Valencia Technologies Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin ® leadless tibial neurostimulator for the treatment of urinary incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB).
eCoin® Pivotal Trial Results Published in the Journal of Urology |
| [02-March-2022] |
| VALENCIA, Calif., March 2, 2022 /PRNewswire/ -- Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin® pivotal trial. The company also announced the publication of these results in the Journal of Urology®, the official journal of the American Urological Association.
eCoin® is a nickel-sized neurostimulator which is implanted subcutaneously in the lower leg during a minimally invasive, outpatient procedure utilizing a local anesthetic. eCoin® is the first implantable tibial nerve stimulator approved by the FDA. The eCoin® device contains a primary battery and once programmed, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms. The device does not require ongoing patient management of a power source or a stepped programmer. The therapy is clinically different from more invasive sacral neuromodulation surgery which typically requires general anesthesia after a testing period as well as ongoing patient device management. “This is a landmark approval for physicians and UUI patients as eCoin® is now the first and only implantable tibial nerve stimulator approved by the FDA,” shared Jeff Greiner, Founder of Valencia. “eCoin® will facilitate a paradigm shift for UUI treatments by offering physicians an efficient option for implantation with high patient satisfaction. The simplicity and effectiveness of eCoin® will enable more patients to achieve the help they desperately need.” The revolutionary design of the eCoin® implantable device is leadless, meaning there are no fragile wires that need to be precisely tunneled to reach the intended nerve for therapy. Instead, the eCoin® device is implanted just above the ankle over the tibial nerve and its forgiving, dome-shaped stimulation field delivers regular stimulation to the nerve to calm the bladder and provide relief from bladder leakage. “Beyond delivering impressive results achieved without the need for prior screening, the eCoin® procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner,” said Dr. Rebecca McCrery, an Investigator in the eCoin® pivotal trial. “Under 5% of OAB patients select burdensome third line interventions due to invasiveness or potential side effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin® neuromodulation therapy will potentially better treat the vast population – often desperate for relief – who are not well managed by the current options available to them.” The PMA application for eCoin® was based upon results from the pivotal trial which followed 133 women and men in the United States who were implanted with eCoin®. In the per protocol population, 75% of patients responded with at least a 50% reduction in Urinary Urge Incontinence (UUI) episodes. There was no trial or screen prior to implantation. 81% of patients responded that they felt “better” to “very much better” one year post procedure. Per the publication, implanted patients reported an excellent experience, with 97% stating that the procedure was adequately explained to them and 89% stating that they would recommend eCoin® therapy to friends or family. “eCoin® is neuromodulation for the masses”, stated Dr. Scott MacDiarmid, Investigator in the feasibility and pivotal trials of the eCoin® device. “Being the first leadless neurostimulator for bladder control is groundbreaking and paves the way for further applications.” The company expects to launch eCoin® commercially in March of 2022 with physician training beginning in April of 2022. Physicians interested in offering eCoin® therapy to their patients may register for eCoin® Physician Certification online using the eCoin® physician website at professionals.eCoin.us Patients are encouraged to visit Valencia’s patient website at www.eCoin.us for more information about this novel therapy for UUI. About Valencia Technologies Corporation Forward-looking Statements Media Contact Investor Contact
SOURCE Valencia Technologies Corporation |
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