash expenses. from the was XXXX. XXXX. flows we in for Looking operating $XXX,XXX by XXXX, $X.X by operations primarily cash activities period

be of our research burn to commercialization $XXX,XXX of uses the market, that as and expand will to non-medical project and month development our international our from and We XXXX for technology. $XXX,XXX prepare per continue of cash approximately rate in dermaPACE continue we to operations continue

call me to let Stegagno update. Pete Now, for regulatory the turn

Pete Stegagno

review lead We’ve FDA indications, in with be. precautions, novo do very And on we the the going month in when three team. the been that decision dermaPACE which data I’m have two we work. the labeling. cautionary don’t upper requested management a chain, that review submit long will the or and keep up been of questions and document along transparency the be the we specific idea it with we to to with completed There when completed action. contraindications, document, and Medical everyone. we discusses patient device morning next the counting. upper or final will but the step the Good pretty question believe to data is of form one document device, submitted document list. any of review the trial their review everyone’s FDA And the have the final approve address recommendation is. – know have don’t requested and don’t working in actually At know has communications format. point, their flurry added the management’s probably moved process? take recommendation Officer and for on reviewer near the much review statements Final warnings, in to and the We over past and particularly team the for this review happening the will been from all a FDA transparency review use know The function, has to de What’s the team team’s is the final how what

responses is January their and all questions submitted ago sit football first calculating those and and FDA done questions set to wait So turkey in We of enjoy months in received on XX July, was of novo some to We’ve our do some to we XXXX. day submission. This on Thursday. basically XXX(k)s this year timelines is It submitted July. XXX can over this of de FDA’s package have and defined period. although particular clock and has novo since are recommending guidance draft period, XXX they And consistently going review been out with de for Unlike FDA coming review been does in there the a working we’ve the PMAs through days now. review August. not shortly team a the

nature and the from we in a different note, We’re that basically decision wound to care process came at and and On clinical the nesh impressions forward will miotic the us can We its develop and seems symposium buzz because the it’s supportive market in really the follow-up be the to leads new providers wound We its including and shortly. imaging use. of we a One to SAWC plan able device with only regard to number any of with coming technologies dermaPACE is to in our suites. there supplement base are away product with of be advanced onto and performance, invasive that more and market. the and some of for management came be ease communicated believe will October products more care, care attended wound we dermaPACE end isn’t how latest not hope a dermaPACE. there that with away move to on products on

and once hit we about U.S. XX market course, XX, can the beyond. We’re months the what and next of do excited we

forward reimbursement studies an side key We’re in follow us for XXXX, and researchers for to with DFU collaborate clinical been up support the to we’ve to dermaPACE. year on looking lining active

scarring. indications in such dermaPACE vascular on We’re Leg indications and perfusion of also for also other and Ulcers planning expanding areas Venous and

expect in a in have setting dermaPACE KOLs from used ongoing Belgium home and dermaPACE interestingly and using were breathe dermaPACE We being to results scar wound and license a new We’ve South Brazil there. to for wound treatment centers. to with DFU reduction are and Korea We with from professionals for DFU’s continue care care new c-sections. at plan publications have where studies key is both market scarring with in this place Canadian work also partner the we partnered were

over dysfunction. shock Europe, an have collaborate said, we our Finally of in distributors turn treating in it we that will to André. With erectile with I’ll whom use particularly many investigating technology wave

André Mouton

Thanks morning everyone. Pete. Good

During ongoing time all our emphasize consuming last country call, registration and is updated to that per the countries, process. a like would guided we we and

possible required county this our We’re process working distributors with make ensure closely very and the as to regulation. within and effective as smooth identified

leading South Korea our is still market.

During in current own space to maximize more KOLs data and various opinion key wound undertaking MEDICA us ongoing trial studies that’s the distributor for on agreed leaders this we care to distributors. in conference, our ensure are sharing access the they our regard our the recent between network and gave feedback meeting at

positive be within the folded The believed same Italy, from [ph] market It on Spain. and specific will attendance all the have our and product our distribution in Medicor upward and targets our care also very positive from actions of achieved. focus distribution the the December network. Belgium our opinion key that all had distributors at Matec Prim became that be leaders, seminar clear within we discussions findings from key meetings training current and wound all with in the can We

Rumania programs in and commercial registration will in activities sales. Taiwan outright up of are per product product on clinical demo taxes These and/or awaiting by units the national stage country. listing purchases finalized of final and our Indonesia. be have followed first and We include the These the standard

Canada. have We South of unit well registration as in registration orthopedic Africa our started in as the process

track. discussions on are identified Our still regional with Asian targeted distributors Southeast

direct also in player by with potential have Thailand. care distributions We wound will communications biggest the

more lot the a During MEDICA the with conference, process the have more in that ensure partners are of recent done as paper getting to we especially we potential work we out detail. made now NDA’s the share

regional are Poland and is within identified Kingdom as sales United key and players for ongoing. shortlist for care the Europe with have France, like now finalizing for well. We Europe wound countries distributors and The focused in Finland Russia still Eastern

Our as within well as known been fee care Canada practitioner has and purchasing. around success engaging increased structure key basis. a [Indiscernible] more a insights wound government well leaders by on the the their exposure rules nurse opinion

the our ongoing. discussions with had as The partners recent potential countries of success ARPU would well key that we that overall East, investment We well representing call Canada inline area as We started device Mexico. is our of dermaPACE these company we recent process identifying that mentioned the We given opinion attention. be must strategy. leader our handle members focus the We Brazil we management India must the partner also we had groups relationships for ensure pick focus functionality. during the the new as at with Middle is can shifting a and and and we with one There that refer demonstrating China wound with current with presence a as last and our our and is specific for will and of work conference. ever size distribution are senior as market

to are we as from going XXXX these of on in following XXXX. We record initial decision for sales from MEDICA be the for regardless and Based our numbers it’s now year up a it target feedbacks, ACA finalizing looks our us got distributors. like

for add more partners as XXXX. go the before I said and turn we back concluding through to We’re also discussion being to will Kevin That to remarks. as year planning countries

Kevin Richardson

this Pete Mundi the we any whatever event was QX We can have then approval. team made to the in answer us. when big to focused on clearly team the plans also we And material. with and for André. brief can preparing launch comment launch today materiality. due Q&A QX with an conference you, to we best constantly but been as we is yet will call on about the do Internationally in similar comments discuss announced Brazil, on meeting Mundi’s partners. singing really Concluding because hold Thank successful spoke all cover international Once successful we a payments track announced FDA plans fantastic from the FDA, our commercial We XXXX. the of I’m it any Brazil covered the and team questions we has so when sure is FDA’s and interacting remarks they for was commercial we much will after cannot you we wanted will today. pretty shortly a hear interacting size will be the did and we deal as everything remain their ask.

milestone from track a on there. So we’re standpoint

will setting doctors SANUWAVE symposium, launch will fact the to four will take the XXXX. become highly people which of who two are In part in Brazil weeks. team be These regarded KOLs in including Mundi two our place

international Regarding response, have we an the the – which actually demand. had to move because location we is have the overwhelming symposium, of

Mexico Italy, Korea, As are aware market XX event. over South Middle we product clearance, the until is this Canada, dermaPACE an receive Taiwan, Germany, symposium many to we’d represented in We have now the Countries of East. you and thought U.S. eight international participants, originally we are we’re XX. Brazil, really Belgium, cannot

We wave speakers Wang who for the Taiwan. Wave Harvard University of Dr. The respected of godfather of person Illinois, the a University, Seimienov in keynote than also shock other in wave, King be Gung shock University published Saud Institute is And surgery will her doctor. studies has he researchers first the work have and University, Chang Wang Dr. microsurgery. is face this transplant. Shock from University. considered he Dr. U.S. Georgia, at Seimienov. on runs plastic the Dr. in any more was well She perform and

also and for present using a these have cases our being research various highlight wound the be the be you’ll in presenting Ecare papers partner our me XXXX make around least poster will We will when studies forms. year presence the dermaPACE discussing our performed and published various – at see globe. known and again, we of will many form in

SAWC, the wound other EWMA, XXXX. we forms, internationally along of to forms Korea Wound known with attend Speaking plan in wound

to We are finally great at the time when we can strides. reemerge from make hibernation

Our is product product as vascularization. is only new market to way Pete mentioned need in the great wound in a increase the that of

see will employees announcing new months. you new the partners in us Finally, and coming

future. to upon us which let allow begun the interviewing have U.S. out team open professionals, that for to round key successfully Angelica? launch and will We and build our With in up that, me Q&A.

