LOS ANGELES, Nov. 1, 2018 /PRNewswire/ -- Last week, The Journal of Urology published the feasibility data of Valencia Technologies' ("Valencia") eCoin™ device indicated for treatment of overactive bladder. The manuscript, "Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence," details the design of Valencia's 46 patient study and the study's excellent clinical results. The manuscript has an embargo date of February 15, 2019.
Implanted in a 20-minute office procedure across seven clinical centers in the United States and New Zealand, the coin-sized and shaped tibial nerve stimulator is distinctly simple to implant in stark contrast to a highly invasive and operator dependent therapy called sacral nerve stimulation. An author of the eCoin™ publication, Dr. Vincent Lucente, concludes, "I believe tibial nerve stimulation with eCoin™ will become the therapy of choice for patients after medications are tried. These early results clearly show a better therapy is on the horizon for patients with urinary incontinence."
Having its own battery, eCoin™ is the only fully-implanted tibial nerve stimulator. The other technologies—all in clinical trials—power their implants from outside of the body using external devices worn on the ankle to administer the therapy.
The published data shows a 70% responder rate at the three month primary endpoint; that is, 70% of all patients were 50% or better in their urgency urinary incontinence (UUI) symptoms. Furthermore, 22% of patients were dry, no longer experiencing UUI, and the results were durable through 6 months. Data was presented in the intention to treat population where all eligible and consented patients were included in both safety and efficacy analyses.
The lead author and investigator, Dr. Scott MacDiarmid, says of the new therapy, "These results are more than encouraging. It appears that eCoin™ delivers similar efficacy to the other treatments without the side effects of drugs or Botox, without the invasiveness of sacral nerve stimulation, and without the patient compliance issues of percutaneous tibial nerve stimulation."
Valencia Technologies Corporation is a medical technology company located in Valencia, California. Valencia's fully-implanted nickel-sized and shaped neurostimulator is implanted in a 20-minute office procedure under local anesthetic. The Company's pivotal trial intended to support a pre-market approval application is now underway.