PURSUIT is a randomized, double-blinded, sham-controlled, IDE-cleared trial that enrolled 415 subjects with moderate SUI at approximately 30 study sites in the United States. Subjects were randomized in a 2:1 ratio to the active Viveve treatment or an inert sham treatment.
Initiation of PURSUIT and full enrollment occurred in 2021. Completion of subject follow-up visits is anticipated by the end of 2022, and topline results will be reported shortly thereafter. If positive, results from the PURSUIT clinical trial may support a new SUI indication in the U.S.
Mechanism of Action of the Viveve Treatment
Strong body of clinical evidence supporting pivotal PURSUIT trial for potential SUI indication in U.S.
based on proven aesthetic commercial technology
documented fibroblast activation, collagen remodeling, no cellular or tissue damage
Single Arm Pilot Trial(s):
safety, efficacy, and durable positive clinical outcomes demonstrated at 6- and 12-months post-treatment for improvement of mild-moderate SUI; No serious adverse events
LIBERATE International Trial:
significant improvement in objective 1-hour Pad Weight Test from baseline in subjects with mild-moderate SUI; CMRF vs Cryo-only treatment groups in LIBERATE trial did not show separation
3-Arm Feasibility and Preclinical Studies:
achieved primary efficacy endpoint of median CFB in 1-hour Pad Weight Test at 5 mos post-treatment between CMRF and Cryo-only Sham to New Inert Sham group; In-vivo preclinical testing validated New Inert Sham tip
The Viveve System is indicated for general surgery for electrocoagulation and hemostasis in the United States.
The Viveve System is indicated for general surgery for electrocoagulation and hemostasis in the United States. The InControl Products (InToneMV) is indicated for the treatment of all forms of urinary incontinence in the United States and Canada.