Viveve Could Hit Reset Button After Failing to Meet Endpoints in Trial

Viveve Medical has hit a snag after it failed to meet the endpoints in a clinical trial for technology to improve the sexual function in women following vaginal childbirth. The Englewood, CO-based company said as a result of the results and impact from the COVID-19 pandemic that it was evaluating strategic alternatives, as well as actively assessing its current organization and cost structure. Viveve is developing a Cryogen-cooled Monopolar Radiofrequency (CMRF) technology that can treat vaginal laxity. The technology delivers RF energy deeply into soft tissues – which results in neocollagenesis, or a straightening or tightening of the skin. In a Securities and Exchange Commission filing, the company said the VIVEVE II study did not meet its primary endpoint of demonstrating a statistically significant improvement in the mean change from baseline in total Female Sexual Function Index (FSFI) score at 12 months. The study included 220 subjects that completed 12-month follow-up. Subjects were randomized in a 1:1 ratio for the active (N=114) and the sham (N=106) treatments at 17 clinical sites in the U.S. The adjusted mean change for the active group was 9.8 and the adjusted mean change for the sham group was 9.0, a difference of 0.8 (p=0.3942). There were no serious device-related adverse events reported. The treatment groups were well balanced, and the number of subjects lost to follow-up was as expected. "We are extremely disappointed that th...
Source: MDDI - Category: Medical Devices Tags: Business Source Type: news

Related Links:

As of April 21, 2020, more than 2.5 million cases of coronavirus disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, have been reported in 210 countries and territories, with the death toll at 171,810. Both chloroquine and hydroxychloroquine have gained considerable media attention as possible therapies, resulting in a significant surge in demand. In overdose, both medications can cause severe, potentially life-threatening effects. Here, we present a brief overview of the pharmacology of chloroquine and hydroxychloroquine, manifestations of toxicity, and treatment considerations.
Source: Western Journal of Emergency Medicine - Category: Emergency Medicine Source Type: research
The coronavirus disease 2019 (COVID-19), seems to have a cardiovascular tropism characterized by high incidence of myocardial infarction especially for patients with severe infections recovered in intensive care units. In their letter, the Authors state that oxidative stress could play a pivotal role to determine cardiovascular complications in COVID-19. We agree about this issue. In particular, NADPH oxidase-2 (NOX-2), that it is considered one of the most important sources of superoxide anion in human [1], plays a role in systemic inflammation and pathogenesis of several RNA virus as the influenza virus [2].
Source: International Journal of Cardiology - Category: Cardiology Authors: Tags: Letter to the editor Source Type: research
Additionally, side effects were more common among participants in the HCQ group than the placebo group. One expert says the results raise the question of whether some ongoing trials should stop.Medscape Medical News
Source: Medscape Allergy Headlines - Category: Allergy & Immunology Tags: Infectious Diseases News Source Type: news
Authors: Kerboua KE Abstract COVID-19 exhibits a non-yet elucidated heterogeneity dominated by mild form of the illness. Nevertheless, mortality is frequent among patients with a delayed innate immune response that suddenly exacerbates during the second week after admission leading to a lethal over inflammation. Therefore, this rapid and unpredictable deterioration requires timely prediction of COVID-19 refractoriness and critical illness. The two biomarkers readily available in routine laboratories, blood lymphocytes and neutrophil counts, are expected to provide an accurate clinical tool to incline reasonable med...
Source: Immunological Investigations - Category: Allergy & Immunology Tags: Immunol Invest Source Type: research
Publication date: Available online 2 June 2020Source: Biosensors and BioelectronicsAuthor(s): Feiyun Cui, H. Susan Zhou
Source: Biosensors and Bioelectronics - Category: Biotechnology Source Type: research
Authors: Arrese M PMID: 32482463 [PubMed - as supplied by publisher]
Source: Annals of Hepatology - Category: Gastroenterology Tags: Ann Hepatol Source Type: research
This article is licensed under aCreative Commons Attribution 3.0 Unported Licence.Michael P. McRae, Glennon W. Simmons, Nicolaos J. Christodoulides, Zhibing Lu, Stella K. Kang, David Fenyo, Timothy Alcorn, Isaac P. Dapkins, Iman Sharif, Deniz Vurmaz, Sayli S. Modak, Kritika Srinivasan, Shruti Warhadpande, Ravi Shrivastav, John T. McDevitt The COVID-19 Severity Score combines multiplex biomarker measurements and risk factors in a statistical learning algorithm to predict mortality. To cite this article before page numbers are assigned, use the DOI form of citation above. The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Lab Chip latest articles - Category: Chemistry Authors: Source Type: research
ConclusionsWe have presented guidance for treating FPMRS conditions via telemedicine based on rapid literature review and expert consensus and presented it in a format that can be actively referenced.
Source: International Urogynecology Journal - Category: OBGYN Source Type: research
Dear Readers: This is a time of uncertainty for everyone, but for people who care for older adults and other vulnerable people, it’s terrifying. Older adults are especially at risk for COVID-19, the respiratory disease caused by the coronavirus, and you want to take care of them, but… Residents in facilities are being cared for, but you are likely not allowed to visit, and facilities, too, are short-staffed because of exposed or ill caregivers. Those at home alone will be more at risk with no one to care for them as even professionals are challenged to find creative ways of providing help. Family careg...
Source: Minding Our Elders - Category: Geriatrics Authors: Source Type: blogs
As caregivers know all too well, the coronavirus (COVID-19) pandemic has forced society into either staying well away from one another or, in many cases into isolation. This necessary step is hard for many people, but for caregivers, it’s downright terrifying. The four major categories that most caregivers occupy are people who have loved ones living in assisted living, nursing homes, or other facilities; caregivers who have older parents or others living in their own homes; those who have an elder living with them (or who live in the elder’s home); and caregivers for younger adults, often our children who have...
Source: Minding Our Elders - Category: Geriatrics Authors: Source Type: blogs
More News: Clinical Trials | COVID-19 | Incontinence | Medical Devices | Pandemics | Skin | Statistics | Study | Women