VALENCIA, Calif., May 2, 2024 /PRNewswire/ — Valencia Technologies is pleased to announce that implantable tibial nerve stimulation (ITNS) has been acknowledged as a minimally invasive OAB treatment option in the recently updated American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) clinical practice Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder (2024). The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB. The eCoin ITNS system commercialized in March 2022 has now been used to treat over 1,100 patients in the United States. This highlights the significant need for evolutionary treatment options to address the growing burden of a largely underserved OAB population.
Further, the updated AUA/SUFU OAB Guideline advocates a continuing evolvement from historical step treatment to a more progressive platform of physician and patient shared decision making, thereby allowing for a more patient-centric treatment approach.
“The updated AUA/SUFU Guideline shows a sophisticated appreciation for advancing physician and patient collaboration in this complicated disease state. The positioning of ITNS as a minimally invasive treatment option along the OAB care pathway coupled with our demonstrated, excellent clinical and commercial patient outcomes, ensures patients and providers will continue to have access to the low patient-burden eCoin treatment option.” said Jerry Schloffman, Valencia Technologies Chief Executive Officer. “Valencia Technologies is humbled and honored to have the opportunity to take a lead role in the implantable tibial nerve stimulation space.”
The eCoin® ITNS device is a fully integrated, coin-sized neurostimulator which is implanted subcutaneously above the fascia, in the lower leg during a minimally invasive, single-stage outpatient procedure requiring only local anesthetic. The eCoin® device contains a primary-cell battery that once activated, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms. The fully, self-contained eCoin device provides patients with automatic treatment without the need for external components like chargers, batteries, cables, remotes, or apps.
The eCoin system received FDA premarket approval (PMA) in March 2022 for the treatment of urge urinary incontinence (UUI) and is currently available throughout the United States. According to the Urology Care Foundation, UUI is the most bothersome symptom associated with OAB syndrome, and most patients afflicted with this chronic condition remain untreated which often dramatically impairs overall health and quality of life.¹
Physicians interested in offering eCoin® therapy to their patients may register for the eCoin® Physician Qualification training program 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.
Forward-looking Statements
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.
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The eCoin Peripheral Neurostimulator (“eCoin”) is part of the eCoin Peripheral Neurostimulator System (“eCoin System”) including device accessories. Indications: The eCoin is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
