Viveve Medical, Inc. (NasdaqCM:VIVE) 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. The analysis was conducted on the intent-to-treat population of 415 subjects. Subjects were randomized in a 2:1 ratio for the active (N=279) and the sham (N=136) treatments at approximately 30 clinical sites in the U.S. The proportion of patients with over a 50% reduction in leakage in the active group was 49.8%, and the proportion of patients with over a 50% reduction in leakage in the sham group was 56.7% (p-value = 0.2035).

The study also did not meet several secondary endpoints. Due to the company's business prospects following the SUI trial, the company has significantly reduced its workforce and intends to explore strategic options, including a sale of the company's business or assets, and/or a wind-down of the company's operations. Further, as previously disclosed, the company's securities are subject to delisting from the Nasdaq Stock Market unless the company presents a plan to regain compliance with Nasdaq's continued listing standards before the Nasdaq hearings panel.

The company has a hearing before the panel on January 19, 2023. As a result of the company's business prospects following the SUI trial, the company is unable to present a plan to regain compliance with Nasdaq's continued listing standards at the hearing. Accordingly, Nasdaq will delist the company by filing a Form 25.

Following the effectiveness of the delisting, the company intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended.