Viveve Medical announced disappointing results from its U.S. PURSUIT clinical trial aimed at treating female stress urinary incontinence (SUI). The trial's primary endpoint was not achieved, as only 49.8% of patients in the treatment group experienced a significant reduction in urine leakage compared to 56.7% in the control group (p-value = 0.2035). Following these results, the company will reduce its workforce and seek strategic alternatives, including potential sale or winding down operations. Additionally, Viveve faces imminent delisting from Nasdaq due to failure to meet listing standards, having a hearing scheduled for January 19, 2023.
Viveve Medical, Inc. (NASDAQ:VIVE) has completed the final 12-month follow-up visits for its U.S. PURSUIT clinical trial aimed at treating stress urinary incontinence (SUI) in women. Out of 415 enrolled patients, 342 completed the follow-up. A 17.6% loss-to-follow-up was recorded. Topline efficacy results are expected in January 2023, which may facilitate a new marketing application for Viveve's treatment. A positive outcome could significantly enhance the company’s commercial prospects, addressing a critical health issue affecting around 15 million women in the U.S.
Viveve Medical has secured U.S. Patent No. 11511110, enhancing its intellectual property portfolio related to the treatment of female stress urinary incontinence (SUI). This development coincides with the anticipated completion of the pivotal PURSUIT clinical trial by year-end, with topline results expected in early 2023. The patented dual-energy technology aims to improve connective tissue function and reduce urethral hypermobility in women. Positive trial results could support a new SUI indication in the U.S.
Viveve Medical reported Q3 2022 revenue of $1.7 million, up from $1.6 million in Q3 2021, driven by sales of 11 Viveve Systems and approximately 3,100 disposable treatment tips. The gross profit increased to $0.5 million (32% of revenue) compared to $0.1 million (7% of revenue) year-over-year. Operating expenses decreased to $5.2 million, leading to a net loss of $6.3 million or ($0.59) per share. The company expects to complete its PURSUIT clinical trial by year-end, with topline results anticipated shortly thereafter.
Viveve Medical (NASDAQ:VIVE) plans to report its third quarter 2022 financial results and provide a corporate update on November 10, 2022, after the U.S. market close. A conference call will occur the same day at 5:00 PM ET. The call can be accessed via phone or live webcast. Viveve, focused on women’s health, is conducting the pivotal PURSUIT clinical trial for treating stress urinary incontinence (SUI) with its innovative Viveve® System, cleared by the FDA. The trial aims to support a new SUI indication in the U.S. with topline results expected shortly after completion of follow-ups.
Viveve Medical, Inc. (NASDAQ:VIVE) announced a Notice of Allowance from the USPTO for U.S. Patent Application 16/454,578, enhancing its intellectual property portfolio for treating female stress urinary incontinence (SUI). This patent bolsters Viveve's dual-energy treatment, aimed at addressing an unmet market need for non-invasive SUI solutions. The company anticipates concluding its pivotal PURSUIT clinical trial by year-end 2022, with topline results expected in early 2023. Positive trial outcomes could support a new U.S. indication for mild-moderate SUI treatment.
Viveve Medical (NASDAQ:VIVE) has launched a significant rebranding initiative aimed at enhancing its focus on the treatment of Stress Urinary Incontinence (SUI) in women. The company anticipates the completion of follow-up visits for its pivotal PURSUIT clinical trial by the end of 2022, with topline results expected soon after. The rebranding includes a new corporate website and communication materials to better inform clinicians and patients. Viveve's innovative dual-energy treatment for SUI aims to address the unmet medical needs in women's health.
Viveve Medical, a medical tech company focused on women's health, will present at the Ladenburg Thalmann Healthcare Conference on September 29, 2022. CEO Scott Durbin will discuss updates on the company's clinical development program for stress urinary incontinence (SUI). The presentation is scheduled for 8:30 AM ET and will be available via webcast on Viveve's website. The company has made significant progress in its SUI clinical trials, with topline results expected soon, which could lead to new U.S. indications if positive.
Viveve Medical, a medical technology company, announced CEO Scott Durbin's participation in the Alliance Global Partners Virtual MedTech Conference on September 21, 2022. The conference will cover updates on Viveve's operations and progress in the stress urinary incontinence (SUI) clinical development program. Viveve's innovative Viveve® System, cleared by the FDA, aims to enhance women's health. The company is advancing its clinical trial for SUI, with topline results expected by the end of 2022, potentially paving the way for a new indication in the U.S.
Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company specializing in women's health, announced that CEO Scott Durbin will participate in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. During the conference, he will present the company's corporate updates and engage with investors. The presentation will be webcast on September 12 at 7:00 AM ET and will be accessible for 90 days on Viveve's website. The company focuses on addressing stress urinary incontinence (SUI) and has received FDA approval for its clinical trials.