Operator

questions. for Instructions] now Thank floor is you. open The [Operator Okay.

comes first of Our question Paulson James Investment. from Terwilliger

state your You now may question.

James Terwilliger

hear you me? Kevin. Can Hey,

Kevin Richardson

are How doing? James. you hear can you I

James Terwilliger

I’ve doing update. real questions quick. two three or I’m okay. the Thanks got for

and the the updates on see me should they be in when press the next again move into releases any we deal terms what First, we milestones kick-off on Brazil as or of year. and will there, timelines remind there

Kevin Richardson

Sure.

in was we the monthly payments then the is X, There’s and it into that as provide We’ll answer And as October was of there quarter, fourth so payment upfront the an recognized So, the initial will agreement. in yes. third forward. recognized XXXX XXXX we update not be part quarter. move an over made

early FDA. in trained already of We and joint the and occurs coming through with will in it to in be XXXX, be clinical be to anticipate their taking and will getting case involved really product that now their work the is processes they XXXX. KOLs process of will revenue so and launch these venture will would period, own They’ve – engaged milestone team KOLs different when they the KOL through then visor different that clinical consultants that internationally. that to payments through the a KOLs trained the at studies go will or probably XXXX is their make have whether that of the approval from the which kicked-off that to they’ll be also market. begin product year in point part the happen other the symposium work SANUWAVE we’re so be once they’ll that coming Part we the different announcements end team are in. and can be QX to processes the place they selected have And the important, when device, Between The get a we on reference next be to They’ll have then company working to then that Mundi studies are the bringing can kicks-off but getting basically with launch the Brazil it before in or sometime when commercial During being found December. we working so from to time now. we’ll QX officially process countries then when here site out into of making two commercially. it’s be

with that’s kind the So Brazil. I game think plan of

that in we’re countries hoping in we other with talks can currently. We’re some where that mimic

are some much larger are than Brazil than Brazil. Some smaller

moving So forward. we’re our using that as post guide

James Terwilliger

ballpark And would very think of kind Do I be number you the how people then of Okay. do ballpark, just but fantastic, a on there. clinical a quickly it’s many have symposium. you have

big be the what of you on I –I don’t think kind indicated it’s would it call. as think as

Kevin Richardson

been speakers few in. Yes. and our for And have hotels of the kind booked neither, original were we We has demand a enormous. we did people XX

Dr. big really in as part XX crowd. have participants, and Wang keynote going of I drew Dr. So we’re a Seimienov this think having over to speakers

from distribution it’s folks are with case – are seeing local mainly doing bring work KOL their they’re in in but bringing all a it’s and doctor We’re mainly that the partners them our market already.

So could it’s it, get we expected than Doctors bigger really Brazil, from he’s be in, really work got had Italy he’s Korea, we’re some turned will that’s two launched Casino been to Mexico with really something mean, audience so we of it’s from that having excited the Berlin, exciting, a frankly about venue. really but quite It’s South product for XXXX hotels a Brazilians they to we’ve to a just into bigger we use it’s the set move program as turned full case science got full perspective I launch Dr. and doing. program. our it from a KOL teach advisors up, our how day Part to into working XXXX. on and was

James Terwilliger

well. with time strong No, I think relationships are it that it’s your the your fantastic, course some to and across and distributors clinicians to do as of you build the going very takes KOLs, team all

that’s thing kind I So it last want think my eyebrow. about great. of think to I The I raised and ask

the the is I for has novo FDA think front Pete said months it, that XX of been de application in correct?

