Viveve, Inc., the wholly owned subsidiary of Viveve Medical, Inc., is a women's intimate health company based in Englewood, Colorado. Viveve is committed to advancing new solutions to improve women’s overall well-being and quality of life. The company is focused on the commercialization of a revolutionary, non-surgical, non-ablative medical device that remodels collagen and restores vaginal tissue. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. In the United States, the Viveve System is cleared by the Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in more than 50 countries.
Viveve continues to advance its clinical development program in stress urinary incontinence (SUI). As reported in December 2020, FDA approved changes to the U.S. pivotal PURSUIT trial protocol are intended to strengthen the overall study and its potential to achieve its primary efficacy endpoint. Study changes including an increase in the trial’s size and more strict patient selection criteria were a result of guidance from Viveve’s Clinical Advisory Board upon review of positive results from the Company’s SUI feasibility and preclinical studies. Viveve received FDA approval of its Investigational Device Exemption (IDE) application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020 and FDA approval of its requested amendments to the IDE protocol as reported on December 10, 2020. Initiation of the trial was reported on January 21, 2021 and completion of subject enrollment was announced December 14, 2021. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
Pharmaceutical and Medicine Industry (3741)