ENGLEWOOD, CO—(Marketwired – March 19, 2018) – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced it received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). The approval allows the company to conduct the VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the ViveveÂ® System for the improvement of sexual function in women following vaginal childbirth.
“The approval of our IDE enabling Viveve to proceed with the VIVEVE II clinical study is a major advancement in our global commercialization strategy and positions our CMRF (cryogen–cooled, monopolar radiofrequency) technology for a broader range of applications in women's intimate health. The initiation of this study, which is expected to occur in the second quarter of 2018, underscores our continued commitment to conducting high–quality, scientific and clinical research, as demonstrated by our previous randomized, blinded and sham–controlled VIVEVE I clinical study, and by our planned randomized, blinded and sham–controlled LIBERATE studies in the U.S. and Canada for the treatment of stress urinary incontinence,” said Patricia Scheller, chief executive officer and director of Viveve. “We believe that VIVEVE II, if successful, will clinically demonstrate that a single treatment with the ViveveÂ® System provides significant benefits to women suffering from diminished sexual function following vaginal childbirth and may support a marketing application for an expanded U.S. indication for the improvement of sexual function.”
VIVEVE II – VIveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy
The VIVEVE II clinical study is a randomized, double–blinded, and sham–controlled trial with a planned enrollment of approximately 250 patients at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments.
A staged approach, or roll–in, for clinical enrollment has been required by the FDA in its IDE approval letter to the company. In the first stage, enrollment is limited to 50 subjects. The roll–in will require safety review by the FDA of a minimum of 25 subjects, one–month post–treatment. Following the roll–in, an IDE Supplement will be submitted to the agency to expand the study up to its intended 250 patients. While the safety data from the initial 25 patients are being reviewed by the FDA, Viveve will continue to enroll up to an additional 25 patients (total of 50 patients enrolled).
The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI (Female Sexual Function Index) at 12 months, following the submission of an IDE supplement. Patients will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints, including various endpoints measured at 6 months post–treatment. Initiation of the VIVEVE II study is anticipated to begin in the second quarter of 2018, pending Institutional Review Board approvals at the selected clinical sites.
Additional information regarding the trial design will be available on clinicaltrials.gov.
Ms. Scheller continued, “Viveve has worked closely with the FDA in the review process and appreciates the thorough review that the Agency has conducted. If the planned VIVEVE II study is successful, we believe it will show that Viveve's CMRF technology can provide a safe and effective, single treatment option to improve sexual function after childbirth.”
Viveve Medical, Inc. is a women's intimate health company passionately committed to advancing new solutions to improve women's overall well–being and quality of life. The internationally patented ViveveÂ® System, that delivers the GENEVEVEâ¢ treatment, incorporates clinically–proven cryogen–cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single, 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. Viveve received approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018 to proceed with VIVEVE II, a multicenter, randomized, double–blind, sham–controlled study to assess improvement of sexual function in women following childbirth. Initiation of the trial is expected to begin in the second quarter of 2018 and if successful, could support a marketing application for a new US commercial indication. Currently, in the United States, the ViveveÂ® System is cleared by the FDA for use in 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 that 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.