Viveve Medical (VIVE) Announces Authorization to Initiate Short-Term Feasibility Study in Stress Urinary Incontinence from Canadian Ministry of Health
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Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve's cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women.
"Our prior clinical research indicates that our advanced CMRF technology could play an important role in the treatment of SUI for millions of women around the world. We are pleased to have received approval from Health Canada to initiate a short-term SUI feasibility study and our outstanding team of investigators and trial sites are positioned to move forward rapidly," said Scott Durbin, Viveve's chief executive officer and director. "This trial represents a significant advance in our strategy to pursue label expansions for Viveve's CMRF technology to maximize the commercial potential of our platform."
In August 2019, Viveve presented results from the LIBERATE-International SUI clinical trial comparing use of the Viveve Treatment (cryogen cooling and 90 Joules/cm2 RF energy) to use of cryogen-only treatment (cryogen cooling with only 1 Joule/cm2 RF energy, identified in the study as "sham treatment") for improvement of SUI in women. Results from this trial showed that both treatments had a clinically meaningful effect on objective and subjective outcomes in patients, although the treatment effects were not statistically different from each other.
"The results from our LIBERATE-International trial provided us with many essential insights indicating the potential efficacy benefits of Viveve's CMRF technology in the treatment of mild to moderate SUI in women and enabled us to determine the optimal path forward for this development program. We look forward to working with our team of investigators to complete this trial in the coming months," Mr. Durbin added.
Pending Investigational Review Board approvals of the ITA cleared SUI treatment protocol, the Company anticipates rapid study initiation and subject enrollment with a potential data readout in the second quarter of 2020. If the results are positive, showing a definitive difference between the study arms, the Company intends to resubmit its pending Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for approval to conduct the LIBERATE-U.S. trial for improvement of mild to moderate SUI in women. SUI is a condition that affects an estimated 25-30 million women worldwide.
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