Viveve Medical, Inc. announced the completion of final 12-month post-treatment follow-up visits in its landmark U.S. PURSUIT clinical trial for the treatment of stress urinary incontinence (SUI) in women. A total of 415 patients were enrolled in the trial, and 342 patients completed 12-month follow-up visits. A 17.6% loss-to-follow-up occurred, which is within the range anticipated for the trial.

Upon completion of clinical data monitoring and analyses in the coming weeks, the company expects to present topline primary efficacy results from the PURSUIT trial in January 2023. If positive, the results may support a marketing application for a potential new SUI indication for the company's dual-energy, noninvasive, single-session treatment in the U.S. PURSUIT is a randomized, double-blinded, sham-controlled trial that enrolled 415 subjects with moderate SUI (= 10ml - 50ml urine leakage on the 1-hour Pad Weight Test) at approximately 30 study sites in the U.S. Randomized in a 2:1 ratio for active and sham treatments, subjects in the active treatment arm received the company's SUI treatment, while subjects in the control arm received a sham treatment. The primary efficacy endpoint is a comparison of the proportion of patients who experience greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment versus a sham treatment.

The study also includes several secondary endpoints, including the proportion of patients who experience a greater than 50% reduction in urine leakage on the standardized 1-hour Pad Weight Test at three and six months post-treatment, percentage change from baseline in the 1-hour Pad Weight Test at three, six, and 12 months; percent of subjects with no incontinence episodes at three, six, and 12 months post-treatment as assessed with the three-day bladder voiding diary; and change from baseline in the MESA Questionnaire (Medical, Epidemiologic and Social Aspects of Aging), Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-1) Questionnaire, and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) at three, six, and nine months post-treatment. Subject safety is monitored throughout the study.