Viveve (NSDQ:VIVE) said today it won approval from Mexico’s regulatory authority, COFEPRIS, to market its Viveve system in Mexico with indications for treating vaginal introitus, after vaginal childbirth and to improve sexual function.
The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. The new regulatory clearance brings the total number of countries where the device is cleared up to 50, Viveve said.
“We are very pleased to receive regulatory approval in Mexico for our clinically-proven device that delivers the Geneveve treatment to improve sexual function. Mexico is one of the largest markets for women’s health in Latin America and represents the continued advancement of our global commercialization strategy. Viveve has received regulatory clearances in nine new markets year-to-date. Vitre-Tech, our distinguished distribution partner in this market, can now provide clinicians with a safe and effective 30-minute single-session treatment option for their patients who suffer from vaginal introital laxity, a condition that can profoundly affect a woman’s sexual satisfaction and overall quality of life,” CEO Patricia Scheller said in a prepared statement.
In August, Viveve saw shares stay steady after the company announced a new exclusive distribution deal with InControl Medical and released 2nd quarter earnings that missed expectations on Wall Street.