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Viveve Announces Positive Interim Results From the VIVEVE I Clinical Trial
Viveve Announces Positive Interim Results From the VIVEVE I Clinical Trial.
About this update from Viveve Medical, Inc.
[{"type":"text","content":"\nViveve Announces Positive Interim Results From the VIVEVE I Clinical Trial\n\nViveve Announces Positive Interim Results From the VIVEVE I Clinical Trial\n\n\nNo Changes to the Study Protocol Are Planned and No Serious Adverse Events Were Reported\n\nSUNNYVALE, CA--(Marketwired - July 15, 2015) - Viveve Medical, Inc. (\"Viveve\") (OTCQB: VIVMF), a company focused on women's health, today announced positive interim results from the VIVEVE I clinical study. Three month, primary outcomes from 62 patients (approximately 50%) were evaluated to assess the appropriate sample size and safety results of the study. The company believes, based on this prospective unblinded analysis, that the study is on track to meet its primary efficacy and safety outcomes. The VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE I) study is the first randomized, blinded and sham-controlled trial designed to demonstrate the efficacy of the Viveve® Treatment versus a sham control procedure for the treatment of vaginal introital laxity. Eight clinical sites in Europe and Canada enrolled patients in either an active treatment group or sham control group. Patients are being followed for six months post-treatment with data being collected at one, three and six month intervals. The primary endpoint of the study is a comparison of the proportion of patients reporting no vaginal laxity in the Viveve treatment group versus the proportion of women reporting no vaginal laxity in the sham group at six months post-treatment. No vaginal laxity is defined as a score of greater than 4 on a proprietary, Viveve questionnaire (VSQ). Secondary endpoints include the percent changes in mean scores from baseline to six months post-treatment in the treatment group compared to the sham group using several other patient reported outcome questionnaires. \"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,\" said Patricia Scheller, Chief Executive Officer of Viveve Medical, Inc. \"We are pleased with the outcome of the interim analysis and look forward to evaluating the final six-month data early next year.\" Ms. Scheller continued, \"Earlier clinical results show that patients experience significant improvement after a single trea...