Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, announced today that it has completed enrollment in its pivotal PURSUIT clinical trial to assess the efficacy and
Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, announced today that it has completed enrollment in its pivotal PURSUIT clinical trial to assess the efficacy and safety of the Viveve procedure in the treatment of stress urinary incontinence (SUI) in women. Positive results from the highly powered study could support an FDA approval for a new indication for Viveve's dual-energy, noninvasive, single session treatment in the U.S.
"We are very pleased to have completed enrollment in our landmark PURSUIT trial, which represents a major milestone and another example of our progress in advancing this important clinical program. The study has fully enrolled our target of 390 patients who met our inclusion criteria. Patient selection criteria in the PURSUIT trial is designed to provide us with the clear and robust data we need to evaluate a future regulatory filing," said Scott Durbin, Viveve's chief executive officer.
"We look forward to successfully completing the patient follow-up visits over the next 12 months and to releasing topline results, anticipated at the end of 2022. If positive, we anticipate filing our marketing application for FDA approval shortly thereafter." He concluded, "We have a high level of confidence in the strength of the PURSUIT study design and in our ability to execute our strategy to position this innovative technology for the final stages of regulatory review with the potential to bring a proven safe and effective treatment option to the millions of women living with SUI in the U.S."
U.S. PURSUIT Trial
PURSUIT is a randomized, double-blinded, sham-controlled trial with targeted enrollment of 390 subjects with moderate SUI (≥ 10ml – 50ml urine leakage on the 1-hour Pad Weight Test) at approximately 30 study sites in the U.S.
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 the inert sham procedure. The study also includes several secondary endpoints, including: 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 will be monitored throughout the study.