VIVE - Viveve crashes ~60% as company decides to delist explore sale after trial fails

Viveve Medical ( NASDAQ: VIVE ) treatment for female stress urinary incontinence (SUI) failed a pivotal trial and the company has decided to seek strategic alternatives and delist from Nasdaq.

The Englewood, Colo.-based company added that due to its business prospects following the SUI trial, it has significantly reduced its workforce and plans to explore strategic options, including a sale of its business or assets, and/or a wind-down of its operations.

The U.S. study, dubbed PURSUIT, did not meet its main goal 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, compared to the sham control group.

A total of 415 subjects people were randomized in which 279 were in the active treatment group while 136 in sham.

The company said the proportion of patients with over a 50% reduction in leakage in the active group was 49.8%, while for the sham group was 56.7%.

The trial also did not meet several secondary goals. There were no serious device-related adverse events, according to the company.

"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," said Viveve's CEO Scott Durbin.

In addition, Viveve noted that it has a hearing before a Nasdaq panel on Jan. 19 to presents a plan to regain compliance with the exchange's listing rule. However, due to its business prospects following the SUI trial, it is unable to present a plan to regain compliance.

Thus Nasdaq will delist the company.

VIVE -59.05% to $0.37 premarket Jan. 17

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