Viveve CMRF technology trial did not demonstrate improvement in SUI
Earlier this evening, Viveve disclosed that its LIBERATE-International trial, a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of its proprietary, cryogen-cooled monopolar radiofrequency, or CMRF, technology for the improvement of stress urinary incontinence, or SUI, in women, did not demonstrate greater improvement in SUI in treated patients as compared with the control group, and therefore did not achieve statistical significance in the intent-to-treat-population on the primary endpoint of change from baseline to six months post-treatment in the 1-hour pad weight test. The median change from baseline at six months post-treatment was -8.0g in the active group of 66 subjects and -8.0g in the sham-control group of 33 subjects. Viveve also announced the transition of its U.S. business model to renting systems versus selling under a capital equipment model. In June 2019, U.S. sales of the Viveve(R) System transitioned from a capital sales model to a recurring revenue rental model intended to lower up-front costs for customers and thus lower hurdles to adoption, increase placement rates, and improve profitability by significantly reducing selling time per unit. The new model has successfully increased physician adoption rates. In June 2019, Viveve placed 27 systems with new North American customers under this new program, a higher monthly productivity rate per rep than any prior month in the company's history.