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Viveve Medical, Inc. (NASDAQ:VIVE), is a medical technology company whose research area is women’s intimate health. The company has recently reported that its three arm feasibility study on five month Stress Urinary Incontinence (SUI), which was based on comparing the Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment to restrain SUI in women ,has showed primarily positive data. Moreover the company also announced positive results from an in-vivo preclinical research that was performed for the validation of company’s new inert sham tip which will be use in pivotal PERSUIT Trial in the U.S.
“We are extraordinarily pleased to report positive results from our 3-arm SUI feasibility study, as well as our in-vivo preclinical study. We believe the combined results from both of these studies support our thesis that the cryogen-cooling treatment tip, used as a sham treatment in our prior LIBERATE-International SUI trial, was likely producing a positive therapeutic effect. The fact that we now have a true inert sham treatment tip provides us more confidence that our upcoming pivotal PURSUIT Trial can achieve its primary efficacy endpoint and position Viveve for a potential SUI indication in the United States,” said Scott Durbin, Viveve’s chief executive officer.
SUI Feasibility Study Analysis:
The comparison between the use of an inert sham treatment to Viveve’s CMRF treatment and a crygen-only sham in women with mild to restrain SUI was entirely undirected and addled clinical trial. Total 36 patients participated in three clinical experimental sites in Canada with 1:1:1 ratio to each of three study arms
The median change from baseline in the cryogen-only sham treatment group and active CMRF treatment group was -6.8 grams and -9.5 grams respectively, as compared to -4.4 grams in the inert sham treatment group. The study showed no distinction between groups while assessing numerous secondary endpoints. No safety related issues were reported for device.