Shares of medical devices provider Viveve Medical (NASDAQ:VIVE) are nosediving in the premarket session today after the company announced topline results from the PURSUIT trial evaluating the safety and efficacy of the Viveve product for the treatment of female stress urinary incontinence (SUI).
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The trial failed to meet its primary endpoint of reaching a statistically significant proportion of patients with more than a 50% reduction in urine leakage as compared to baseline. Additionally, the trial also did not meet multiple secondary endpoints.
The company’s CEO, Scott Durbin said, “Based on the reported results, we do not see a path forward, nor do we intend to pursue FDA registration of our Viveve System and its dual-energy treatment for SUI in women.”
Viveve has already lowered its headcount and plans to explore strategic options. This could entail a sale of its business or assets or winding up of its operations.
Furthermore, Viveve has a hearing date of January 19 to present a plan for a continued NASDAQ listing. Given its bleak business prospects after the failure of PURSUIT, the company is “Unable to present a plan to regain compliance with NASDAQ’s continued listing standards” and consequently, it will be delisted by filing a Form 25 by NASDAQ.
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