Unblinded top-line results of the 12-month U.S. study anticipated in April
If positive, results may support a 2020 marketing application for an expanded U.S. indication for improvement of sexual function in women
ENGLEWOOD, CO / ACCESSWIRE / March 12, 2020 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, announced today that all patients have now completed participation in the VIVEVE II pivotal FDA clinical trial. VIVEVE II is a multicenter, randomized, double-blinded, sham-controlled study to evaluate the safety and efficacy of the Company's proprietary, Cryogen-cooled Monopolar Radiofrequency (CMRF) technology for the improvement of sexual function in women following vaginal childbirth.
"Completion of our VIVEVE II trial represents an important milestone for our Company. An estimated 12-14 million women worldwide suffer from diminished sexual function following vaginal childbirth who are candidates for our treatment. Through several prior clinical studies, our CMRF technology has shown the potential to provide women with a safe and effective, single session treatment for sexual dysfunction associated with vaginal childbirth. We anticipate reporting the top-line results from the VIVEVE II trial in April 2020. If the trial results are positive, we intend to apply for an expanded U.S. indication for the improvement of sexual function in women," said Scott Durbin, chief executive officer of Viveve.
"The burgeoning field of female sexual health and wellness is gaining tremendous attention on a global basis. Viveve continues its tradition of high-quality clinical research to provide safe and effective treatment options to millions of women experiencing intimate health conditions such as sexual dysfunction and its related symptoms," stated Michael Krychman, M.D., executive director, The Southern California Center for Sexual Health and Survivorship, and chief medical consultant for Viveve. "The Company has been at the forefront of providing clinically proven treatments with its CMRF technology as demonstrated by the success of the randomized, blinded and sham-controlled VIVEVE I clinical study and two earlier single-arm clinical studies conducted in the U.S. and Japan."
"Viveve II is a landmark trial in female sexual function," continued Dr. Krychman. "Completion of all patient visits in this large-scale, 12-month, randomized, prospective, double-blind trial is a significant milestone. The medical community, focused on women's health, looks forward to the upcoming trial results, and if positive, the impact it could have on the women we care for with sexual dysfunction conditions."