Viveve Medical (NASDAQ:VIVE) remedy for feminine stress urinary incontinence (SUI) failed a pivotal trial and the company has determined to search strategic options and delist from Nasdaq.
The Englewood, Colo.-based company added that due to its enterprise prospects following the SUI trial, it has considerably diminished its workforce and plans to explore strategic choices, together with a sale of its enterprise or property, and/or a wind-down of its operations.
The U.S. research, dubbed PURSUIT, didn’t meet its major objective of reaching a statistically important larger proportion of sufferers who skilled better than a 50% discount in urine leakage in contrast to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment within the lively remedy group, in contrast to the sham management group.
A complete of 415 topics individuals had been randomized during which 279 had been within the lively remedy group whereas 136 in sham.
The company mentioned the proportion of sufferers with over a 50% discount in leakage within the lively group was 49.8%, whereas for the sham group was 56.7%.
The trial additionally didn’t meet a number of secondary objectives. There had been no critical device-related adversarial occasions, in accordance to the company.
“Based on the reported outcomes, we don’t see a path ahead, nor will we intend to pursue FDA registration of our Viveve System and its dual-energy remedy for SUI in ladies,” mentioned Viveve’s CEO Scott Durbin.
In addition, Viveve famous that it has a listening to earlier than a Nasdaq panel on Jan. 19 to presents a plan to regain compliance with the change’s itemizing rule. However, due to its enterprise prospects following the SUI trial, it’s unable to current a plan to regain compliance.
Thus Nasdaq will delist the company.
VIVE -59.05% to $0.37 premarket Jan. 17