The trial will assess the improvement of stress urinary incontinence in women with Viveve’s cryogen-cooled monopolar radiofrequency technology
This trial is to assess the improvement of stress urinary incontinence (SUI) in women with Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) technology.
CMRF provides uniformly delivered volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single in-office session. In this case, the technology is being used to improve urine leakage and quality of life for the patients.
“The results of LIBERATE-International, if successful, could support multiple international clearances for use of our CMRF technology in the treatment of SUI around the world, including Health Canada and CE Mark clearances, among others,” Scott Durbin, CEO of Viveve, said in the press release.
The first-subject-first-visit has now been completed under an approved Investigational Testing Application with the Canadian Ministry of Health and central investigational review board approval.
The primary efficacy endpoint is the mean change from baseline in the standardized one-hour pad weight test at six months post-treatment, recommended by the US Food and Drug Administration (FDA).
This test is taking place in Canada at up to 10 study sites, and the plan is to enroll about 100 participants in the randomized, double-blinded and sham-controlled trial. The Liberate-International is one of two planned trials for the improvement of SUI.
The company is preparing for an Investigational Device Exemption (IDE) application submission to the FDA for the US version of this trial, Liberate-US. Viveve plans to submit this application in Q3 2018.
The results of these studies could support marketing applications in the US and additional countries around the world for this commercial indication.
The other international clearances that Durbin was referring to are for vaginal laxity and/or improved sexual function indications in over 50 countries. In Q2 2018, Viveve commenced another trial, Viveve 2, to assess the improvement of sexual function in women following childbirth following an IDE application approval from the FDA.
Currently the Viveve System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis.
Viveve is a women’s intimate health company focused on advancing new solutions to improve women’s overall wellbeing and quality of life. The company has also received regulatory clearance in Argentina for the improvement of urinary incontinence.
As of market close on Tuesday, Viveve’s share price had increased 7.5 percent to US$3.01.
Analyst consensus on TipRanks indicates that shares of the company could reach a high of US$9, or a low of US$4 over a six-month period. Viveve has three updated notes from investors, according to TipRanks, all with reiterated “buy” targets.
For investors wanting to stay updated on events, including the IDE application submission and approval, check the company’s site for further news.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.