our I'd and initiatives everyone, to new core quarter result are to afternoon, this our for thank focus potential its positive financial incontinence entire call. efforts conference towards the begin program our indication. Good urinary Jim. stating the of by rapidly advance our Thanks, like a our stress which listening on results that future you we today continues organization, as of
trial trial continues of PURSUIT the end execute U.S. Our progress clinical completion landmark as year. the of visits to towards subject follow-up we the by
have SUI our high achieve the the in a indication the to in to design in United ability study strength execute a strategy We level PURSUIT confidence our potential and States. of of
QX through XXXX, the continue PURSUIT focused our following efforts capital trial, including strategic the to operations be areas. resources of the on our core completion With support the to
are end thereafter. If hypermobility FDA for the SUI to shortly women. completing trial to results positive, year first trial follow-up execute First, line enrolled launch of top commercially preparing novo SUI by the visits approval pursuit for reporting preparing be improve by successfully patient continuing and the dual-energy what office-based treatment to submit for and our the application urethral in fully results to patent-protected could endovaginal to the quickly FDA-approved de
continuing gynecology on increased and tip Asia core of our to urogynecology, expansion sales. the third, market current installed targeting commercial treatment support our Pacific Secondly, regions our continuing and future drive development utilization to finally, customers base focus initiatives with successful the and efforts through disposable urology and U.S. specialties. and And to
entire our to clinical potential U.S. areas some to a previously, committed I'd the new fully program indication stated now around towards development I've trial pivotal SUI. to continue in organization our these PURSUIT focus is for As discuss advance core SUI our as of we enrolled U.S. the specifics strategic like of
leakage XX% than nine The study. also using urine full weight voiding leakage the three-day XX As ml baseline, subject monopolar bladder a that one-hour XXXX, one-hour Post-treatment active sham months in monitored weight SUI. procedure. pad and subjects treatment. treatment January on SUI patients double-blinded States. post-treatment safety being test. We pad a diary up the complete Initiated comparison is cryogen-cooled more as sham-controlled is a proportion or of standardized endpoint arm energy control as follow-up XX also The study ratio, enrolled quality objective the received visits a and to is United compared at XXX to reminder, patients in rapidly approximately an PURSUIT than the XX trial CMRF enrollment questionnaires. subjects greater in the at of in and throughout of in other weight or study moderate Moderate true the randomized several three, enrolled assessed test, defined the is ml arm efficacy with and frequency test follow-up secondary endpoints trial urine XX sites primary the a months advancing. treatment visits PURSUIT received behavioral X:X occurring six, is one-hour pad experienced are of radio in list the the the are of and at of Randomized versus life subjects and inert reduction includes XX while the who treatment, post using
strict endpoint better powered assess probability was highly a moderate with of of positive is proper to trial diagnosis the The PURSUIT primary criteria potentially for Importantly, inclusion intentionally increase efficacy and the outcome. designed the SUI.
as completed XX% visit, and three their X-month six XX-month their study The visits. completed XXX% of of those have subjects and have not posttreatment have PURSUIT of count from all shortly final the last we their and year follow-up of final study line today, top post-treatment withdrawn end As months X-month subjects the of last XX% of results visit. have completed and five patient those complete to subjects phase the Again, we next to who announcement post-treatment anticipate visits visit. plan thereafter. by represent the the of down the patient
execute level design strategy and high a trial in SUI strength have to clinical ability and States. the regulatory achieve our of indication PURSUIT a We of in the power confidence and to United our potential the in
represents SUI SUI $XX clinically the million noninvasive, an $XX safe our a a and alone. for space for as consumable endovaginal that affects a XX is opportunity. XX condition million States total United need billion considerable. the to women estimates, office market procedure to estimated proven on billion available women Importantly, with Based this in
a for As a Viveve. commercial opens result, opportunity a approval pursuit FDA multibillion-dollar outcome and positive
dedicated to commercial market service the volumes our and and provide increased drive and partners front, development U.S. in team distribution to disposable installed and continue high-quality On internationally treatment the utilization. procedure support our expand base tip
remain today urogynecology, specialties Asia on of efforts core gynecology. regions towards and directed the Pacific Our and urology U.S. focused the
innovative limited to SUI reveal sized Although, continue commercial our physician efforts their for receptivity strong we organization, procedure. have a
as clinical upon Our goal new the a efficacy of we build our and SUI and U.S. of indication is body increase potential Viveve towards to that advance our of safety the evidence in supports to treatment program awareness continue the
to to of intend second focus of advance this Pacific program with remainder two new the the States organization achieved our efficiencies our to expand our During successfully the of our PURSUIT the we and core drive the to SUI the customers was regions Through tip existing development quarter we successfully installed and XXXX, Asia financial continue have support landmark utilization entire year, over trial, base in our initiatives. execute our increased sales specialties, medical clinical and United to and treatment core last years. complete to continue and
thank I'd prepared much. incredibly quarter closing, conference listening our this talented and to for everyone our Viveve call team Finally, dedicated today. in for concludes at their to remarks. this efforts Thank so the you to as well Operator, continuing as like