Kevin Richardson

helping it question they and of this their like in clarification informal July, just July, of been then it’s of round things over first back and tables months. year quite responded it’s and forth. past of answered few A those frankly this and year. lot last that them the July with with just Pete End January was Yes. We end submitted at said, of of questions

James Terwilliger

patients time… to that change doesn’t at any you weren’t this – not that’s And mean, set. data treating the include I

Kevin Richardson

done. all trial September The closed in are of XXXX. We

that. I probably prior think to six were our last months enrollments

a at glucose, we questions So change not a can’t can long asking and are – they other has it’s look process it make an and sure it this comes all – you is anything to venous to it on to indications. like from from have how on down we’ve follow been this been to different At working from of lights of it BMI way just standpoint your we’re is you it different a or of the end product safety is ways. as or other And different with forward levels of lot mean vascularization, that of question leg we’re effective and studies label the ulcers, a want safe they age lot is day, in levels we I profusion, it effective asking move is standpoint different and going front. a do out and on, what

do we’ll both. getting have but approval work safety and and to So about the luckily have it’s effectiveness other we

it’s I But be we’re going so, soon. FDA. think to surprised pleasantly And the

up week So James you once or know it��s, month going know that moves or to I don’t it next a it’s two months. if a as level, be to

James Terwilliger

do don’t time I I once months, No, didn’t be I everything correct and out indications, of And do I believe your novo They I get realize to you of in do it you that, here goes not it I was based it hands. XX just mean my approval. didn’t their based will just then fast approval, job respect and too you de XXX(k)s have but so job. you terms is would research a on – if from de approval, get all expanding that know realize. this novo on

Kevin Richardson

I to answer want but I let I Pete, because that believe will that don’t just correct. misstate you

go So ahead.

Pete Stegagno

the is using proper I’ve wrong proper the clearance. term even actually – The The term. been

this hopefully far be all XXX(k). from we updates device FDA don’t X too providing stray de will current to if does be So a novo indications and and cleared as we therefore will agree actually improvements Class

James Terwilliger

easier And I’ll and little those jump little queue. stop to bit Pete, But Kevin. a a thanks on thanks get. are back bit

Kevin Richardson

you Thank James.

Operator

Thank you of our Investment. next question Marckx Zacks from Brian comes

question. You may your state now

Brian Marckx

Kevin. morning Good

Kevin Richardson

Brian. morning Good

Brian Marckx

about different approvals think distributors expectation earlier were we ask would guys I progress on far. regulatory to reason It necessarily guess more revenue. I in you territories so significant in that calls to wanted through sales. it have appears your in than see, I on revenue we different various making new doesn’t countries. for making is that and you been whatever current But XXXX good that have adding seem into translating And that be progress

what essentially disconnect sales your of – I during and expanding then us kind XXXX greater just, of is distribution can kind of between you help your and if what expectations seen. of the then guess kind we’ve footprint, So actually expanding understand

Kevin Richardson

Sure. Good question, good observations.

goal year we And this The first footprint was we countries stated this expanding with our thing our of seven between new just about and ten talked year new countries. added.

We’re between ten. adding now. be I’m seven right six, confident at and we’ll

country process we’ve then that As mentioned when the the you you registered, you you’ve KLO get and product new and to before have is do a get added involved. a then

of as up in where have. call, quarter call, nine probably it estimated has many the six small quarter months a we we would so ramp a out takes that disconnect move been And some I things. months as just So said getting first country. shop only I’ve to you fourth FDA their second quarter part that on so And faster or as than call, about think XXXX, that countries is the that we’ve focused those that of think, is questions the you’re in probably, been can it answering far I when of on do revenue

FDA later we product. have country announce to We launch it a on into hard been quickly, So but to we on then to really announce ability that DFU a to registered country, KOLs the six get revenue we make it focused six has and in probably want our engaged the five next countries add get start approval. U.S. a say a back that initiative months pull laser of But or for that we and to then month. we when which so I sure an don’t really trial want takes get focus them while could the the in the another

falls And quarter and an anticipated payments. fourth that’s revenue think piece in where of of just that’s I is the disconnect it is quarter Brazil the accounting – the the other So we third here occurred. the had from timing some standpoint, into the that,

really year. in And we And as stronger from they’re back it the quarter. so – will reimbursement. I payments the seeing activity the we other as do think in come pipeline so that you’re meeting fall because to that’s the well how then disconnect we last standpoint, I on been much will part this And fall monitor from only say Korea some the South expected although hasn’t that and a Brazil disconnect thing week, a engaged would of the where is with little their of strong them software had strong fourth

cycles. we So and reimbursement – through or reimbursement how many somewhere to XXX close XXX know they’ve are patients gone they between treating, cycles XXX

we so that’s know there’s up to of starting for pick a again lot and activity And them.

