Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023. The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.

Source: Accesswire, January 17, 2023

Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence

Viveve, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today that the Company has received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a stress urinary incontinence (SUI) multicenter, randomized, double-blinded, sham-controlled clinical trial entitled PURSUIT – Prospective U.S. Radiofrequency SUI Trial. The trial is designed to evaluate the safety and efficacy of Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment versus an inert sham tip for the improvement of SUI in women. Read more.

Source: BioSpace, July 7, 2020

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.

Source: Yahoo Finance!, March 4, 2020

Viveve Medical (VIVE) Announces Authorization to Initiate Short-Term Feasibility Study in Stress Urinary Incontinence from Canadian Ministry of Health

Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. Read more.

Source: Street Insider, December 18, 2019