VIVEVE I Trial Sub-Analysis Published in Journal of Women's Health

ENGLEWOOD, CO—(Marketwired – December 05, 2017) – Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and wellness, today announced the Journal of Women's Health (JWH) published a sub–analysis of the Female Sexual Functions Index (FSFI) domains from the VIVEVE I trial (VIveve Treatment of the Vaginal Introitus to EValuate Efficacy). The article, authored by Dr. Michael Krychman, et al, will appear in an upcoming 2018 print issue and is currently available in an online version.

“The publication by the JWH of our FSFI domain sub–analysis data from the VIVEVE I clinical trial is an important scientific milestone for the Viveve System's cryogen–cooled monopolar radiofrequency (CMRF) technology for women's sexual health conditions,” said Patricia Scheller, chief executive officer of Viveve. “The findings, that a single, non–ablative CMRF treatment significantly improves overall sexual function in women, with statistically significant and/or clinically important improvement in four of the six FSFI domains of Desire, Arousal, Lubrication, and Orgasm, reinforces our continued commitment to reporting sound clinical data supporting treatments that have demonstrated benefits to women's sexual health and wellness.”

Results of the full VIVEVE I clinical trial, published in February 2017, provided the first comparative effectiveness data between a standard clinical treatment and a sham treatment to support the safe and effective use of CMRF therapy for the treatment of vaginal laxity for improved sexual function. These new data represent a sub–analysis of the VIVEVE I trial evaluating the impact of CMRF therapy of the vaginal introitus in women with sexual dysfunction (baseline FSFI score ≤26.5) on each of the FSFI domains that contribute to female sexual function.

  • At six months, women with sexual dysfunction randomized to active treatment (n=73) had greater improvement in all FSFI domains of sexual function versus sham subjects (n=35).
  • Change from baseline analyses showed statistically significant improvements in the active treatment group for Sexual Arousal (p=0.004), Lubrication (p=0.04) and Orgasm (p=0.007).
  • Clinically important and statistically significant improvements in Sexual Desire (Odds Ratio[OR]=3.01), Arousal (OR=2.73) and Orgasm (OR=2.58) were additionally shown in women with sexual dysfunction who received active treatment versus sham.

Michael Krychman, M.D., executive director of the Southern California Center for Sexual Health and Survivorship Medicine and primary author of the publication, commented, “The VIVEVE I domains sub–analysis findings of sexual function improvement provide further evidence supporting the clinical utility of CMRF treatment for millions of women worldwide experiencing the condition of vaginal laxity. I believe these scientific data validate the GENEVEVE treatment as a non–surgical, 30–minute, in–office procedure that can improve vaginal introital laxity and sexual function. It advances the practice of clinical sexual medicine with the potential to benefit both clinicians and the patients they serve.”

About Viveve
Viveve Medical, Inc. is a women's health and wellness company passionately committed to advancing new solutions to improve women's overall well–being and quality of life. The internationally patented Viveve® System, that delivers the GENEVEVE™ treatment, incorporates clinically–proven cryogen–cooled, monopolar radiofrequency (CMRF) energy–based technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in one 30–minute in–office session.

International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Consistent with these approvals, Viveve is seeking an IDE from the FDA to conduct a pivotal study on use of the device for improvement in sexual function. Currently, in the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis.

InControl Products by Viveve are FDA cleared medical devices that treat stress, urge, and mixed incontinence conditions and products to improve pelvic floor strength. Viveve exclusively distributes InControl Medical's products to healthcare providers in the United States.
For more information visit Viveve's website at www.viveve.com.

Safe Harbor Statement
All statements in this press release that are not based on historical fact are “forward–looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward–looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward–looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward–looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward–looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve is a registered trademark of Viveve, Inc.
Geneveve is a trademark of Viveve, Inc.

Comments are closed

RSS Daily Times Nigeria

  • NGO donates improved seedlings to 50, other items to 340 IDPs in Plateau
    The Justice Development and Peace Commission (JDPC), of the Catholic Archdiocese of Jos, on Saturday donated improved seedlings to 50 Internally Displaced Persons (IDPs) at Ban, Barkin Ladi Local Government Area (LGA), of Plateau. Presenting the seedlings, Rev. Fr. Polycarp Gana, the Assistant Coordinator of the NGO, said the gesture was aimed at alleviating the […]
  • FRSC doctorates 25 newly promoted officers in Nsukka
    The Federal Road Safety Commission (FRSC) on Saturday decorated 25 newly promoted officers in Nsukka Unit Command. READ ALSO: FRSC decorates 24 newly promoted officers in Badagry Mr Kalu Ogbonnaya, the Enugu State Sector Commander of FRSC, at the decoration ceremony in Enugu, congratulated the officers and urged them to be more committed to their […]
  • Africa has potential to be biggest economic miracle, says AfDB President
    Dr Akinwunmi Adesina, President,  African Development Bank (AfDB) on Saturday said Africa had the potential of becoming the biggest economic hub with the right policies and investments. Adesina made the assertion at the Inspiration Conference 2020 of the Redeemer’s Men Fellowship (Lagos Regions) in Lagos.The News Agency of Nigeria reports that the conference had as […]
  • Kaigama tasks Gov Lalong on inclusive governance
    The Catholic Apostolic Administrator of Jos, Arch Bishop Ignatius Kaigama, has urged Gov. Simon Lalong of Plateau, to ensure an all-inclusive governance in order to foster peace in the state. Kaigama made the call on Saturday in Jos, at the award of the Knight of St Gregory the Great, to Lalong, as directed by the […]

Weather for Abuja

[forecast]

RSS Vanguard News

  • Lassa fever: 29 deaths, 195 confirmed cases reported in 11 states — NCDC
    The Nigeria Centre for Disease Control (NCDC) has disclosed that 29 deaths and 195 confirmed cases of Lassa fever had been reported in 11 states of the federation. The post Lassa fever: 29 deaths, 195 confirmed cases reported in 11 states — NCDC appeared first on Vanguard News.
  • Impeachment: Trump lawyers prepare to deliver defence in Senate
    Donald Trump’s lawyers prepared to deliver his first full-throated defence Saturday in the Senate’s historic impeachment trial after Democratic prosecutors spent three days making their case for the United States president’s removal from office. Capping 24 total hours of arguments, Democrats told the 100 senators that Trump abused the power of the presidency in pressuringRead […]
  • Police arrest Abuja monarch, secretary over cop’s murder
    …CP condemns barbaric act, vows to fish out other culprits. By Kingsley Omonobi – Abuja. Following the murder of a senior Police Officer, ASP Eric Isaiah and one Moses Emmanuel over land dispute by persons mobilised by the traditional ruler of Ushafa community, Alhaji Mohammed Baba and his secretary, Danlami Busa in Abuja, and injuriesRead […]

© 2020 Nigeria Newsline. All Rights Reserved. Log in -