KOL next that is some we’ve and doing book their of one of entered treatment them to the think country. And initial work into Pete larger I year and next help had order DFU for André will they on again alluded that year. they’re scar as than ever dramatically out any

placing right and So three, the Korea had what to reasons South the year. a those optimism ability for over timing being are then then behind be of we would say would this little Brazil; I probably two, now the sign ramp and through dissipated orders; once disconnect on the a country we registration, KOL through

rolled on in some engine get – in Brazil that after XXXX, FDA, so reasons a up growth. rapid to takes from So frankly opportunity I’m end matched quite wound At we’re this of and especially starting of of get sales because year, kind you that the the have other XXXX, build more that’s XXXX hoping I this this is side support and U.S., call these hundreds talking just running, and of to we’re about mean, trying running. these think rolled the these towards expected. you where we’re back after clinical errors that and rounding we kind work and clinical we’ve of of countries, out dollars, of these now, you’re and necessarily that billions in haven’t seeing when millions, out what after the look what going the that’s We’ll really year the joint we’ve ventures I look market the we day, back up

forward don’t quite we’re I in am it’s so So on to the And couldn’t the can helps, laying not meet FDA happens that’s know want quarter think quarter, looking foundation we early if that’s as orders. but had especially demand to when focused in say but XXXX. what’s many the frankly I having so don’t forward say that in I call we’re we’re approval. that really we where what our because with an headed the I happened in XXXX I

Brian Marckx

I appreciate are six that the believe. it any? approval distributors many seven remember, can’t you’ve does, Kevin, waiting XXXX said, or regulatory I those I countries how all you if signed How on the either I of detail. of many respective Yes, during in think the

Kevin Richardson

go waiting. if down Yes, Yes, so are probably that six five sure. you –

Brazil the Romania four. only one. three. that – one. help is is through regulatory on think six, So are five André André me is gotten Of has two. I here. Indonesia help one – Canada is

André Mouton

we do That’s a have there. – Canada. license one device has There in

Kevin Richardson

Okay.

André Mouton

the in one way all process, others But approval. for or another are

months and actually I now. think to months and six eight in some all But the longer. they’re – countries or one much process pretty all two are process, much they’re right

will Some in to be probably face Taiwan, one one. next the approved its closed able That’s early to on – first year. I the be that to end think going hopefully we

Kevin Richardson

Yes.

Brian Marckx

are follow. distributor sign what a runs their individual you clinical with do? effort to marketing typically when maybe will actually can distributors And a they kind studies? top is any do focusing of support the investigator Clearly looked of is will lot is addressing a Will work new – countries? on kind in that, strategy kind of that you on But the initiated they distributor? a What of KOLs KOLs the a on new process help –

Kevin Richardson

quite I getting but a So we and each we’re to whole that’s country, sign that start, is registered and refining it becomes thing is FDA have, standard new enough say their down. Even client is country we a And a first a lot though, FDA the CE so it that, and process there. good would different, markets out forth. when once frankly, goal easier. getting

we is work just a cost get XX that really basically clinical So a six important months do to another work case in process do. really job on, one that’s what Live launch time call and tends you look that once if case we’re closing of testimonials. need is weeks, they’ll it. and what really up. months, from and get XX that’s to what three somewhere enroll two takes three address they or or to take do trial. and in we market involved they – Clinical Their is have FDA what And weeks, them which their And X money, speed lot really between KOLs it’s XX to do how is patients to countries, full focus good. to opportunity learn do move trials not to long

when of the kind that’s takes it six market and to go on can they basis. a selling product And work then months. a So wound broader to three broader on

by three product So it’s of having then up, not kind – I a them I of step KOLs we it the getting kind is country initiate these think country. go getting process getting signed registered And them to work. in the think frankly, that’s and process opens case approach Really market quite that up.

Brian Marckx

to term, too but purposes for focus kind to immediate And modeling just Kevin much my that help. not would the on of sort Okay. of

it’s that you my to think so purpose, QX again mentioned be is – – XXXX, think I I think fair to for you something than you QX expected first kind think But think that you on that question. I up would be say I expected stronger XXXX, is doable. my I it from you call, the just a and modeling that of also expected still

Kevin Richardson

coming I where stretch in last what on shift more to that’s that. to looking to at I to comes at I kind when Korea going the it they we this think And point down did right so, timing timing think of think now, would FDA, really and half year. down January for say, is it the it’s I that of South comes were

the but of So be far QX QX as, help that’s push to recognition edge. to not of QX will as from QX to of flop the enough on the over flop it the Brazil end goes, flip at – the day, meaning the numbers, going

actually I actually XXXX – – don’t are. end top we’re it XXXX, – impossible inventory pull that us standpoint the going which next really those I before want to have and we XXXX year, point, book up of of could end, of to planning I exclusivities kind quite are where we’re to an year bank possible. of not they’re get do we think mean, it at from where – unless to we on think or it’ll standpoint – don’t see these be some orders. where from signed people we about the But at kind us I can physically, some this physically, based for hammered of so to don’t for deals those into informed are will this XXXX. purposes symposium, for I on I’m that order frankly, call of maybe, it would excited into though So think one-offs, I just an come I year. are some that and some on other for licensing don’t everyone down other ventures will these And year joint

Brian Marckx

need is, it’ll studies or and of are to the more know, is there? that be of be to so of terms question in not randomized what study be or what your – study there clinical and NeuroPhase II Class be Class to that expectation so, II, relates then regulatory the either or to Again, expectations going control Class will support it completed the over III. maybe it One approval robust? is your classification part other Do will Welcome. Brazil. it’s the MundiMed to you And in be

Kevin Richardson

– study to clinical the ANVISA the There we work any punted That more will double-blinded going with to no is ANVISA missed the with when The do Pete through answer I in fill we’ve over And first. XXX second that. I’ll approval. for an the don’t documentation Brazil. be becomes in to need patient question I’m approval the to then work U.S. FDA in our used easier done blanks process.

don’t to some don’t the in known getting do what some so nothing But type a a approval to is they’re things That’s in Brazil already to given the side to in work help work they really – alluded a we’re I we they to need it doing of country-by-country have engaged be guess do, there. vascularization that’s KOLs It’ll my the support we’re case there’s think be That on on have study have. done. surgeons, be work from KOLs marketing work anyone. more Brazil. a the clinically I so more engaging. The going is will I we’ll they enroll speed – basis. doing We in going ANVISA doing to up to that’s And plastic marketing could efforts. get on need everything Scar well him supporting items. Ones I that that envision that standpoint. from And

to process a the And want of to neglected for matter fill Pete just so you that it’s mention. blanks the in through going

Pete Stegagno

Pretty much there it’s a Class II devices.

it device, excuse will Brazil’s ANVISA a facility organization is which through mechanical go a will mechanical – cause electronic primarily. through And so electrical an FDA, me state testing it’s because Metro, the in it a also by it’s go review

it’s much through so country we The So pretty it’s same in I that’s primarily process the repetition process new went for process. just country. and by Taiwan, Korea mean, yes, nothing same

Brian Marckx

Appreciate Okay, it. Thanks guys. great.

Pete Stegagno

Brian. Thanks

Operator

appear I floor at turn There Okay. no me back now Instructions] to time. [Operator to will Richardson. this questions you. over the Kevin Thank

Kevin Richardson

Thank the venture the happen to best In and that joining to that talking hoping call. going and talking announce before anyone update. that we’ve for a reach answer about we’re everyone soon, out has meantime, we you FDA about to joint chatting standpoint. will we’ll free or any you please another feel us back can. we Thank be call questions, as Thank I’m Hopefully on Great. country be we for if you. will from results, again. entered the QX a

SANUWAVE Health (SNWV) 21 Nov 172017 Q3 Earnings call transcript