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.
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 :
- 73% of participants were considered responders, and reported a greater than or equal to 50% improvement in UUI episodes compared to their baseline.
- 30% of participants were dry, experiencing a 100% improvement in UUI episodes.
- The implant was well tolerated with a benign safety profile and a low explant rate of 2.3% due to infection with no other significant adverse events.
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.
Valencia Technologies Corporation is a medical technology company located in Valencia, California. Valencia’s fully-implanted nickel-sized and shaped eCoin® Peripheral Neurostimulator delivers automated low-duty cycle stimulation to the tibial nerve. Implanted subcutaneously in an office or outpatient procedure under local anesthetic, the leadless system is a first-in-kind. eCoin® is approved for investigational use only.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Valencia undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
 Data representative of patient-reported outcomes of 122 available patients