SOURCE: Viveve Medical, Inc.

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July 15, 2015 08:28 ET

Viveve Announces Positive Interim Results From the VIVEVE I Clinical Trial

No Changes to the Study Protocol Are Planned and No Serious Adverse Events Were Reported

SUNNYVALE, 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 treatment with the Viveve System. We believe that the demonstrated safety and efficacy profile of this painless, minimally invasive procedure make the Viveve Treatment the best alternative for treating a condition that can profoundly impact a woman's sexual satisfaction and quality of life."

About Viveve

Viveve, Inc., the operating subsidiary of 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, which is the result of the over-stretching of tissue during childbirth that can result in a decrease in 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 Europe, Canada and Hong Kong 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.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are to be detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve is a registered trademark of Viveve, Inc.

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