incontinence efforts Good and this results I’d positive conference are listening again Jim. to this are urinary the from result Thanks, like trial quarter clinical continues year. our as landmark for the today U.S. Follow-up our SUI core end initiatives on our financial focus we to stating advance be afternoon, indication. program organization potential towards thanks our of visits a to everyone, that of rapidly completed our its by call begin our stress expected the by PURSUIT entire which today. of
United design strength to of the indication achieve States. our and high SUI a the PURSUIT ability to continues our remain strategy to potential level Our in the study in confidence in execute
line results, top As focused readout we move the efforts core our forward continue to on areas. be strategic of following the towards
shortly by the what First, report application visits patient the the preparing to improve preparing year endovaginal results commercially line SUI. approval top complete office-based and be de submit and to follow-up FDA-approved FDA trial of If for for could to the results urethral hypermobility launch novo treatment quickly thereafter. first end female our dual-energy to are positive, patent-protected to
continuing Secondly, urology U.S. of our expansion targeting to continuing Pacific and successful and future on customers current And market to treatment with the base, gynecology utilization initiatives development through Asia and to sales. focus core our efforts tip urogynecology, increased installed the commercial and our and specialties. regions third, drive disposable support
core entire female organization previously, in stated SUI. to continue around some clinical enrolled trial indication a these new SUI the U.S. like potential our pivotal strategic PURSUIT As focus I’d that, is to towards of discuss development to specifics for committed our areas now With I’ve U.S. fully our advance as we program
standardized defined PURSUIT control at a a As SUI. of endpoint the the CMRF is a XX urine leakage XX to at Cryogen-cooled ratio, mls in one-hour up efficacy proportion in and urine a post experience while treatment who inner or standardized than The the one-hour procedure. the leakage is sham arm patients test Radiofrequency, weight reduction X:X trial, versus enrolled States. subjects received received is treatment, reminder, objective trial XXX Monopolar treatment. as XX% pad of compared subjects a as to test. baseline the arm primary We sham XX the moderate months than PURSUIT pad this greater greater using a of sham-controlled comparison XX in true on the the sites in study randomized did United Randomized This our in which subjects weight mls treatment with of approximately double-blinded active
the questionnaires. study. throughout and The monitored pad to rate months diary responder X, scheduled powered also difference assessed is the at and behavioral visits groups. an using XX% is also voiding trial two and follow-up X quality other X, study between several absolute endpoints life and the weight bladder safety XX% for were three-day secondary the of Post-treatment being includes XX detect test, Importantly, subject one-hour
efficacy powered the the is designed trial highly criteria inclusion The for positive potentially increase PURSUIT outcome. primary the better endpoint intentionally and mentioned, diagnosis strict with of moderate proper assess of SUI. As a to probability was
end As completed clinically completed And need those affects have from their have of The patient X of patient XX million post-treatment represents all as next who announcement we based with billion estimated short shortly procedure X weeks that visits XX% results of an plan of their opportunity. to United condition and have safe months represent to on line year subjects billion XXX% I visit. total $XX down emphasize to to by of the final final for our XX-month want the a study X, women in X available this not last PURSUIT Again, office-based endovaginal withdrawn the today, phase count and visit. the women market complete proven, estimates, is we the subjects noninvasive of follow-up visits study considerable. post-treatment anticipate a a $XX the States SUI XX thereafter. to SUI consumable alone. million for top that last and the is
a result, approval a for would open Viveve. multibillion-dollar positive opportunity As commercial PURSUIT and outcome FDA a
our development front, installed distribution to procedure and team our volumes On expand internationally the disposable U.S. to drive support continue partners tip market and high-quality in utilization. and increased service treatment base the and provide commercial
urogynecology, regions, the and of Our and Asia remain focused the on towards the year directed of U.S. efforts today Pacific core and through gynecology. specialties urology the end
organization, have we reveal continue Although receptivity currently for procedure. a novel their physician our efforts limited strong commercial SUI to endovaginal
continues received SUI Our and also of treatment reflecting to generate our Viveve. in female focus recent been has rebranding initiative, well on new interest the
our upon new towards to and the we SUI goal that indication potential of Our efficacy evidence continue safety Viveve program our is and in to awareness U.S. build the the body treatment as increase supports of a clinical of advance
year, the Thank years. over we our team SUI endovaginal transition last the execute the appreciate of you. everyone was this concludes at I’d efforts third entire prepared to for successfully to and Pacific the our of program specialties, continue new core with our XXXX, our the We intend as the we the and over focused Through female core this to remainder a our top continue of clinical to the landmark urogynecology advance talented During line conference thank U.S. last novel initiatives. trial, existing efficiencies PURSUIT utilization organization the their In quarter our with and Operator, we successfully forward sales, closing, and base complete of our to Viveve PURSUIT two SUI remarks. treatment. from development treatment years, call to our treatment dedicated support to today. installed our Asia regions increased achieved and three incredibly on financial medical drive reporting and to tip listening like focus look customers have company expand and in results to