Valencia Technologies Announces Best in Category Prize for OAB at the ICS 2020 Meeting for the eCoin® Peripheral Neurostimulator
VALENCIA, Calif., Nov. 23, 2020 /PRNewswire/ -- Valencia Technologies Corporation ("Valencia"), a private medical device company, today announced the presentation of positive results from their pivotal study, as well as the award for Best in Category Prize for Overactive Bladder (OAB) at the International Continence Society (ICS) 2020 meeting. This is the second year in a row Valencia's eCoin studies have received this designation from ICS after the 12-month feasibility eCoin data received this award in 2019. This is the second year in a row Valencia's eCoin studies have received this designation from ICS.
Pivotal study results were presented by Dr. Alex Rogers, MD on November 19 at the International Continence Society (ICS) 2020 meeting during the Best Urology Virtual Program. The prospective, multi-center, single-arm study of the safety and effectiveness of the eCoin peripheral neurostimulator showed clinically significant improvements. The study, intended to support Food and Drug Administration (FDA) approval of the eCoin device, enrolled 133 subjects with urgency urinary incontinence. All available data was presented and the protocol did not include a trial of the therapy prior to eCoin implantation. The Best in Category Prize for Overactive Bladder (OAB) award recognizes the presentation, titled "Pivotal study of subcutaneous tibial nerve stimulation with coin-sized implantable tibial neurostimulator (eCoin® device) for urinary urge incontinence (UUI)," which summarized the 36-week outcomes showing that patients enrolled in the study received clinically meaningful and statistically significant improvements in both UUI and quality of life symptoms. Data Highlights at 36-weeks [1]:
Alexandra Rogers, MD, an investigator in the trial, commented, "From an implanter standpoint, the eCoin® device offers a forgiving electrical field delivered with a brief reproducible procedure that eliminates many of the inherent issues of current burdensome and/or undesirable OAB therapies such as compliance, invasiveness, immodesty or pain that leave many frustrated patients untreated." Chief of Clinical and Regulatory for Valencia Technologies, Stacy Chambliss shared, "We are more than pleased with the exceptional pivotal clinical results produced without a screening test and by physicians new to the procedure demonstrating their competence and supporting enthusiasm for incorporating eCoin into their practices." In August 2020, a Pre-Market Approval (PMA) application was accepted by the FDA for review and Valencia expects approval as early as the first half of 2021. About Valencia Forward-looking Statements Contact: [1] Data representative of patient-reported outcomes of 122 available patients View original content to download multimedia:http://www.prnewswire.com/news-releases/valencia-technologies-announces-best-in-category-prize-for-oab-at-the-ics-2020-meeting-for-the-ecoin-peripheral-neurostimulator-301178645.html SOURCE Valencia Technologies Corporation |