Viveve Announces Positive Topline Results For VIVEVE I Clinical Trial
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."
Study Design and Enrollment
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 the requisite 6 month follow-up and did not have a major protocol violation.
Primary Efficacy Endpoint
The primary endpoint of the study was a comparison of the proportion of women 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).
• At 6 months, the proportion of subjects reporting no vaginal laxity in the active group was 41.7% versus the sham group of 19.2% with a Chi-Squared p-value of 0.005.
• Subjects receiving the active treatment were 3 times more likely to report no vaginal laxity at 6 months versus the sham group with a p-value of 0.006 (based on logistic regression).
• Mean change from baseline for the active group was 1.9 versus the sham group of 1.1 on the 7 point VSQ scale with a p-value of 0.007.
Safety and Tolerance
In the population of 174 subjects (117 active, 57 sham) who underwent safety evaluation, the number of reported events was virtually identical between the active and sham groups:
• There were 0 (0.0%) subjects with a serious adverse event (SAE) in the active group and 1 (1.8%) in the sham group.
Viveve will host a live presentation at 5:30 p.m. EDT on Tuesday, April 26 to present further clinical trial results. Participants can register for the conference call and webcast at http://dpregister.com/10084623. The dial in telephone number will be provided upon registration either in advance of or at the time of the webcast.
About Viveve
Viveve Medical, Inc., is a women's health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The company's lead product, the globally patented Viveve System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue with only one treatment session. The Viveve System treats the condition of vaginal laxity that can result in decreased physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten vaginal tissue in one 30-minute out-patient treatment in a physician's office. The Viveve System has received regulatory approval in many countries throughout the world and is available through physician import license in Japan. It is currently not available for sale in the U.S. For more information, please visit Viveve's website at www.viveve.com.
"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."
Study Design and Enrollment
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 the requisite 6 month follow-up and did not have a major protocol violation.
Primary Efficacy Endpoint
The primary endpoint of the study was a comparison of the proportion of women 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).
• At 6 months, the proportion of subjects reporting no vaginal laxity in the active group was 41.7% versus the sham group of 19.2% with a Chi-Squared p-value of 0.005.
• Subjects receiving the active treatment were 3 times more likely to report no vaginal laxity at 6 months versus the sham group with a p-value of 0.006 (based on logistic regression).
• Mean change from baseline for the active group was 1.9 versus the sham group of 1.1 on the 7 point VSQ scale with a p-value of 0.007.
Safety and Tolerance
In the population of 174 subjects (117 active, 57 sham) who underwent safety evaluation, the number of reported events was virtually identical between the active and sham groups:
• There were 0 (0.0%) subjects with a serious adverse event (SAE) in the active group and 1 (1.8%) in the sham group.
Viveve will host a live presentation at 5:30 p.m. EDT on Tuesday, April 26 to present further clinical trial results. Participants can register for the conference call and webcast at http://dpregister.com/10084623. The dial in telephone number will be provided upon registration either in advance of or at the time of the webcast.
About Viveve
Viveve Medical, Inc., is a women's health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The company's lead product, the globally patented Viveve System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue with only one treatment session. The Viveve System treats the condition of vaginal laxity that can result in decreased physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten vaginal tissue in one 30-minute out-patient treatment in a physician's office. The Viveve System has received regulatory approval in many countries throughout the world and is available through physician import license in Japan. It is currently not available for sale in the U.S. For more information, please visit Viveve's website at www.viveve.com.