Viveve Announces Initiation of VIVEVE II Clinical Study

Viveve Medical (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, today announced that patient enrollment is underway in the multicenter randomized VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical study to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth.

As quoted in the press release:

“We are extremely excited about the recent initiation of the VIVEVE II study and we are already seeing rapid patient enrollment and a high level of enthusiasm from our clinical investigators. As a result, we anticipate submitting the 30-day safety data from the first 25 treated patients to the FDA for review by the end of the second quarter,” said Scott Durbin, chief executive officer of Viveve. “We believe that VIVEVE II, if successful, will clinically demonstrate that a single treatment with the Viveve System provides significant benefits to women suffering from diminished sexual function following vaginal childbirth and may support a marketing application for an expanded U.S. indication for the improvement of sexual function.”

Click here to read the full press release.