Healthcare Industry News: Neurostimulator
News Release - March 2, 2022
Valencia Technologies Announces FDA Approval of eCoin(R) Therapy to Treat Urinary Urge IncontinenceeCoinŽ Pivotal Trial Results Published in the Journal of Urology
VALENCIA, Calif., March 2, 2022 -- (Healthcare Sales & Marketing Network) -- 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 eCoinŽ 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 eCoinŽ pivotal trial. The company also announced the publication of these results in the Journal of UrologyŽ, the official journal of the American Urological Association.
"This is a landmark approval for physicians and UUI patients as eCoinŽ is now the first and only implantable tibial nerve stimulator approved by the FDA," shared Jeff Greiner, Founder of Valencia. "eCoinŽ 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 eCoinŽ will enable more patients to achieve the help they desperately need."
The revolutionary design of the eCoinŽ 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 eCoinŽ 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 eCoinŽ 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 eCoinŽ 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 eCoinŽ 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 eCoinŽ was based upon results from the pivotal trial which followed 133 women and men in the United States who were implanted with eCoinŽ. 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 eCoinŽ therapy to friends or family.
"eCoinŽ is neuromodulation for the masses", stated Dr. Scott MacDiarmid, Investigator in the feasibility and pivotal trials of the eCoinŽ device. "Being the first leadless Neurostimulator for bladder control is groundbreaking and paves the way for further applications."
The company expects to launch eCoinŽ commercially in March of 2022 with physician training beginning in April of 2022. Physicians interested in offering eCoinŽ therapy to their patients may register for eCoinŽ Physician Certification online using the eCoinŽ 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
Valencia Technologies Corporation ("Valencia") is a private medical technology company located in Valencia, California. The company designed and manufactured its eCoinŽ device for the treatment of urinary urge incontinence (UUI). Learn more about Valencia at www.valenciatechnologies.com or the eCoinŽ device at www.eCoin.us.
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.
Source: Valencia Technologies
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