Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence
Study’s most important efficacy endpoint was not obtained at 12 months post-treatment method
Firm has implemented a reduction in drive
Enterprise will search for strategic options and will be delisted from Nasdaq
ENGLEWOOD, CO / ACCESSWIRE / January 17, 2023 / Viveve Health care, Inc. (NASDAQ:VIVE), a professional medical technologies company concentrated on women’s wellbeing and the treatment method of female pressure urinary incontinence (SUI), today declared topline consequence from the U.S. Pivotal PURSUIT clinical demo. PURSUIT was a multicenter, randomized, double-blinded, sham-managed U.S. research to evaluate the basic safety and efficacy of the Viveve cure for SUI in women. The success have been attained by the company on Friday evening, January 13, 2023.
The PURSUIT review did not satisfy its main endpoint of attaining a statistically important increased proportion of individuals who experienced larger than a 50% reduction in urine leakage in comparison to baseline on the standardized 1-hour Pad Fat Check at 12 months submit-remedy in the active procedure team as opposed to the sham regulate group. The assessment was done on the intent-to-take care of population of 415 topics. Topics had been randomized in a 2:1 ratio for the active (N=279) and the sham (N=136) treatment options at about 30 clinical sites in the U.S. The proportion of people with above a 50% reduction in leakage in the active team was 49.8%, and the proportion of patients with in excess of a 50% reduction in leakage in the sham team was 56.7% (p-worth = .2035). The research also did not satisfy various secondary endpoints. There have been no critical unit-relevant adverse activities claimed.
“We are exceptionally dissatisfied that the PURSUIT demo did not achieve its major efficacy endpoint. Primarily based on the reported final results, we do not see a route forward, nor do we intend to go after Food and drug administration registration of our Viveve® Process and its twin-strength procedure for SUI in gals,” mentioned Scott Durbin, Viveve’s main government officer.
“We want to thank our investigators, clinical websites, and people for their committed efforts and participation in the U.S. PURSUIT trial. Additionally, I want to personally admit the remarkable efforts of the whole Viveve organization over the final a few decades, such as our clinical advisors and consultants, for their contributions to Viveve’s SUI development plan,” concluded Mr. Durbin.
Because of to the company’s organization prospective clients next the SUI demo, the corporation has drastically minimized its workforce and intends to take a look at strategic alternatives, such as a sale of the firm’s enterprise or assets, and/or a wind-down of the company’s functions.
More, as formerly disclosed, the company’s securities are subject matter to delisting from the Nasdaq Inventory Market place unless of course the enterprise offers a program to get back compliance with Nasdaq’s ongoing listing standards ahead of the Nasdaq hearings panel. The firm has a listening to prior to the panel on January 19, 2023. As a final result of the company’s business enterprise prospective customers subsequent the SUI demo, the organization is unable to present a plan to get back compliance with Nasdaq’s ongoing listing standards at the listening to. Appropriately, Nasdaq will delist the enterprise by filing a Type 25. Following the efficiency of the delisting, the organization intends to file a Variety 15 with the Securities and Trade Commission to suspend its reporting obligations less than the Securities Trade Act of 1934, as amended.
Safe Harbor Statement
All statements in this push launch that are not primarily based on historic actuality are “forward-looking statements” within the indicating of Section 27A of the Securities Act of 1933 and Area 21E of the Securities Trade Act of 1934. Whilst management has primarily based any ahead-wanting statements integrated in this push release on its present anticipations, the data on which such expectations were primarily based could adjust. These ahead-searching statements depend on a amount of assumptions concerning upcoming functions and are topic to a quantity of threats, uncertainties, and other components, numerous of which are outside the house of our manage, which could trigger genuine outcomes to materially differ from these kinds of statements. These types of dangers, uncertainties and other things incorporate, but are not restricted to, the timing, development and final results of our evaluation of strategic choices, such as whether or not the analysis of alternate options results in any transaction, basic economic disorders and other aspects that are comprehensive in our periodic and latest stories available for evaluation at www.sec.gov. Also, we work in a really aggressive and speedily transforming environment in which new and unanticipated hazards may perhaps arise. Appropriately, investors should really not location any reliance on ahead-on the lookout statements as a prediction of real benefits. We disclaim any intention to, and undertake no obligation to, update or revise ahead-searching statements to mirror functions or situation that subsequently arise or of which we hereafter grow to be conscious, except if essential by law.
Viveve is a registered trademark of Viveve, Inc.
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