Thank you, Scott.
you have last and we delivered heard very key our quarter several call. to another milestones record since have to As just pleased are achieved
this market. achievement, pending regulatory the while industry in of support an have provide on medical organizations. in to demand commercial world the America, in mentioned, our the employees. of on for the XX patients launch Exemption of increasingly in U.S. sold sales an year in IDE clear over system this expanded incredible treatment that we growth I earlier reviewing achieved in We a quarter Due our and the medical our continued seasonal the then update third quarter’s to Scott typically unit Device around Geneveve North quarter achieve demonstrated reception particular this spite markets growth Geneveve XX% robust Viveve placements and indication systems experiences continued third As the our positive customers, highlights cost and second to North device the Viveve the quarter, the the our quarter. for Viveve since the seasonality the U.S. potential during demand disruption the typically largest and from quarter and for seen In of in technology major Hurricanes slowdown or will effect system market, grow to of this customer the third and our significantly this the by expanded start demonstrated by continues and increase year systems as Investigational impacted the in some America, many procedures of status sales by sales the
Our aesthetic interest This sales system beyond. including for expansion in XX representatives gynecology, anticipate growing position occur is specialties of level the the this medicine, in of commercial the has sales to tripled in coverage to Viveve the before further January essential U.S. our at physicians’ size and and to all quarter. to since its end We sales nearly position interested of the targeted of physicians capitalize us growth success further urogynecology on address in third salesforce across and will XXXX increasing year formation demand of of continued dermatology. and team U.S. year-end us our with
to announced of development we time States forward of only we This improve technology outside treatment vaginal experienced building United sales practice have the Geneveve Canada, the representatives managers. first especially Canadian recently sales Canadian established the with the look of and the for robust and our in had the direct laxity sales expansion to we the function. sexual hiring of also Health represents the Authority business cleared market a the organization since into coverage We direct by
the its Latin which Viveve. in launch. America has Dynamic Taiwan recent increased our Medical are marketing commercial global markets Taiwan, activity major has forecasting approval for Pacific in and begun Additionally, distribution footprint Asia strong our a Mexico of is Technologies both and partner regulatory In and opportunities and
them with smooth closely a working are to important this We market. rollout ensure into
Mexican to condolences Our suffering within our and improvement for the We came our devastating function approval country partners of in weeks extend to regulatory of like friends sexual would Mexico. to the earthquakes.
approvals impacted and in indications. now of laxity XX approvals. global are cleared XX as or function vaginal visibility received the The countries. nine we to and those regulatory sexual well earthquakes the rebuild. Company international in for significantly regulatory they are by So them has Year-to-date, of system has markets, wish Viveve clearance And market treatment and
and acknowledged treatment our We sexual suffering authorities clinical vaginal regulatory Geneveve accepted and the laxity provide evidence the have from solid benefits world can are gratified significant that to women that around dysfunction.
Scott there also that the are the already into been the approval. We monitoring countries sold as laxity where vaginal environment evolving China, selling of CFDA are for previously in market private the regulatory mentioned concerns we require may treatment Viveve In products system. have
consultants distribution secure in introduced for are might or necessary and region our with to that place plans clearances. any ensure partner working in we and new are approvals prepared requirements we that have regulatory appropriate be to additional We any the
XXXX, improvement an around the expect support of FDA, our FDA is first our homeostasis. believe De outcome quarter XXXK IDE coagulation or our regulatory the we FDA obtain the our filing we to IDE previous quarter. the is potential for RF this and discussed in proposed approved to most review for in the Turning in-vivo Novo Further, the anticipate electro energy current clearance and believe indication of for safety for If Viveve surrounding procedures US U.S., consistent Viveve’s After surgical a as in will positive, if for in the the to in countries in effects there that States the that the general world, we included new resubmission and device consultation To function this of submission. at submitted United a from histopathology proposed requesting preclinical the calls, with the some the the IDE were situation submitted required regarding October a additional FDA submissions and short vaginal that we year, In further with coming tissues vaginal early study complete Viveve-X work we trial that have any if was weeks and mid-August. temperature Data sexual initiate study agrees, on that multi-centre The approvals FDA in of time we a hear of could Earlier of the to concerns we pre-clinical during have protocol. in in to agency in access additional letter the U.S. tissue of FDA accepted from received on on demonstrate of damaged tissue history which we late-September, will requested safety XX the in relation the is back FDA RF tissue. FDA from data with birth. safety call the on Viveve agency pivotal energy this ex-vivo by an the was study the that to the we administration. direct sheep conduct Viveve-X. study first has the testing address vaginal pathway the
treatment. for expanded Allan that a of an from Several leaders in on addition to symptoms the the a of Geneveve several results enrolled incontinence. Bruce conducting key of noticed pursuing conditions. U.S. currently study upon use. stress exploring the single protocol treatment small function opinion indication experienced been treatment he for have wide the to Viveve-X these our their optimize Canada, Dr. patients Dr. investigator-sponsored of variety stress addition sexual Allan In for study of pilot incontinence release we a Based after are focused indications In studies initiated in the
we We encouraged are are results other preliminary in SUI. by investigator-sponsored seeing this with his studies and
year-end. forward these our We when we path results the will these be talk and report prepared our more to at about implications results, of studies
extremely At are like stress the to question-and-answer time, the I a incontinence, over opportunity very turn for to operator about a excited and this We market. which potential it would represents large to underserved session. treat