Main milestone achieved in Firm’s advance towards a brand new U.S. SUI indication
ENGLEWOOD, CO / ACCESSWIRE / December 14, 2021 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical expertise firm centered on girls’s intimate well being, introduced right now that it has accomplished enrollment in its pivotal PURSUIT medical trial to evaluate the efficacy and security of the Viveve process within the therapy of stress urinary incontinence (SUI) in girls. Constructive outcomes from the extremely powered research might assist an FDA approval for a brand new indication for Viveve’s dual-energy, noninvasive, single session therapy within the U.S.
“We’re very happy to have accomplished enrollment in our landmark PURSUIT trial, which represents a serious milestone and one other instance of our progress in advancing this essential medical program. The research has absolutely enrolled our goal of 390 sufferers who met our inclusion standards. Affected person choice standards within the PURSUIT trial is designed to supply us with the clear and sturdy knowledge we have to consider a future regulatory submitting,” stated Scott Durbin, Viveve’s chief govt officer.
“We look ahead to efficiently finishing the affected person follow-up visits over the subsequent 12 months and to releasing topline outcomes, anticipated on the finish of 2022. If constructive, we anticipate submitting our advertising software for FDA approval shortly thereafter.” He concluded, “Now we have a excessive degree of confidence within the power of the PURSUIT research design and in our skill to execute our technique to place this revolutionary expertise for the ultimate phases of regulatory evaluate with the potential to deliver a confirmed protected and efficient therapy choice to the hundreds of thousands of girls dwelling with SUI within the U.S.”
U.S. PURSUIT Trial
PURSUIT is a randomized, double-blinded, sham-controlled trial with focused enrollment of 390 topics with reasonable SUI (≥ 10ml – 50ml urine leakage on the 1-hour Pad Weight Take a look at) at roughly 30 research websites within the U.S.
The first efficacy endpoint is a comparability of the proportion of sufferers who expertise larger than a 50% discount in urine leakage in comparison with baseline on the standardized 1-hour Pad Weight Take a look at at 12 months post-treatment versus the inert sham process. The research additionally contains a number of secondary endpoints, together with: proportion of sufferers who expertise a larger than 50% discount in urine leakage on the standardized 1-hour Pad Weight Take a look at at three and 6 months post-treatment; proportion change from baseline within the 1-hour Pad Weight Take a look at at three, six, and 12 months; p.c of topics with no incontinence episodes at three, six, and 12 months post-treatment as assessed with the three-day bladder voiding diary; and alter from baseline within the MESA Questionnaire (Medical, Epidemiologic and Social Points of Growing older), Incontinence High quality of Life (I-QOL), Affected person World Impression of Enchancment (PGI-1) Questionnaire, and Worldwide Session on Incontinence Modular Questionnaire-Urinary Incontinence Brief Type (ICIQ-UI-SF) at three, six, and 9 months post-treatment. Topic security will likely be monitored all through the research.
Stress Urinary Incontinence
Urinary incontinence is a lack of bladder management, typically resulting in uncontrollable urine leakage. This situation is usually seen in girls and older adults. One in three girls experiences urinary incontinence, of which SUI is the commonest type. Prevalence knowledge counsel that 14 million girls within the U.S. alone undergo every day from SUI episodes that may be related to causes together with coughing, sneezing, laughing, train, or vaginal childbirth.
About Viveve
Viveve Medical, Inc. is a medical expertise firm centered on girls’s intimate well being. Viveve is dedicated to advancing new options to enhance girls’s general well-being and high quality of life. The internationally patented Viveve System incorporates CMRF expertise to uniformly ship volumetric heating whereas gently cooling floor tissue to generate neocollagenesis in a single in-office session. Within the U.S., the Viveve® System is cleared by the Meals and Drug Administration (FDA) to be used normally surgical procedures for electrocoagulation and hemostasis. Worldwide regulatory approvals and clearances have been acquired for vaginal laxity and/or enchancment in sexual operate indications in 50 international locations.
For extra info go to www.viveve.com.
Secure Harbor Assertion
All statements on this press launch that aren’t based mostly on historic reality are “forward-looking statements” inside the which means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934. Whereas administration has based mostly any forward-looking statements included on this press launch on its present expectations, the knowledge on which such expectations have been based mostly could change. These forward-looking statements depend on a variety of assumptions regarding future occasions and are topic to a variety of dangers, uncertainties, and different elements, a lot of that are outdoors of our management, which might trigger precise outcomes to materially differ from such statements. Such dangers, uncertainties and different elements embody, however should not restricted to, the fluctuation of worldwide financial situations, the impression of the novel coronavirus termed COVID-19 on our medical growth and regulatory evaluate and clearances and on the manufacturing, placements and affected person utilization of our Viveve Techniques, the efficiency of administration and our workers, our skill to acquire financing, our analysis of strategic options, our skill to acquire approval or clearance on the market of our medical system for all indications sought, competitors, common financial situations and different elements which might be detailed in our periodic and present studies obtainable for evaluate at www.sec.gov. Moreover, we function in a extremely aggressive and quickly altering atmosphere the place new and unanticipated dangers could come up. Accordingly, buyers shouldn’t place any reliance on forward-looking statements as a prediction of precise outcomes. We disclaim any intention to, and undertake no obligation to, replace or revise forward-looking statements to mirror occasions or circumstances that subsequently happen or of which we hereafter turn into conscious, until required by regulation.
Viveve is a registered trademark of Viveve, Inc.
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SOURCE: Viveve Medical, Inc.
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