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

  • Nigeria imports decrease, other oil exports gain in 3rd quarter — NBS
    Abuja – The National Bureau of Statistics (NBS), said total imports into the country in the third quarter of 2019 decreased by 2.70 per cent, while exports of other oil products rose by 6.14 per cent. The Bureau made this known in a report made available to newsmen in Abuja on Friday. Specifically, NBS said […]
  • NCDMB says 70 per cent Nigerian content by 2027 still achievable
    Port Harcourt – Mr Simbi Wabote, the Executive Secretary, Nigerian Content Development and Monitoring Board (NCDMB), says the board’s 10-year plan to achieve 70 per cent Nigerian content in the oil and gas sector remains realisable. Wabote, represented by Dr Gina Gina, General Manager, Corporate Communications at NCDMB, spoke at a workshop for media stakeholders […]
  • Emefiele attributes Nigeria’s economic growth to CBN’s policy measures
    Ogun – Dr Godwin Emefiele the Governor of Central Bank of Nigeria (CBN), has attributed the country’s economic growth to series of policy measures put in place by the apex bank. Emefiele made the assertion at the 11th Annual Bankers Committee Retreat with theme: “Delivering Inclusive Growth: Leveraging Digital Finance” in Ogere, Ogun State. The […]
  • PDP extols Gov. Wike’s virtues
    Abuja – The Peoples Democratic Party (PDP) has described Gov. Nyesom Wike of Rivers as an exceptional leader, with extraordinary commitment and sacrifice towards national stability and well-being of Nigerians. PDP said this in a goodwill message issued by its National Publicity Secretary, Mr Kola Ologbondiyan, on Friday in Abuja to congratulate Wike on his […]

Weather for Abuja

[forecast]

RSS Vanguard News

  • Brazil’s Bolsonaro: God made me president
    President Jair Bolsonaro said on Friday God, a fellow Brazilian, had handed him the election victory that propelled him to office in South America’s largest economy. “I never imagined that I’d be president. No one gave us victory, but I think it was God’s will. He saved my life first, then he gave me that […]
  • Kenya’s police arrest suspects with 73kg of ivory
    Kenyan officers on Friday reported that two suspects had been nabbed with ten pieces of ivory weighing 73 kilograms, valued at 7.3 million shillings (73,000 U.S. dollars) in Samburu village, Kwale. The two, Charles Mweni, 32, and Tabitha Mueni 43 were arrested by Kenya’s Directorate of Criminal Investigations (DCI) officers on Thursday. The operation was […]
  • Benin City APC rally: l stayed away on my own volition ― Oshiomhole
    The National Chairman of the All Progressive Congress (APC), Adams Oshimhole, has revealed that it was on his own volition that he stayed away from the rally in Benin City, the Edo State capital. Oshiomhole explained that he did not want the enemies of the party to take advantage of the situation to cause mayhem […]

© 2019 Nigeria Newsline. All Rights Reserved. Log in -