Table 2 Prolapse reduction while using the ProVate Device (POP-Q staging, 94 usage cycles, PP set, POP = Pelvic Organ Prolapse, POP-Q = Pelvic Organ Prolapse Quantification)

Primary Objective Efficacy Endpoint

Prolapse Reduction

(# of stages reduced)

% of subjects with ≥1 stage POP reduction from baseline

100.00%

% of subjects with ≥2 stages POP reduction from baseline

100.00%

% of subjects with ≥3 stages POP reduction from baseline^a

96.97%

Secondary objective Efficacy Endpoint

Final POP-Q Stage Achieved With ProVate at visit 5;

(% Subjects)

POP-Q stage 0 while using the ProVate

97.83%

POP-Q stage 1 while using the ProVate

2.17%

POP-Q stage 2 while using the ProVate

0.00%