Business
Viveve(R) Announces Positive Topline Results for VIVEVE I Clinical Trial
Viveve(R) Announces Positive Topline Results for VIVEVE I Clinical Trial.
About this update from Viveve Medical, Inc.
[{"type":"text","content":"\nViveve(R) Announces Positive Topline Results for VIVEVE I Clinical Trial \n\nViveve(R) Announces Positive Topline Results for VIVEVE I Clinical Trial\n\n\nStudy Achieves Final Primary Safety and Efficacy Endpoints -- Viveve Will Host a Live Webcast at 5:30 p.m. EDT on Tuesday, April 26th \n\n\n SUNNYVALE, CA--(Marketwired - April 21, 2016) - Viveve Medical, Inc. (\"Viveve\") (OTCQB: VIVMD), a company focused on women's health, today announced positive top-line results from the VIVEVE I clinical study. The VIveve Treatment of the Vaginal Introitus to EValuate Efficacy study is the first randomized, single-blinded and sham-controlled trial designed to demonstrate the efficacy and safety of the Viveve Treatment versus a sham control procedure for the treatment of vaginal introital laxity.\"We are extremely pleased with the final results of the study, which further validate the safety and efficacy of the Viveve Treatment. Equally as significant is the fact that Viveve is the first and only company to have undertaken, and successfully completed, a study of this magnitude for the treatment of vaginal laxity, further establishing us as a leader in this burgeoning area of women's sexual health,\" said Patricia Scheller, chief executive officer of Viveve. \"The Viveve System has already demonstrated a favorable safety and efficacy profile in two previously completed single-arm clinical studies conducted in the United States and Japan. We look forward to reviewing the VIVEVE I results in greater detail during our webcast on April 26th at 5:30pm EDT.\" \n Study Design and Enrollment\n The target population for this study was pre-menopausal females 18 years of age or older who experienced at least one full term vaginal delivery ( > 37 completed weeks gestation). Subjects were randomized in a 2:1 ratio to either the active group or sham group. The active group received a target treatment dose of 90 J/cm2 and the sham group received a sub-treatment dose of 1 J/cm2. Subjects had follow-up office visits at 10 days; and 1, 3, and 6 months post-treatment.The efficacy results for the study are based on 155 per protocol subjects from 9 clinical sites in Europe, Canada and Japan. The per protocol population is defined as randomized subjects who received either an active (n=103) or sham treatment (n=52), completed t...